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The Compress® Segmental Humeral Replacement System is indicated for:

1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
2. Tumor resections.
3. Revision of previously failed total joint arthroplasty.
4. Trauma.

The Compress® Segmental Humeral Replacement System components are intended for uncemented use.

The Compress® Segmental Humeral Replacement System is a metallic segmental fixation system intended to replace the resected part of the humerus in cases of severe bone loss. The Compress® Segmental Humeral Replacement System components are intended for uncemented use. The design of the Compress® System allows a compressive load to be applied at the prosthetic implant-bone interface at the time of device insertion. This is accomplished through a spring system built into the stem.

The information provided states that no clinical or non-clinical data was submitted or deemed necessary for the determination of substantial equivalence for the Compress® Segmental Humeral Replacement System. Therefore, there is no study that proves the device meets specific acceptance criteria based on performance data.

Instead, the submission relied on demonstrating substantial equivalence to a predicate device (Compress® Segmental Humeral Replacement System, K112905) for an addition of compatibility to another system.

Given this, I cannot provide the requested information:

1. A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are mentioned.
2. Sample size used for the test set and the data provenance: No test set or data provenance mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No test set or ground truth established by experts mentioned.
4. Adjudication method for the test set: No test set or adjudication method mentioned.
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, as this is a medical implant, not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical implant.
7. The type of ground truth used: No ground truth used.
8. The sample size for the training set: No training set mentioned.
9. How the ground truth for the training set was established: No training set or ground truth mentioned.

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