VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART by CONMED CORP.

I am sorry, but the provided text from the FDA letter and attachment does not contain information regarding the acceptance criteria for a medical device and the study that proves the device meets those criteria. The documents are a formal FDA communication about a 510(k) clearance for the ConMed™ VersaStim Neuromuscular Stimulator/TENS and its electrodes.

Specifically, the documents include:

A letter granting 510(k) clearance, indicating the device is substantially equivalent to legally marketed devices.
Information about regulatory requirements and general controls.
An "Indications for Use" statement for the device.

There is no mention of:

Specific acceptance criteria (e.g., performance metrics, thresholds).
A study design or methodology.
Sample sizes for test or training sets.
Data provenance.
Details about expert ground truth establishment or adjudication.
Multi-Reader Multi-Case (MRMC) studies or their outcomes.
Standalone algorithm performance.
Type of ground truth used (pathology, expert consensus, etc.).

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, or details about a study, as this information is not present in the provided text.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 2004

Ira Duesler Director, RA/QA ConMed Corporation 525 French Road Utica. New York 13502

Re: K041953

Ko+1755
Trade/Device Name: ConMed™ VersaStim Neuromuscular Stimulator/TENS Regulation Number: 21 CFR §882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: July 19, 2004 Received: July 20, 2004

Dear Mr. Duesler:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectorn o ready fee device is substantially equivalent (for the indications felerenced above and nave determined in the enclicate devices marketed in interstate 101 use stated in the encrosare) to regars) to regars and the Medical Device Amendments, or to commerce provision to May 20, 1978, are excerdance with the provisions of the Federal Food, Drug, devices that have occh recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the rist labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it IT your device is elassified (500 a0070) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FD may oc subject to back adderal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advisou that I Dri bristian that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I odolar states and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (DF OFF Part 820); and if applicable, the electronic form in the quarty by evens (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ira Duesler

This letter will allow you to begin marketing your device as described in your Section 510(k)
The same of the Cases of a lot of a lot stick assisselesses of your device to a This letter will anow you to begin makemig your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, per premarket notification. The PDA midning of succement or your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
s and the may be and cases of the collection and any and on anython entitle If you desire specific advice for your de vice on on on on on any mease note the regulation entitled, would of the may obtain Comact the Office of Comphance at (301) vification" (21CFR Part 807.97). You may obtain " Misoranding by reletence to premarket to title active act from the Division of Small
other general information on your responsibilities under the Act from the (800) 638, 00 other general information on your responsion in the mander (800) 638-2041 or
Manufacturers, International and Consumer Assistance at the last demansman broke Manufacturers, International and Consultier Provisions Pages/cdrh/dsma/dsmamain.html

Sincerely yours,

L. Mark N. Milburn

Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ConMed Corporation Special 510(k) Application Attachment 2 Page 1 of 1 Revised August 5, 2004

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

ConMed Neuromuscular Stimulation/TENS Electrodes _____________________________________________________________________________________________________________________________ Device Name:

Indications For Use:

For TENS and Neuromuscular Stimulation

Prescription Use __ × (Part 21 CFR 801 Subpart D) and/or

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Mellauso

Division Sign-C Division of General, Restorative, and Neurological Devices

510(k) Number K041953

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).