The EIUS® Unicompartmental Knee System is intended for use in unicompartmental kncc arthroplasty. It is intended to be used for patients with moderately disabling joint discase of the knee resulting from painful osteoarthritis or traumatic arthritis; revision of previous unsuccessful unicompartmental knec replacement or other procedure, or as an alternative to tibial osteotomy in patients with unicompartmental ostcoarthritis.

The FIUS® Knee System components are for use in Unicompartmental knee arthroplasty as a result of:

Moderately disabling joint disease of the knee resulting from painful osteo- or post . traumatic arthritis
Revision of previous unsuccessful unicompartmental knee replacement or other . procedure
As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis .
These components are single use only and are intended for implantation with bone cement.

Device Description

This submission is intended to address a line extension to the EUS® Unicompartmental Knee System. The linc cxtension includes additional tibial components, 8mm, 10mm, and 12mm components without a keel and 6mm components with and without a keel. Also, some changes werc made to the cement recess of the tibial component to ensure adequate thickness under the femoral condyle. Finally, the material will change from the current polycthylene material to the polyethylene material used in the Scorpio Knee System. The new components will be used for resurfacing of either the medial or lateral proximal tibia.

AI/ML Overview

The provided document is a 510(k) Special Summary of Safety and Effectiveness for a line extension to the EIUS® Unicompartmental Knee System. It focuses on device modifications and substantial equivalence to predicate devices, primarily through mechanical testing.

Therefore, the information required to answer many of your questions regarding AI/ML device performance (e.g., acceptance criteria for diagnostic metrics, sample size for test sets/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance) is not present in this document. This is because the device described is a physical medical implant (a knee system), not an AI/ML diagnostic or prognostic device.

Here's an attempt to answer the questions based only on the provided text, acknowledging the limitations for an AI/ML context:

A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied for medical implants)	Reported Device Performance
Mechanical Properties: Comparable to predicate devices.	"Mechanical testing demonstrated comparable mechanical properties to the predicate devices."
Material Equivalence: Material of new components is equivalent to existing, legally marketed components.	"The material will change from the current polyethylene material to the polyethylene material used in the Scorpio Knee System." (Scorpio Knee System material was cleared under K962152, implying equivalence).
Design Features: New features (cement recess without a keel) are equivalent to existing, legally marketed components.	"the cement recess without a keel is equivalent to the UNIX Unicompartmental Knee and the Biomet Repicci Unicompartmental All Polyethylene Tibia component (also available without a keel)." (UNIX cleared under K923011, Biomet under K980665).
Intended Use: Same intended use as predicate devices.	"The subject components share the same intended use and basic design concept as that of the predicate devices." Also, "The EIUS® Unicompartmental Knee System is intended for use in unicompartmental knee arthroplasty."
Safety & Effectiveness: Device is substantially equivalent to predicate devices.	Device received 510(k) clearance (K033769) based on substantial equivalence to predicate devices.

Sample size used for the test set and the data provenance
- Sample Size: Not specified. The study mentioned is "mechanical testing," which typically involves multiple samples of the components under various load conditions, but the exact number isn't reported.
- Data Provenance: Not specified. Mechanical testing is generally conducted in a lab setting rather than from patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. For mechanical testing of a physical implant, "ground truth" is typically established by engineering standards and measurements, not expert human interpretation in the way it is for image analysis or diagnostic tasks.
Adjudication method for the test set
- Not applicable/Not specified. This concept is typically relevant for subjective human assessments, not objective mechanical testing.
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. This is irrelevant for a knee implant system. MRMC studies are used for evaluating diagnostic performance with human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is irrelevant for a knee implant system.
The type of ground truth used
- For the mechanical testing: Engineering specifications, material properties, and comparison to established predicate device performance. The "ground truth" here is the objective, measurable performance characteristics of the device and its compliance with standards relevant to knee implants.
The sample size for the training set
- Not applicable/Not specified. This concept is for AI/ML models.
How the ground truth for the training set was established
- Not applicable/Not specified. This concept is for AI/ML models.

Summary

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FEB 1 3 2004 Special 510(k) Summary of Safety and Effectiveness: Line Extension to the EIUS® Unicompartmental Knee System

Proprietary Name:	EIUS® Unicompartmental Knee System
Common Name:	Unicompartmental Knee System
Proposed Regulatory Class:	Class II
	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented,
	Metal Polymer, 21 CFR 888.3520
Device Product Code:	87 HSX
For Information contact:	Denise Duchene
	Sr. Regulatory Affairs Specialist
	Howmedica Osteonics Corp.
	325 Corporate Dr.
	Mahwah, NJ 07430
	Telephone: (201) 831-5612
	Fax: (201) 831-6038
	Email: dduchene@howost.com)
Date Summary Prepared:	November 12, 2003

Predicate Device Identification

The EIUS® Unicompartmental Knee System consists of femoral components and tibial components and the Scorpio Total Knee System consists of various femoral, tibial and patcllar components. The EIUS Unicompartmental Knec System additional tibial components are equivalcul to the currently marketed EIUS tibial components with the exception of the thickness, cement recess and material. The material is equivalent to the currently marketed Scorpio Knee System tibial inscrts; whereas the coment recess without a keel is equivalent to the UNIX Unicompartmental Knee and the Biomet Repicci Unicompartmental All Polycthylene Tibia component (also available without a keel). The EIUS Unicompartmental Knee System was determined substantially equivalent under K992287, the UNIX Unicompartmental Kncc was determined substantially equivalcnt under K923011, the Biomet component was cleared under K980665, and the Scorpio Total Kncc Tibial Insert components were determined substantially equivalent under K962152.

Description of Device Modification

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Intended Use:

Statement of Technological Comparison:

The subject components share the same intended use and basic design concept as that of the predicate devices. Mechanical testing demonstrated comparable mechanical properties to the predicate devices.

page 2 of 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2004

Ms. Denise Duchene Senior Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430

Re: K033769

Trade/Device Name: EIUS® Unicompartmental Knee System - Tibial Components Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: HSX Dated: January 16, 2004 Received: January 20, 2004

Dear Ms. Duchene:

We have reviewed your Scction 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 Mcdical 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. Denise Duchene

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,

L. Mark A. Milburn

elia 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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Indications for Use

510(k) Number (if known): K033769

Device Name: EIUS® Unicompartmental Knee System - Tibial Components

Indications For Use:

The FIUS® Knee System components are for use in Unicompartmental knee arthroplasty as a result of:

Moderately disabling joint disease of the knee resulting from painful osteo- or post . traumatic arthritis
Revision of previous unsuccessful unicompartmental knee replacement or other . procedure
As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis .

These components are single use only and are 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mad A. Mellem

Restorative,

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510(k) Number K033769

Regulation Number and Section

§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.