Hemi-arthroplasty implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.

Device Description

The 7.0mm MTP Taper Post is a reduced length and diameter version of the sponsor's previously cleared and commercially marketed 8.0mm Taper Post, but is otherwise identical.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared device, rather than proving the device meets specific acceptance criteria through a study with the features requested in the prompt.

Therefore, the information requested in your prompt (specific acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information) is not present in the provided document.

Here's why and what the document does provide:

Acceptance Criteria and Reported Device Performance: This document states the new device (Contoured Articular Prosthetic (CAP) ™ 7.0mm MTP Resurfacing Hemi-arthroplasty) is "substantially equivalent" to a previously cleared device (K031859 Toe joint phalangeal (hemi-toe) polymer prosthesis, Arthrosurface, Inc.). It explicitly states: "The intended use, materials, design features and application of the Proposed Device are substantially equivalent to the sponsor's previously cleared and commercially marketed device (K031859 Toe joint phalangeal (hemi-toe) polymer prosthesis, Arthrosurface, Inc.)." and "The fundamental scientific technology of the proposed device has not changed relative to the predicate device."
- Implication: For a 510(k), the "acceptance criteria" isn't a set of performance metrics for a clinical study comparing the new device to a standard. Instead, the acceptance criterion is that the new device is as safe and effective as the predicate device. The "reported device performance" is the assertion of substantial equivalence due to the similarity in design, materials, and intended use.
Sample Size, Data Provenance, Number of Experts, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth, Training Set Size, Training Set Ground Truth: None of these details are provided because a 510(k) submission primarily relies on comparing the new device's characteristics to a predicate device, not on new clinical studies or AI algorithm performance tests. The device described is a physical implant, not an AI/ML-driven diagnostic tool.

In summary, the provided document does not contain the information you requested about acceptance criteria and a study proving their fulfillment because it's a 510(k) premarket notification for a medical implant, which demonstrates substantial equivalence to an existing device rather than presenting new quantitative performance data in the manner you've outlined for an AI/ML diagnostic.

Summary

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K063370 p qe 'f²

510(k) Owner:	Arthrosurface, Inc.28 Forge ParkwayFranklin, MA 02038
Tel:	508.520.3003
Fax:	508.528.4604

JAN 12 2007

Contact:	Dawn WilsonDirector, Quality Systems
Date of Preparation:	October 18, 2006
Trade Name:	Contoured Articular Prosthetic (CAP) ™7.0mm MTP Resurfacing Hemi-arthroplasty
Common Name:	7.0mm MTP Resurfacing Prosthesis
Device:	Prosthesis, Toe, Hemi-, Phalangeal
Classification Regulation:	Regulation Number 888.3730
Device Class:	Class II
Review Panel:	Orthopedic
Product Code:	KWD

Device Intended Use

Device Description

The 7.0mm MTP Taper Post is a reduced length and diameter version of the sponsor's previously cleared and commercially marketed 8.0mm Taper Post, but is otherwise identical.

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000015

Substantial Equivalency:

The intended use, materials, design features and application of the Proposed Device are substantially equivalent to the sponsor's previously cleared and commercially marketed device (K031859 Toe joint phalangeal (hemi-toe) polymer prosthesis, Arthrosurface, Inc.).

The fundamental scientific technology of the proposed device has not changed relative to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle-like bird with three stylized stripes forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Arthrosurface, Inc. % Ms. Dawn Wilson Director, Quality Systems 28 Forge Parkway Franklin, Massachusetts 02038

JAN 1 2 2007

Re: K063370

Trade/Device Name: Contoured Articular Prosthetic CAP™ 7.0mm MTP Resurfacing Hemi-arthroplasty Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: II Product Code: KWD Dated: November 2, 2006 Received: November 13, 2006

Dear Ms. Wilson:

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 udications for use stated in the enclosure) to legally marketed predicate devices marketed in internate 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 Fedral Food, Or us, 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 misbaandijng 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, TDA 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 proctice 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.

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Page 2 - Ms. Dawn Wilson

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), please contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara fuchund

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ Kob 3370

Device Name:

Contoured Articular Prosithetic (CAP) ™ 7.0mm MTP Resurfacing Hemi-arthroplasty

Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Brichum

Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K063370 000013

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.