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The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy failed joint replacement with a grossly rotator cuff deficient shoulder joint.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The Reverse Shoulder Prosthesis- Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder ioint, severe arthropathy failed ioint replacement. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo. The glenoid component is intended for cemented application.

The Medacta Anatomic Shoulder Prosthesis - Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application.

The Medacta Shoulder System Short Humeral Diaphysis is an implantable device used to replace the humeral side of the gleno-humeral joint. The product is intended to be used with the Medacta Shoulder System cleared under K170452 and the Medacta Anatomic Shoulder Prosthesis cleared under K170910, as an alternative to the Standard Humeral Diaphysis - Cementless provided with those systems.

The Medacta Shoulder System Short Humeral Diaphysis couples with the Humeral Reverse Metaphysis (K170452) in the reverse configuration and the Humeral Anatomical Metaphysis -Cementless (K170910) in the anatomic configuration. The short humeral diaphysis implant minimizes the violation of the humeral intramedullary canal (IM).

The product is manufactured from titanium alloy (Ti6Al7Nb) and is provided sterile in 11 sizes.

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter and a 510(k) Summary for the "Medacta Shoulder System Short Humeral Diaphysis."

While it mentions that "verification activities, as identified through risk analysis, were conducted on the worst-case implants to written protocols with pre-defined acceptance criteria," it does not provide specific details on these acceptance criteria or the results of those tests for the subject device. It primarily states that the subject device did not represent a new worst-case for mechanical testing and that performance tests were conducted on the predicate devices (K170452 and K170910).

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: The document mentions "pre-defined acceptance criteria" but does not state what they are, nor does it report the performance against these criteria for the subject device.
2. Sample size used for the test set and the data provenance: Not mentioned for the subject device.
3. Number of experts used and their qualifications: Not applicable, as this is a mechanical device clearance, not an AI/diagnostic device.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable.
6. Standalone performance (algorithm only): Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on establishing substantial equivalence based on intended use, design, technological characteristics, and that the performance data from predicate devices were reviewed.

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