884 karma · joined June 7, 2022
We all learn better together!
https://wcedmisten.fyi
wcedmisten@gmail.com
There's a 4GB option for 9 Euros.
I recently migrated my personal projects from DO to Hetzner for this reason
https://www.joelonsoftware.com/2002/06/12/strategy-letter-v/
Additionally, not having the data in a structured format prevents seeing overall trends in the data.
Basically this device was cleared through a DAG of other devices that were "substantially equivalent". I made a website to visualize these relationships, and any recalls that occurred in the parent devices. If anyone is curious about this particular device, see here [2]
[1] https://wcedmisten.fyi/post/medical-device-analysis/
[2] https://www.510k.fyi/devices/?id=K232380 (click on "Predicate ancestry graph")
[1]: Transport Map Layer https://www.openstreetmap.org/#map=15/42.3594/-71.1051&layer...
I wonder what goals of Americana the author feels are fallen short? [1]
> The purpose of the Americana project is to:
* Promote collaboration and shared purpose in the American mapping community
* Express the American experience through cartography, taking inspiration from the familiar features of North American paper maps
* Close technology gaps that impede the use of American cartographic principles. Where the technology to build our map doesn't exist, we will build it.
I was thinking it would be cool to make an app that helps you learn navigation. Maybe like a game to find your way to a given place, and you get hints if you're off track.
I thought an interesting visualization would be to see who owns the hospital "territory" in Virginia. I pulled all the hospitals from OpenStreetMap and calculated a voronoi diagram from the data to get regions that are closest to any given hospital. Then I color-coded these regions by the hospital network operator, to see how much competition a given area has.
[1]: https://kffhealthnews.org/news/article/ballad-health-er-wait...
Here’s an assignment for tonight, and I hope Ms. Lockwood will flunk you if you don’t do it: Write a six line poem, about anything, but rhymed. Make it as good as you possibly can. But don’t tell anybody what you’re doing. Don’t show it or recite it to anybody, not even your girlfriend or parents or whatever, or Ms. Lockwood. OK? Tear it up into teeny-weeny pieces, and discard them... You will find that you have already been gloriously rewarded for your poem. You have experienced becoming, learned a lot more about what’s inside you, and you have made your soul grow.
The irony of this on an article about how developers ignore users on low-performance mobile devices
Since the website is open source, there's even a github issue confirming this: https://github.com/FDA/openfda/issues/200
[1]: https://findthatmeme.com/blog/2023/01/08/image-stacks-and-ip...
My understanding is that with pharmaceuticals, new drugs must always go through clinical trials to prove safety and effectiveness before the FDA approves them for public use, so there's not really an equivalent to the 510(k) process for drugs.
Fig 2 [2] shows a graph of similarity of all devices to their predicate for each year.
However the discussion sections mentions difficulty with using Word2Vec because of the jargon used to describe these devices, so I'm not totally sure how to interpret the graph.
[1]: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8496833/
[2]: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8496833/figure/...
So even if the new device works as well as the predicate, that predicate might be equivalent to a whole chain of devices that have never gone through clinical trials.
This might be fine if the device is low risk, but the 510(k) process has a history of clearing devices that have resulted in patient deaths.
Of course it's a balance between too much red tape and having unsafe devices, I was just personally surprised at where the FDA draws the line today.
I believe the EU has a similar pathway (in the EU Medical Device Regulation) for new devices relying on equivalence to a predicate, but the requirements for demonstrating equivalence are a higher bar. Joint prostheses (like the one causing cobalt poisoning in the US) are not allowed through this process in the EU.
[1]: https://www.sciencedirect.com/science/article/pii/S002013832...
My concern is mostly around the class II devices cleared through this process, such as the recently recalled Philips CPAP machines, which resulted in 561 deaths. [1]
Philips also knew about complaints without informing the FDA. [2]
[1]: https://www.cbsnews.com/news/fda-sleep-apnea-philips-recall-...
[2]: https://www.propublica.org/article/philips-kept-warnings-abo...
That's a good point, I should probably add a disclaimer about what recalls mean in this context. Unfortunately I couldn't find a good way to determine whether the recall might be a systemic design issue that would affect other similar devices or something that can be remediated for an individual product, like a labeling issue.
I was also thinking of changing the color code based on the recall severity (class I, II, or III)
My goal for this project is to create a free/open source website that enhances this 510k data based on the public data dumps. I'd be very interested in hearing about how you use the current website for work, and what improvements would be useful for you! My email is in my about page.
The major enhancement is to show predicate device information as a first-class property of each 510k, since right now the data is buried inside various PDFs.
That's true, and I actually used that dump[1] and OCR to automate about 80% of this project. The manual data entry was only required for the 20% that couldn't be found automatically.
Since this was just to fill in the gaps, I figured there would be diminishing returns on re-implementing fuzzy search on the data, but adding shortcuts to my manual workflow took less time for a reasonable speedup.
[1] I also used the JSON dump of this data that the FDA provides here: https://open.fda.gov/apis/device/510k/download/