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The Catalyst R1 Reverse Shoulder System is a reverse total shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:

• · Severe arthropathy with a grossly deficient rotator cuff;
• · Previously failed joint replacement with a grossly deficient rotator cuff;
• · Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
• · Bone defect in proximal humerus;
• · Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid;
• · Inflammatory arthritis including rheumatoid arthritis;
• · Correction of functional deformity

The humeral stems are intended for cemented or uncemented applications.

The glenoid baseplate is intended for uncemented use with the addition of screws for fixation.

The Catalyst R1 Reverse Shoulder System is a total shoulder prosthesis designed for use in patients with a non-functional rotator cuff. The articulation of this reverse design is inverted compared to a traditional anatomic total shoulder prosthesis, where the articulating sphere is on the glenoid side of the joint, and the mating insert is fixed into the humeral stem implant.

The Catalyst R1 Reverse Shoulder System was previously cleared per K202611 and modified to add semi-constrained polyethylene inserts per K211991. This submission is to add humeral spacers to the R1 Reverse Shoulder System. The humeral spacers allow for a height extension of the humeral stems cleared in K202611. These humeral spacers are an additional option and are compatible with all components within the Catalyst R1 Reverse Shoulder System.

This looks like a 510(k) summary for a medical device, the Catalyst R1 Reverse Shoulder System, and not a study describing AI/ML performance. Therefore, I cannot provide the requested information about acceptance criteria and studies proving the device meets those criteria, as the information is not present in the provided text.

The document discusses:

• The device's name and classification.
• Its indications for use.
• A comparison to a predicate device for substantial equivalence.
• Non-clinical performance data (construct fatigue tests) but explicitly states "Clinical testing was not necessary to demonstrate substantial equivalence".

There is no mention of:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI/ML.
• Sample sizes for test sets or data provenance.
• Experts used to establish ground truth or their qualifications.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or effect sizes of AI assistance.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Training set sample sizes or how ground truth for training was established.

This document seems to be focused on demonstrating substantial equivalence for a physical implantable device based on its design, materials, intended use, and mechanical performance, rather than evaluating a diagnostic or AI-driven system.

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