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The Reverse Shoulder Monoblock Prosthesis is indicated for patients with a functional deltoid muscle with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint:

• In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, including humeral head fracture or displaced 3-or 4-part fractures of proximal humerus.
• In cases of bone defect in proximal humerus.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s).

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

This is a modification to the RSP Monoblock Stem cleared under K100741. The cleared RSP Monoblock Prosthesis system consists of a monoblock humeral stem with socket, humeral socket inserts, glenoid head, and glenoid head baseplate.

This change consists of the addition of an 8mm spacer and screw placed between the socket insert and the humeral shell portion of the RSP Monoblock stem to allow for 8mm humeral offset.

There is no change to the intended use or fundamental scientific technology. This includes no changes to packaging or sterilization.

The provided document is a 510(k) premarket notification letter from the FDA for a medical device (Reverse® Shoulder Monoblock Prosthesis). This type of document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria, study methodologies, and performance metrics as would be found in a clinical trial report or a performance study summary.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details, or how ground truth was established.

Here's what the document does state regarding testing:

• Non-Clinical Testing: "Mechanical testing has demonstrated the device's ability to perform under expected conditions. Testing includes torque, lever out strength, load cycle, and screw torque."
• Clinical Testing: "None provided."

This implies that for this particular 510(k) submission, the FDA's decision was based on non-clinical (mechanical) testing and the device's substantial equivalence to previously cleared predicate devices, rather than new clinical effectiveness or performance studies.

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