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 Arthrosurface MTP implant incorporates an articular resurfacing component and a taper post component that mate together via a morse taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.

Per K132496, the MTP can be used in conjunction with the Arthrosurface Proximal Phalanx Implant as a Total Toe option. K132496 also cleared the most recent version of the mating articular component.

Fixation components are being included in the system that contain an additional ring of material intended to improve stabilization in a first metatarsal that presents with a distal bone void. The articulating component and taper configuration are unchanged. The phalangeal implant is unchanged.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've outlined for an AI/algorithm-based medical device.

The document is a 510(k) premarket notification for the BOSS Toe Fixation System, which is a physical implant (a hemi-arthroplasty implant for the metatarsophalangeal joint).

Therefore, I cannot extract the following information from the provided text:

A table of acceptance criteria and the reported device performance (for an algorithm)
Sample size used for the test set and the data provenance (for an algorithm)
Number of experts used to establish the ground truth for the test set and their qualifications (for an algorithm)
Adjudication method (for an algorithm's ground truth)
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
If a standalone performance study was done (for an algorithm)
The type of ground truth used (for an algorithm)
The sample size for the training set (for an algorithm)
How the ground truth for the training set was established (for an algorithm)

The document focuses on demonstrating substantial equivalence to an existing predicate device based on its indications for use, operating principle, materials, instrumentation, packaging, sterilization, and non-clinical tests (mechanical strength, cadaveric evaluation, bacterial endotoxins test). These tests are standard for a physical implant, not for an AI/algorithm.

Summary

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August 14, 2019

Arthrosurface, Inc. Dawn Wilson VP, Quality & Regulatory 38 Forge Parkway Franklin, Massachusetts 02038

Re: K190261

Trade/Device Name: BOSS Toe Fixation System Regulation Number: 21 CFR 888.3730 Regulation Name: Toe Joint Phalangeal (Hemi-Toe) Polymer Prosthesis Regulatory Class: Class II Product Code: KWD Dated: July 17, 2019 Received: July 18, 2019

Dear Dawn 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K190261

Device Name BOSS Toe Fixation System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary
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:	August 14, 2019
Proprietary Name:	BOSS™ Toe Fixation System
Common Name:	MTP Fixation Component
Device:	Prosthesis, Toe, Hemi-, Phalangeal
Regulation Description:Review Panel:Product Code:	888.3730OrthopedicKWD

Device Description

Per K132496, the MTP can be used in conjunction with the Arthrosurface Proximal Phalanx Implant as a Total Toe option. K132496 also cleared the most recent version of the mating articular component.

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Indications for Use

The device is a single use implant intended to be used with bone cement or without bone cement.

Substantial Equivalence Information

Arthrosurface, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the MTP fixation component is substantially equivalent in indications and design principles to the following predicate devices, which have been previously cleared by the FDA:

HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant (fixation component) K131377

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

Has the same Indications for Use
Uses the same operating principle
Is manufactured using the same implant grade orthopedic materials
Utilizes the same instrumentation for proper placement
ls packaged and sterilized using the same materials and processes

Support

In support of this submission, the following non-clinical tests and/or analysis were performed for the Subject Device:

Device comparative analysis
Device mechanical strength including pullout and shear
Cadaveric evaluation (e.g. Radiographs, Axial Pullout)
A Kinetic Chromogenic LAL Test for Devices which meets the standard limit of 0.5 EU/mL or 20 EU/ Device per United States Pharmacopeia (USP) Chapter <85> Bacterial Endotoxins Test, USP Chapter <161> Transfusion and Infusion Assemblies and Similar Medical Devices, and AAMI ST72:2002/R2010, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing.

Conclusion

The results have demonstrated the safety and effectiveness of the Arthrosurface® BOSS Toe Fixation system along with substantial equivalence to the HemiCAP® system (predicate device K131377).

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.