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The Coonrad/Morrey Total Elbow is indicated for:

• Post-traumatic lesions or bone loss contributing to elbow instability
• Ankylosed joints, especially in cases of bilateral ankylosis from causes other than sepsis
• Advanced rheumatoid or degenerative arthritis with incapacitating pain
• Instability or loss of motion when the degree of joint damage precludes less radical procedures

The candidate for total elbow arthroplasty should exhibit joint destruction which significantly compromises the activities of daily living. Patients with single-joint involvement (generally those with traumatic or degenerative arthritis) or significant lower extremity disability which require walking aids are less amenable to treatment than patients with advanced and predominantly upper extremity involvement. If possible, elbow replacement should be done after hip or knee surgery to avoid excessive stress to the prosthesis required by crutch walking during total hip or knee rehabilitation.

The Coonrad/Morrey Total Elbow is closely based on the Coonrad III Total Elbow (K883665) cleared by FDA on February 3, 1989, with several exceptions.

The provided text is a K973357 510(k) Pre-Market Notification for a medical device (Coonrad/Morrey Total Elbow, New Hinge Pin). It describes the device, its intended use, and states that performance testing was conducted. However, the document does NOT contain the detailed information required to answer most of the questions about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Here's what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance

Missing Information:

• Specific numerical acceptance criteria (e.g., minimum force to unlock).
• Detailed quantitative results of the performance testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of experts: Not applicable, as this was a physical performance test for a mechanical device, not a diagnostic or image-based study requiring expert ground truth establishment in the typical sense.
• Qualifications of experts: Not applicable.

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

• Not applicable, as this was a physical performance test.

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

• Not applicable. This is a K973357 510(k) for a joint replacement device, not an AI/imaging diagnostic device.

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

• Not applicable. This is a K973357 510(k) for a joint replacement device, not an AI/imaging diagnostic device.

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

• The "ground truth" for this device would be its mechanical integrity and function as measured by the "force required to unlock the hinge pin assembly." This is a physical measurement, not a diagnostic finding.

8. The sample size for the training set

• Not applicable. This is a physical performance test, not a machine learning study with training sets.

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

• Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device, not a study report for an AI or diagnostic device. Therefore, most of the requested information regarding AI study methodologies, expert ground truth, and training/test sets is not present and not applicable to this type of submission. The document only generically states that "Performance testing was conducted to determine force required to unlock the hinge pin assembly. Results indicate the product is safe and effective." without providing the specific criteria or quantitative outcomes.

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