The CINCHT™ Knotless Fixation Implant includes single-use, sterile Anchor (3.5mm in diameter), which is preloaded onto a disposable anchor inserters. The CINCH™ Knotless Fixation Implant System is comprised of nondegradable suture anchors each pre-loaded onto an inserter.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the CINCHT™ Knotless Fixation Implant System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study or AI performance metrics.

Therefore, many of the requested categories for AI/clinical study performance data are not applicable to this document. The submission focuses on bench testing and comparison to existing devices.

Here's a breakdown of what can be extracted and what is N/A:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Bench Test)	Reported Device Performance
Meets specifications	Functioned as intended
Does not raise new issues of safety or effectiveness	No new issues of safety or effectiveness raised

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document refers to "bench testing" but does not give specific numbers of tests or implants used.
Data Provenance: Not specified, but generally, bench testing for a 510(k) submission would be conducted by the manufacturer (C2M Medical, Inc. in San Antonio, Texas, USA) or a contracted lab. This is a retrospective analysis of the device's characteristics against its design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable. For a medical device 510(k) submission based on bench testing, "ground truth" is established by engineering and materials science principles and validated through empirical measurements (bench testing), not by expert consensus in the way AI models define it.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are typically used in clinical trials or for establishing ground truth for AI models with human interpretation. This document describes bench testing.

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

Not Applicable. This is a medical device (surgical implant), not an AI-powered diagnostic or assistive tool.

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

Not Applicable. This is a medical device (surgical implant), not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Bench Testing Results / Engineering Specifications: The "ground truth" for this device's performance is its ability to meet engineering specifications and function as intended during bench tests. This is a physical or mechanical "ground truth."

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not Applicable. As above, no AI model, no training set, no ground truth to establish for a training set.

Summary

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DEC 0 7 2007

Page 1/2 510(k) Number K073226

510(k) Summary

Trade Name:	CINCHT™ Knotless Fixation Implant System
Sponsor:	C2M Medical, Inc.3463 Magic Drive, Suite 320San Antonio, Texas 78229Telephone: 1-877-300-5010Fax: 1-210-582-5811Contact Person: Gabriele G. Niederauer, Ph.D.
Date of Summary:	November 13, 2007
Device Classification Name:	21 CFR §888.3040Fastener, fixation, nondegradable, soft tissue
Classification:	According to Section 13 of the Federal Food, Drug andCosmetic Act, the device classification is Class II,Performance Standards.
Predicate Devices:	Original CINCHT™ Bone Anchor SystemDePuy/Mitek Rotator Cuff QuickAnchor® Plus
Device Description:	The CINCHT™ Knotless Fixation Implant includes single-use, sterile Anchor (3.5mm in diameter), which ispreloaded onto a disposable anchor inserters.
Purpose of theSpecial 510(k) notice:	The CINCHT™ Knotless Fixation Implant System is amodification to the original CINCHTM Bone AnchorSystem
Indications for Use:	The CINCHT™ Knotless Fixation Implant System isintended to be used for fixation of soft tissue to bone duringrotator cuff repair.

Results of bench testing demonstrate that the CINCH™ Knotless Safety and Performance: Fixation Implant System meets its specifications and does not raise new issues of safety or effectiveness. In all instances, the CINCH™ Knotless Fixation Implant functioned as intended.

Technological Characteristics

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The CINCH™ Knotless Fixation Implant System is comprised of nondegradable suture anchors each pre-loaded onto an inserter.

Substantial Equivalence

The modified CINCH™ Knotless Fixation Implant System is substantially equivalent to the original CINCH™ Bone Anchor System and DePuy/Mitek Products' Rotator Cuff QuickAnchor® Plus. The CINCH™ Knotless Fixation Implant System has the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between the CINCH™ Knotless Fixation Implant System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the CINCH™ Knotless Fixation Implant System is as safe and effective as the predicate devices. Thus, the CINCH™ Knotless Fixation Implant System is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with a bird-like figure intertwined. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the logo.

DEC 0 7 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

C2M Medical, Inc. % Gabriele G. Niederauer, Ph.D. Vice President, Research and Development 3463 Magic Drive, Suite 320 San Antonio, Texas 78229

Re: K073226

Trade/Device Name: CINCH™ Knotless Fixation Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: November 14, 2007 Received: November 15, 2007

Dear Dr. Niederauer:

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 commence 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 r ca mayyuttors provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Gabriele G. Niederauer, Ph.D.

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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M. Attachment 13 - Indications for Use Statement

Indications for Use Statement

K073226 510(k) Number (if known):

Device Name: CINCH™ Knotless Fixation Implant System

Indications for Use:

The CINCH™ Knotless Fixation Implant System is intended for the fixation of soft tissue to bone during rotator cuff repair.

Prescription Use _X (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device (Division Division of General, Restorat and Neurological Devices

510(k) Number

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.