The Arthrotek® Meniscal Hybrid Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.

Device Description

The Arthrotek® Meniscal Hybrid Device incorporates two toggle anchors attached by two suture loops, one suture loop containing a sliding knot. The toggle anchors are approximately 7mm long and have beveled tips on each end. Incorporated into the body of the toggle anchor is an eyelet for the suture to pass through. They are constructed of Lactosorby, a bio-resorbable copolyment of PLLA/PGA

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Arthrotek® Meniscal Hybrid Device, which is a meniscal repair device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy from scratch.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Set by Sponsor/FDA)	Reported Device Performance
Premarket Requirement: Substantial Equivalence to Predicate Device (K982095)	Demonstrated substantial equivalence in pullout strength to predicate Meniscal Repair Device (K982095).
Specific Performance Metric: Pullout Strength	Equivalent pullout strength.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified for the mechanical testing. The document states "Mechanical testing found the Arthrotek® Meniscal Hybrid Device to be substantially equivalent...". This implies testing was performed on a sample of the new device and the predicate device, but the exact number of units tested is not provided.
Data Provenance: The testing was non-clinical (mechanical), so geographic origin of patient data is not applicable. It was a controlled laboratory study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This was a non-clinical mechanical test. Ground truth would have been established by engineering and materials science standards for measuring pullout strength, not by clinical expert consensus.

4. Adjudication Method for the Test Set

Not applicable. As a mechanical test, the results are quantitative measurements, not subjective evaluations requiring adjudication by experts.

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 is not an AI-powered diagnostic or assistive device. It is a medical device for surgical repair.

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

Not applicable. This is not an AI-powered algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was quantitative mechanical measurement of pullout strength, established through validated engineering test methods and equipment. This would have involved measuring the force required to pull the device out of a simulated tissue or testing medium.

8. The Sample Size for the Training Set

Not applicable. There was no "training set" in the context of an algorithm or AI. This was a physical medical device.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, there was no AI training set.

Summary of the Study and Acceptance Criteria:

The study proving the device meets its acceptance criteria was a non-clinical mechanical testing study. The primary acceptance criterion was demonstrating substantial equivalence in pullout strength to the predicate device (K982095). The study found the Arthrotek® Meniscal Hybrid Device to be "substantially equivalent in pullout strength, to the predicate Meniscal Repair Device." No clinical testing was required or performed for this specific 510(k) submission, as substantial equivalence was established through non-clinical means.

Summary

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K041988 pg 192

OCT 2 0 2004

510(k) Summary

Applicant/Sponsor:	Arthrotek. Inc.(A wholly owned subsidiary of Biomet, Inc.)56 East Bell DriveP.O. Box 587Warsaw, Indiana 46581-0587
Contact Person:	Gary BakerBiomet Manufacturing Corp.P.O. Box 587Warsaw, Indiana 46581-0587Phone: (574) 267-6639
Proprietary Name:	Arthrotek® Meniscal Hybrid Device
Common Name:	Meniscal Repair Device
Classification Name:	Fastener, Fixation, Biodegradable, Soft Tissue 21 CFR §888.3045

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

K982095 Lactosorb® Meniscal Repair Device Biomet Inc., Warsaw, IN *
K965228 Surgical Dynamics Meniscal Staple U.S. Surgical, Norwalk, CT *

Device Description:

Intended Use:

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Summary of Technologies:

Summal your receintered. Lactosorb® PLLA/PGA copolymer as the predicate Meniscal Repair Device (K982095).

Non-Clinical Testing:

Mechanical testing found the Arthrotek® Meniscal Hybrid Device to be substantially equivalent in pullout strength, to the predicate Meniscal Repair Device (K982095).

Clinical Testing:

Clinical testing was not required for these components to support substantial equivalence.

All trademarks are property of Biomet, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 0 2004

Mr. Gary Baker Regulatory Specialist Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana 46581

Re: K041988

Trade/Device Name: Arthrotek® Meniscal Hybrid Device Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR, MAI Dated: July 22, 2004 Received: July 23, 2004

Dear Mr. Baker:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became innd the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease in the enactment date of the Medical Device Amendments, or to conimered pror to may 20, 2011 accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic (110) that be device, subject to the general controls provisions of the Act. The r ou may, mereleve, mains of the Act include requirements for annual registration, listing of general controll profiter 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 If your device is elabilitional controls. Existing major regulations affecting your device can may or babyer to been to begulations, 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 r rease be actived that i Drimination 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 - Mr. Gary Baker

This letter will allow you to begin marketing your device as described in your Section 5 10(k) I ms letter will anow you to begin maneting your and equivalence of your device to a legally prematket notification. The PDA mining of basification 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 Patt 801), please if you desire specific advice for your do the research and the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Misorallumg Oy Telefono to premainsmonsibilities under the Act may be obtained from the Other general information on your responsible 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 yours,
Mark A. Millburn

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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INDICATIONS FOR USE

510(k) Number (if known): K041958

Device Name: Arthrotek® Meniscal Hybrid Device

Indications For Use:

The Arthrotek® Meniscal Hybrid Device is indicated for the repair of vertical longitudinal full The Arthrotek® Meniscal Hybrid Device is the red-white zones. These devices are not to
thickness tears (i.e. bucket-handle) in the red-red-white somes. These devices are not unckliess toars (no. I tears in the avascular zone of the meniscus.

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

Over-The-Counter Use_ 1/0 (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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number	K041988

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.