The CINCH Bone Anchor System provides surgeons with a fixation anchor that can be used during arthroscopic shoulder procedures. The device is available in two configurations, the CINCH WRC Anchor and the CINCH RRC Anchor. Both configurations are provided pre-loaded in a delivery instrument.

The CINCH WRC Anchor configuration is comprised of a curved PEEK base, a flared nitinol clip, two nitinol laser cut rings and a nitinol anchor pin. The device is preloaded in the CINCH Inserter

The CINCH RRC Anchor, is comprised of a machine molded cylindrical PEEK base, two nitinol laser cut rings and a nitinol anchor pin This device is also preloaded in a CINCH Inserter.

The design of the CINCH Bone Anchors is intended to permit surgeons to have direct tactile feedback of the tension in the suture between the tissue and the bone. Additionally, the CINCH Anchors are designed to allow the two ends of a suture to be individually adjusted. This permits the surgeon to fine-tune the placement of the tissue with respect to the bone, and then secure the suture without tying a knot.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "SAPPHIRE MEDICAL, INC. CINCH™ BONE ANCHOR SYSTEM." This documentation focuses on demonstrating substantial equivalence to predicate devices, rather than establishing efficacy through clinical trials with detailed acceptance criteria and performance metrics for a novel medical device. Therefore, the information typically requested in an AI/Software as a Medical Device (SaMD) context (such as detailed acceptance criteria, sample sizes for test sets, ground truth establishment, expert qualifications, and MRMC studies) is largely not applicable to this submission.

Here's a breakdown of the available information:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Meets specifications and does not raise new issues of safety or effectiveness.	"Results of bench testing demonstrate that the CINCH Bone Anchor System meets its specifications and does not raise new issues of safety or effectiveness. In all instances, the CINCH Bone Anchor functioned as intended." (Performance Data section) Additionally, the submission argues "The minor technological differences between the CINCH Bone Anchor System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the CINCH Bone Anchor System is as safe and effective as the predicate devices." (Substantial Equivalence section)
Biocompatibility	"The materials used in the CINCH Bone Anchor System are biocompatible. The same materials are commonly used in similar medical devices." (Biocompatibility Data section)
Substantial Equivalence to predicate devices	The entire submission is focused on demonstrating substantial equivalence in intended use, indications, technological characteristics, and principles of operation to listed predicate devices (DePuy/Mitek Products' Rotator Cuff QuickAnchor® Plus, Arthrex, Inc.'s PEEK Corkscrew FT, Smith & Nephew, Inc.'s BioRaptor 2.9 Suture Anchor, and Linvatec Corporation's UltraFix® RC). The FDA concurrence letter confirms this finding: "...determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The submission refers to "bench testing" without providing details on the number of anchors tested, the specific testing protocols, or any human/animal data. It's highly likely this was purely lab-based mechanical testing.
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. This is a medical device, not an AI or imaging diagnostic device requiring expert interpretation for ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is a medical device, not an AI or imaging diagnostic device.
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:
- No. This is a physical bone anchor, not an AI-assisted diagnostic or therapeutic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a physical bone anchor. Performance relates to its mechanical properties and function as a surgical implant, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For this type of device (bone anchor), "ground truth" for performance would be established by engineering specifications, mechanical testing standards, and possibly cadaveric studies to assess surgical technique and initial fixation. The document states "bench testing" results met specifications.
The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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510(k) SUMMARY

SAPPHIRE MEDICAL, INC. CINCH™ BONE ANCHOR SYSTEM

FEB 1 3 2007

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Sapphire Medical, Inc 690 Oak Grove Avenue Menlo Park, CA 94025

Phone: 650-322-3544 Facsimile: 650-322-3546

Contact Person: Brooke Campbell

Date Prepared: September 13, 2006

Name of Device and Name/Address of Sponsor

CINCH Bone Anchor System

Sapphire Medical, Inc 690 Oak Grove Avenue Menlo Park, CA 94025

Common or Usual Name

Bone Anchor

Classification Name

Class II Classification: Classification Name: Fastener, fixation, nondegradable, soft tissue.

Predicate Devices

DePuy/Mitek Products, Rotator Cuff QuickAnchor® Plus .
Linvatec Corporation, UltraFix® RC .
ArthroCare Corporation, Opus® Magnum .
Arthrex, Inc., PEEK Corkscrew FT ●
Smith & Nephew, Inc., BioRaptor 2.9 Suture Anchor .

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Intended Use / Indications for Use

The CINCH Bone Anchor System is intended to be used for fixation of soft tissue to bone during rotator cuff repair.

Device Description

The CINCH WRC Anchor configuration is comprised of a curved PEEK base, a flared nitinol clip, two nitinol laser cut rings and a nitinol anchor pin. The device is preloaded in the CINCH Inserter

The CINCH RRC Anchor, is comprised of a machine molded cylindrical PEEK base, two nitinol laser cut rings and a nitinol anchor pin This device is also preloaded in a CINCH Inserter.

Performance Data

Results of bench testing demonstrate that the CINCH Bone Anchor System meets its specifications and does not raise new issues of safety or effectiveness. In all instances, the CINCH Bone Anchor functioned as intended.

Biocompatibility Data

The materials used in the CINCH Bone Anchor System are biocompatible. The same materials are commonly used in similar medical devices.

Substantial Equivalence

The CINCH Bone Anchor System is substantially equivalent to the DePuy/Mitek Products' Rotator Cuff QuickAnchor® Plus, Arthrex, Inc.'s PEEK Corkscrew FT, Smith & Nephew, Inc.'s BioRaptor 2.9 Suture Anchor, and Linvatec Corporation's UltraFix® RC. The CINCH Bone Anchor 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 Bone Anchor System and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the CINCH Bone Anchor System is as safe and effective as the predicate devices. Thus, the CINCH Bone Anchor System is substantially equivalent.

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Summary

1 1 1

Based on the intended use, technological characteristics, and performance information Based on this notification, the subject device has been shown to be substantially provided in this nothriouncil, the such predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sapphire Medical, Inc. % Janice M. Hogan, Esq. Partner Hogan & Hartson, L.L.P. 1835 Market Street, 28th Floor Philadelphia, Pennsylvania 19103

FEB 1 3 2007

Re: K062739

Trade/Device Name: CINCH Bone Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: January 26, 2007 Received: January 26, 2007

Dear Ms. Hogan:

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.

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.

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Page 2 - Janice M. Hogan, Esq.

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 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.

Budara Muehlus

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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Indications for Use Statement

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: CINCH Bone Anchor System

Indications for Use:

The CINCH Bone Anchor System is intended for the fixation of soft tissue to bone during rotator cuff repair.

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (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 Evaluation (ODE)

Oalbara Barehn
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K062739

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Regulation Number and Section

N/A