Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
Omarthrosis.
Rheumatoid arthritis.
Revision of shoulder prosthesis.
Traumatology: the only cone to be used in traumatological indications is the traumatology cone.

Device Description

The system consists of the following:

Humeral stem, uncemented .
Humeral stem, cemented ●
Humeral stem, revision, cemented ●
Ball-cone with taper .
Glenoid .
Humeral head .
The Anatomical Shoulder™ System with Removable Head was designed to enable the surgeon to remove the head, including the sphere connection, from the stem at any time. This is possible due to the introduction of an oval cone connection. The head is removable in order to gain access to the glenoid or to select other types of humeral heads.

AI/ML Overview

The provided text is a 510(k) summary for the Sulzer Orthopedics Anatomica Humeral Stem/Heads, seeking substantial equivalence to already marketed devices. It describes the device, its indications for use, and a comparison to predicate devices. However, this document does not contain explicit acceptance criteria or a detailed study proving the device meets such criteria in the way typically expected for a software or AI/ML device.

This submission is for a physical medical device (shoulder prosthesis components) and relies on a concept of "substantial equivalence" to predicate devices, rather than establishing performance against specific, pre-defined acceptance metrics through clinical or algorithmic studies.

Therefore, many of the requested items related to AI/ML device performance evaluation, ground truth, sample sizes for test/training sets, and expert adjudication are not applicable or cannot be extracted from this document.

Here's a breakdown of what can be inferred or directly stated, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Devices (K003801, K990137, K003832, Sulzer Select Shoulder, Kirschner/Biomet Mod II-C Shoulder, Biomet Bio-Modular Total Shoulder, Depuy Global Advantage Shoulder System)	Design verification testing indicated performance equivalent to commercially marketed products.
Safety and Effectiveness	Design verification testing did not raise any new issues of safety or effectiveness.

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

Not applicable/Not provided. This document does not describe a "test set" in the context of an algorithmic evaluation. Design verification testing typically involves mechanical and material tests of device components, not a patient-data-based test set for performance metrics.

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

Not applicable/Not provided. Ground truth, in the AI/ML sense, is not established for this type of device submission.

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

Not applicable/Not provided.

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:

No. This is not an AI/ML device, so no MRMC study involving human readers and AI assistance was conducted or reported.

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

Not applicable. This relates to AI/ML algorithms and is not relevant to this physical device.

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

For physical devices like this, the "ground truth" for proving substantial equivalence often comes from established engineering principles, material science data, prior clinical use of similar devices, and mechanical testing standards. The document states "Design verification testing" was performed, implying tests against validated physical properties and performance benchmarks for orthopedic implants.

8. The sample size for the training set:

Not applicable/Not provided. This document does not describe a "training set" in the context of an algorithmic evaluation.

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

Not applicable/Not provided.

Summary of the study/evidence presented in the document:

The "study" in this context is the design verification testing mentioned on page 1. This testing aimed to demonstrate that the new device, the "Centerpulse Orthopedics Anatomical Shoulder™ System with Removable Head," performs equivalently to already legally marketed predicate devices.

The document explicitly states: "Design verification testing did not raise any new issues of safety or effectiveness and indicated that this device should provide performance equivalent to commercially marketed products."

This implies that the tests performed (likely mechanical strength, fatigue, material compatibility, dimensional accuracy, etc.) confirmed that the device meets the established engineering and safety standards expected for such implants, aligning its performance with the predicate devices to establish substantial equivalence.

Summary

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K030259

P. 1/2

APR 2 4 2003 510(k) SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Sulzer Orthopedics Anatomica Humeral Stem/Heads.

Manufacturer:	Centerpulse Orthopedics Ltd.Grabenstrasse 25CH 6341 Baar, Switzerland
US Designated Agent:	Centerpulse Orthopedics Inc.9900 Spectrum DriveAustin, Texas 78717(512) 432-9900
Date:	January 17, 2003
Contact Person:	Audrey Swearingen, RACProgram Manager, Regulatory Affairs
Classification Name:	Shoulder joint metal/polymer semi-constrained cementedprosthesis - 21 CFR 888.3660; andShoulder joint humeral (hemi-shoulder) metallic uncementedprosthesis - 21 CFR 888.3690.
Common/Usual Name:	Humeral Stem and Head Components
Trade/Proprietary Name:	Centerpulse Orthopedics Anatomical Shoulder™ System withRemovable Head

Specific Diagnostic Indications:

Anatomical Shoulderm System with Removable Head is intended for use in treatment of the following:

1. Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
1. Omarthrosis.
1. Rheumatoid arthritis.
1. Revision of shoulder prosthesis.
1. Traumatology: the only cone to be used in traumatological indications is the traumatology cone.

Product Description:

The system consists of the following:

Humeral stem, uncemented .
Humeral stem, cemented ●
Humeral stem, revision, cemented ●
Ball-cone with taper .

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Glenoid .
Humeral head .

The Anatomical Shoulder™ System with Removable Head was designed to enable the surgeon to remove the head, including the sphere connection, from the stem at any time. This is possible due to the introduction of an oval cone connection. The head is removable in order to gain access to the glenoid or to select other types of humeral heads.

Humeral Stem

The cemented stem is manufactured of cast cobalt-chromium-molybdenum alloy. CoCrMo. The uncemented stem is made of forged titanium alloy, Ti6Al7Nb. Both stems are offered in four sizes based on the distal diameter of the stem. The cemented revision stems are extended in length by 100 mm. The stem is straight and features a "trumpet shaped" proximal geometry to match the metaphysis of the humeral shaft. Rotational stability is achieved via the proximal and medial portions of the stem body also feature a hole for placement of a wire or strong suture, if needed, for refixation of the tuberosities.

Ball-taper

The ball-taper component is made from forged titanium alloy. The ball-cone of the Anatomical Shoulder with Removable Head is a separate component The ball-taper features a slit cone on one side and an oval cone on the other, and is identical for all sizes of stems. Either the standard cone or fracture cone is introduced into the ball-taper component, and an impact screw is utilized to expand the slit oval cone for attachment to the selected modular humeral head. The fixation is secured against rotation by means of the oval conical coupling.

Humeral Head

The humeral heads used with the Anatomical Shoulder with Removable Head are the same as those used with the existing cleared Anatomical Shoulder System.

Glenoid

The glenoid used with the Anatomical Shoulder with Removable Head is that used with the existing cleared Anatomical Shoulder System.

Substantial Equivalence:

The Centerpulse Orthopedics Anatomical Shoulder System with Removable Head is substantially equivalent to the Sulzer (Centerpulse) Orthopedics Anatomical Press-Fit Humeral Stem (K003801) and cemented Anatomical Humeral Stem/Head (K990137, K003832), as well as to the Sulzer (Centerpulse) Orthopedics Select Shoulder, the Kirschner/Biomet Mod II-C Shoulder, the Biomet Bio-Modular Total Shoulder, and the Depuy Global Advantage Shoulder System.

Design verification testing did not raise any new issues of safety or effectiveness and indicated that this device should provide performance equivalent to commercially marketed products.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three intertwined snakes and a staff.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 4 2003

Ms. Audrey Swearingen, RAC Regulatory Affairs Manager Centerpulse Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717

Re: K030259

Trade/Device Name: Centerpulse Orthopedics Anatomical Shoulder™ System with Removable Head Regulation Number: 21 CFR 888.3660 and 888.3690 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis and Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Code: KWS and HSD Dated: January 21, 2003 Received: January 24, 2003

Dear Ms. Swearingen:

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 accordatice 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. Iisting 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. Audrey Swearingen, RAC

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) 594-4659. 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,

for Mark N. Millerson

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):

Device Name: Anatomical Shoulder™ System with Removable Heads

Indications for Use Statement:

The Centerpulse Orthopedics Anatomical Shoulder™ System with Removable Head is intended for use in treatment of the following:

1. Advanced wear of the shoulder joint resulting from degenerative, post-traumatic or rheumatic arthritis
1. Omarthrosis
Rheumatoid arthritis 3.
1. Revision of shoulder prosthesis.
Traumatology: the only cone to be used in traumatological indications is the traumatology cone. રું

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N. Milkerss
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number	K030259
---------------	---------

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use

(Optional Format 1-2-96)

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.”