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. The devices covered in this 510(k) are intended to be used with Repicci Femoral component. The device is intended to be used with bone cement.

Device Description

The Repicci II® Metal Back Inlay Unicompartmental Tibial component comprised of ultra-high molecular polyethylene (UHMWPE), with a thin corrugated metal plate molded into the inferior surface of the device. The tibial components are available in six profiles and two thicknesses and is intended for cemented fixation.

AI/ML Overview

The provided text describes a 510(k) submission for the Biomet Repicci II® Metal Back Inlay Unicompartmental Tibial Bearing Component. This is a medical device, specifically a knee implant component, and its approval process relies on demonstrating "substantial equivalence" to already legally marketed devices.

Crucially, the submission explicitly states "Clinical Testing: None provided as a basis for substantial equivalence." This means that traditional clinical studies, as understood in terms of evaluating performance against acceptance criteria using patient data, were not performed for this device's approval.

Therefore, many of the questions regarding acceptance criteria, study design, ground truth, and human reader performance are not applicable to this specific submission. The "study" that proves the device meets acceptance criteria here is a non-clinical, bench testing study comparing the new device to its predicates.

Here's a breakdown of what can be extracted based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functional within intended use	The results indicated that the device was functional within its intended use. (Demonstrated through Non-Clinical Testing)
Substantially Equivalent to predicate devices (Repicci II® Unicondylar Knee K971938 and Repicci III® Unicondylar Knee All Poly Tibial Components K980665)	The technological characteristics (material, design, sizing, and indications) of the Repicci II® Metal Back Inlay Unicompartmental Tibial Bearing Component are similar or identical to the predicate devices.

Study Details (Based on Non-Clinical Testing)

Since no clinical study was performed, the following points are addressed in the context of non-clinical testing, which is the basis for substantial equivalence in this case.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document. Non-clinical testing typically involves a set number of physical devices or models.
- Data Provenance: Not human data. This would be laboratory data generated from mechanical testing, material analysis, and design comparisons.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the human reader/clinical context. For non-clinical testing, "ground truth" would be established by engineering specifications, material standards, and biomechanical principles, evaluated by qualified engineers and scientists. The document does not specify the number or qualifications of these individuals.
Adjudication method for the test set:
- Not applicable. Adjudication typically refers to resolving discrepancies in human expert opinions, which did not occur here. Testing results would be analyzed against predetermined engineering specifications and standards.
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:
- No such study was done. This device is a physical implant, not an AI-assisted diagnostic tool or an imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used:
- For the non-clinical testing, the "ground truth" would be established by:
  - Engineering specifications: Design parameters, material properties, and manufacturing tolerances.
  - Biomechanical performance standards: Requirements for strength, wear, and fatigue.
  - Comparison to predicate devices: The established performance and safety profiles of the legally marketed predicate devices.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of non-clinical testing for a physical implant device. The concept of training data is relevant for AI/machine learning models.
How the ground truth for the training set was established:
- Not applicable. See point 7.

In summary, the approval for the Biomet Repicci II® Metal Back Inlay Unicompartmental Tibial Bearing Component was based on non-clinical testing demonstrating its functional performance and substantial equivalence in "material, design, sizing, and indications" to its predicate devices, rather than clinical trials with patient data.

Summary

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BIOMET

KO61681

510(k) Summary

Preparation Date:	June 9, 2006
Applicant/Sponsor:	Biomet Manufacturing Corp.P.O. Box 587Warsaw, Indiana 46581-0587
Contact Person:	Lester F. Padilla
Proprietary Name:	Repicci II® Metal Back Inlay Unicompartmental Tibial Bearing Component
Common Name:	Tibial component for uni-condylar knee replacement
Classification Name:	Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis(21 CFR 888.3530)
	OCT 19 2006

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

1. Repicci II® Unicondylar Knee (K971938)
1. Repicci III® Unicondylar Knee All Poly Tibial Components (K980665)

Device Description:

Intended Use:

Summary of Technologies: The technological characteristics (material, design, sizing, and indications) of the Repicci II® Metal Back Inlay Unicompartmental Tibial Bearing Component are similar or identical to the predicate devices.

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.

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

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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 574.267.6639

FAX
574.267.8137

E-MAH. biomet@biomet.com

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet. Inc. % Lester F. Padilla, RAC Regulatory Affairs Associate P.O. Box 587 56 East Bell Drive Warsaw, Indiana 46581

OCT 1 9 2006

Re: K061681

Trade/Device Name: Repicci II® Metal Back Inlay Unicompartmental Tibial Bearing Component 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: September 18, 2006 Received: September 21, 2006

Dear Mr. Padilla:

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 – Mr. Lester F. Padilla

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,

To My Son

Mark N. Melkerson 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® Metal Back Inlay Unicompartmental Tibial Bearing Component

Indications for Use:

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

The device is intended to be used with bone cement.

Prescription Use _________X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use NO (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)

Page 1 of 1

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number_ L001141

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.