Extra-capsular Repairs:
1a. Medial Collateral Repair
1b. Lateral Collateral Ligament
1c. Posterior Oblique Ligament
Iliotibial band tenodesis
Patellar realignment and tendon repairs, including vastus medialis obliquos advancement

Device Description

The Twin Fix AB 6.5 mm anchor is a bi-lobed, bioabsorable anchor to which multiple USP No. 2 absorbable or non-absorbable sutures are attached.

AI/ML Overview

I am sorry, but the provided text describes a medical device (Twin Fix AB™ 6.5 mm suture anchor) and its intended use, along with regulatory information, but it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a medical device and primarily focuses on demonstrating substantial equivalence to a predicate device. It lists:

The device's name, common name, and classification.
The predicate device.
A description of the device.
Its intended use and specific indications for use across different anatomical areas.
A statement of comparison of technological characteristics, asserting it is "identical in design, operating principle, material and intended use" to the predicate device.
The FDA's decision letter of substantial equivalence.

Therefore, for the information you requested, I can only state the following based on the provided text:

A table of acceptance criteria and the reported device performance: Not available in the provided text.
Sample size used for the test set and the data provenance: Not available in the provided text.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in the provided text.
Adjudication method for the test set: Not available in the provided text.
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, as this is a physical medical device (suture anchor), not an AI/imaging diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
The type of ground truth used: Not available in the provided text.
The sample size for the training set: Not applicable, as this describes a physical medical device, not a machine learning model.
How the ground truth for the training set was established: Not applicable, as this describes a physical medical device, not a machine learning model.

This type of 510(k) submission for a Class II device like a suture anchor typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive new clinical trial data with acceptance criteria for device performance. The "study" mentioned would likely refer to bench testing and material characterization to ensure consistency with the predicate, which is not detailed in this summary.

Summary

{0}------------------------------------------------

K032197 PMGL 1/2

AUG - 8 2003

Endoscopy Division

Smith & Nephew, Inc. 160 Dascomb Road, Andover, MA 01810 U.S.A. Telephone: (978) 749-1000 Toll Free: 1-800-343-8386 Fax: (978) 749-1599

Smith@Nephew

SECTION V 510(k) Summary

Twin Fix AB™ 6.5 mm suture anchor

Date Prepared: June 15, 2003

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR $807.92.

A. Submitter

Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, MA 01810 508. 261.3699

B. Company Contact

Jason Bilobram Regulatory Affairs Manager

C. Device Name

Trade Name:	Twin Fix AB 6.5 mm anchor
Common Name:	Absorbable Suture Anchor
Classification Name:	Class II, Fastener, Fixation, Biodegradable, Soft TissueProduct Code MAI
D. Predicate Devices	5.0 mm Absorbable Polymer Anchor (K011299)Proprietary Name: Twin Fix AB 5.0 mm suture anchor

E. Description of Device

The Twin Fix AB 6.5 mm anchor is a bi-lobed, bioabsorable anchor to which multiple USP No. 2 absorbable or non-absorbable sutures are attached.

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F. Intended Use

The Twin Fix AB 6.5 mm anchor is a bioabsorable suture anchor utilized for the reattachment of soft tissue to bone.

The indications for the Twin Fix AB 6.5 mm anchor are:

Shoulder:

1. Bankart Lesion Repair
1. Slap Lesion Reapir
1. Acromioclavicular separation repairs
1. Rotator Cuff Repair
1. Capsular shift or capsulolabral reconstruction
1. Biceps tenodesis
1. Deltoid Repair

Foot and Ankle:

1. Hallux Valgus repair
1. Medial or Lateral instability repairs/reconstruction
1. Achilles tendon repair/reconstruction
1. Midfoot reconstruction
1. Metatarsal ligament/tendon repairs/reconstruction

Elbow, Wrist, and Hand:

1. Scapholunate ligament reconstruction
1. Ulnar or radial collateral ligament reconstruction
1. Lateral epicondylitis repair
1. Biceps tendon reattachment

Knee:

1. Extra-capsular Repairs:
- Medial Collateral Repair 1a.
- 1b. Lateral Collateral Ligament
- Posterior Oblique Ligament 1c.
1. Iliotibial band tenodesis
1. Patellar realignment and tendon repairs, including vastus medialis obliquos advancement

G. Comparison of Technological Characteristics

The Twin Fix AB 6.5 mm anchor is identical in design, operating principle, material and intended use to the Twin Fix AB 5.0 mm anchor.

foan Bilah

n Bilobram las Regulatory Affairs Manager

{2}------------------------------------------------

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 - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a symbol that looks like three stylized waves or lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 2003

Mr. Jason Bilobram Regulatory Affairs Manager Smith & Nephew, Inc. Endoscopy Division 130 Forbes Boulevard Mansfield, Massachusetts 02048

Re: K032197

Trade Name: Twin Fix AB™ 6.5mm Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: MAI Dated: July 17, 2003 Received: July 18, 2003

Dear Mr. Bilobram:

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

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Page 2 - Mr. Jason Bilobram

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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name: 6.5 mm Absorbable Polymer Anchor

(Proprietary Name) Twin Fix™ AB 6.5 mm anchor

Intended Use: Reattachment of soft tissue to bone

Indications for Use:

Shoulder:

Bankart Lesion Repair 1.
SLAP Lesion Repair 2.
Acromioclavicular separation repairs 3.
Rotator Cuff Repair 4.
Capsular shift or capsulolabral reconstruction ട്.
Biceps tenodesis 6.
Deltoid Repair 7.

Foot and Ankle:

Hallux Valgus repair 1.
Medial or Lateral instability repairs/reconstruction 2.
Achilles tendon repair/reconstruction 3.
Midfoot reconstruction 4.
Metatarsal ligament/tendon repairs/reconstruction 5.

Elbow, Wrist, and Hand:

Scapholunate ligament reconstruction 1.
Ulnar or radial collateral ligament reconstruction 2.
Lateral epicondylitis repair 3.
Biceps tendon reattachment 4.

Knee:

Extra-capsular Repairs: 1.
- Medial Collateral Repair la.
- 1b. Lateral Collateral Ligament
- Posterior Oblique Ligament 1c.
1. Iliotibial band tenodesis
Patellar realignment and tendon repairs, including vastus medialis obliquos advancement 3.

(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Miriam C. Provost
(Division Sign-Off) Over-the-Counter

Division of General, Re ptional Format 1-2-96) and Neurological De

(03219 510(k) Number.

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.