The Arthrosurface Total Toe Resurfacing System is a two-piece implant that is intended to be used as prosthesis for the metatarso-phalangeal joint (MTP). The device is intended for cemented use only.

Indications for use include:

Painful degenerative metatarso-phalangeal joint change .
. Hallus rigidus stage 3 and 4
. Hallux valgus and hallux rigidus
Hallux limitus with painful arthrofibrosis .
Revisions after moderate proximal phalanx resection .

Device Description

The Arthrosurface® Total Toe System consists of a metatarsal component and a phalangeal component designed for resurfacing the 15 metatarsal head and the base of the proximal phalanx. These two implants replace the metatarso-phalangeal joint by complete functional preservation of the joint and maintaining of the sesamoid complex.

The Metatarsal Implant incorporates a CoCrMo articular resurfacing component per ASTM F799 with CP Ti Plasma Spray coating per ASTM F1580 and a Ti-6AI-4V ELI alloy fixation component per ASTM F136 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 device is 15mm articular implant with a dorsal flange feature for additional implant coverage in the dorsal plane.

The Proximal Phalanx Implant consists of a Ti-6Al-4V ELI alloy fixation component per ASTM F136 with CP Ti Plasma Spray coating per ASTM F1580 and an Ultra High Molecular Weight Polyethylene inlay per ASTM F648.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Arthrosurface® Total Toe - Proximal Phalanx Implant:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantifiable acceptance criteria such as "the device must achieve X performance metric." Instead, the document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

The acceptance criteria can be inferred from the list of non-clinical tests performed, with the implication that the device's performance in these tests was acceptable and comparable to the predicate devices.

Acceptance Criteria (Inferred from Test Performed)	Reported Device Performance
Wear testing	Demonstrated safety and effectiveness; substantially equivalent to predicates.
Contact area / Contact stress	Demonstrated safety and effectiveness; substantially equivalent to predicates.
Assembly / Disassembly of Articular and Fixation components	Demonstrated safety and effectiveness; substantially equivalent to predicates.
Bending moment / Flexural load	Demonstrated safety and effectiveness; substantially equivalent to predicates.
Strength of delivery tool	Demonstrated safety and effectiveness; substantially equivalent to predicates.
Finite Element Analysis	Demonstrated safety and effectiveness; substantially equivalent to predicates.

Explanation: The document explicitly states: "The results have demonstrated the safety and effectiveness of the Arthrosurface® Total Toe - Proximal Phalanx Implant along with substantial equivalence to the predicate devices." This is the overarching performance claim based on the non-clinical tests.

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

The provided text describes non-clinical (bench) testing, not clinical studies involving human subjects or data. Therefore:

Sample Size for Test Set: Not specified in terms of human subjects or patient data. For bench testing, the sample size would refer to the number of physical devices or components tested, which is not provided.
Data Provenance: Not applicable as it's non-clinical testing. It's not retrospective or prospective patient data from any specific country.

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

Not applicable. This device underwent non-clinical bench testing to establish its performance and substantial equivalence. "Ground truth" in the context of expert consensus regarding patient data or images is not relevant here. The ground truth for the engineering tests would be the established scientific and engineering principles, material properties, and test standards (e.g., ASTM standards referenced).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or image review where inter-rater variability needs to be managed for establishing ground truth. This was non-clinical bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers perform with and without AI assistance, which is irrelevant for a physical orthopedic implant undergoing non-clinical testing for substantial equivalence.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone algorithm performance study was not done. This type of study refers to the performance of an AI algorithm independent of human interaction, which is not applicable to a physical medical device like an orthopedic implant.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests conducted would be based on:

Established engineering standards and methodologies: (e.g., ASTM F799, ASTM F1580, ASTM F136, ASTM F648 for material properties).
Physical measurements and observations during the wear, contact, assembly, bending, and strength tests.
Computational models and simulations for the Finite Element Analysis.

8. Sample Size for the Training Set

Not applicable. There is no mention of a training set as this is not an AI/ML device that requires a training data set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set mentioned, there's no ground truth establishment for it.

Summary

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FEB 2 6 2014

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:	February 21, 2014
Trade Name:	Arthrosurface® ToeMotion™
Common Name:	Arthrosurface® Total Toe - Proximal Phalanx Implant
Device:	Prosthesis, Toe (metatarso-phalangeal), Joint,Metal/polymer, Semi-constrained
Classification Regulation:Device Class:Review Panel:Product Code:	Unclassified (Reason: Pre-Amendment)UnclassifiedOrthopedicLZJ

Device Intended Use

The Arthrosurface Total Toe Resurfacing System is a two-piece implant that is intended to be used as prosthesis for the metatarso-phalangeal joint (MTP). The device is intended for cemented use only.

Indications for use include:

Painful degenerative metatarso-phalangeal joint change .
. Hallus rigidus stage 3 and 4
. Hallux valgus and hallux rigidus
Hallux limitus with painful arthrofibrosis .
Revisions after moderate proximal phalanx resection .

Device Description

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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:

Ascension MOVEMENT Great Toe System K102549 �
. Merete ToeMobile Anatomical Great Toe Resurfacing System K072251

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

Total arthroplasty for the MTP joint .
Same indications for use .
Similar device designs o
Same implant materials .

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

Wear testing .
Contact area / Contact stress .
Assembly / Disassembly of Articular and Fixation components .
Bending moment / Flexural load .
Strength of delivery tool .
. Finite Element Analysis

The results have demonstrated the safety and effectiveness of the Arthrosurface® Total Toe - Proximal Phalanx Implant along with substantial equivalence to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and centered.

Image /page/2/Picture/1 description: The image is a simple black and white image. The image is mostly white, with a few small black dots scattered around. The dots are concentrated in the upper right and lower right corners of the image.

Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 26, 2014

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

Re: K132496

Trade/Device Name: Arthrosurface® Total Toe - Proximal Phalanx Implant Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: LZJ Dated: January 24, 2014 Received: January 28, 2014

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 or any 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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Vincent J. Devlin -S

for

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

K132496 510(k) Number (if known):

. Device Name: Arthrosurface® Total Toe - Proximal Phalanx Implant

Indications for Use:

The Arthrosurface Total Toe Resurfacing System is a two-piece implant that is intended to be used as prosthesis for the metatarso-phalangeal joint (MTP). The device is intended for cemented use only. Indications for use include:

Painful degenerative metatarso-phalangeal joint change ●
o Hallus rigidus stage 3 and 4
Hallux valgus and hallux rigidus 0
Hallux limitus with painful arthrofibrosis o
. Revisions after moderate proximal phalanx resection

Prescription Use X (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)

Page 1 of 1

Image /page/4/Picture/16 description: The image shows the text "Casey L. Hanley, Ph.D." above a horizontal line, with the text "Division of Orthopedic Devices" below the line. The text is surrounded by a stylized FDA logo. The logo appears to be a stylized version of the letters FDA.

510(k) Page 15

Regulation Number and Section

N/A