LACTOSORB TIBIAL L-15 SCREW AND WASHER by BIOMET, INC.

ACL and PCL reconstruction
Medial collateral ligament repair
Lateral collateral ligament repair
Posterior oblique ligament repair
Iliotibial band tenodesis reconstruction
Patellar ligament and tendon repair
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 device description of the LactoSorb® Tibial L-15 Screw and Washer is as follows:

Resorbable screw in varying diameters
Screw pre-assembled with a washer
Fixation achieved by sandwiching the soft tissue between the two washers and screwing into the bone
85% L-Lactide/15% Glycolide copolymer

AI/ML Overview

Here's an analysis of the provided information regarding the LactoSorb® Tibial L-15 Screw and Washer, focusing on the absence of information related to acceptance criteria and a study proving those criteria:

Explanation of Missing Information:

The provided document is a 510(k) Summary for a medical device. For devices seeking 510(k) clearance, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific, pre-defined acceptance criteria through a standalone performance study.

Therefore, the document explicitly states: "Clinical Testing: None provided" and describes "Non-Clinical Testing: Mechanical testing demonstrated pull-out testing comparable to the predicate device." This means the manufacturer did not conduct a study to establish specific acceptance criteria and then demonstrate the device meets them in the way described in your request (e.g., in terms of sensitivity, specificity, accuracy, or human reader performance).

Instead, the "acceptance criteria" here are implicitly tied to demonstrating performance similar to the predicate device. The "study" proving this is the non-clinical mechanical testing that showed comparable pull-out strength.

Given this context, I cannot provide the detailed information requested in points 1-9 as it directly relates to a type of performance study that was explicitly not provided or required for this 510(k) clearance.

However, based on the information provided, here's what can be extracted and inferred regarding the "acceptance criteria" and "study" in the context of a 510(k) submission focused on substantial equivalence:

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

Acceptance Criteria (Implied for 510(k) Substantial Equivalence to Predicate)	Reported Device Performance
Mechanical Performance: Equivalent pull-out strength to the predicate device.	"Mechanical testing demonstrated pull-out testing comparable to the predicate device."
Material Composition: Use of similar resorbable copolymer (85% L-Lactide/15% Glycolide).	"85% L-Lactide/15% Glycolide copolymer." (Same as predicate - inferred from "similarities" abstract)
Overall Design/Processing: Similar to predicate device.	"The overall design, materials and processing methods are similar to the predicate device."

2. Sample size used for the test set and the data provenance:

Sample Size (Non-Clinical Mechanical Testing): Not specified in the provided summary.
Data Provenance: Not specified, but generally, mechanical testing for 510(k) submissions is conducted by the manufacturer or a contracted lab. It is not clinical human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This pertains to clinical studies often involving expert review of images or patient outcomes, which were not conducted for this submission. The "ground truth" for mechanical testing would be the physical properties measured by engineering instruments.

4. Adjudication method for the test set:

Not applicable. This refers to consensus among multiple human reviewers for clinical data, which is not relevant here.

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 type of study (MRMC, AI-assisted performance) is completely irrelevant to the submission for this particular medical device (a screw and washer) and the type of data provided.

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

Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used:

For the non-clinical mechanical testing, the "ground truth" would be the measured physical properties (e.g., force in Newtons for pull-out strength) derived from standardized test methods.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/algorithm-based device.

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

Not applicable. As above, no training set.

In summary: The provided 510(k) summary for the LactoSorb® Tibial L-15 Screw and Washer demonstrates substantial equivalence to a predicate device via non-clinical mechanical testing. It does not contain information about specific acceptance criteria, clinical study results, or AI-related performance metrics because these were not part of the submission or the regulatory pathway chosen. The "acceptance criteria" were implicitly met by demonstrating "comparable" mechanical performance to the predicate device.

Summary

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033233 1/2

NOV - 5 2003

BIOMET

510(k) Summary

Applicant/Sponsor:Biomet Orthopedics, Inc.

Contact Person: Patricia Sandborn Beres Senior Requlatory Specialist

Proprietary Name: LactoSorb® Tibial L-15 Screw and Washer

Common Name: Non-metallic screw and washer

Classification Name: Screw, Fixation, Bone, Non-Spinal, Non-Metallic (21 CFR 888.3040

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Arthrotek Resorbable No-Profile LactoSorb® L-15 Screw and Washer cleared in 510(k) K021832).

Device Description: The device description of the LactoSorb® Tibial L-15 Screw and Washer is as follows:

· Resorbable screw in varying diameters
Screw pre-assembled with a washer .
Fixation achieved by sandwiching the soft tissue between the two washers . and screwing into the bone
85% L-Lactide/15% Glycolide copolymer .

Intended Use: The LactoSorb® Tibial L-15 Screw and Washer is indicated for the following procedures:

1-11

574.267.8137

1. ACL and PCL reconstruction
1. Medial collateral ligament repair
1. Lateral collateral ligament repair
1. Posterior oblique ligament repair

574.267.6639

1. Iliotibial band tenodesis reconstruction
1. Patellar ligament and tendon repair

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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.

Summary of Technologies: The overall design, materials and processing methods are similar to the predicate device

Non-Clinical Testing: Mechanical testing demonstrated pull-out testing comparable to the predicate device.

Clinical Testing: None provided

All trademarks are property of Biomet, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles an abstract caduceus, featuring three curved lines above a wavy line.

Public Health Service

NOV = 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Orthopedics, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0578

K033233 Re:

Trade Name: LactoSorb® Tibial L-15 Screw and Washer Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MAI Dated: October 1, 2003 Received: October 6, 2003

Dear Ms. Beres:

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 requiréments 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 (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 - Ms. Patricia Sandborn Beres

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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Mark N Mulhearn

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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510(k) NUMBER (IF KNOWN):_____________________________________________________________________________________________________________________________________________________

DEVICE NAME: LactoSorb® Tibial L-15 Screw and Washer

INDICATIONS FOR USE:

The LactoSorb® Tibial 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

(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)

Over-The-Counter-Use__
(Optional Format 1-2-96)

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number

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.