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Primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis, severe joint pain of osteoarticular origin compromising the patient's quality of life, joints which are defective in shape and function, a revision intervention on a previous arthroplasty and other disorders in which arthrodesis is not an acceptable solution.

The press fit Æqualis® Shoulder Prosthesis is made from titanium alloy (TA6V4, titanium alloy in accordance with standard ISO 5832-3) and is used with humeral heads made of cobalt chromium alloy steel. This provides material compatibility with the existing line of Equalis® Shoulder implant humeral heads.

The provided text is a 510(k) premarket notification for a medical device, the Æqualis® Shoulder Prosthesis. It does not describe a study that proves the device meets acceptance criteria. Instead, it demonstrates substantial equivalence to previously marketed devices.

Here's how to break down the information based on your request, highlighting what's not present:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria or reported device performance in the context of a new study proving safety and effectiveness. The "acceptance criteria" here are met by demonstrating substantial equivalence to predicate devices. The "performance" is implicitly deemed equivalent to those predicate devices based on shared characteristics.

Important Note: The FDA's letter explicitly states a conditional acceptance for the glenoid component: it "may not be labeled or promoted for non-cemented use" and "must prominently state that the glenoid component is intended for cemented use only." Any non-cemented use is considered investigational. This is a critical distinction from full equivalence for all fixation methods.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. This document is a 510(k) submission based on substantial equivalence to predicate devices, not a clinical trial with a "test set" of patients for the device itself.
• Data Provenance: Not applicable. There is no specific patient data from a test set presented. The data is largely derived from material specifications, design comparisons, and the regulatory history of predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. As above, there is no "test set" in the context of a clinical performance study. The "ground truth" for substantial equivalence is established by regulatory review based on engineering, material, and design comparisons with existing devices.

4. Adjudication Method for the Test Set

• Not applicable. There is no test set or adjudication process for clinical outcomes described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This document focuses on the physical and functional equivalence of the device to existing ones, not on human reader performance, with or without AI assistance.

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

• No, a standalone performance study was not done. This device is a physical shoulder prosthesis, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" used for demonstrating substantial equivalence is based on:
  • Regulatory definitions: Classification of devices (Class II, Class III).
  • Industry standards: ISO and ASTM standards for materials.
  • Technical specifications: Material composition, dimensions, method of fixation.
  • Clinical experience of predicate devices: Implicit assumption that if the new device is sufficiently similar to legally marketed predicate devices, it will also be safe and effective for the stated indications.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set was Established

• Not applicable. There is no "training set."

In Summary:

The provided document details a 510(k) submission for the Æqualis® Shoulder Prosthesis. The core "study" and "proof" presented is a comparison of the new device's features (materials, design, intended use, fixation methods, and compliance with standards) to legally marketed predicate devices to demonstrate substantial equivalence. It is not a clinical trial or performance study with acceptance criteria and results from a new patient cohort. The FDA's letter confirms substantial equivalence, with a significant caveat regarding the cemented-only use of the glenoid component.

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