REPICCI LOCKED KEEL TIBIAL BEARING by BIOMET, INC.

Partial replacement of articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

The devices covered in this 510(k) are intended to be used with Repicci™ Femoral Components.

The device is a single use implant intended for implantation with bone cement.

Device Description

The Repicci II® Unicondylar Knee System consists of a femoral and tibial component. The Repicci™ tibial bearing is used with the Repicci™ femoral components (K971938).

The all polyethylene tibial components are anatomical in geometry with right and left medial/lateral allocations. Located on the inferior surface of the implant is a face with fixation holes and a keel.

AI/ML Overview

The provided document does not describe acceptance criteria for a device, nor does it detail a study that proves a device meets such criteria.

Instead, this document is a Summary of Safety and Effectiveness and a 510(k) clearance letter for a medical device called the "Repicci™ Locked Keel Tibial Bearing." This type of submission to the FDA is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving that a device meets specific performance acceptance criteria through detailed studies.

Here's a breakdown of why this information is not present in the provided text, and what is present:

Key Takeaways from the Document:

Device: Repicci™ Locked Keel Tibial Bearing (part of a unicompartmental knee system).
Purpose of Submission: Seek 510(k) clearance from the FDA by demonstrating substantial equivalence to a predicate device (Worland Unicondylar All Poly Tibial Bearing -- K011795).
Basis for Substantial Equivalence:
- Non-Clinical Testing: An engineering justification determined that the Repicci™ Locked Keel tibial component presented no new risks and was substantially equivalent. This suggests design and material comparisons, but no specific performance metrics or studies are detailed. The change from the predicate device is a modification to the keel and removal of a waffle pattern.
- Clinical Testing: "None provided as a basis for substantial equivalence." This explicitly states that no clinical trials or studies were conducted to prove the device meets specific performance criteria.
FDA Decision: The FDA granted 510(k) clearance, concluding that the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.

Addressing your specific points based on the absence of the requested information in the text:

A table of acceptance criteria and the reported device performance
- Not Available. The document does not specify any quantitative acceptance criteria or report device performance against them. The basis for clearance was "engineering justification" and "substantial equivalence" to a predicate, not performance against defined metrics.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Available. No specific test set or data from a study is mentioned, as clinical testing was not provided for substantial equivalence. The "engineering justification" would involve design comparisons and possibly bench testing, but details on sample size, provenance, or type are not in this summary.
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/Not Available. There was no clinical study described that would require experts to establish ground truth for a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Available. No test set or related adjudication method is described.
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 knee implant, not an AI-powered diagnostic tool. MRMC studies involving human readers and AI are irrelevant to this product type.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical orthopedic implant, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Available. No clinical study result requiring ground truth is presented.
The sample size for the training set
- Not Applicable/Not Available. No algorithm or machine learning component is involved in this device, therefore no training set exists.
How the ground truth for the training set was established
- Not Applicable/Not Available. As above, no training set or ground truth for one is relevant here.

In summary, the provided document is a regulatory submission demonstrating "substantial equivalence" based on engineering justification and comparison to a predicate device, rather than a study proving performance against defined acceptance criteria.

Summary

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BIOMET

030446
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SUMMARY OF SAFETY AND EFFECTIVENESS

Sponsor:	Biomet Orthopedics, Inc.P.O. Box 587Warsaw, IN 46581-0587	MAR 0 6 2003
Contact Person:	Tracy J. Bickel(574) 267-6639
Proprietary Name:	Repicci™ Locked Keel Tibial Bearing
Common Name:	Unicompartmental Knee Tibial Component

Classification Name: Prosthesis, Knee, Femorotibial, semi-constrained, cemented, metal/polymer (21 CFR 888.350)

Substantially Equivalent Devices: Worland Unicondylar All Poly Tibial Bearing -- K011795

The Repicci II® Unicondylar Knee System consists of a femoral and tibial Device Description: component. The Repicci™ tibial bearing is used with the Repicci™ femoral components (K971938).

Intended Use: Partial replacement of articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

The devices covered in this 510(k) are intended to be used with Repicci™ Femoral Components.

The device is a single use implant intended for implantation with bone cement.

Summary of Technologies: The Repicci™ Locked Keel Tibial components materials, design, sizing, and indications are similar to, or identical to the predicate devices. This submission modifies the keel on the inferior surface of the implant and removes the waffle pattern.

Non-Clinical Testing: An engineering justification determined that the Repicci™ Locked Keel tibial components presented no new risks and were; therefore, substantially equivalent to the predicate device.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

()FFICE 574.267.6639

FAX 574.267.8137

E-MAIL biomet@biomet.com

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MAR 0 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tracy J. Bickel Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw. Indiana 46581-0587

Re: K030446

Trade/Device Name: Repicci™ Locked Keel Tibial Bearing Regulation Number: 21 CFR 888.3530 Regulation Names: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HRY Dated: February 7, 2003 Received: February 11, 2003

Dear Ms. Bickel:

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

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Page 2- Ms. Tracy J. Bickel

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. 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), 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" (21CFR 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 A. Mulkerson

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): Device Name: Repicci™ Unicondylar Tibial Bearings Indications for Use:

The devices covered in this 510(k) are intended to be used with Repicci® Femoral Components.

The device is a single use implant intended for implantation with bone cement.

for Mark A. Mulkerson

Di ision of General, Restorative and Neurological Devices

KO30446 710(k) Number _

(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)

Regulation Number and Section

§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.