The CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System is intended for use in stabilization and fixation of the 1st MTP joint in the foot for fusion, osteotomy, nonunion, malunion or revision surgery.

Device Description

The CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System consists of anatomically contoured bone plates and screws which are intended to be used for surgical fusion (arthrodesis) of the 1st MTP joint. The plate is available in both left and right configurations. Locking, non-locking and interfragmentary screws are included as part of the system.

AI/ML Overview

This document is a 510(k) summary for the CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove device performance as typically understood in a clinical trial context. This device is a bone fixation appliance, and its acceptance is based on mechanical performance and comparison to existing, cleared devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Material Equivalence: Materials used are comparable to predicate devices.	Stated that "materials" of the proposed device are substantially equivalent to predicate devices. Specific material properties or tests are not detailed in this summary.
Design Equivalence: Design features are comparable to predicate devices.	Stated that "design features" of the proposed device are substantially equivalent to predicate devices. Specific design parameters or comparisons are not detailed in this summary.
Functional Equivalence (Mechanical Strength/Stability): The device performs mechanically at least as well as predicate devices for its intended use.	Comparative static and dynamic four-point bending test results were used to support equivalence to predicate devices. No specific numerical thresholds (acceptance criteria) or quantitative results (reported performance) from these tests are provided in this summary.
Dimensional Equivalence: Dimensions are comparable, ensuring proper fit and function similar to predicate devices.	Comparative dimensional analyses were used to support equivalence to predicate devices. No specific numerical thresholds (acceptance criteria) or quantitative results (reported performance) from these analyses are provided in this summary.

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

Sample Size for Test Set: This document does not specify a "sample size for the test set" in the context of human subjects or clinical data. The tests performed were mechanical (static and dynamic four-point bending, dimensional analyses) on the device itself. The number of devices tested is not provided.
Data Provenance: The data provenance is from in-vitro mechanical testing and dimensional analyses of the proposed device and specified predicate devices. This is not clinical data, so country of origin or retrospective/prospective classification is not applicable.

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

This information is not applicable to this 510(k) submission. The ground truth for device performance in this context is established through engineering and biomechanical testing, not through expert clinical consensus on patient data. Experts involved would be engineering and materials science professionals performing the tests and interpreting the results, but their number and specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

This information is not applicable to this 510(k) submission. Adjudication methods like 2+1 or 3+1 typically refer to agreement among human readers/experts for clinical ground truth establishment. For mechanical testing, the "adjudication" is based on established engineering standards and comparison methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable. This 510(k) is for a mechanical orthopedic implant, not an AI-assisted diagnostic or therapeutic device. No MRMC studies or AI components are mentioned.

6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done

This information is not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this device's performance is established through comparative in-vitro mechanical testing against predicate devices and adherence to relevant engineering standards (though specific standards are not cited in this summary). The implicit ground truth is that if the proposed device performs mechanically equivalent or superior to the predicate devices, it is safe and effective for its indicated use.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this 510(k) submission for a mechanical device.

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

This information is not applicable. There is no "training set" or corresponding ground truth establishment process for this type of device submission.

Summary

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12 K113762 .

Section 5 510(k) Summary

510(k) Owner:	Arthrosurface, Inc.28 Forge ParkwayFranklin, MA 02038
Tel:	508.520.3003
Fax:	508.528.4604
Contact:	Dawn WilsonVP, Quality & Regulatory
Date of Preparation:	December 16, 2011
Trade Name:	CheckMate™ Metatarso-Phalangeal (MTP)Arthrodesis System
Common Name:	Arthrosurface Toe Plate System
Device:	Plate, fixation, bone
Classification Regulation:	Regulation Number 888.3030
Device Class:	Class II
Review Panel:	Orthopedic
Product Code:	HRS

Device Intended Use

The CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System is intended for use in stabilization and fixation of the 155 MTP joint in the foot for fusion, osteotomy, nonunion, malunion or revision surgery.

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:

DePuy ALPS Small Bone Locked Plating System K101240 t
Arthrex Low Profile Plate and Screw System K052614 .
Synthes 2.4 mm/2.7 mm Variable Angle (VA)-LCP K100776 . Forefoot/Midfoot System

Comparative static and dynamic four point bending test results, along with comparative dimensional analyses were used to support equivalence to predicate devices.

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

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

FEB - 6 2012

Arthrosurface, Inc. % Ms. Dawn Wilson 28 Forge Parkway Franklin, MA 02038

Re: K113762

Trade/Device Name: CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: December 16, 2011 Received: December 21, 2011

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

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Page 2 – Ms. Dawn Wilson

device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

for D.T.A.
Deplies

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative 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): K113762

Device Name:

CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System

Indications for Use:

Over-The-Counter Use Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR
(Part 21 CFR 801 Subpart D) AND/OR (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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(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K113762

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.