The Resorbable LactoSorb-L® ACL Crosspin is comprised of a PI LA:PGA copolymer. The threadless, push-in device is used for femoral fixation of a soft tissue graft. The Resorbable LactoSorb-L® ACL Crosspin includes a suture eyelet at the tip. This eyelet allows the device to be used with a technique similar to that utilized by cannulated devices, however, the crosspin is not cannulated.

AI/ML Overview

The provided document does not describe any clinical studies or acceptance criteria in the context of device performance in humans.

Instead, the document is a 510(k) premarket notification for the Resorbable LactoSorb-L® ACL Crosspin, where the manufacturer is seeking to establish substantial equivalence to previously marketed devices.

Here's what the document does state regarding testing:

Non-Clinical Testing: "Mechanical testing was performed to establish substantial equivalence."
Clinical Testing: "Clinical testing was not used to establish substantial equivalence."

This means the device's safety and effectiveness were demonstrated through benchtop mechanical tests, comparing its physical properties to predicate devices. There was no human-subject study reported that would involve acceptance criteria for clinical performance or human reader analysis.

Therefore, I cannot provide the requested information regarding:

A table of acceptance criteria and reported device performance (in human studies).
Sample size used for the test set and data provenance.
Number of experts and their qualifications for ground truth.
Adjudication method.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study and effect size.
Standalone (algorithm only) performance.
Type of ground truth used (pathology, outcomes data, etc.).
Sample size for the training set.
How ground truth for the training set was established.

Summary

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

K0/4305-

MAR 2 9 2002

Image /page/0/Picture/2 description: The image shows the logo for Biomet Corporate Headquarters. The word "BIOMET" is in a stylized, bold font with horizontal lines above and below the letters. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller, sans-serif font.

SUMMMARY OF SAFETY AND EFFECTIVENESS

Applicant or Sponsor:

Arthrotek, Inc. (A wholly owned subsidiary of Biomet, Inc.) 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Contact Person:

Sara B. Shultz Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587 Phone: (219) 267-6639 FAX: (219) 372-1683

Proprietary Name:

Resorbable LactoSorb-L® ACL Crosspin

Common or Usual Name:

Classification Name:

Pin, Fixation, Smooth, Non-metallic (888.3040)

HTY and MAI Device Product Code:

Legally Marketed Devices To Which Substantial Equivalent Is Claimed: Arthrotek Interference Screw (K988497), Mitek 3.3 ST Cross Pin (K974341), Bone Mulch Screw (K K941941/K991298/K993025), Arthrex Bio-Transfix (K011172).

Indications for Use: The Resorbable LactoSorb-L® ACL Crosspin is indicated for ACL reconstruction.

Device Description: The Resorbable LactoSorb-L® ACL Crosspin is comprised of a PI LA:PGA copolymer. The threadless, push-in device is used for femoral fixation of a soft tissue graft.

The Resorbable LactoSorb-L® ACL Crosspin includes a suture eyelet at the tip. This eyelet allows the device to be used with a technique similar to that utilized by cannulated devices, however, the crosspin is not cannulated.

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

1

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

000230

OFFICE 219.267.6639

I³AX 219.267.8137

E-MAIL biomet@biomet.com

{1}------------------------------------------------

Page 2 of 2

Image /page/1/Picture/1 description: The image shows the logo for Biomet Corporate Headquarters. The word "BIOMET" is in large, bold, sans-serif font. Below that, the words "CORPORATE HEADQUARTERS" are in a smaller, serif font.

Summary of Technologies: The device's technological characteristics (materials, design, sizing, and indications) are similar to or identical to the predicate devices.

Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence.

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

트

0002

OFFICE 219.267.6639

I·AX 219.267.8137

E-MAIL biomet@hiomet.com

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2002

Ms. Sara B. Shultz Regulatory Specialist Arthrotek, Inc. C/O Biomet Orthopedics P.O. Box 587 Warsaw, IN 46581

Re: K014305

Rol 1505
Trade/Device Name: Resorbable LactoSorb-L® ACL Crosspin Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: December 28, 2001 Received: December 31, 2001

Dear Ms. Shultz:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained health equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manetted to the Medical Device Ameralments, or to commerce prof to May 28, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have been icclassified in acceraalite while approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval and and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The
You may, therefore, market the device, subject to the general controls prov You may, therefore, market me device, baojeer to the see annual registration, listing of general controls provisions of the fret mercial required to the managainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in II your device is classifica (seculoro) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Lines. Title 21, Parts 800 to 898. In addition, FDA may be found in the Our deements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease be advised that I Dri 3 issuance or our device complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must of any I edelal statutes and regulations and including, but not limited to: registration and listing (21 comply with an the Act 3 requirements, moraans, and manufacturing practice requirements as set CrK Fatt 607), laocing (21 CFRT art 820), and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820), and if applicable, 1959, 1959 forth in the quality systems (Q2) regarders (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Ms. Sara B. Shultz

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis ictier wifi anow you to ogin mains of substantial equivalence of your device to a legally prematics notification: "The Pro Intentiges cation 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 II you desire spoolite ad roo for you in vitro diagnostic devices), please contact the Office of additionally 21 CHT an 007.10 101 in The vise vises on the promotion and advertising of Compliance at (301) 59 + 2 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation chitted, "Whiording of responsibilities under the Act may be obtained from the Oinci general information on your new 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,

O. Mark n. Mulkann

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

{4}------------------------------------------------

Page / of /

510(k) NUMBER (IF KNOWN): K014365

DEVICE NAME: Resorbable LactoSorb-L® ACL Crosspin

INDICATIONS FOR USE:

The Resorbable LactoSorb-L® ACL Crosspin is indicated for ACL reconstruction.

(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) yu
OR
Over-The-Counter-Use No
(Optional format 1-2-96)

Mark n' Millen
for Division Sign-Off
Division of General Restorative
and Neurological Devices

510(k) Number: K014305 000003

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.