LACTOSORB MENISCAL REPAIR DEVICE by BIOMET, INC.

The LactoSorb® Meniscal Repair Device is indicated for the repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in 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 LactoSorb® devices are made of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is 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 in animal and clinical studies to be biocompatible in both soft tissue and bone tissue.

AI/ML Overview

This document describes a 510(k) premarket notification for the "LactoSorb® Meniscal Repair Device". The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria that the device meets. Therefore, much of the requested information about device performance, ground truth, and expert evaluation is not explicitly available in the provided text.

Here’s a breakdown of the available information and what cannot be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Mechanical Performance (In vitro)	Demonstrated to perform "as well as resorbable predicate devices indicated for use in Meniscal tissue approximation."
Material Biocompatibility (In vivo)	Found to be "biocompatible in both soft tissue and bone tissue" in animal and clinical studies.
Material Resorption (In vivo)	"Degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids, which are then metabolized by the body."
Indications for Use	Repair of vertical longitudinal full thickness tears (i.e., bucket-handle) in red-red and red-white zones. Not for meniscal tears in the avascular zone. (This is an intended use, not a performance criterion itself, but the device must meet it).

Explanation: The document does not provide specific quantitative acceptance criteria or detailed results of specific tests (e.g., tensile strength, degradation rates compared to a defined threshold). Instead, it makes a general statement of equivalency for in vitro performance and biocompatibility for in vivo performance.

2. Sample size 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 for in vitro or in vivo studies. The document only mentions "animal and clinical studies" generally.
Data Provenance: Not specified.

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

This information is not provided. The assessment relies on the FDA's determination of substantial equivalence, which primarily reviews the submission's claims and supporting data, not necessarily an independent expert panel for ground truth generation on a specific test set for this device.

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

This information is not provided.

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:

This device is a meniscal repair device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not applicable and was not done.

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

Not applicable as this is a medical device, not an algorithm.

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

For the "in vitro testing", the ground truth would likely be established mechanical properties of predicate devices or established engineering standards.
For the "animal and clinical studies" related to biocompatibility and resorption, the ground truth would be based on histopathological analysis, observation of tissue response, and material degradation analysis, which can be considered a form of scientific/pathological ground truth. Specific details are not given.

8. The sample size for the training set:

This concept is not applicable in the context of this device and submission. There is no AI model or algorithm being "trained." The "animal and clinical studies" mentioned are for evaluating the material's properties and performance, not for training a model.

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

Not applicable, as there is no training set in the context of this device.

Summary of the K982095 Submission:

This 510(k) submission for the LactoSorb® Meniscal Repair Device is a premarket notification where Biomet, Inc. sought to demonstrate that their device is "substantially equivalent" to legally marketed predicate devices. The key evidence presented for substantial equivalence involved:

In Vitro Testing: Showing that the device performs "as well as" predicate devices in meniscal tissue approximation.
Bioresorbable and Biocompatible Materials: Leveraging the known properties of polylactic/polyglycolic acid copolymer, which has been used in surgical procedures for years and degrades in vivo by hydrolysis. The biocompatibility was supported by existing "animal and clinical studies" (presumably prior studies on the material itself, or limited studies on this specific device, though not detailed here).

The FDA's review concluded that the device was substantially equivalent, allowing it to be marketed. The documentation does not detail specific "acceptance criteria" in the sense of predefined numerical thresholds for a specific study conducted for this submission, nor does it provide the granular data (sample sizes, expert qualifications, ground truth establishment methods) that would be expected for a detailed performance study as one might see for a diagnostic device or AI algorithm. Instead, it relies on general claims of equivalency and established material properties.

Summary

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K98 2095

JAN 27 1999 Summary of Safety and Effectiveness 510 (K)

Biomet, Inc. Submitter: P.O. Box 587 Airport Industrial Park Warsaw, IN 46580-0587

Mary L. Verstynen Contact Person :

Product Code: MAI

LactoSorb® Meniscal Repair Device Device Name:

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

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

IN VITRO testing demonstrated that the LactoSorb® Meniscal Repair Device will perform as well as resorbable predicate devices indicated for use in Meniscal tissue approximation.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird or symbol, composed of three curved lines that resemble a human profile.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 27 1999

Ms. Mary L. Verstynen Manager of Clinical Affairs Biomet, Inc. Airport Industrial Park P.O. Box 587 46581-0587 Warsaw, Indiana

K982095 Re: LactoSorb® Meniscal Repair Device Trade Name: Regulatory Class: II Product Codes: MAI and GAM Dated: December 17, 1998 December 18, 1998 Received:

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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗ್ಗ 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 regulations.

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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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 qeneral 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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510 (k) NUMBER (IF KNOWN) :

LactoSorb Meniscal Repair Device DEVICE NAME:

INDICATIONS FOR USE:

The LactoSorb Meniscal Repair 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.

(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 (Optional Format 1-2-96)

(Division Sign-Off) General Restorative Devi Division of 510(k) Numb

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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.