The ToeMATE® Hammertoe Correction System consists of two intramedullary bone screws, a taper lock pin and a set of instruments used for implant site preparation and delivery. The implants are offered in three size options, x-small, small and large. The taper lock pin provides a press fit connection between the two screws with light contact pressure and is available in straight and angled configurations. The implant components are manufactured using implant grade titanium alloy and cobalt-chrome alloy.

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding the "ToeMATE® Hammertoe Correction System". This document focuses on the regulatory clearance process and establishing substantial equivalence to previously cleared predicate devices.

It does not contain information about acceptance criteria, device performance, or any specific study details such as sample sizes, data provenance, expert qualifications, ground truth establishment, or specific study types like MRMC or standalone performance. The document primarily discusses:

Device Name and Regulation Information: ToeMATE® Hammertoe Correction System.
Indications for Use: Small bone fusion, fractures, and inter-digital fusion of the fingers, toes, and small bones.
Device Description: Two intramedullary bone screws, a taper lock pin, and instruments, made from implant grade titanium alloy and cobalt-chrome alloy.
Substantial Equivalence: Claiming substantial equivalence to predicate devices (K130859, K101165, K120645) based on similar indications for use, operating principles, materials, instrumentation, packaging, and sterilization.
Non-Clinical Tests: Lists "Device Comparative Analysis," "Mechanical Testing" (static and dynamic cantilever bending, torque to failure, insertion/removal torque, axial pullout, and disassembly), and a "Kinetic Chromogenic LAL Test" for bacterial endotoxins.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement, as this information is not present in the provided document. The document states that the results demonstrated substantial equivalence but does not provide those results or the detailed methodology of how performance was assessed against any specified acceptance criteria.

Summary

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

March 3, 2017

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

Re: K170350

Trade/Device Name: ToeMATE® Hammertoe Correction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: March 1, 2017 Received: March 3, 2017

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 and Part 809); medical device reporting (reporting of medical 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

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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 and Part 809), 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" (21 CFR 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,

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

510(k) Number (if known) K170350

Device Name

ToeMATE® Hammertoe Correction System

Indications for Use (Describe)

Indicated for small bone fusion, fractures and inter-digital fusion of the fingers, toes and small bones.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Special 510(k): Device ModificationToeMATE® Hammertoe Correction System
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:	February 01, 2017
Confidentiality:	Reference Section 3
Proprietary Name:Common Name:	ToeMATE® Hammertoe Correction SystemScrew, Fixation, Bone
Regulation Description:Regulation Number:Device Class:Review Panel:Product Code:	Smooth or Threaded Metallic Bone Fixation Fastener21 CFR 888.3040Class IIOrthopedicHWC

Indications for Use

Indicated for small bone fusion, fractures and inter-digital fusion of the fingers, toes and small bones.

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Device Description

Substantial Equivalence Information

Arthrosurface, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the additional sizes for the ToeMATE® Hammertoe Correction System are substantially equivalent in indications and design principles to the following predicate and/or reference devices, which have been previously cleared by the FDA:

Primary Predicate

K130859 Arthrosurface, Inc.'s Hammertoe Correction System

Additional Predicate(s)

K101165 Wright Medical PRO-TOE™ VO Hammertoe Implant System K120645

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,
ls manufactured using common orthopedic implant materials,
Utilizes similar instrumentation for proper placement,
ls packaged and sterilized using the same materials and processes.

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

Device Comparative Analysis
. Mechanical Testing: static and dynamic cantilever bending, torque to failure, insertion/removal torque, axial pullout and disassembly
A Kinetic Chromogenic LAL Test on the finished product 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

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Medical Devices, and AAMI ST72:2002/R2010, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing.

Conclusions

The results have demonstrated that the ToeMATE® Hammertoe Correction System is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.