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The EPOCA Custom Offset Shoulder Systsem can be used for either hemi or total shoulder replacement. It is a single-use device intended for cemented reconstruction of the humeral portion of severely destroyed (4-part fractures) and/or disabled and/or very painful shoulder joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis or avascular necrosis where radiographic evidence of sufficient sound bone to seat the prosthesis is present. This device is intended for use with components of the EPOCA Custom Offset Shoulder System only.

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The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "EPOCA Custom Offset Shoulder System." This letter addresses the device's substantial equivalence to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance metrics, or the results of a study that proves the device meets specific acceptance criteria. It is a regulatory approval document confirming the device's substantial equivalence under certain conditions for marketing, not a technical report detailing performance studies.

Therefore, I cannot provide the requested information from this document. The sections you asked for, such as:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance study results
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

...are not present in this 510(k) clearance letter. This type of information would typically be found in a separate study report or the technical documentation submitted to the FDA, which is not provided here.

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