Talk:Theradome

FDA "approval"

The type of "approval" this device received has nothing to do with its effectiveness. It only means that this device is similar to devices in use before the FDA was formed. Talking about the FDA implies something about effectiveness that is not true. — rsjaffe 🗣️ 21:35, 28 January 2023 (UTC)

I am following guidelines of using citations to support my statements. The FDA letters and article say the product was cleared. That is all I am saying, if you can suggest a better verbiage, please go ahead and suggest it for discussion, but why remove the whole sentence??? AndoKleer (talk) 21:39, 28 January 2023 (UTC)

Because it is not relevant to understanding the product and is often used as a marketing technique: pulling the FDA in as if that meant something good about the product. All it means is that the product probably won't kill someone or harm them. It's like saying a cosmetic was "approved" by the FDA when all that happened was it was determined that the product included authorized substances. Also, the reference to "women only" appears to be incorrect, though I'd have to look at it again.

Probably the best term would be that the "product was marketed beginning in 19xx" and use the FDA approval as the evidence of that. — rsjaffe 🗣️ 21:45, 28 January 2023 (UTC)

BTW, I dont want you to think I reverted your edits a second time, you just happened to revert while I was making another edit, so your revert got reverted. I dont want to go to edit wars, so I will not revert until we have a resolution. FDA Cleared simply means it passed safety and effecacy. I never stated anything about its effectives and never implied that. I am simply posting what the articles state and what FDA letter says. You seem to be a more experienced editor than I am, but not an admin. However, you still cannot bully people for your own feelings. Please share with me specific Wikipedia guidelines regarding this issue, otherwise you cannot just decide on your own that this cannot be posted. You use wikipedia guidelines, so if you can share with how you come up with what you said from specific Wikipedia guidelines regarding FDA verbiage, then there should be no issue. AndoKleer (talk) 21:52, 28 January 2023 (UTC)

I'm not trying to bully. I reverted and said to see talk page and placed it here. You then reverted without referring to talk page, which is why I used exclamation marks when saying talk page.

The FDA clearance has nothing to do with adequacy. That's an important distinction that I'm trying to make. Devices like this are cleared under criteria that show it's similar to older devices. Also, FDA typically does not clear a device only for women, which makes that reference suspect. The first reference used to say it's cleared for females is a quote from the manufacturer, so is a primary source, and not useful. The second is simply a list of references. I figured out from there where the actual approval letter is: https://www.accessdata.fda.gov/cdrh_docs/pdf12/K122950.pdf .

Claims about effectiveness are restricted by WP:MEDRS, which are stricter criteria than used in non-medical articles. That's why I'm being very careful about the wording here.

In any event, the wording cannot imply anything about effectiveness or usefulness, as there is nothing that meets WP:MEDRS for this device that would allow that. — rsjaffe 🗣️ 22:05, 28 January 2023 (UTC)

Please check this article https://www.druganddevicelawblog.com/2018/06/california-district-court-rules-that-510k-clearance-relates-to-safety-and-effectiveness.html

So the correct word is "CLEARED" and that is what I used. Maybe you can suggest a revision and comprise, so that it explains that this about its "Safety and Effectiveness" AndoKleer (talk) 22:08, 28 January 2023 (UTC)

Also I meant "efficacy" not "adequacy" that was a typo....I have revised it. AndoKleer (talk) 22:11, 28 January 2023 (UTC)

I found several articles that have used "FDA Cleared" without any issues, so I think you are totally wrong that this cannot be used. You yourself provide the actual citation from FDA, so it cannot be argued that it is not reliable.

Da Vinci Surgical System

Pulsed electromagnetic field therapy

Withings

Alivecor

Polyether ether ketone

Bacteriophage

Mucositis

Medline Industries

So what I suggest that if you still are not agreeing, we post a message to the admins to review articles using "FDA Cleared" verbiage and clarify if it can be used or not. AndoKleer (talk) 22:19, 28 January 2023 (UTC)

Admins do not decide content, we do. - Roxy the dog 22:44, 28 January 2023 (UTC)

Cleared is fine, but effective is not. I went back through the antecedent devices (each antecedent device has its own) and never got to one that had effectiveness demonstration as a criterion. Again, what I'm trying to avoid is to imply that this item is effective at hair restoration. The manufacturer failed to report on its FDA-registered study, which is a no-no (but often happens), so it is appropriate to have significant reservations about it. — rsjaffe 🗣️ 22:53, 28 January 2023 (UTC)

What I suggest, and am going to do (since it means reverting my edit to restore your edit) is go back to your last edit. I think that doesn't include any efficacy language and is fairly neutral. — rsjaffe 🗣️ 22:56, 28 January 2023 (UTC)

I'm uncomfortable with the part about being cleared only for women, as I'm not sure that's well-backed by secondary or reliable primary references, but leaving it for now. It's not such a big deal that it has to be corrected immediately. — rsjaffe 🗣️ 22:59, 28 January 2023 (UTC)