The Nextremity Solutions InCore® TMT System is a three-part construct intended for internal fixation for Lesser Tarsometatarsal Joint Arthrodesis (also known as Lisfranc Joint Fusion or 2nd/ 3rd Tarsometatarsal Fusion).

Device Description

The InCore® TMT System consists of a post and two headless compression screws. Posts are available with a 4.9mm diameter, in an 18mm length, and left orientations. Screws are available in a 2.7mm diameter and lengths of 16 to 52mm. The post is inserted into the cuneiform and compression screws are inserted into the metatarsal and into the post to maintain apposition of the bones during fusion. A post plug screw is threaded into the top of the post after all components have been implanted to prevent tissue ingrowth into the post and facilitate removal, if needed. All implants are manufactured from color anodized Ti-6Al-4V alloy conforming to ASTM F-136. The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.

AI/ML Overview

The provided document is an FDA 510(k) Premarket Notification review letter and associated summary for the Nextremity Solutions InCore® TMT System. This document focuses on demonstrating substantial equivalence to predicate devices for a bone fixation fastener, not on assessing the performance of an AI/ML-based device.

Therefore, the information required to answer your questions about acceptance criteria and a study proving an AI/ML device meets those criteria (e.g., sample size, expert ground truth, MRMC studies, standalone performance) is not present in this document.

Specifically, the document states:

"Clinical testing was not necessary to demonstrate substantial equivalence of the InCore® TMT System to the predicate device." This explicitly confirms that a clinical study, which would typically contain the performance data you're asking about, was not performed or required for this submission.
The non-clinical testing mentioned (endotoxin testing, axial pull-out strength, torque to failure, 3-point bend tests) are mechanical and material property tests to ensure the device itself is robust, not to evaluate the performance of an AI model.

In summary, this document does not describe an AI/ML device, nor does it contain the kind of study data you are asking for. It pertains to a physical medical device (a bone screw system) and its mechanical performance relative to similar existing devices.

Summary

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December 31, 2019

Nextremity Solutions. Inc. Elise Fox Quality Engineer 210 North Buffalo Street Warsaw, Indiana 46580

Re: K192578

Trade/Device Name: InCore TMT System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: October 31, 2019 Received: November 4, 2019

Dear Elise Fox:

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

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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 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 (QS) 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 medical devices and radiation-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,

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices 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 SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.
Indications for Use
510(k) Number (if known)	K192578
Device Name	InCore® TMT 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)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary
Prepared:	December 27th, 2019
Submitter:	Nextremity Solutions, Inc.210 North Buffalo StreetWarsaw, IN 46580
Contact:	Elise FoxQuality Engineerelise.fox@nextremity.comPhone: 574-376-2062FAX: 574-966-1396
Proprietary Name:	InCore® TMT System
Common Name:	Bone Screw System
Classification:	21 CFR §888.3040: Smooth or threaded metallic bone fixation fastener;Class II
Product Code:	HWC

Substantially Equivalent Devices:

Extremity Medical Screw and Washer System (IO FiX), K121349-Primary Predicate
Nextremity Solutions InCore® Lapidus System, K180257 ●

Device Description:

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The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.

Intended Use / Indications:

Summary of Technologies/Substantial Equivalence:

The InCore® TMT System is substantially equivalent to the predicate devices in regard to its intended use and indications, material, design, sizes, and mechanical properties. Differences between the subject device system and the predicate device systems do not raise new types of safety and effectiveness questions.

Non-Clinical Testing:

Endotoxin testing was performed on another Nextremity product which is considered worst case. Results met the endotoxin limit of <20 EU / kit. During manufacturing, endotoxin testing will be conducted on the worst case product in each sterilization lot. Endotoxin testing is performed using the Limulus Amebocyte Lysate (LAL) test Kinetic-Chromogenic Method according to the European Pharmacopeia and the United States Pharmacopeia. To evaluate the strength of the InCore® TMT System and components, axial pull-out strength, torque to failure and 3-point bend tests were performed on worst case compression screws according to ASTM F543-13 and ASTM F1264-16. Static 3-point bend and dynamic 3-point bend tests were performed on worst case constructs according to ASTM F382-17. These tests confirmed that the strength of the InCore® TMT System is substantially equivalent to predicate devices with similar indications and is adequate for its intended use.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the InCore® TMT System to the predicate device.

Conclusions/Substantial Equivalence:

Differences between the subject device system and the predicate device systems do not raise new types of safety and effectiveness questions. The InCore® TMT System is substantially equivalent to the predicate devices in regard to its intended use, material, design, sizes, and mechanical properties.

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.