The Titanium Repicci II(® Unicondylar Femoral Knee Components and CoCr Repicci II(8) Unicondylar Knee are indicated for 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.

These devices are single-use implants intended for implantation with bone cement.

Device Description

The Titanium Repicci II® Unicondylar Femoral Knee Components are medial or lateral unicondylar knee replacement implants available in six sizes. Each size is anatomical in nature and is available in two configurations - one for the medial side of right knees and lateral side of left knees (LL/RM), and one for the lateral side of right knees and the medial side of left knees (RL/LM).

The CoCr Repicci II® Unicondylar Knee (K020264) is available in five sizes. Each size is anatomical in nature and is available in two configurations – one for the medial side of right knees and lateral side of left knees (LL/RM), and one for the lateral side of right knees and the medial side of left knees (RL/LM),

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

Important Note: The provided document is a 510(k) summary for a knee implant, which in many cases, especially for predicate devices, relies heavily on substantial equivalence to already approved devices rather than new clinical trials demonstrating performance against specific clinical acceptance criteria. The information you're asking for (e.g., acceptance criteria, test set details, expert qualifications, HRMC studies) is typically found in the clinical study reports for devices that require extensive new clinical evidence, often for novel devices or those with higher risk classifications.

Based on the provided text, the device is being cleared based on substantial equivalence, meaning it's demonstrated to be as safe and effective as a legally marketed predicate device. This often involves non-clinical testing (e.g., mechanical, materials) and comparison of design and indications for use, rather than extensive human clinical trials with performance metrics.

Analysis of Acceptance Criteria and Study for K063515

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" for the device's performance in the clinical sense are not explicitly stated in terms of specific sensitivity, specificity, accuracy, or similar clinical metrics. Instead, the "acceptance criteria" are implied by demonstrating that the new device is as safe and effective as its predicates.

The "study that proves the device meets the acceptance criteria" largely relies on non-clinical testing and comparison to predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (as per document)
Technological Characteristics: Similar or identical material, design, and sizing to predicate devices.	"The technological characteristics (material, design and sizing) of the Titanium Repicci II® Unicondylar Femoral Knee Components and the CoCr Repicci II® Unicondylar Knee Components are similar or identical to the predicate devices."
Intended Use/Indications: Same as predicate devices.	"The indications are exactly the same as the predicate Repicci II® Unicondylar knee systems."
Functional Performance: Device functions within its intended use.	"Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."
Safety and Effectiveness: Demonstrated to be as safe and effective as predicate through comparison and non-clinical testing.	This is the overarching conclusion of the 510(k) clearance based on the above points.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of a human clinical test set. The evaluation primarily involved non-clinical laboratory testing.
Data Provenance: Not applicable for clinical data. The non-clinical testing would have been performed in a laboratory setting, likely at Biomet or a contracted facility.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided because the submission did not involve a clinical study requiring expert ground truth for a test set in the way a diagnostic AI device would. The "ground truth" for non-clinical testing would be measured physical properties and performance against established engineering standards or predicate device benchmarks.

4. Adjudication Method for the Test Set

Not applicable as there was no human clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was explicitly NOT done. The document states: "Clinical Testing: None provided as a basis for substantial equivalence."
Therefore, there is no effect size reported for human readers with or without AI assistance.

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

Not applicable. This device is a physical knee implant, not a software algorithm.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" would be established engineering specifications, material properties (e.g., tensile strength, fatigue life), and performance metrics (e.g., wear testing, load bearing capacity) as defined by relevant ISO or ASTM standards, and comparative data from the predicate devices. There is no mention of expert consensus, pathology, or outcomes data being used to establish "ground truth" for the new device itself in a clinical context.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there was no training set in the context of machine learning.

Summary

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K063515 1/2

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510(k) Summarv

FEB - 2 2007

Inc. Inc. Inc. Inc.

Preparation Date:	November 20, 2006
Applicant/Sponsor:	Biomet Manufacturing Corp.
Contact Person:	Susan Alexander
Proprietary Name:	Titanium Repicci II® Unicondylar Femoral Knee ComponentsCoCr Repicci II® Unicondylar Knee
Common Name:	Knee femoral
Classification Name:	Prosthesis, Knee Femorotibial, Semi-Constrained, Cemented, Metal/Polymer(21 CFR §888.3530)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Titanium Femoral Knee Components(Maxim® and AGC®)	K041466	Biomet
Repicci II® Unicondylar Knee System	K020264	Biomet
Titanium Femoral Component	K981996	Biomet
Repicci II® Unicondylar Knee	K971938	Biomet

Device Description:

Intended Use:

The Titanium Repicci II® Unicondylar Femoral Knee Components and the CoCr Repicci II® Unicondylar Knee are indicated for 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.

These devices are single-use implants intended for implantation with bone cement.

Image /page/0/Figure/13 description: This image shows the mailing address, shipping address, office number, fax number, and email address. The mailing address is P.O. Box 587, Warsaw, IN 46581-0587. The shipping address is 56 E. Bell Drive, Warsaw, IN 46582. The office number is 574.267.6639, the fax number is 574.267.8187, and the email address is biomet@biomet.com.

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K063515 2/2

Summary of Technologies: The technological characteristics (material, design and sizing) of the Titanium Repicci II® Unicondylar Femoral Knee Components and the CoCr Repicci II® Unicondylar Knee Components are similar or identical to the predicate devices. The indications are exactly the same as the predicate Repicci II® Unicondylar knee systems.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

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

All trademarks are property of Biomet, Inc.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Manufacturing Corp. % Ms. Susan Alexander Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587 FEB - 2 2007

Re: K063515

Trade/Device Name: Titanium Repicci II® Unicondylar Femoral Knee Components and CoCr Repicci II® Unicondylar Knee Components Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY Dated: November 20, 2006 Received: November 21, 2006

Dear Ms. Alexander:

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. Susan Alexander

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Barbara Brem

Mark N. Melkerson 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):	K063515
---------------------------	---------

Device Name: Titanium Repicci II(® Unicondylar Femoral Knee Components CoCr Repicci II® Unicondylar Knee

Indications For Use:

These devices are single-use implants intended for implantation with bone cement.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Snehl D. MCN
(Division Sign. or Org.)

Division of General, Restorative, and Neurological Devices

510(k) Number < 0h3515

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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.