MEMBRANE TACK by BIOMET, INC. | FDA 510(k) Summary

The Membrane Tack is a barrier membrane fixation tack used in oral/maxillofacial surgical procedures for stabilizing membranes in Guided Bone Regeneration (GBR) or Guided Tissue Regeneration (GBR) procedures or other clinical situations that require membrane use/fixation. The Membrane Tack is used to fixate commercially available resorbable and nonresorbable barrier membranes. The Membrane Tacks are made of LactoSorb® which are composed of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and Polylactic/polyglycolic acid copolymer glycolic acids. degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Membrane Tack." It focuses on establishing substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria with detailed performance metrics. Therefore, explicit information required to fill out the table and answer all questions about acceptance criteria and a detailed study is not available in the given document.

However, I can extract the information that is present and indicate where information is missing.

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

The document does not explicitly define acceptance criteria in terms of quantitative performance metrics (e.g., specific thresholds for strength or resorption rates that differentiate success from failure). Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device.

The reported performance is qualitative and comparative:

Acceptance Criteria (Explicitly Stated)	Reported Device Performance
Mechanical Strength	Will maintain its strength for 6-8 weeks (qualitative assessment for functional period)
Resorption	Completely resorbs by 12 months (qualitative assessment for bioresorbability)
Material Biocompatibility	Biocompatible in both soft tissue and bone tissue (based on animal studies of LactoSorb®)
Safety and Effectiveness	Found to be both safe and effective (based on prior marketing of LactoSorb® devices for over two years)
Substantial Equivalence	Substantially equivalent to a marketed bioresorbable membrane tack.

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. The document primarily refers to prior studies or general knowledge about the material (LactoSorb®) and comparisons to a predicate device. There is no new test set described for the Membrane Tack itself in this summary.
Data Provenance: Not specified for any new testing. References are made to "animal studies" for LactoSorb® and "prior marketing" of LactoSorb® devices, implying historical data. No country of origin is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document does not describe a study involving expert assessment to establish ground truth for a test set for this device. The assessment is based on material properties, prior use of the material, and comparison to a predicate device.

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

Not applicable. No expert-adjudicated test set is described.

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

Not applicable. This device is a physical medical device (a tack for membrane fixation), not an AI diagnostic or assistance tool. Therefore, an MRMC study related to interpretation by human readers is irrelevant.

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

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

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

The "ground truth" for the claims in this submission is derived from:

Material Science Data: Properties of LactoSorb® concerning degradation, resorption, and biocompatibility.
Pre-clinical (Animal) Studies: Mentioned for LactoSorb®'s biocompatibility.
Clinical Experience/Outcomes Data (Indirect): Reference to LactoSorb® devices being "marketed for over two years" and found "both safe and effective" in other applications.
Comparison to a Predicate Device: The primary method for proving substantial equivalence. The predicate device's established safety and effectiveness serve as a benchmark.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI algorithm requiring a training set in the machine learning sense.

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

Not applicable. As above, this is not an AI algorithm.

Summary

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JUL 1 4 1998

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510(k) Summary of Safety and Effectiveness

Biomet, Inc. Submitter: P.O. Box 587 Airport Industrial Park 46581-0587 Warsaw, IN

Mary L. Verstynen Contact Person:

76DZL Product Code:

Membrane Tack Device Name:

The Membrane Tacks are made of LactoSorb® which are composed of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and Polylactic/polyglycolic acid copolymer glycolic acids. degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. In animal studies LactoSorb® has been found to be biocompatible in both soft tissue and bone tissue. LactoSorb® devices have been marketed for over two years for use in trauma and reconstructive procedures in the craniomaxillofacial skeleton and have been found to be both safe and effective.

The Membrane Tack is substantially equivalent to a marketed bioresorbable membrane tack. It will maintain its strength for 6-8 weeks and completely resorbs by 12 months.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 1998

Ms. Mary Verstynen Clinical Research Manager Biomet, Incorporated Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587

K981459 Re : Membrane Tack Trade Name: Requlatory Class: II Product Code: DZL Dated: April 22, 1998 April 23, 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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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

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Page 2 - Ms. Verstynen

through 542 of the Act for devices under the Electronic Chrough 542 OF the not is not is on other Federal laws or requlations.

This letter will allow you to begin marketing your device as Inis recei will area for your market notification. The FDA described in your siet., p="ivalence of your device to a legally marketed predicate device results in a classification for your marketed predicate actros your device to proceed to the market.

If you desire specific advice for your device on our labeling II you debite bpoories and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Victo diagnobere actroob// place of additionally, for questions on comprimeet at (302) 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 807.97). "Other general 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/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Director

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ਦਾ Page of ਹ

1981459 510(k) NUMBER (IF KNOWN) :

Membrane Tacks DEVICE NAME:

INDICATIONS FOR USE:

The Membrane Tack is indicated for use as a means of membrane fixation in Guided Bone Regeneration (GBR) procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANCTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801 109)

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

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

Regulation Number and Section

§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.