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 or without bone cement.

Device Description

The HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant incorporates an articular resurfacing component and a cancellous taper post 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.

AI/ML Overview

The provided text describes a 510(k) summary for the HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant. It details the device's intended use, description, materials, and claims of substantial equivalency to previously cleared devices.

Based on the provided information, the following points can be made regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific, quantifiable acceptance criteria in the traditional sense (e.g., a minimum accuracy, sensitivity, or specificity value). Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if it is found to be substantially equivalent.

Therefore, a table of acceptance criteria and reported device performance cannot be directly extracted from the provided text in the requested format. The document focuses on demonstrating that the new device is as safe and effective as existing, legally marketed devices.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: The document states, "Clinical data was provided in support of the substantial equivalency. Data was obtained from over 100 patients with follow-up ranging out to 5 years." This "over 100 patients" represents the size of the clinical dataset used to support the substantial equivalency claim, which can be considered the "test set" in this context.
Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective. Given that it refers to "follow-up ranging out to 5 years," it implies that the data collected over time rather than just at a single point, but the exact study design (retrospective or prospective) is not detailed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The text focuses on the device itself and its comparison to predicates, not on the methodology of expert review or ground truth establishment. Clinical outcomes from the "over 100 patients" likely formed the basis for evaluating the device's performance, but how these outcomes were assessed or validated by experts is not described.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

This type of study was not conducted for this device submission. The submission relies on demonstrating substantial equivalence to predicate devices based on clinical data from over 100 patients. There is no mention of human readers, AI assistance, or comparative effectiveness in the context of an MRMC study. This device is a physical implant, not a diagnostic or AI-powered tool that would typically undergo such a study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable as the device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the assessment of the HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant would be the clinical outcomes and performance observed in "over 100 patients with follow-up ranging out to 5 years." This would include measures of pain relief, stability, restoration of function, and absence of adverse events, assessed by medical professionals in a clinical setting related to the treatment of degenerative and post-traumatic arthritis in the metatarsal joint. The document does not specify if pathology or other objective measures were exclusively used.

8. The Sample Size for the Training Set:

This information is not applicable in this context. This device is a physical implant, and the submission is based on clinical data and substantial equivalence to predicates, not on a machine learning model that would require a "training set."

9. How the Ground Truth for the Training Set was Established:

This is not applicable as there is no "training set" for a machine learning model.

In summary, the core of this submission is demonstrating "substantial equivalency" to existing, legally marketed predicate devices, rather than meeting specific quantitative acceptance criteria through a de novo clinical trial with defined endpoints and ground truth adjudication by experts in the context of a new diagnostic or AI device. The "study" mentioned is the collection of clinical data from "over 100 patients" to support this claim of substantial equivalency.

Summary

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NOV 1 9 2013

Section 5 510(k) Summary

510(k) Owner:	Arthrosurface, Inc.28 Forge ParkwayFranklin, MA 02038Tel: 508.520.3003Fax: 508.528.4604
Contact:	Dawn WilsonVP, Quality & Regulatory
Date of Preparation:	May 13, 2013
Trade Name:	HemiCAP® MTP Resurfacing Hemi-ArthroplastyImplant
Common Name:	MTP hemi-toe prosthesis
Device:Regulation Number:Regulation Name:Device Class:Review Panel:Product Code:	Prosthesis, Toe, Hemi-, Phalangeal21 CFR 888.3730Toe joint phalangeal (hemi-toe) polymer prosthesClass IIOrthopedicKWD

Device Intended Use

Device Description

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Materials

Articular Resurfacing Component: Cobalt-Chromium Alloy (Co-Cr-Mo) Surface Coating: Titanium (CP Ti) Taper Post Component: Titanium Alloy (Ti-6Al-4V)

The HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant is a single use implant with updated indications for use with or without bone cement to be consistent with predicates, and updated general terminology for MTP. The implant is otherwise identical to the sponsor's previously cleared and commercially marketed implant.

Referencing predicate devices, similar indications have been cleared since 2007. Such history of use demonstrates the differences in indications are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, nor do they affect the safety and effectiveness of the device when used as labeled.

Substantial Equivalency:

The intended use, materials, design features and application of the Proposed Device are substantially equivalent to the following previously cleared and commercially marketed devices:

• CAP™ Great Toe Resurfacing Hemi-Arthroplasty Implant	K031859
• Solana Surgical LLC, Metatarsal Decompression Implant	K113752

Vilex Cannulated Metallic Hemi Implant . K102401
The fundamental scientific technology of the proposed device has not changed relative to the predicate devices:
Intended for the metatarsophalangeal joint .
Similar indications for use .
. Similar device designs
o Same Cobalt and Titanium implant materials
Implants available anatomically curved .
Similar fixation options .

Clinical data was provided in support of the substantial equivalency. Data was obtained from over 100 patients with follow-up ranging out to 5 years. Results demonstrated the safety and effectiveness of the HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant is adequately supported by the substantial equivalence information provided within this Premarket Notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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" arranged around the perimeter. Inside the circle is a stylized symbol resembling a bird or abstract human figure, composed of three curved lines.

Public Health Service

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

November 19, 2013

Arthrosurface, Incorporated Ms. Dawn J. Wilson Vice President of Quality and Regulatory 28 Forge Parkway Franklin, Massachusetts 02038

Re: K131377

Trade/Device Name: HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: Class II Product Code: KWD Dated: November 5, 2013 Received: November 6, 2013

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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Dawn J. Wilson

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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.

Lori A. Wigqins

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

Enclosure

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Section 4 Indications for Use Statement

510(k) Number (if known): K131377

Device Name: HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ΠΠ
Casey L-Hanley, Ph.D.
١٦٢٦
10/11/
Division of Orthopedic 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.