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The Zimmer Trabecular Metal Shoulder System is indicated for the following:

Hemiarthroplasty/Anatomic application:

• the treatment of severe pain or significant disability in degenerative, theumatic disease of the glenohumeral joint;
• ununited humeral head fractures of long duration;
• irreducible 3-and 4-part proximal humeral fractures;
• avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

Reverse application:

• the treatment of severe pain or significant disability in degenerative, theumatoid, or traumatic disease of the glenohumeral joint;
• ununited humeral head fractures of long duration;
• irreducible 3-and 4-part proximal humeral fractures;
• avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthroplasty or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable.

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications).

The humeral components are intended for either cemented or uncemented use. The reverse base plate is intended for uncemented use, and requires two screws for initial fixation. When used in a total shoulder application, the allpolyethylene glenoid components are intended for cemented use only. In the USA, the Trabecular Metal Glenoid must be cemented under the base (see surgical technique for details) or fully cemented in place.

The proposed devices are a line extension of the Zimmer® Trabecular Metal™ Reverse Shoulder System, which consists of conventional (anatomic) and reverse, semi- and non-constrained shoulder prostheses for total or hemiarthroplasty applications.

This document is a 510(k) premarket notification for a medical device called the "Zimmer® Trabecular Metal™ Reverse Shoulder System, Mini Glenoid." It's an FDA clearance letter, not a study report, so it doesn't contain information about acceptance criteria or a study proving device performance in the way requested. Instead, it demonstrates substantial equivalence to a predicate device.

Here's a breakdown of why the requested information cannot be fully provided from this document:

• Acceptance Criteria of the Device: The document focuses on showing substantial equivalence to a legally marketed predicate device rather than providing specific performance acceptance criteria for the new device. The "Summary of Performance Data (Nonclinical and/or Clinical)" section mentions that non-clinical testing "demonstrated that the proposed devices meets performance requirements as defined by Design Control activities," but it does not enumerate those requirements or concrete acceptance criteria with specific thresholds.
• Study Proving Device Meets Acceptance Criteria: This document is a regulatory submission for premarket clearance, not a clinical trial report or a detailed engineering test report. It summarizes performance data but doesn't present the full studies.

However, based on the information provided, here's what can be extracted and inferred regarding performance and ground truth, with clear acknowledgment of the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds in this summary. The general statement is that the devices meet "performance requirements as defined by Design Control activities."
• Reported Device Performance: The document states that non-clinical testing demonstrated that the proposed devices met their performance requirements and are "substantially equivalent to the predicate device in terms of safety and efficacy." Specific numerical performance metrics or acceptance criteria for each test are not provided.

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

• Sample Size for Test Set: Not specified in this 510(k) summary. These would be details within the individual non-clinical test reports, which are not included here.
• Data Provenance: The tests are non-clinical (laboratory/bench testing), not from human patients. Therefore, country of origin or retrospective/prospective does not apply in the same way it would for clinical data.

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

• Ground Truth Establishment for Non-Clinical Tests: For non-clinical (bench) tests, "ground truth" is typically established by engineering specifications, material science standards, and established testing methodologies (e.g., ISO, ASTM standards). The specific number and qualifications of experts overseeing these tests are not mentioned but would typically involve qualified engineers and technicians.

4. Adjudication Method for the Test Set

• Not applicable as this involves non-clinical testing against engineering requirements, not human-read interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not Applicable. This document pertains to a shoulder implant, not an AI or imaging device that would typically undergo an MRMC study. It is a submission demonstrating substantial equivalence of a physical medical device.
• Effect Size of Human Readers with/without AI Assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

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

7. Type of Ground Truth Used

• For Non-Clinical Tests: The "ground truth" for the non-clinical tests would be established engineering specifications, mechanical properties, material integrity standards, and safety/performance benchmarks derived from the predicate device and relevant industry standards.
• Clinical Ground Truth: No clinical data were needed or provided for this 510(k) submission, as stated: "Clinical Tests: Clinical data and conclusions were not needed for this device."

8. Sample Size for the Training Set

• Not Applicable. This device is a physical implant, not an AI model that requires a training set.

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

• Not Applicable. As above, no training set for an AI model.

In summary, this document is a regulatory clearance for a medical device, focusing on its substantial equivalence to an existing device through non-clinical testing. It does not provide the detailed study results, acceptance criteria, or ground truth methodologies that would be presented for, for example, a new diagnostic AI device.

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