Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepation and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
a. Joint destruction and/or subluxation visible on x-ray
b. Resistance to conservative treatment
Primary replacement after fracture of the radial head
Symptomatic sequelae after radial head resection
Revision following failed radial head arthroplasty
The long stem is for single cemented use only. The short stem coated with titanium plasma-spray is for single use with or without cement.

Device Description

The RHS has been designed in order to provide surgeons and patients with a joint prosthesis to restore function and relieve pain of the radial part of the elbow joint. The RHS has an anatomical design, which reproduces the kinematics of the radial joint. The RHS consists of two components: a metal radial stern and a metal-polyethylene radial head.

AI/ML Overview

This is a radial head prosthesis submission, not an AI/ML device, therefore, the requested information about acceptance criteria, study details, and AI/ML specific metrics (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable.

The provided document is a 510(k) Premarket Notification for the "RHS" radial head prosthesis. The purpose of this type of submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not to prove performance against specific acceptance criteria in the manner of an AI/ML diagnostic device study.

The FDA's letter states: "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..."

However, based on the general information provided for medical devices, I can extract information relevant to "claims" and "indications for use" as they relate to what a device is designed to do, which can be seen as a form of "acceptance criteria" in a broader sense for a non-AI/ML device.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from Indications for Use and Device Description)

Since this is a prosthesis and not a diagnostic device, "performance" is largely demonstrated through substantial equivalence to predicate devices and the physical properties of the materials, rather than metrics like sensitivity or specificity. "Acceptance criteria" in this context refer to the conditions under which the device is intended to be used and the clinical problems it aims to address.

Acceptance Criteria (Indications for Use)	Reported Device Performance (Implicitly met by S.E. to predicates and device design)
Purpose: Restore function and relieve pain of the radial part of the elbow joint.	Achieved by anatomical design and material properties.
For replacement of radial head for degenerative or post-traumatic disabilities with:
- Pain, crepitation, and decreased motion at radio-humeral and/or proximal radio-ulnar joint
- Joint destruction and/or subluxation visible on x-ray
- Resistance to conservative treatment
Primary replacement after fracture of radial head
Symptomatic sequelae after radial head resection
Revision following failed radial head arthroplasty
Material Composition: Radial head: UHMWPE with CoCr shell. Stem: CoCr, some with Ti plasma-spray.	Confirmed via material specification.
Stem Usage: Long stem for single cemented use only. Short stem (Ti plasma-spray) for single use with or without cement.	Confirmed via design specification.

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

Not Applicable. This is a 510(k) for a physical implant, not an AI/ML diagnostic device requiring a "test set" in the computational sense. Substantial equivalence is typically demonstrated through comparison of design, materials, manufacturing processes, intended use, and sometimes non-clinical testing (e.g., mechanical testing, biocompatibility) to predicate devices, rather than a clinical study with a "test set" of patient data for performance evaluation against specific metrics.

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. See point 2.

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

Not Applicable. See point 2.

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 is a physical implant, not an AI-assisted diagnostic tool.

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

Not Applicable. This is a physical implant, not an algorithm.

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

Not Applicable directly for performance evaluation in the AI/ML sense. For a prosthesis, "ground truth" might pertain to established biomechanical principles, material standards (e.g., ASTM, ISO), and historical clinical outcomes of predicate devices that establish the safety and effectiveness of the type of device. Formal "ground truth" to evaluate diagnostic accuracy is not relevant here.

8. The sample size for the training set:

Not Applicable. See point 2.

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

Not Applicable. See point 2.

Summary

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1 9 2006 Implants Chirurgicau

Summary of Safety and Effectiveness information 510(k) Premarket Notification - RHS

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

K06043

1) Device name
Trade name:	RHS
Common name:	Radial head prosthesis
Classification name:	888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis
	888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis

Classification number: 2) Submitter Tornier Rue Doyen Gosse 38330 Saint Ismier - France

Company contact Tornier Mrs Mireille Lémery Regulatory affairs Manager 161, rue Lavoisier - Montbonnot 38334 Saint Ismier Cedex - France Tel: 00 33 4 76 61 38 98 Fax: 00 33 4 76 61 35 33 e-mail : mircille.lemery@tornier.fr
Classification Device class: Class II Classification panel: Orthopedic Product code: JDB &KWI
Equivalent / Predicate device Radial Head Prosthesis, Tornier, K994041 Radial Head, Avanta, K023604 Explor, Biomet, K051385

Image /page/0/Picture/8 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is bold and black, with a unique design where the top part of the 'T' is slightly separated and elevated above the vertical stem. The hexagon provides a border around the 'T', creating a distinct and recognizable emblem.

TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE

Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33

S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B

Page 1/ page 2

SIEGE SOCIAL : rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE

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Image /page/1/Picture/0 description: The image shows the text "KC6043 (pg 2 of 2)" at the top. Below that is the word "TORNIER" in large, bold letters. Underneath "TORNIER" is the phrase "Implants Chirurgicaux".

6) Device description

7) Materials

The radial head is made of ultra high molecular weight polyethylene (UHMWPE), with a chromium-cobalt alloy (CoCr) shell. The stem is made of chromium-cobalt alloy. Some stems are plasma-spray coated with titanium.

8) Indications

The RHS is intended for:

1. Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radio-humeral and/or proximal radio-ulnsor joint with:
- a. Joint destruction and/or subluxation visible on x-ray
- Resistance to conservative treatment b.
1. Primary replacement after fracture of the radial head
1. Symptomatic sequelae after radial head resection
1. Revision following failed radial head arthroplasty

The long stem is for single cemented use only. The short stem coated with titanium plasma-spray is for single use with or without cement.

Image /page/1/Picture/14 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is bold and has a unique design, with a smaller hexagon shape incorporated within its structure. The logo is simple, using only black lines on a white background, giving it a clean and modern appearance.

TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE

Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33

S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B

Page 2/ page 2

SIEGE SOCIAL : rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE

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Image /page/2/Picture/1 description: The image shows a circular logo with the words "U.S. Public Health Services" around the perimeter. Inside the circle is a stylized image of a bird or abstract shape with three curved lines representing its wings or body. The logo is in black and white and appears to be a simple, clean design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tornier c/o Mrs. Mireille Lémery Regulatory Affairs Manager 161, rue Lavoisier - Montbonnot 38334 Saint-Ismier Cedex FRANCE

APR 1 8 2006

Re: K060438

Trade/Device Name: RHS Regulation Number: 21 CFR 888.3160 Regulation Name: Elbow joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDB, K WI Dated: February 16, 2006 Received: February 27, 2006

Dear Mrs. Lémery:

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 cnactment 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 affècting 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 - Mrs. Mireille Lémery

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 (240) 276-0120. 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/industry/support/index.html.

Sincerely yours,

Herber Lener (as)

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices ()ffice of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): 〈○ЄΟ 4 33

Device Name: RHS

Indications For Use:

The RHS is intended for:

1. Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- a. Joint destruction and/or subluxation visible on x-ray
- b. Resistance to conservative treatment
1. Primary replacement after fracture of the radial head
1. Symptomatic sequelae after radial head resection
Revision following failed radial head arthroplasty 4)

The long stem is for single cemented use only. The short stem coated with titanium plasma-spray is for single use with or without cement.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(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, Restorative,
and Neurological Devices

Page 1 of 1

510(k) Number K060135

Regulation Number and Section

§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow 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 humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.