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The indications for use for the Discovery™ Elbow - Mosaic™ Distal Humeral Replacement System include:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis
3. Revision procedures where other treatments or devices have failed
4. Correction of functional deformity
5. Treatment of acute and chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods
6. Oncology applications
   This device is intended to be used with bone cement.

The Discovery™ Elbow - Mosaic™ Distal Humeral Replacement System is an elbow replacement device designed for use in cases where there is distal humeral bone loss. The device consists of a ulnar stem with a pre-assembled bearing, a distal humeral component which, with a humeral condyle kit, completes the hinge of the elbow, an extramedullary modular distal segment for bone replacement and a intramedullary humeral stem. Soft tissue attachment sleeves and canal cement plugs complete the system.

The provided text is a 510(k) Summary for a medical device (Discovery™ Elbow - Mosaic™ Distal Humeral Replacement System). It does not contain any information about acceptance criteria or a study proving the device meets those criteria.

Instead, it's a submission to the FDA for market clearance, primarily demonstrating substantial equivalence to pre-existing devices. This type of submission often relies on a comparison to predicate devices, rather than new performance studies with acceptance criteria.

Therefore, I cannot fulfill your request for the tables and study details based on the provided text. The output would be:

No information regarding acceptance criteria or a study proving the device meets those criteria is present in the provided document.

To elaborate on why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on indicating uses and comparing the new device to existing predicate devices.
2. Sample sized used for the test set and the data provenance: No test set is mentioned, as no performance study is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
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 document pertains to a physical elbow prosthesis, not an AI or imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The "Non-Clinical Testing/ Clinical Testing: None was provided as a basis of substantial equivalence" statement explicitly indicates that no new performance studies were submitted for this clearance.

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