Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; non-union humeral head fracture; displaced 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable.

Device Description

The present Device Modification submission corresponds to the addition of humeral heads made from Cobalt-Chromium-Molybdenum Alloy according to the standard ISO 5832-12 to the previous range with the same indications for use already covered by the previous 510(k) clearance. The hunteral stem and the glenoid component are unchanged.

The manufacturing methods, intended use, packaging and sterilization of the subjected device are identical to the predicate device.

AI/ML Overview

The provided text describes a Special 510(k) submission for a device modification to the AEQUALIS Shoulder System. This document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating the performance of the device against specific acceptance criteria.

The submission is specifically for the addition of humeral heads made from Cobalt-Chromium-Molybdenum Alloy (ISO 5832-12) to the existing AEQUALIS Shoulder System. The manufacturing methods, intended use, packaging, and sterilization of the modified device are stated to be identical to the predicate device.

Therefore, the acceptance criteria and study information typically associated with evaluating a device's performance (e.g., sensitivity, specificity, accuracy, reader studies) are not present in this document. This is because the regulatory pathway chosen (Special 510(k) for device modification) relies on demonstrating that the changes do not alter the fundamental safety and effectiveness of the device compared to its already cleared version.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: Not applicable. The document does not describe performance metrics or acceptance criteria for the modified device in terms of clinical outcomes or diagnostic accuracy. It focuses on material equivalence and manufacturing processes.
Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of clinical performance evaluation is mentioned. The submission is based on engineering and material equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is described.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating diagnostic performance, which is not the focus of this submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical implant, not an AI algorithm.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable. This is not a machine learning model.
How the ground truth for the training set was established: Not applicable.

Summary of what is available in the document regarding the "study" (which is essentially the justification for substantial equivalence):

Device Type: Aequalis Shoulder System (humeral heads made from Cobalt-Chromium-Molybdenum Alloy).
Regulatory Pathway: Special 510(k): Device modification - Premarket Notification.
Basis for Acceptance: Substantial equivalence to a legally marketed predicate device (the previous Aequalis Shoulder System).
Key Argument for Equivalence:
- The modification is the addition of humeral heads made from a different but suitable alloy (Cobalt-Chromium-Molybdenum Alloy according to ISO 5832-12).
- The intended use remains the same.
- The humeral stem and glenoid component are unchanged.
- Manufacturing methods, packaging, and sterilization are identical to the predicate device.
- Materials for other components (stem, glenoid) are specified (Cobalt Chromium alloy according to ISO 5832-4, UHMWPE according to ISO 5834-2).

In essence, the "study" demonstrating the device "meets the acceptance criteria" in this context is the technical and material comparison to the predicate device, arguing that the new material for the humeral head is equally safe and effective for the stated indications. The acceptance criteria are implicit in the FDA's "substantial equivalence" determination, meaning the modified device performs as safely and effectively as, and is as technologically advanced as, existing legally marketed devices.

Summary

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AUG 1 5 2001

K0122/2

Special 510(k): Device modification - Premarket Notification 510(k AEQUALIS Shoulder System

Summary of Safety and Effectiveness Information	Aequalis Shoulder System
Special 510(k): Device modification	Tornier S.A.S.
Premarket Notification, Section 510(k)

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

Device name 1)

AEQUALIS Shoulder System Trade name: Total-Shoulder System and Hemi-Shoulder System Common name: - Shoulder joint, metal/polymer semi-constrained cemented prosthesis Classification name:

2) Manufacturer

Tornier S.A. B.P. 11 - Rue Doyen Gosse 38330 Saint Ismier - France

3) Classification

$ 888.3660 Shoulder joint, metal/polymer semi-constrained cemented prosthesis.

Classification panel:	Orthopedic
Product code:	87 KWS
Device class:	Class II

4) Device description :

The manufacturing methods, intended use, packaging and sterilization of the subjected device are identical to the predicate device.

5) Indications :

Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability in degenerative, theumatoid, or traumatic disesse of the glenohumeral head fracture; displaced 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable.

6) Materials :

The stem is made from Cobalt Chromium alloy according to ISO 5832-4. The humeral head is available in both Cobalt-Chromium alloy according to ISO 5832-7 and ISO 5832-12. The glenoid components are produced from implant grade ultra-high molecular weight polyethylene (UHMWPE) according to ISO 5834-2, with a small cobalt-chrome pin included as an opaque radiographic marker.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with three human profiles incorporated into the design.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2001

Ms. Irene Gosset Regulatory Affairs Tornier S.A. 161. rue Lavoisier 38330 Montbonnot France

Re: K012212

Trade/Device Name: Aequalis Shoulder System Regulation Number: 888.3660, 888.3690 Regulatory Class: I Product Code: KWS, HSD Dated: July 10, 2001 Received: July 16, 2001

Dear Ms. Gosset:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Irene Gosset

This letter will allow you to begin marketing your device as described in your 510(k) premarket I nis lotter will and hy your ding of substantial equivalence of your device to a legally marketed nvellicate 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 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, (Jease contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

hheeeerfor

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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Page 1 of of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

AEQUALIS Shoulder System Device name:

Indication for use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Mitchell Womack

(Division Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number_(D

Prescription use

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional format 1-2-96)

Tomier S.A.

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing 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. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”