20-HOLE ADAPTATION PLATE by BIOMET, INC.

The 20-Hole Adaptation Plate is made of LactoSorb®. LactoSorb®, resorbable copolymer, is a synthetic polyester" derived from lactic and glycolic acids. Polylactic/ polycolic 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 to be biocompatible in both soft tissue and bone.

AI/ML Overview

The provided text describes a 510(k) submission for the "20-Hole Adaptation Plate" and includes a summary of safety and effectiveness, but it does not contain information about acceptance criteria or a specific study proving the device meets them in the way a modern AI/software device submission would.

The context is a 1998 submission for a medical device (physical product made of LactoSorb®) and not a software/AI product. Therefore, the questions related to AI/software performance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI models are not applicable to this document.

Based on the provided document, here's what can be extracted and what cannot be:

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

Acceptance Criteria: Not explicitly stated as "acceptance criteria" in the traditional sense for an AI/software device. For a physical device like this plate, the implied acceptance criteria revolve around biocompatibility and biomechanical strength relative to predicate devices.
Reported Device Performance:
- Biocompatibility: "The LactoSorb® material has been found to be biocompatible in both soft tissue and bone."
- Biomechanical Strength: "The 20-Hole Adaptation Plate was found to have similar biomechanical strength as predicate devices used in similar indications."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This information is for AI/software model validation, not a physical implant. The document does not describe a "test set" in this context.

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. This information is for AI/software model validation. The ground truth for a physical device's characteristics (biocompatibility, strength) would typically be established through laboratory testing and materials science evaluations, not expert consensus on data interpretation.

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

Not applicable. This is for AI/software model validation.

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 is for AI/software comparative effectiveness.

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

Not applicable. This refers to AI/software performance.

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

For biocompatibility: Likely in vitro and in vivo biological testing results.
For biomechanical strength: Likely in vitro mechanical testing results.

8. The sample size for the training set

Not applicable. This is for AI/software model training.

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

Not applicable. This is for AI/software model training.

In summary, the provided document is a regulatory submission for a physical medical implant from 1998. It addresses safety and effectiveness through statements about biocompatibility and biomechanical equivalency to predicate devices, rather than through the detailed data-driven validation studies typically required for modern AI/software as a medical device (SaMD).

Summary

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MAY 20 1998

510(k) Summary of Safety and Effectiveness

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

Contact Person: Mary L. Verstynen

Product Code: 87 HRS

Device Name: 20-Hole Adaptation Plate

SUMMARY :

The 20-Hole Adaptation Plate is intended for use in the following indications:

1. comminuted fractures of the naso-ethmoidal infraorbital areas
1. comminuted fractures of the frontal sinus wall
1. orbital floor fractures

The 20-Hole Adaptation Plate was found to have similar biomechanical strength as predicate devices used in similar indications.

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing its wing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 1998

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

K981070 Re : 20-Hole Adaptation Trade Name: Requlatory Class: II Product Code: JEY Dated: March 23, 1998 March 24, 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 reqistration, 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. A -----...... 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 requlation (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 requlation 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 emrough 542 or the notrol provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your sie\n privalence of your device to a legally marketed predicate device results in a classification for your marketed production wour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 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 Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K981070 510 (k) NUMBER (IF KNOWN) :

20-Hole Adaptation Plate DEVICE NAME:

INDICATIONS FOR USE:

The 20-Hole Adaptation Plate is used in the following ・ indications:

1. comminuted fractures of the naso-ethmoidal infraorbital areas
1. comminuted fractures of the frontal sinus wall
1. orbital floor fractures

(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)
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Suser Runve
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices

510(k) Number	RAK 1070
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Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.