The Fixed Bearing Uni Component is indicated for use for 1) Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; 2) Correction of varus, valgus, or posttraumatic deformity; and 3) Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. This device is intended to be used with bone cement.

Device Description

The tibial component consists of polyethylene plateau molded over a one-piece Co-Cr-Mo base and central keel. The molded tibial components are anatomical in geometry with right and left medical/lateral allocations. The overall form of the implant is tear-shaped. The Fixed Bearing Uni Components will be used in conjunction with the Oxford Unicompartmental Knee Femoral Component (K011138) and the Repicci IITM Unicondylar Knee (K971938).

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the "Fixed Bearing Uni Component." It describes the device, its indications for use, and the basis for its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria in the traditional sense of a performance study (e.g., accuracy, sensitivity, specificity thresholds). Instead, the acceptance was based on demonstrating substantial equivalence to a legally marketed predicate device (Repicci IITM Unicondylar Knee, K971938).

The "performance" of the device is implied by its similarity to the predicate.

Acceptance Criteria Category	Reported Device Performance	Comments
Material Equivalence	The Fixed Bearing Uni Components - the materials, design, sizing, and indications are similar or identical to the predicate devices.	The materials of the new device are stated to be similar or identical to the predicate device.
Design Equivalence	The Fixed Bearing Uni Components - the materials, design, sizing, and indications are similar or identical to the predicate devices.	The design of the new device is stated to be similar or identical to the predicate device.
Sizing Equivalence	The Fixed Bearing Uni Components - the materials, design, sizing, and indications are similar or identical to the predicate devices.	The sizing of the new device is stated to be similar or identical to the predicate device.
Indications for Use Equivalence	The Fixed Bearing Uni Components - the materials, design, sizing, and indications are similar or identical to the predicate devices.	The indications for use of the new device are stated to be similar or identical to the predicate device.
Safety Equivalence	Non-Clinical Testing: Engineering Justifications, Mechanical Testing, and a Finite Element Analysis (FEA) determined that the Fixed Bearing Uni Components presented no new risks and was, therefore, substantially equivalent to the predicate device.	Engineering justifications, mechanical testing, and FEA were used to demonstrate no new risks compared to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No clinical testing was conducted or provided. The basis for substantial equivalence relied solely on non-clinical testing (engineering justifications, mechanical testing, and Finite Element Analysis). Therefore, there is no "test set" in the context of clinical data, no sample size, and no data provenance from human subjects.

3. 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. Since no clinical testing was performed, there was no test set requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As there was no clinical test set, no adjudication method 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 device is a physical knee implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with AI assistance is not relevant to this submission.

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 an algorithm or software. Its performance is evaluated through mechanical and engineering means as an implantable medical device, not as a standalone AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing:

Mechanical Testing: Ground truth would be defined by established engineering standards, material properties, and biomechanical parameters.
Finite Element Analysis (FEA): Ground truth is based on physical laws, material science, and computational models that predict mechanical behavior.
Engineering Justifications: Ground truth is based on established engineering principles and comparison to the known performance of the predicate device.

8. The sample size for the training set

Not applicable. There was no "training set" in the context of machine learning. The design and validation of the device relied on engineering principles and comparison to a predicate device. If one were to interpret "training set" very broadly as the data used for the design and analysis, it would include things like material property data, CAD models, and results from previous mechanical tests on similar devices (including the predicate). However, this is not a "training set" in the typical AI/ML sense.

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

Not applicable. As explained above, there was no training set in the context of AI/ML. The "ground truth" for the engineering design and non-clinical assessment was based on established engineering standards, material specifications, and the historical performance and regulatory approval of the predicate device.

Summary

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JUN 0 5 2002

Image /page/0/Picture/1 description: The image shows the logo for Biomet Corporate Headquarters. The word "BIOMET" is in a stylized font with thick, black lines. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller, sans-serif font. The text is all in black and the background is white.

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SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant or Sponsor:	Biomet Orthopedics, Inc.P.O. Box 587Warsaw, IN 46581-0587
Contact Person:	Dalene T. BinkleyTelephone: (574) 267-6639
Proprietary Name:	Fixed Bearing Uni Component

Common Name: Molded Uni Tibial Bearing

Classification: Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer (21 CFR 888.3530)

Device Classification: Class II

Legally Marketed Device to which Substantially Equivalence is Claimed: Repicci IITM Unicondylar Knee (K971938)

Device Description: The tibial component consists of polyethylene plateau molded over a one-piece Co-Cr-Mo base and central keel. The molded tibial components are anatomical in geometry with right and left medical/lateral allocations. The overall form of the implant is tear-shaped.

The Fixed Bearing Uni Components will be used in conjunction with the Oxford Unicompartmental Knee Femoral Component (K011138) and the Repicci IITM Unicondylar Knee (K971938).

Indications for Use: The indications for the Fixed Bearing Uni Components are for painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The Fixed Bearing Uni Components are for use with bone cement.

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

프

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 219.267.6639 FAX 219.267.8137

. biomet@biomet.com

E-MAIL

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Summary of Technologies: The Fixed Bearing Uni Components -the materials, design, sizing, and indications are similar or identical to the predicate devices.

Non-Clinical Testing: Engineering Justifications, Mechanical Testing, and a Finite Element Analysis (FEA) determined that the Fixed Bearing Uni Components presented no new risks and was, therefore, substantially equivalent to the predicate device.

Clinical Testing: No clinical testing was provided as a basis for substantial equivalence.

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K021621

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

JUN 0 5 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Dalene T. Binkley Regulatory Affairs Specialist . Biomet, Inc. P.O. Box 587 Warsaw, IN 46581-0587

Re: K021621

Trade Name: Fixed Bearing Uni 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: April 26 2002 Received: May 16, 2002

Dear Ms. Binkley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 - Ms. Dalene T. Binklev

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" (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.

Sincerely yours,

Mark N Millers

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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Page _ of _

510 (k) NUMBER (if KNOWN): _ KO2 1621_

DEVICE NAME: Fixed Bearing Uni Component

INDICATIONS FOR USE:

This device is intended to be used with bone cement.

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

Comments of the manage of the management of the comments of the programment of the management of the management of the management of the manufacturer
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)

for Mark N. Melkerson
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number K021621

ONAB

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.