Indications for the Composite Hitch™ Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, elbow, and knee. Specific indications are as follows:

Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.

Wrist/Hand: Scapholunate ligament reconstruction

Elbow: Tennis elbow repair, Biceps tendon reconstruction, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.

Knee: Extracapsular repair: Medial collateral ligament repair, lateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.

Device Description

The Composite Hitch™ Suture Anchor is made with a composite, resorbable material. The soft tissue anchor, preloaded with polyethylene surgical suture, enables the implantable anchor by screwing it in through a tapped pre-drilled hole or by simply pushing the point directly into the bone without pre-drilling a starter hole.

AI/ML Overview

This document is a 510(k) summary for the Biomet Composite Hitch™ Suture Anchor. It details the device, its intended use, and claims substantial equivalence to predicate devices. However, it explicitly states "Clinical Testing: None provided as a basis for substantial equivalence."

Therefore, the provided text does not contain information about acceptance criteria, device performance from a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The submission relies solely on non-clinical testing and comparison to legally marketed predicate devices.

Based on the provided text, the following information can be extracted:

A table of acceptance criteria and the reported device performance:
- N/A. The document states, "Clinical Testing: None provided as a basis for substantial equivalence." The basis for substantial equivalence relies on non-clinical testing and comparison to predicate devices, not on meeting specific acceptance criteria from a clinical performance study. The non-clinical testing "results indicate that the anchors are substantially equivalent to predicate anchors with similar indications for use," but no specific performance metrics or acceptance criteria are listed.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. No clinical test set was used. Non-clinical laboratory testing was performed, but sample sizes for this testing are not provided in this summary.
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):
- N/A. No clinical test set with human-established ground truth was performed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No clinical test set was used requiring adjudication.
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:
- N/A. No MRMC comparative effectiveness study was done, as no clinical testing was performed. This device is a suture anchor, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device is a medical implant (suture anchor), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. No clinical study involving ground truth determination was performed. The non-clinical testing would likely have used engineering specifications or material properties as "ground truth" for evaluating the anchor's physical characteristics, but these are not detailed.
The sample size for the training set:
- N/A. This device is a medical implant, not an AI/machine learning model. Therefore, there is no "training set."
How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set for this device.

Summary

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K081172 page 174

Image /page/0/Picture/1 description: The image shows the logo for BIOMET MANUFACTURING CORP. The logo is in a simple, sans-serif font. The word "BIOMET" is in a larger font than the words "MANUFACTURING CORP."

510(k) Summarv

JUL 1 7 2008

Preparation Date: April 22, 2008

Applicant/Sponsor: Biomet Sports Medicine, Inc. (formerly known as Arthrotek, Inc.)

Contact Person: Becky Earl

Proprietary Name: Composite Hitch™ Suture Anchor

Common Name: Suture anchor

Classification Name: Fastener, fixation, biodegradable, soft tissue (21 CFR 888,3030)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Hitch™LactoSorb® Suture Anchor, K061657, Biomet, Inc. �
Soft Tissue Screw and Washer, K012572, Biomet, Inc. �
t Biocryl Rapide Bioknotless BR Anchor, K070925, DePuy Mitek

Device Description:

Intended Use:

Indications for the Composite Hitch™ Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, elbow, and knee. Specific indications are as follows:

Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.

Wrist/Hand: Scapholunate ligament reconstruction

Elbow: Tennis elbow repair, Biceps tendon reconstruction, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.

Summary of Technologies: The Composite Hitch™ Suture Anchor has similar or identical technological characteristics (design, materials, and functional performance) as the predicate devices.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicate that the anchors are substantially equivalent to predicate anchors with similar indications for use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet Inc.

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Shipping address 9.923 Dat Cars

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. To the left of the eagle is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2008

Biomet Manufacturing Corp. % Ms. Becky Earl Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K081172 Trade/Device Name: Composite Hitch™ Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR, HWC Dated: April 22, 2008 Received: April 24, 2008

Dear Ms. Earl:

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.

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.

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Page 2 - Ms. Becky Earl

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 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millican

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

510(k) Number (if known):____________________________________________________________________________________________________________________________________________________

Device Name: Composite Hitch™ Suture Anchor

Indications for Use:

Indications for the Composite Hitch™ Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, elbow, and knee. Specific indications are as follows:

Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.

Wrist/Hand: Scapholumate linament reconstruction

Elbow: Tennis elbow repair, Biceps tendon reconstruction, medial and lateral repairs, ulhar or radial collateral ligament reconstruction.

Knee: Extracapsular repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.

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

Over-The-Counter Use _ NO (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Вавеневир

Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number_k081172

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.