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 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 HemiCAP® MTP Resurfacing Hemi-Arthroplasty System-Phalangeal HemiCAP® incorporates an articular resurfacing component and a cancellous taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.

The enclosed phalangeal base HemiCAP® implant is intended for hemiarthroplasty only. Do not use in conjunction with metallic metatarsal implant.

The present device modification includes the addition of modified phalangeal base (concave) implants and a corresponding taper post to the existing system.

AI/ML Overview

This document pertains to the 510(k) premarket notification for the HemiCAP® MTP Resurfacing Hemi-Arthroplasty System. It describes a medical device, specifically a hemi-arthroplasty implant for the metatarsophalangeal joint. The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way this request is framed. This document, being an FDA 510(k) clearance letter, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria as might be expected for an AI/software device.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document describes:

Device Name: HemiCAP® MTP Resurfacing Hemi-Arthroplasty System
Intended Use: Hemi-Arthroplasty implant for the metatarsophalangeal joint for treatment of degenerative and post-traumatic arthritis in the metatarsal joint with good bone stock, hallux valgus or hallux rigidus, and unstable/painful MTP joint.
Device Description: Incorporates an articular resurfacing component and a cancellous taper post fixation component that mate via a taper interlock. The modification includes modified phalangeal base (concave) implants and a corresponding taper post.
Substantial Equivalence: The device is considered substantially equivalent to previously cleared predicate devices based on having the same Indications for Use, operating principle, manufacturing materials, shelf life, packaging, and sterilization processes.
Non-clinical Tests: Comparative Engineering Analyses and Comparative Mechanical Testing (Assembly and Disassembly Testing, Resistance to Torsion Testing, Cyclic Fatigue Testing, Fretting Corrosion Testing, Pull-out Strength Testing, Finite Element Analysis) were performed to demonstrate safety, effectiveness, and substantial equivalence.

Without a detailed clinical or performance study report, or specific quantifiable acceptance criteria for a software/AI device, I cannot fulfill the request for a table of acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert involvement.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 11, 2016

Arthrosurface, Incorporated Ms. Dawn Wilson VP, Quality & Regulatory 28 Forge Parkway Franklin, Massachusetts 02038

Re: K152454

Trade/Device Name: HemiCAP® MTP Resurfacing Hemi-Arthroplasty System Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: Class II Product Code: KWD Dated: March 10, 2016 Received: March 14, 2016

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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement Section 4

510(k) Number (if known): K152454

HemiCAP® MTP Resurfacing Hemi-Arthroplasty System Device Name:

Indications for Use:

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Section 5 510(k) Summary

HemiCAP® MTP Resurfacing Hemi-Arthroplasty System Phalangeal HemiCAP®

Special 510(k) Submission: Device Modification

510(k) Owner:	Arthrosurface, Inc.28 Forge ParkwayFranklin, MA 02038Tel: 508.520.3003Fax: 508.528.4604
Contact:	Dawn WilsonVP, Quality & RegulatoryTel: 508.520.3003Fax: 508.528.4604dwilson@arthrosurface.com
Establishment RegistrationNumber:	3004154314
Date of Preparation:	March 30th, 2016
Confidentiality:	Reference Section 3
Proprietary Name:	HemiCAP® MTP Resurfacing Hemi-Arthroplasty System-Phalangeal HemiCAP®
Common Name:	MTP Hemi-Toe Prosthesis
Device:	Prosthesis, Toe, Hemi, Phalangeal
Regulation Description:	Toe joint phalangeal (hemi-toe) polymerprosthesis
Regulation Number:	888.3730
Device Class:	Class II
Review Panel:	Orthopedic

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Product Code: KWD

Intended Use

Device Description

The enclosed phalangeal base HemiCAP® implant is intended for hemiarthroplasty only. Do not use in conjunction with metallic metatarsal implant.

The present device modification includes the addition of modified phalangeal base (concave) implants and a corresponding taper post to the existing system.

Substantial Equivalence Information

Arthrosurface, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the HemiCAP® MTP Resurfacing Hemi-Arthroplasty System is substantially equivalent in indications and design principles to the following predicate devices, which have been previously cleared by the FDA:

The sponsor's previously cleared CAP® Great Toe Resurfacing Hemi-
Arthroplasty (K031859, Cleared on 02/18/2004)
The sponsor's previously cleared HemiCAP® MTP Resurfacing Hemi-● Arthroplasty System (K131377, Cleared on 11/19/2013)
. The sponsor's previously cleared Arthrosurface® Total Toe - Proximal Phalanx Implant (K132496, Cleared on 02/26/2014)

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

Has the same Indications for Use, ●
. Has the same operating principle,
Is manufactured using the same material, ●
Has the same shelf life, ●
. Is packaged and sterilized using the same materials and processes.

In support of this submission, the following non-clinical tests and analyses have been performed on the Subject Device:

Comparative Engineering Analyses .
. Comparative Mechanical Testing
- Assembly and Disassembly Testing
- o Resistance to Torsion Testing
- Cyclic Fatigue Testing o
- Fretting Corrosion Testing o
- Pull-out Strength Testing
- Finite Element Analysis

The results have demonstrated the safety and effectiveness of the HemiCAP® MTP Resurfacing Hemi-Arthroplasty System-Phalangeal HemiCAP® Implants along with substantial equivalence to the predicate devices.

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.