The Synde-Lock™ Syndesmosis Repair Kit contains an implant designed as two bone anchors, one a stainless steel screw and the other a PEEK T-nut, connected by a distribution bridge comprised of UHMWPE suture and a threaded PEEK rod. The stainless steel screw is pre-threaded with the UHMWPE suture section of the distribution bridge. The PEEK T-nut engages the threads of the PEEK section of the distribution bridge allowing the effective length of the bridge to be shortened. A clipper is also contained in the kit to cut away excess distribution bridge material, once the implant is in place. The Tarsus Synde-Lock Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma.

AI/ML Overview

The provided text describes a medical device, the "Synde-Lock™ Syndesmosis Repair Kit," and its approval process, but it does not include detailed acceptance criteria or a dedicated study report proving the device meets specific performance metrics in the way typically seen for AI/ML-based medical devices.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device for a traditional medical implant. The "acceptance criteria" here are implicitly built into the substantial equivalence paradigm (i.e., the new device performs at least as well as the predicate for its intended use).

Here's an analysis based on the provided text, structured to address your points as much as possible, while acknowledging the limitations of the input:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit, quantitative acceptance criteria (e.g., "sensitivity must be > 90%") are not detailed in this submission. The "acceptance criteria" for this traditional medical device are met by demonstrating substantial equivalence to a legally marketed predicate device. The "reported device performance" is framed in comparison to that predicate.

Acceptance Criterion (Implicit)	Reported Device Performance
Substantial Equivalence to Predicate Device (TightRope Syndesmosis Device Plus) in terms of:	"The test results demonstrate that the Synde-Lock™ Syndesmosis Repair Kit is substantially equivalent to the legally marketed predicate device."
- Intended Use	"The intended use... are either identical or substantially equivalent to the existing legally marketed product." (The intended use for both is fixation during healing after syndesmotic trauma.)
- Method of Operation	"method of operation... are either identical or substantially equivalent to the existing legally marketed product." (Implies similar biomechanical function for syndesmotic repair.)
- Methods of Construction	"methods of construction... are either identical or substantially equivalent to the existing legally marketed product." (Implies similar design principles and manufacturing processes.)
- Materials Used	"materials used, are either identical or substantially equivalent to the existing legally marketed product." (The Synde-Lock uses 316 LVM stainless steel, UHMWPE suture, and PEEK, conforming to specific ASTM and USP standards.)
- Mechanical Performance (Lateral Displacement, External Rotation, Fatigue, Tensile-to-Failure)	Non-clinical tests were performed for "lateral displacement testing, external rotation testing, fatigue testing with lateral tensile to failure, and external rotation to failure." These tests confirmed substantial equivalence to the predicate.

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

Sample Size: Not explicitly stated as a numerical value within the provided text. The text mentions "Both synthetic bone analog and cadaveric bone were used for testing." This implies multiple test samples of each type were used, but the exact count is not given.
Data Provenance: The testing was "performed by the company" (Tarsus Medical, Inc.). It's non-clinical/pre-clinical testing. The text does not specify the country of origin for the cadaveric bone, nor does it classify the study as retrospective or prospective (which typically applies to clinical patient data, not mechanical testing).

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

This question is not applicable in the context of this submission. The "ground truth" for this device is not established by human experts interpreting data (like in an AI/ML study). Instead, it's established by the physical testing and engineering principles to demonstrate mechanical performance compared to a predicate device.
The comparison is to the predicate device's established performance, and the assessment of "substantial equivalence" would be made by FDA reviewers, who are experts in regulatory compliance and device mechanics, but they are not establishing a "ground truth" for the device's technical performance in this manner.

4. Adjudication Method for the Test Set

This question is not applicable. There's no human interpretation or "adjudication" of results in the sense of expert consensus for mechanical testing data. The results are quantitative measurements against defined test protocols. The "adjudication" process is the FDA's regulatory review of the company's test reports and their claim of substantial equivalence.

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 question is not applicable. This is a traditional mechanical implant, not an AI/ML-driven device or an imaging interpretation tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

This question is not applicable. This is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance demonstration relies on biocompatibility standards (ASTM, USP for materials) and established mechanical testing methodologies to simulate physiological conditions and compare against the predicate device. It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic tool would be. The "truth" is whether the device meets the mechanical demands for its intended use and performs comparably to a proven device.

8. The Sample Size for the Training Set

This question is not applicable. This is a traditional medical device, not an AI/ML system, so there is no "training set."

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

This question is not applicable for the reasons stated above.

Summary

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5. 510(k) Summary

General Information	JAN 2 3 2012
Date Compiled	January 21, 2012
Classification	Class II, 21 CFR § 888.3040 Smooth or threaded metallic bone fixation fastenerPrimary Product code HWCClass II, 21 CFR § 888.3030, Single/multiple component metallic bone fixationappliances and accessoriesSecondary Product code HTN
Trade Name	Synde-Lock™ Syndesmosis Repair Kit
Submitter	Tarsus Medical, Inc.465 Fairchild DriveSuite 230Mountain View, CA 94043
Contact	Nicholas MourlasPresident and CEOTel: (650) 237-0070Fax: (650) 237-0071

Intended Use

The Tarsus Synde-Lock Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma.

Predicate Device TightRope Syndesmosis Device Plus Manufactured by Arthrex

K043248

Device Description

Materials

The Synde-Lock™ Syndesmosis Device is comprised of 316 LVM stainless steel conforming to ASTM F138-08, Ultra High Molecular Weight Polyethylene (UHMWPE) suture conforming to USP 33, and Polyetheretherketone (PEEK) conforming to ASTM F2026-08.

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Testing

The non-clinical tests performed by the company include lateral displacement testing, external rotation testing, fatigue testing with lateral tensile to failure, and external rotation to failure. Both synthetic bone analog and cadaveric bone were used for testing. The test results demonstrate that the Synde-Lock™ Syndesmosis Repair Kit is substantially equivalent to the legally marketed predicate device.

Summary of Substantial Equivalence

Tarsus Medical, Inc. believes the Synde-Lock™ Syndesmosis Repair Kit is substantially equivalent to the predicate product. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to the existing legally marketed product.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal 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

Tarsus Medical, Inc. % Nicholas J. Mourlas, Ph.D. 465 Fairchild Drive, Suite 230 Mountain View, CA 94043

JAN 2 3 2012

Re: K111971

Trade/Device Name: Synde-Lock™ Syndesmosis Repair Kit Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, HTN Dated: December 8, 2011 Received: December 12, 2011

Dear Dr. Mourlas:

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 - Nicholas J. Mourlas, Ph.D.

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.

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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4. Indications for Use Statement

510(k) Number(if known):	This application	$K 1 l q 7 l$
------------------------------	------------------	-----------------

Synde-Lock™ Syndesmosis Repair Kit Device Name:

The Tarsus Synde-Lock Syndesmosis Repair Kit is intended to provide fixation during Indications for Use: the healing process following a syndesmotic trauma.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

T. N. Shepard

for (Division Sigh-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111971

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.