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

Device Description

The additional components that are the subject of this Special 510(k) submission are the tibial inserts and baseplates. These components are to be used with the femoral components of the Uni Knee cleared in K020741.

The tibial inserts of this submission are the similar the tibial components in K020741 with the addition of a snap feature on the non-articulating side. This snap feature is meant to be used with the tibial baseplate. The tibial inserts are manufactured from UHMWPE that conforms to ASTM F648 and are available in 5 sizes (35-45 mm) and 3 thicknesses (6-8 mm).

The tibial baseplates are manufactured from CoCr alloy that conforms to ASTM F75 and are available in 5 sizes (35-45 mm) and 2 configurations (left medial/right lateral and right medial/left lateral).

AI/ML Overview

The provided text describes a submission for "Uni Knee Additional Components" to the FDA, but it does not contain any information regarding acceptance criteria, device performance metrics, or the details of a study that proves the device meets specific criteria.

The 510(k) summary focuses on:

Device identification: Submitter, device name (Uni Knee Additional Components), common name, classification, and predicate devices.
Device description: Details the tibial inserts (UHMWPE, snap feature, 5 sizes, 3 thicknesses) and tibial baseplates (CoCr alloy, 5 sizes, 2 configurations).
Intended use: Partial replacement of articulating knee surfaces for specific conditions, for single use with bone cement.
Basis for Substantial Equivalence: States similarity in design, materials, and indications to a previously cleared device (K020741).

The FDA's response letter (K022437) confirms that the device is substantially equivalent to legally marketed predicate devices. This indicates that the FDA found the device to be as safe and effective as existing devices, based on the information provided in the 510(k) submission.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving device performance because it is not present in the provided document. The document is a regulatory submission for substantial equivalence, not a detailed performance study report.

To address the specific points you requested, if such information were available, here's how it would typically be presented:

Hypothetical Response (if the information were available in the provided text):

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (e.g., Mechanical Strength, Wear Rate, Biocompatibility)	Reported Device Performance (e.g., "X MPa ultimate tensile strength," "Y mm^3/million cycles wear," "Meets ISO 10993 standards")
[Specific criteria would be listed here]	[Corresponding performance data would be listed here]
...	...

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

Sample Size (Test Set): [e.g., N=10 implants for fatigue testing, N=5 animal models for biocompatibility]
Data Provenance: [e.g., In-vitro lab testing conducted in the USA, Retrospective clinical data from European clinics, Prospective animal study conducted in Canada]

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

Number of Experts: [e.g., 3 orthopedic surgeons]
Qualifications: [e.g., Each with over 15 years of experience in knee arthroplasty, Board-certified and affiliated with major academic medical centers]

4. Adjudication Method for the Test Set

Adjudication Method: [e.g., 2+1 (two experts agree, or a third expert resolves disagreement), Consensus panel, Majority rule, None (if ground truth is objective, like pathology reports)]

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Conducted?: [Yes/No]
Effect Size (Human Readers with AI vs. Without AI): [e.g., "Human readers demonstrated a 15% improvement in diagnostic accuracy with AI assistance (p < 0.01)," or "Mean reduction of 30 seconds per case in reading time," or "No statistically significant improvement observed."]

6. Standalone (Algorithm Only) Performance Study

Standalone Study Conducted?: [Yes/No]
Standalone Performance Metrics: [e.g., Sensitivity: 92%, Specificity: 88%, Area Under the Curve (AUC): 0.95 (for a diagnostic algorithm)]

7. Type of Ground Truth Used

Type of Ground Truth: [e.g., Histopathology, Surgical confirmation, Long-term patient outcomes (e.g., 5-year re-operation rates), Expert consensus based on clinical imaging, Objective mechanical measurements]

8. Sample Size for the Training Set

Training Set Sample Size: [e.g., 10,000 images, 500 patient records, N=100 implant designs used for finite element analysis model training]

9. How Ground Truth for the Training Set was Established

Ground Truth Establishment (Training Set): [e.g., "Annotated by a team of 5 resident radiologists under the supervision of a fellowship-trained musculoskeletal radiologist using a standardized annotation protocol," "Derived from electronic health records using natural language processing and validated by manual chart review," "Determined by predefined engineering specifications and validated through mechanical testing."]

Summary

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022437
page 1 of 1

510(k) Summary of Safety and Effectiveness

(1) Submitter's name: Submitt_r's address: Submitter's telephone number: Contact person: Date summary prepared:
Encore Medical, L.P. 9800 Metric Blvd, Austin, TX 78758 (512) 834-6255 Joanna Droege July 23, 2002
(2) Uni Knee Trade or proprietarv device name: Common or usual name: Knee system Classification name: Class II
(3) Predicate devices:

Encore Uni Knee (K020741) Biomet Repicci II (K971938, K980665) DePuy Preservation (K010810) Wright Advance (K012591)

(4) Subject device description:

(5) Subject device intended use:

Basis for Substantial Equivalence: (6)

The Uni Knee additional components are similar in design, materials and indications to the Encore Uni Knee cleared in K020741.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 2002

Ms. Joanna Droege Regulatory/QA Engineer Encore Medical Corporation 9800 Metric Boulevard Austin, Texas 78758

Re: K022437

Trade/Device Name: Uni Knee System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HRY Dated: July 23, 2002 Received: July 25, 2002

Dear Ms. Droege:

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 - Ms. Joanna Droege

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 yours,

A. Mark A. Mellecker

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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K022437

510(k) Number (if known):	KO2026
---------------------------	--------

): RV2273/

Device Name:

Uni Knee Additional Components

Indications For Use:

Uni Knee Indications For Use

Intended for partial replacement of the articulating surfaces of the only one side of the joint is affected due to compartmental primage or post-traumatic degenerative disease, previous tibial congress or fractures, deformity or revision of previous arthroplasty. The device use implant intended for implantation with bone cement.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark M. Weaver
(Division Sign-Off)

Division of General, Recorative and Neurological Devices

510(k) Number K022437

Prescription Use (per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)_

SKSO
OR
II

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.