Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or posttraumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. This device is intended for cemented application only.

Device Description

The Repicci II® Onlay Tibial Component is an all-polyethylene unicondylar tibial component with four inferior fixation pegs. The inferior surfacy has macro grid (waffle) texture as well as four undercut pegs for cement fixation. Components in five profiles and four thicknesses are available.

AI/ML Overview

This document describes the Biomet Repicci II® Onlay Unicompartmental Tibial Component. The provided text is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through technological characteristics and mechanical testing.

The document explicitly states "Clinical Testing: None provided." This means that no studies demonstrating device performance, clinical efficacy, or safety in human subjects were conducted or submitted as part of this 510(k) Pre-market Notification.

Therefore, I cannot provide information on acceptance criteria based on human performance, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these were not part of the submission for this device.

Here's what can be inferred from the provided text regarding acceptance criteria and "study" (mechanical testing) for this specific device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Material composition equivalent to predicate devices.	The device is an all-polyethylene unicondylar tibial component. Its materials are "similar to or identical" to predicate devices.
Design equivalent to predicate devices (e.g., macro grid texture, undercut pegs).	Features four inferior fixation pegs, macro grid (waffle) texture, and four undercut pegs for cement fixation. Design characteristics are "similar to or identical" to predicate devices.
Sizing equivalent to predicate devices (e.g., range of profiles and thicknesses).	Components in five profiles and four thicknesses are available, "similar to or identical" to predicate devices.
Intended Use equivalent to predicate devices.	Intended for partial replacement of knee articulating surfaces for similar conditions to predicate devices (degenerative disease, fractures, deformity, revision). Intended for cemented application only, consistent with predicate devices.
Mechanical properties (e.g., strength, durability, fatigue resistance) demonstrated through non-clinical testing to be acceptable and comparable to predicate devices.	"Mechanical testing provided" (details not specified in this summary). The implication is that the mechanical testing demonstrated equivalence or acceptable performance for its intended use.

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

Test Set Sample Size: Not applicable. No human clinical test set was used. Mechanical testing was performed.
Data Provenance: Not applicable for clinical data. For mechanical testing, the data would have been generated by Biomet Manufacturing Corp. in a laboratory setting. Its provenance would be internal Biomet testing.

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

Not applicable. No human clinical test set was used, therefore no experts were required to establish ground truth for clinical outcomes. For mechanical testing, engineers and technicians would be involved in setting up and interpreting the tests, but this is not "ground truth" in the clinical sense.

4. Adjudication method for the test set

Not applicable. No human clinical test set was used.

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 a medical device (knee implant), not an AI diagnostic or assistive tool. No MRMC studies were conducted.

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

Not applicable. This is a medical device (knee implant), not an algorithm.

7. The type of ground truth used

For demonstrating substantial equivalence: Comparison to the known characteristics (materials, design, sizing, intended use) and established mechanical performance of legally marketed predicate devices.
For mechanical testing: Engineering standards and internal performance specifications. This is not "ground truth" in the clinical sense but rather acceptable engineering performance parameters.

8. The sample size for the training set

Not applicable. No clinical training set was used.

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

Not applicable. No clinical training set was used.

In summary, for this specific 510(k) submission, Biomet relied on the "Summary of Technologies" (comparison of materials, design, sizing, and indications to predicate devices) and "Non-Clinical Testing" (mechanical testing) to demonstrate substantial equivalence, rather than clinical studies.

Summary

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510(k) Summary

Applicant/Sponsor: Biomet Manufacturing Corp.

Contact Person: Patricia Sandborn Beres Senior Requlatory Specialist
Proprietary Name: Repicci II® Onlay Unicompartmental Tibial Component

Common or Usual Name: Tibial component for Uni-Condylar knee replacement

Classification Name: Knee joint, femoratibial metal/polymer semi-constrained cemented prosthesis (21 CRF 888.3530, 87 HRY)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Repicci II® Unicondylar Knee (Biomet-K971938, K980665) .
DePuy Preservation™ Unicondylar Knee Prosthesis (DePuy Orthopedics, Inc. -. K010810)
ADVANCE® Unicondylar Knee System (Wright Medical Technology, Inc.-K012591) .

Device Description: The Repicci II® Onlay Tibial Component is an all-polyethylene unicondylar tibial component with four inferior fixation pegs. The inferior surfacy has macro grid (waffle) texture as well as four undercut pegs for cement fixation. Components in five profiles and four thicknesses are available.

Intended Use: Partial replacement of the 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. This device is intended for cemented application only.

Summary of Technologies: The technological characteristics (materials, design, sizing and indications) of the Repicci II® Onlay Tibial Component are similler to or identical the predicate devices or other previously cleared devices.

Non-Clinical Testing: Mechanical testing provided

Clinical Testing: None provided.

Prepared: January 4, 2006

All trademarks are owned by Biomet. Inc. except for the following: Preservation is a trademark of DePuy. Inc.

ADVANCE is a trademark of Wright Medical Technology. Inc.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 5 2006

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corp. P. O. Box 587 Warsaw, Indiana 46581-0578

Re: K053299

Trade/Device Name: Repicci II Onlay Unicompartmental Tibial Component Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HRY Dated: November 23, 2005 Received: November 25, 2005

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

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Page 2 - Ms. Patricia Sandborn Beres

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. 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Repicci II® Onlay Unicompartmental Tibial Component

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

This device is intended for cemented application only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number_ KOS3299

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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.