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The Centerpulse Orthopedics Anatomical Shoulder™ 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.
2. Omarthrosis.
3. Rheumatoid arthritis.
4. Revision of shoulder prosthesis.
5. Traumatology: the only cone to be used in traumatological indications is the traumatology cone.

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.

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:

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.

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