ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER by BIOMET, INC.

This device is also intended to be used as back-up fixation in ACL reconstruction in conjunction with other marketed devices in order to provide additional fixation strength in instances of questionable bone quality.

Device Description

The Arthrotek Resorbable No-Profile LactoSorb® L-15 Screw and Washer consists of a resorbable 6.5 mm screw that varies in length from 25 mm to 55 mm (5 mm increments) and a 18 mm diameter washer with eight spikes on the distal surface. The screw is machined from an 85% L-Lactide/15% Glycolide material that is a high viscosity copolymer. The washer is injection molded from the same material.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device, the Arthrotek Resorbable No-Profile LactoSorb® L-15 Screw and Washer. This type of submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing, rather than presenting a clinical study with acceptance criteria and performance metrics for an AI-powered device.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable or cannot be extracted from this document.

Here's an analysis of what can be inferred from the provided text, and where the information is unavailable:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device. The "acceptance criteria" for a 510(k) submission like this are demonstrating substantial equivalence to a predicate device.
Reported Device Performance: The document states "Non-clinical testing demonstrated statistical equivalence between this device and the predicate." No specific performance metrics or values are provided in the extracted text.

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

Test Set Sample Size: Not applicable. This was a non-clinical testing (likely mechanical or material testing) and did not involve a "test set" in the context of clinical data or AI evaluation.
Data Provenance: Not applicable. The "testing" referred to non-clinical evaluations.

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

Not applicable. As noted above, this was non-clinical testing, not a study requiring expert-established ground truth.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document explicitly states: "Clinical testing was not used to establish substantial equivalence." This means no human reader studies, with or without AI assistance, were performed or presented for this submission.

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

Not applicable. This is a physical medical device (screw and washer), not an algorithm or AI.

7. The Type of Ground Truth Used:

Not applicable for the reasons stated above. The "ground truth" for this device's approval was its equivalence to a predicate device based on non-clinical (e.g., mechanical, material) testing.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI device, so there is no training set.

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

Not applicable.

In summary, the provided document (a 510(k) premarket notification for a physical medical device) does not contain the type of information requested for evaluating an AI-powered device's performance against specific acceptance criteria in a clinical study setting. The approval was based on demonstrating substantial equivalence through non-clinical testing to a legally marketed predicate device.

Summary

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K021832

JUN 2 6 2002

Image /page/0/Picture/2 description: The image shows the logo for Biomet Corporate Headquarters. The logo is in black and white. The word "BIOMET" is in a stylized font with a box around the "B" and lines through the "E" and "T". Below the logo, the words "CORPORATE HEADQUARTERS" are written in a smaller, sans-serif font.

SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant or Sponsor:	Arthrotek, Inc.(A wholly owned subsidiary of Biomet, Inc.)56 East Bell DriveP.O. Box 587Warsaw, Indiana 46581-0587
Contact Person:	Sara B. ShultzBiomet Orthopedics, Inc.56 East Bell DriveP.O. Box 587Warsaw, IN 46582Phone: (574) 267-6639FAX: (574) 372-1683
Proprietary Name:	Arthrotek Resorbable No-ProfileLactoSorb® L-15 Screw and Washer
Common Name:	Resorbable screw and washer
Classification Name:	Screw, Fixation, Bone, Non-spinal, Non-metallic (888.3040)Washer, Bolt Nut, Non-spinal, Non-metallic(888.3030)
Device Product Code:	87HWC and HTN

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Resorbable No Profile Screw and Washer, Biomet, Inc. (K012469).

Intended Use: The Arthrotek Resorbable No-Profile LactoSorb® L-15 Screw and Washer is indicated for the following procedures:

1. ACL and PCL reconstruction
1. Medial collateral ligament repair
1. Lateral collateral ligament repair
1. Posterior oblique ligament repair
1. Iliotibial band tenodesis reconstruction
1. Patellar ligament and tendon repair

MAILING ADDRESS	SHIPPING ADDRESS
P.O. Box 587	56 E. Bell Drive
Warsaw, IN 46581-0587	Warsaw, IN 46582
OFFICE219.267.6639	OFFICE	219.267.6639	FAX219.267.8137	FAX	219.267.8137
OFFICE
219.267.6639
FAX
219.267.8137

bioE-MAIL biomet@ki……

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Image /page/1/Picture/1 description: The image shows the logo for Biomet Corporate Headquarters. The word "BIOMET" is in a bold, sans-serif font, with each letter connected to the next. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller, serif font.

Device Description: The Arthrotek Resorbable No-Profile LactoSorb® L-15 Screw and Washer consists of a resorbable 6.5 mm screw that varies in length from 25 mm to 55 mm (5 mm increments) and a 18 mm diameter washer with eight spikes on the distal surface. The screw is machined from an 85% L-Lactide/15% Glycolide material that is a high viscosity copolymer. The washer is injection molded from the same material.

Non-Clinical Testing: Non-clinical testing demonstrated statistical equivalence between this device and the predicate.

Clinical Testing: Clinical testing was not used to establish substantial equivalence.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 219.267.6639

l·Ax 219.267.8137

biomet

E-MAIL

Image /page/1/Picture/10 description: The image shows the number 00068 in a bold, sans-serif font. The numbers are aligned horizontally and are of uniform size. The background is plain and white, which makes the numbers stand out.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a serif font. The text is centered on the image and is the only element in the image. The text is likely the header of a document or website.

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2002

Ms. Sara B. Shultz Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K021832

Trade/Device Name: Arthrotek Resorbable No-Profile LactoSorb® L-15 Screw and Washer Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: June 3, 2002 Received: June 4, 2002

Dear Ms. Shultz:

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 (OS) 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. Sara B. Shultz

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 and additionally 21 CFR Part 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" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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 yours,

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

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 cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 DGRND D.O. f/t: POSung:bxw:6/25/02

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510 (k) Number (if known) : K021832

DEVICE NAME: Arthrotek Resorbable No-Profile LactoSorb® L-15 Screw and Washer

INDICATIONS FOR USE:

The Arthrotek Resorbable No-Profile LactoSorb® L-15 Screw and Washer is indicated for the following procedures:

1. ACL and PCL reconstruction
1. Medial collateral ligament repair
1. Lateral collateral ligament repair
1. Posterior oblique ligament repair
1. Iliotibial band tenodesis reconstruction
1. Patellar ligament and tendon repair

for Mark N. Mulkeron

Division Sign-C Di- ision of General, Restorative and Neurological Devic

510(k) Number _

(PLEASE DO NOT 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

OR Over-The-Counter-Use NO
(Optional Format 1-2-96)

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.