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The New Bio-Moore Endo Heads is indicated for use in:

• a.) non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
• b.) rheumatoid arthritis
• c.) revisions procedures where other devices or treatments have failed
• d.) correction of functional deformities
• e.) Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement.

The Bio-Moore Endo Heads are intended for impaction on either a press-fit or cemented femoral component and are for single use implantation.

The New Bio-Moore Endo Heads are used as a hemi device and only replaces the head and not the acetubulum. The purpose is to preserve as much bone as possible. The heads allows for the use of taper inserts to vary the lengths of the neck which allows the surgeon greater flexibility in the OR. The taper inserts are assembled during surgery to insure an accurate fit.

The provided text is a 510(k) summary for a medical device (New Bio-Moore Endo Heads), which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against acceptance criteria through a dedicated study.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria.

A 510(k) submission typically relies on a comparison to an already legally marketed device (predicate device) and demonstrates that the new device is as safe and effective as the predicate. It doesn't usually include a standalone study that establishes and then meets specific performance acceptance criteria in the way a PMA (Premarket Approval) submission would.

Here's a breakdown of why the requested information is absent:

1. Table of acceptance criteria and reported device performance: Not present. The document focuses on intended use and device description, and then lists predicate devices.
2. Sample size used for the test set and data provenance: No test set is described. The filing is a regulatory submission for substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no such study is detailed.
4. Adjudication method for the test set: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory filing for substantial equivalence and does not detail a study proving specific performance against defined acceptance criteria.

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