The Biomet Calcaneal Plate is an open structure bone plate with a cross-strut in the center manufactured from 316 LVM Stainless Steel. The device has 11 or 13 screw holes, depending on plate size, to ensure bone purchase of screws. The devices is slightly malleable, to conform to each patient's anatomy at the time of surgery. The device can also be cut in the operating room it achieve better fit.

The device is universal in design and therefore may be used on either the right or left foot. Three sizes are available, small, large and extra-large. A series of 3.5mm cortical screws are used in conjunction with the device.

AI/ML Overview

The presented document is a 510(k) premarket notification for the Biomet Calcaneal Plate, a bone plate used for fixation of calcaneal fractures and osteotomies.

Based on the provided information, no acceptance criteria or study demonstrating device performance are described.

The document explicitly states:

Non-Clinical and Clinical Testing: None provided (from the "Summary of Safety and Effectiveness" section).

This indicates that the submission for the Biomet Calcaneal Plate did not include specific performance criteria or a study to demonstrate its performance against such criteria. The device's approval or "substantial equivalence" determination by the FDA was based on its similarity to legally marketed predicate devices, not on a new study showing its performance against pre-defined acceptance criteria.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: Not provided.
Sample size used for the test set and the data provenance: Not applicable as no testing was provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
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 bone plate, not an AI or imaging device).
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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0022515

page 1 of 1

Summary of Safety and Effectiveness

Applicant/Sponsor:Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

SFP 1 7 2002

Contact Person: Patricia Sandborn Beres Senior Regulatory Specialist Telephone: (574) 267-6639 Fax: (574) 372-1683

Proprietary Name: Biomet Calcaneal Plate

Common Name: Bone Plate

Classification Name: Single/multiple component, metallic, bone fixation appliances and accessories.

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Synthes Calcaneal Plate (K991407, K010518, K020401) .
Kirschner Small Fragment Fixation System (K864924) .

Device Description: The Biomet Calcaneal Plate is an open structure bone plate with a cross-strut in the center manufactured from 316 LVM Stainless Steel. The device has 11 or 13 screw holes, depending on plate size, to ensure bone purchase of screws. The devices is slightly malleable, to conform to each patient's anatomy at the time of surgery. The device can also be cut in the operating room it achieve better fit.

Intended Use: 1) Intra-articular fractures of the calcaneus 2) Extra-articular fractures of the calcaneus and 3) Osteotomies of the calcaneus.

Summary of Technologies: The materials, surface finishes and processing of the device are similar to the predicate devices.

Non-Clinical and Clinical Testing: None provided

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

■

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

제

OFFICE -574.267.6639

FAX 574.267.8137

E-MAIL biomet@biomet.com

000030

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle or bird symbol on the right side. To the left of the bird symbol is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Orthopedics, Inc. Patricia Sandborn Beres Senior Regulatory Specialist P. O. Box 587 Warsaw, Indiana 46581-0587

Re: K022515

Trade/Device Name: Biomet Calcaneal Plate Regulation Number: 888.3030 Regulation Name: Single/multiple component, metallic, bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: July 29, 2002 Received: July 30, 2002

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 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 (OS) 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 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.

Sincerely yours,

Mark N. Milliman

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): K022515

Device Name: Biomet Calcaneal Plate

Indications For Use:

Intra-articular fractures of the calcaneus .
Extra-articular fractures of the calcaneus ●
Osteotomies of the calcaneus .

Mark A Milkersm

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

510(k) Number K022515

(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)

000003

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.