The UC-PLUS Solution Unicondylar Knee is intended for use in uni-compartmental degenerative arthritis, local osteonecrosis of the femoral condyle, light to medium uni-compartmental destruction of the knee joint due to idiopathic and posttraumatic degenerative arthritis, traumatic uni-compartmental bone and/or cartilage lesions. It is intended for use with bone cement only.

Device Description

This knee system consists of a femoral component. The femoral component is fabricated from cast CoCrMo alloy (ASTM F79) and is 4mm thick. Symmetrical, the femoral components can be used on right or left knees. Cement pockets are cast into the components to provide a minimum 1mm cement mantle. The femoral component is available in four sizes.

The tibial component is manufactured from ultra-high molecular weight polyethylene. A cemented metal backed tibial component is also available. Both tibial components are available in five sizes and four thicknesses.

The subject of this Special 510(k) submission is the modification to the implant/bone interface of the femoral component and the elimination of the smallest size femoral component.

AI/ML Overview

The provided text describes a Special 510(k) submission for a modification to an existing medical device, the UC-PLUS Solution Unicondylar Knee. This type of submission focuses on demonstrating that the modified device is substantially equivalent to its predicate device, primarily through non-clinical testing.

Here's an analysis of the provided information in the context of acceptance criteria and a study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Structural Integrity & Fatigue Loading (due to fin height modification)	The change in fin height of the femoral component resulted in no increased risks and decreased the stresses in the component due to fatigue loading.
Equivalence to Predicate Device (K982859)	The modified component is equivalent in terms of indications, usage, and materials.

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

Test Set Sample Size: The document does not specify a distinct "test set" in the context of a clinical study or a large number of physical units. The testing described is non-clinical, focusing on the mechanical properties of the femoral component. Therefore, the "sample size" would refer to the number of femoral components subjected to stress and fatigue analysis. This number is not explicitly stated but would likely be a small number of physical samples or computational models.
Data Provenance: The data is derived from non-clinical tests conducted on the device's femoral component. The provenance is internal testing performed by PLUS Orthopedics. No geographical origin of data (country) is mentioned, nor is it described as retrospective or prospective in a clinical sense.

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

This question is not applicable in the traditional sense of clinical studies with expert-established ground truth. The "ground truth" for the non-clinical tests is established by engineering principles and validated testing methods for material strength, stress distribution, and fatigue. There are no "experts" in the sense of clinical reviewers establishing diagnostic ground truth. The experts involved would be biomechanical engineers or materials scientists conducting the tests and interpreting the results, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies where multiple human readers or experts evaluate cases. The study described is a non-clinical, engineering-based assessment.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers perform with and without AI assistance, which is irrelevant for a mechanical knee implant modification.

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

This question is not applicable. There is no AI algorithm or standalone software component described for this device. The device is a physical knee implant.

7. The Type of Ground Truth Used

The ground truth used in this context is engineering and materials science standards and principles. This involves:

Physical measurements of stress and strain.
Fatigue testing results.
Comparison against established biomechanical performance requirements for knee implants.
Analytical or computational models demonstrating reduced stress.

8. The Sample Size for the Training Set

This is not applicable. There is no mention of a "training set" as this is not a machine learning or AI-based device. The design, analysis, and testing of the implant are based on established engineering principles and prior knowledge.

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

This is not applicable as there is no training set.

Summary

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Date June 27, 2003

Submitter

PLUS Orthopedics 6055 Lusk Blvd San Diego, CA 92121

Contact person J.D. Webb 1001 Oakwood Blvd

Round Rock, TX 78681 512-388-0199

Trade name UC-PLUS Solution Unicondylar Knee

Common name Unicondylar Knee

Classification name

Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/Polymer

888.3530 (per 21 CFR section)

Indications for Use

The UC-PLUS Solution Unicondylar K nee is intended for use in uni-compartmental degenerative arthritis, local osteonecrosis of the femoral condyle, light to medium uni-compartmental destruction of the knee joint due to idiopathic and post-traumatic degenerative arthritis, traumatic uni-compartmental bone and/or cartilage lesions. It is intended for use with bone cement only.

Equivalent Device

This modified component is equivalent to the previously cleared UC-PLUS Solution Unicondylar Knee (K982859) in terms of indications, usage and materials.

Device Description

The subject of this Special 510(k) submission is the modification to the implant/bone interface of the femoral component and the elimination of the smallest size femoral component.

Summary Nonclinical Tests

The change in fin height of the UC-PLUS Solution Unicondylar Knee femoral component resulted in no increased risks and decreased the stresses in the component due to fatigue loading.

JUL 25 2003

K032052
page 1 of 1

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 25 2003

PLUS Orthopedics c/o Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K032052

Trade/Device Name: UC-PLUS Solution Unicondylar Knee Regulation Numbers: 21 CFR 888.3530 Regulation Names: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HRY Dated: June 27, 2003 Received: July 2, 2003

Dear Mr. Webb:

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. J.D. Webb

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 (301) 594-4659. 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/dsma/dsmamain.html

Sincerely yours.

Sincerely yours,

for Mark A. Milliman

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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510(k) number (if known):__KO32052

Device Name: UC-PLUS Solution Unicondylar Knee

Indications for Use:

UC-PLUS Solution Unicondylar Knee Indications for Use

It is intended for use with bone cement only.

(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, Neurological and Restorative Devices

510(k) Number

Prescription Use (per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional format 1-2-96)

Mark A. Milliman
(Division Sign-Off)

Di ision of General, Restorative and Neurological Devices

510(k) Number K032052

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.