DISTAL RADIUS PLATING SYSTEM by BIOMET, INC.

The Distal Radius Plating System is indicated for use in open reduction and internal fixation of Frykman type I-IV dorsally displaced Colles fractures, intomies, and carpal fusions of the distal radius in the presence of appropriate immobilization.

Device Description

The Distal Radius Plating System consists of resorbable dorsal and volates. The plates are used in conjunction with 2.5mm resorbable screws. The plates and screws are made of a L-lactide/glycolide co-polymer.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Distal Radius Plating System." It outlines the device's description, intended use, and a comparison to substantially equivalent devices. However, it explicitly states that no clinical data was completed. Therefore, the request for acceptance criteria and a study proving the device meets those criteria cannot be fully answered as these were not provided or conducted for this specific submission.

Given the information provided, here's what can be extracted and what cannot:

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

Acceptance Criteria	Reported Device Performance
Mechanical Properties Equivalence (to predicate devices: Bionx Biodegradable Threaded Distal Radius Screw and Resorbable Bone Pins)	"Extensive testing determined that the Distal Radius Plating System and Bionx Biodegradable Threaded Distal Radius Screw have equivalent mechanical properties."
Biocompatibility (non-toxic, non-mutagenic, non-pyrogenic)	"Biocompatibility testing was completed and demonstrated that the co-polymer material is non-toxic, non-mutagenic, and non-pyrogenic."
In-vitro Mechanical Testing (equivalence to predicate devices)	"In-vitro mechanical testing was completed and demonstrated that the Distal Radius Plating System was equivalent to the predicate devices."
Clinical Performance (e.g., fracture healing rates, complication rates, functional outcomes)	NOT APPLICABLE - "No clinical data was completed."

2. Sample sized used for the test set and the data provenance

Mechanical and biocompatibility testing: The document does not specify the sample sizes used for the in-vitro mechanical testing or the biocompatibility testing.
Clinical test set: There was no clinical test set.

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

This information is not applicable as no clinical testing was performed for this 510(k) submission. For the non-clinical testing (mechanical and biocompatibility), the "ground truth" would be established by the testing methodology itself, rather than expert consensus on retrospective data.

4. Adjudication method for the test set

This information is not applicable as no clinical testing was performed.

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 information is not applicable. The device is a physical orthopedic implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study and AI-related metrics are irrelevant.

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

This information is not applicable. The device is a physical orthopedic implant, not an algorithm.

7. The type of ground truth used

For mechanical properties, the "ground truth" was established by recognized testing standards and comparison to the mechanical integrity of legally marketed predicate devices.
For biocompatibility, the "ground truth" was established by standardized laboratory tests to assess toxicity, mutagenicity, and pyrogenicity.
For clinical outcomes, there was no ground truth established as no clinical data was collected.

8. The sample size for the training set

This information is not applicable as the device is not an AI algorithm requiring a training set. The "training" for this type of device development involves materials science, engineering design, and testing, not machine learning.

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

This information is not applicable as the device is not an AI algorithm.

Summary

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APR 2 2 2002

ARTERS CORPORA

Summary of Safety and Effectiveness

Applicant or Sponsor:	Biomet, Inc.P.O. Box 587Warsaw, Indiana 46581-0587
Contact Person:	Michelle L. McKinleyRegulatory Specialist
Proprietary Name:	Distal Radius Plating System
Common or Usual Name:	plate system
Classification Name:	Plate, fixation, bone (888.3030);
Device Product Code:	HRS

Substantially Equivalent Device(s): Bionx Biodegradable Threaded Distal Radius Screw (K974876) , Resorbable Bone Pins (K011522)

Device Description: The Distal Radius Plating System consists of resorbable dorsal and volates. The plates are used in conjunction with 2.5mm resorbable screws. The plates and screws are made of a L-lactide/glycolide co-polymer.

Intended Use: The Distal Radius Plating System is indicated for use in open reduction and internal fixation of Frykman I-IV dorsally displaced Colles fractures, osteotomies, and carpal fusions of the distal radius in the presence of appropriate immobilization.

Summary of Technologies: Extensive testing determined that the Distal Radius Plating System and Bionx Biodegradable Threaded Distal Radius Screw have equivalent mechanical properties. Biocompatibility testing was completed and demonstrated that the co-polymer material is non-toxic, non-mutagenic, and non-pyrogenic,

Non-clinical Testing: In-vitro mechanical testing was completed and demonstrated that the Distal Radius Plating System was equivalent to the predicate devices.

Clinical Testing: No clinical data was completed.

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

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 219.267.6639

I·AX 219.267.8137

E-MAIL biomet@biomet.com

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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 is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing left. The eagle is composed of three thick, curved lines that suggest feathers.

Public Health Service

APR 2 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mary Verstynen Biomet, Inc. P.O. Box 587 Warsaw, IN 46581-0587

Re: K020819

Trade/Device Name: Distal Radius Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: January 31, 2002 Received: March 13, 2002

Dear Ms. Verstynen:

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 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 (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. Mary Verstynen

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.

Mark McMullen

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): __K020819

Device Name: Distal Radius Plating System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-the-Counter Use Prescription Use A (Optional Format 1-2-96) (Per 21 CFR 801.109)

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

510(k) Number K020819

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.