The HLS Uni Evolution prosthesis is intended for the replacement of the medial or lateral compartment of the femoro-tibial knee joint, when only one side of the knee is affected. This device is indicated in case of primary or secondary femoro-tibial arthritis. The HLS Uni Evolution prosthesis is intended for cemented use only.

Device Description

The HLS Uni Evolution prosthesis is intended to replace the medial or lateral compartment of the femoro-tibial knee joint. This system is an intermediate solution between osteotomy and total prosthesis. The HLS Uni Evolution prosthesis of a metallic distal femoral resurfacing component and a tibial component. Two kinds of tibial component may be associated with the femoral component, one that is all polyethylene and one that is polyethylene metal-backed. The femoral part is manufactured from cast Cobalt-Chromium alloy according to ISO standard 5832-4. The articulating surface, in contact with the bearing component, is mirror polished and the finished aspect of the part in contact with the bone is fine shotblasted. The all polyethylene tibial component is manufactured from implant grade ultra-high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2. The metal backed tibial component is composed of a polyethylene part, made from implant grade ultra-high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2, inserted in a stainless steel metal back that conforms to ISO standard 5832-1.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a medical device (HLS Uni Evolution prosthesis), not a study report detailing acceptance criteria or device performance in the way a clinical or AI-based diagnostic study would. The document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory requirement for market clearance.

Therefore, many of the requested categories are not applicable to this type of document. I will fill in what can be inferred or directly stated from the provided text and mark the rest as not applicable (N/A).

Acceptance Criteria and Device Performance Study Details for HLS Uni Evolution Prosthesis

Given that this document is a 510(k) Premarket Notification, it does not present acceptance criteria and performance data in the typical format of a clinical trial or AI device validation study. Instead, it focuses on demonstrating "substantial equivalence" to existing legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this context refers to demonstrating equivalence to predicate devices. The "performance" is primarily described by material composition, dimensions, method of fixation, and indications for use, all of which are aligned with the predicate devices.

Acceptance Criteria (Demonstration of Equivalence to Predicate Devices)	Reported Device Performance (Characteristics of HLS Uni Evolution Prosthesis)
Materials:
- Femoral implant material equivalent to predicate.	- Femoral Implant: Cobalt Chromium alloy (ISO 5832-4), mirror polished articulating surface, fine shotblasted bone contact surface. (Matches predicates like Miller/Gallante, Advance Unicondylar, Link Endo-Model Sled Uni-Knee which use Cobalt Chromium alloy, though Miller/Gallante and Advance use ASTM F 75 as standard).
- All poly Tibial implant material equivalent to predicate.	- All Poly Tibial Implant: Ultra-high molecular weight polyethylene (UHMWPE) (ISO 5834-2). (Matches Advance Unicondylar Knee System and Link Endo-Model Sled Uni-Knee; Miller/Gallante does not have an all-poly tibial component listed).
- Metal backed component materials equivalent to predicate.	- Metal Backed Tibial Component: UHMWPE (ISO 5834-2) + Stainless steel (ISO 5832-1). (Differs from predicates which use Titanium alloy or Cobalt Chromium alloy for the metal backing, but still considered substantially equivalent).
Sizes:
- Comparable sizing options to predicate devices.	- Femoral Implant: 5 sizes in 2 thicknesses (3 & 5 mm). (Comparable, but not identical to predicates which have 7, 4, or 4 sizes).
- All poly Tibial implant: Comparable sizing options.	- All Poly Tibial Implant: 5 sizes in 3 thicknesses (9, 11 & 13mm). (Comparable to predicates with varying sizes and thicknesses).
- Metal backed component: Comparable sizing options.	- Metal Backed Tibial Component: 5 sizes in 3 thicknesses (9, 11 & 13mm). (Comparable, but not identical to predicates with varying sizes and thicknesses).
Method of Fixation: Equivalent to predicate.	- Method of Fixation: Cemented. (Matches all predicate devices).
Indications for Use: Equivalent to predicate.	- Indications for Use: Replacement of medial or lateral compartment of femoro-tibial knee joint when only one side is affected, for primary or secondary femoro-tibial arthritis. For cemented use only. (Matches all predicate devices).
Sterilization Method: Equivalent to predicate.	- Sterilization Method: Gamma radiation. (Matches Miller/Gallante Precoat Unicompartmental; unknown for other predicates listed).

2. Sample size used for the test set and the data provenance

Sample Size: N/A. This document is a 510(k) submission and does not describe a clinical study with a test set of patients or data. The "test set" here refers to the characteristics and specifications of the device itself being compared to predicate devices.
Data Provenance: N/A. No patient or clinical data is provided or analyzed for device performance in this submission. The "data" consists of device specifications and material standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: N/A. No ground truth establishment by experts for a test set is described. The "ground truth" for this regulatory submission is essentially compliance with material standards and design principles consistent with predicate devices, evaluated by Tornier S.A.'s regulatory and quality personnel and subsequently by the FDA.
Qualifications of Experts: N/A.

4. Adjudication method for the test set

Adjudication Method: N/A. No test set requiring expert adjudication is described in this document.

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

MRMC Study: N/A. This document is for a knee prosthesis, not an AI-assisted diagnostic device. It does not involve human readers interpreting cases or AI.
Effect Size: N/A.

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

Standalone Performance: N/A. This document describes a physical medical implant, not a standalone algorithm.

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

Type of Ground Truth: For the purposes of this 510(k) submission, the "ground truth" is established by adherence to industry standards (e.g., ISO 5832-4 for Cobalt-Chromium alloy, ISO 5834-2 for UHMWPE), and demonstration of substantial equivalence in design, materials, and intended use to already legally marketed predicate devices. This is a regulatory "ground truth" rather than a clinical one.

8. The sample size for the training set

Training Set Sample Size: N/A. This is a physical device, not an AI model requiring a training set.

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

Ground Truth Establishment for Training Set: N/A. See above.

Summary

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Premarket Notification 510(1 HLS Uni Evolution prosthesis

Summary of Safety and Effectiveness information	HLS Uni Evolution prosthesis
Premarket Notification, Section 510(k)	Tornier S.A.

Safe Medical Devices Act of 1990, 21 CRF 807.92 Regulatory authority:

MAY 22 2003

1. Device name

Trade name:	HLS Uni Evolution prosthesis
Common name:	Unicompartmental Knee Prosthesis
Classification name:	Prosthesis, Knee, Femorotibial, Non-constrained, Cemented,Metal/Polymer

2) Submitter

Tornier S.A. Mrs Anne Le Rouzo Regulatory affairs and Quality Manager B.P. 11 - Rue Doyen Gosse 38330 Saint Ismier France Tel: 00 33 4 76 61 35 19 Fax: 00 33 4 76 61 35 44 e-mail : anne.le.rouzo@tornier.fr

3) Company contact

Tornier S.A. Mrs Mireille Lémery Regulatory affairs & Quality Engineer ZIRST - 161, rue Lavoisier 38330 Montbonnot France Tel: 00 33 4 76 61 38 98 Fax: 00 33 4 76 61 35 44 e-mail : mircille.lemery@tornier.fr

4) Classification

Sec. 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 minimally limits (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 components made of alloys, such as cobalt-chromium-molybdenum, and a tibial components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (Sec. 888.3027). (b) Classification. Class II.

Device class:	Class II
Classification panel:	Orthopedic
Product code:	HSX

ર) Equivalent / Predicate device

Miller / Gallante Precoat Unicompartmental, Zimmer, Inc; K010685 Advance Unicondylar Knee System, Wright Medical Technology, Inc; K014171 Link Endo-Model Sled Uni-Knee, Link America, Inc; K954186

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HLS Uni Evolution prosthesis

6) Device description

The usual goal of a unicompartmental knee prosthesis is to restore the knee joint to its best working condition and to reduce or eliminate pain when only one side of the joint is affected. The HLS Uni Evolution prosthesis is intended to replace the medial or lateral compartment of the femoro-tibial knee joint. This system is an intermediate solution between osteotomy and total prosthesis.

The HLS Uni Evolution prosthesis of a metallic distal femoral resurfacing component and a tibial component. Two kinds of tibial component may be associated with the femoral component, one that is all polyethylene and one that is polyethylene metal-backed.

7)

The femoral part is manufactured from cast Cobalt-Chromium alloy according to ISO standard 5832-4. The articulating surface, in contact with the bearing component, is mirror polished and the finished aspect of the part in contact with the bone is fine shotblasted. The all polyethylene tibial component is manufactured from implant grade ultra-high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2. The metal backed tibial component is composed of a polyethylene part, made from implant grade ultra-high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2, inserted in a stainless steel metal back that conforms to ISO standard 5832-1.

8) Indications

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9) Comparison table

		HLS Uni Evolutionprosthesis	Miller / GallantePrecoatUnicompartmental	AdvanceUnicondylar KneeSystem	Link Endo-ModelSled Uni-Knee	SE?
Materials	Femoralimplant	Cobalt Chromiumalloy	Cobalt Chromiumalloy	Cobalt Chromiumalloy	Cobalt Chromiumalloy	YES
	All polyTibialimplant	UHMWPE	no	UHMWPE	UHMWPE	YES
	Metalbackedcomponent	UHMWPE +Stainless steel	UHMWPE +Titanium alloy	UHMWPE +Titanium alloy	UHMWPE + CobaltChromium alloy	NO
Sizes	Femoralimplant	5 sizes in 2 thickness(3 & 5 mm)	7 sizesright and left	4 sizes	4 sizes	YES
	All polyTibialimplant	5 sizes in 3 thickness(9, 11 & 13mm)	-	4 sizes in 4 thickness(7, 8, 9 & 10mm)	3 sizes in 2 thickness(11 & 13mm)	YES
	Metalbackedcomponent	5 sizes in 3 thickness(9, 11 & 13mm)	5 sizes with 4thickness(8, 10, 12 & 14mm)right and left	4 sizes in 3 thickness(10, 11 & 12mm)	3 sizes in 4 thickness(7, 9 11 & 13mm)	YES
	Method ofFixation	cemented	cemented	cemented	cemented	YES
	Indications forUse	Unicompartmental(medial or lateral)knee replacement	same	same	same	YES
	StandardsSpecificationsCrCo	ISO 5832-4	ASTM F 75	ASTM F 75	ISO 5832-4	YES
	StandardsSpecificationsUHMWPE	ISO 5834-2	ASTM F 648	ASTM F 648	ISO 5834-2	YES
Sterilizationmethod		Gamma radiation	same	unknown	unknown	YES
Manufacturer		Tornier	Zimmer, Inc	Wright MedicalTechnology, Inc	Link America	-
K-number		pending	K010685	K014171	K954186	-

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Image /page/3/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a bird in flight or a stylized representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 22 2003

Ms. Mireille Lemery Regulatory Affairs and Quality Engineer Tornier S.A. ZIRST - 161, rue Lavoisier 38330 Montbonnot France

Re: K022211 Trade/Device Name: HLS Uni Evolution Prosthesis Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: HSX Dated: February 20, 2003 Received: February 24, 2003

Dear Ms. Lemery:

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

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Page 2 - Ms. Mireille Lemery

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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) 594-4639. 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 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,

Mark A Millken

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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of 1 1 Page

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

HLS Uni Evolution Device name:

Indication for use:

The HLS Uni Evolution prosthesis is intended for cemented use only.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number	K022211
Prescription use	Yes
OR Over-The-Counter Use	No
(Per 21 CFR 801.109) (Optional format 1-2-96)

Regulation Number and Section

N/A