The Anatomical Bankart Tack™ is intended for use to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Anatomical Bankart Tack™ will be specifically indicated for use to provide internal fixation of soft tissue to bone for repair of anterior shoulder instability by reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with primary or reoccurrent anterior dislocation or subluxation of the shoulder (i.e., Bankart lesions).

Device Description

The Anatomical Bankart Tack™ is an absorbable device designed to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Anatomical Bankart Tack is composed of 100% poly-L-lactide ("PLLA") polymer, its length is 20mm and diameter 3.5mm.

AI/ML Overview

The provided text is a 510(k) summary for the Bionx Implants Inc. Anatomical Bankart Tack, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific performance acceptance criteria. The document explicitly states:

"The Anatomical Bankart Tack™ is substantially equivalent to the cleared Bionx Bankart Tack™ (K973849). Both devices have intended use, similar principles of operation and technological characteristics. Furthermore, the minor technological differences between the Anatomical Bankart Tack™ and the predicate devices do not raise any new issues of safety or effectiveness."

Therefore, based on the provided text, I cannot extract the information required for your request. The document does not describe:

A table of acceptance criteria and reported device performance.
Sample sizes, data provenance, or details about test sets.
The number or qualifications of experts, or adjudication methods for ground truth establishment.
MRMC comparative effectiveness study or related effect sizes.
Standalone algorithm performance.
Type of ground truth used (beyond implying equivalence to a predicate).
Details about a training set, its sample size, or how its ground truth was established.

This is a regulatory submission for substantial equivalence, which typically involves showing similarity to an already approved device, often through bench testing and sometimes limited clinical data, but not necessarily a comprehensive study demonstrating new performance against defined acceptance criteria in the way you've outlined for an AI/diagnostic device.

Summary

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510(k) Summary

Bionx Implants Inc.

Anatomical Bankart Tack

992567

Submitter´s Name, Address, Telephone Number, and Contact Person

Bionx Implants, Inc. 1777 Sentry Parkway West Gwynedd Hall, Suite 400 Bluebell, PA 19422

Contacts:

Gerry Carlozzi President, CEO (215) 643-5000 Phone: Facsimile: (215) 653-0984

Bionx Implants Ltd. Tuija Annala Regulatory Affairs Assistant P.O.Box 3 FIN-33721 Tampere Finland Phone: 358-3-316 5679 Facsimile: 358-3-316 5688

July 14th, 1999 Date prepared:

Name of the device:

Trade or Proprietary Name: Anatomical Bankart Tack™ A.

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B.	Common Name:	Bionx Anatomical Bankart Tack
C.	Classification Name:	Biodegradable soft tissue fixationfasteners
D.	Device Product Code:	87 MAI

Predicate Device:

Bionx Implants Inc. Bankart Tack™ Biodegradable soft tissue fixation fastener (K973849)

Intended Use:

Device Description:

Substantial Equivalence:

The Anatomical Bankart Tack™ is substantially equivalent to the cleared Bionx Bankart Tack™ (K973849). Both devices have intended use, similar

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principles of operation and technological characteristics. Furthermore, the minor technological differences between the Anatomical Bankart Tack™ and the predicate devices do not raise any new issues of safety or effectiveness.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping human figures, which are meant to represent the department's mission of promoting health and well-being. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 27 1999

Mrs. Tuija Annala Regulatory Affairs Assistant Bionx Implants, LTD. P.O. Box 3 FIN-33721 Tampere, Finland

Re: K992567

Anatomical Bankart Тасктм Regulatory Class: II Product Code: MAI Dated: July 16, 1999 Received: August 2, 1999

Dear Mrs. Annala:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Tuija Annala

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Celia M. Witten,

for

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(K) Number (if known): _ K 992567

Device Name:

Anatomical Bankart Tack™

Indications for Use:

The Bionx Anatomical Bankart Tack™ is intended for use to maintain the proximity between soft tissue and bone to facilitate soft tissue reattachment in the repair of shoulder injuries. The Bionx Bankart Tack will be specifically indicated for use to provide internal fixation of soft tissue to bone for repair of anterior shoulder instability by reattachment of the glenoid labrum and/or inferior glenohumeral ligaments in patients with primary or recurrent anterior dislocation or subluxation of the shoulder (i.e. Bankart lesions).

(Please do not write below this line - continue on another page is needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR Over-The-Counter Use

(Per 21 CFR 801.109)

NRO Sur IZD

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992567

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.