ARTHROTEK INTERFERENCE SCREW by BIOMET, INC.

1. To provide interference fixation of patellar bone-tendonbone grafts in anterior cruciate ligament (ACL) reconstruction.
1. To provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
1. To provide interference fixation during posterior cruciate ligament (PCL) reconstruction.
  Implantation of the Intereference Screw is accomplished through arthroscopy and arthrotomy.

Device Description

The Arthrotek Interference Screw is made of LactoSorb®, which is comprised of bioresorbable, and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found to be biocompatible in animal and clinical studies in both soft tissue and bone tissue.

AI/ML Overview

The provided text is a 510(k) summary for the Arthrotek Interference Screw, focusing on its substantial equivalence to a predicate device. It describes the device's indications for use and material composition, and mentions "IN VITRO testing demonstrated that the Arthrotek Interference Screw will perform as well as a resorbable predicate device indicated for use in ACL or PCL reconstruction." However, it does not provide details about specific acceptance criteria or a study that rigorously proves the device meets those criteria in a way that allows for a quantitative table or the other requested information regarding sample sizes, expert involvement, or AI performance.

Therefore, many of the requested fields cannot be filled based on the provided document.

Here's a breakdown of what can and cannot be answered:

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

Acceptance Criteria	Reported Device Performance
Specific quantitative criteria for "performance as well as a resorbable predicate device"	"IN VITRO testing demonstrated that the Arthrotek Interference Screw will perform as well as a resorbable predicate device indicated for use in ACL or PCL reconstruction." (No specific quantitative metrics or thresholds are provided in the document for comparison.)

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 in the document. The statement "IN VITRO testing" does not elaborate on the number of samples tested.
Data provenance: Not specified in the document.

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. The described testing is "IN VITRO," meaning it was conducted in a laboratory setting. There is no mention of human experts establishing ground truth for the performance testing in this context.

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

Not Applicable. No human adjudication method is described for the in vitro performance 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

No. This document pertains to the regulatory submission of a medical device (interference screw) and does not involve AI or human readers for diagnostic interpretation.

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

Not Applicable. This document does not concern an algorithm or AI.

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

The "ground truth" for the in vitro performance testing would likely be based on engineering measurements and specifications related to the mechanical properties and fixation strength of the device compared to the predicate. The document states it performed "as well as a resorbable predicate device," implying a comparative standard.

8. The sample size for the training set

Not Applicable. No training set is mentioned in the context of this device's performance testing, as it is not an AI/ML device.

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

Not Applicable. No training set is mentioned.

Summary

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Summary of Safety and Effectiveness 510 (K)

Biomet, Inc. Submitter: P.O. Box 587 Airport Industrial Park Warsaw, IN 46581-0587

Mary L. Verstynen Contact Person:

Product Code: MAI

Device Name: Arthrotek Interference Screw

The Arthrotek Interference Screw is indicated for the following uses:

1. To provide interference fixation of patellar bonetendon-bone grafts in anterior cruciate ligament (ACL) reconstruction.
1. To provide interference fixation during femoral and/or tibial fixation in anterior cruciate liqament reconstruction using a soft-tissue graft (semitendinosus, gracilis) .
1. To provide interference fixation during posterior cruciate ligament (PCL) reconstruction.

Implantation of the Interference Screw is accomplished through athroscopy or arthrotomy.

IN VITRO testing demonstrated that the Arthrotek Interference Screw will perform as well as a resorbable predicate device indicated for use in ACL or PCL reconstruction.

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure. The symbol is composed of three curved lines that form the body and wings of the bird or the torso and arms of the human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 16 1998

Ms. Mary L. Verstynen Manager of Clinical Affairs Biomet, Inc. P.O. Box 487 Warsaw, Indiana 46581-0587

K982497 Re: Trade Name: Arthrotek Interference Screw Regulatory Class: II Product Codes: HWC and MAI Dated: July 16, 1998 Received: July 20, 1998

Dear Ms. Verstynen:

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, Druq, 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 aqainst 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 In addition, FDA may publish further announcements action. 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 requlations.

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Page 2 - Ms. Mary L. Verstynen

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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

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

Enclosure

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Page 1 of 1

510(k) NUMBER (IF KNOWN) : _ K982497

Arthrotek Interference Screw DEVICE NAME:

INDICATIONS FOR USE:

The Arthrotek Interference Screw is indicated for the following uses:

1. To provide interference fixation of patellar bone-tendonbone grafts in anterior cruciate ligament (ACL) reconstruction.
1. To provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
1. To provide interference fixation during posterior cruciate ligament (PCL) reconstruction.

Implantation of the Intereference Screw is accomplished through arthroscopy and arthrotomy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-The-Counter-Use Prescription Use OR (Per 21 CFR 801.109) (Optional Format 1-2-96) (Divis on Sign-Off) Division of General Restorative Devices 510(k) Number_k982497

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.