GREAT TOE IMPLANT by SIGNAL MEDICAL CORP.

The Signal Medical Corporation Great Toe Implants are manufactured from ASTM F75 Cobalt Chrome. The porus coating is ASTM F75 sintered beads, -45+60 mesh. The device is intended for non-cemented use. The stem of the device is intended to be inserted into the proximal end or base of the first phalangel bone. The convex surface of the implant is intended to articulate with the distal end or head of the first metatarsal bone. The design is made available in multiple sizes equivalent to the toe implants in the Townley Great Toe Joint 510K (K911378) and the Zimmer Great Toe 510K (K823405).

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets them.

The document is a 510(k) summary and an FDA clearance letter for the Signal Medical Corporation Great Toe Implants. It focuses on:

Device Description: What the device is made of and its general function.
Intended Use/Indications for Use: What the device is for (osteoarthritis, when conservative procedures fail).
Substantial Equivalence: The FDA's determination that this device is substantially equivalent to previously marketed predicate devices (Townley Great Toe Joint 510K (K911378) and Zimmer Great Toe 510K (K823405)). This is the core of a 510(k) submission, confirming that a new device is as safe and effective as a legally marketed one without requiring new clinical trials or extensive performance testing if the predicate device itself didn't necessitate them.
Regulatory Information: FDA regulations, general controls, and contact information.

This type of submission typically relies on comparison to predicate devices, material testing, and sometimes bench testing, rather than extensive clinical studies with specified acceptance criteria as would be found in a Premarket Approval (PMA) application or a more complex medical device.

Therefore, I cannot provide the requested table or answer the questions related to acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment because this information is not present in the given text.

Summary

{0}------------------------------------------------

JUL 1 2002

K021063

page loft

510K SUMMARY OF SAFETY AND EFFECTIVENESS

Indications for use

Osteoarthritis .

Where the use of a more conservative procedure has failed or is unacceptable.

Contact Information

If further information is required please contact Dr. Louis Serafin, Signal Medical Corporation, 3777 Lapper Road Suite 3C, Port Huron, Michigan 48060, phone (810) 966-3917.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 2002 JUL

Louis A. Serafin, Jr., M.D. Signal Medical Corporation 3777 Lapeer Road. Suite 3C Port Huron, Michigan 48060

Re: K021063

Trade/Device Name: Great Toe Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: Class II Product Code: KWD Dated: March 19, 2002 Received: April 2, 2002

Dear Dr. Serafin, Jr .:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{2}------------------------------------------------

Page 2 - Dr. Louis A. Serafin

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Stipt Rhodes

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

Enclosure

{3}------------------------------------------------

Page i of 1

510(k) Number (if known):__________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Osteoarthritis

Where the use of a more conservative procedure has
failed or is unacceptable failed or is unacceptable.

The device is intended for non-cemented use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stupt Rurly

Division of General, Restorative and Neurological Devices Over-The-Counter Use___ 510(k) Number (Optional Formal 1-2-96)

Prescription Use_ (Per 21 CFR 801.109)

Regulation Number and Section

§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.

(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.