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The Catalyst CSR Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst CSR Shoulder System is intended for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable.

• Osteoarthritis
• Avascular Necrosis
• Rheumatoid Arthritis
• Post-traumatic Arthritis
• Correction of functional deformity
  Both components of the Catalyst CSR Shoulder System are intended for cemented use only.

The Catalyst CSR Shoulder System is a bone preserving total shoulder prosthesis designed for use in patients where the humeral head, neck and glenoid vault are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed.
This submission adds 3 peg glenoids to the CSR Shoulder System. The Catalyst CSR 3 peg glenoid components are manufactured from UHMWPE conforming to ASTM F648. Three sizes of glenoid components are available. The bearing surface has a symmetrical, oval shaped profile allowing use of each component on either the right or the left side. The glenoid component is designed to allow insertion at an angle, in the same orientation as the surgeon's exposure, to reduce the forceful retraction and soft tissue trauma usually required to insert standard glenoid components. Three backside pegs are engineered to provide implant fixation within the dense cortical and subchondral bone. Two versions of the 3 peg glenoid are available with the pegs angled at either 17 or 25 degrees.

The provided text is a 510(k) summary for the Catalyst CSR 3 Peg Glenoids, a shoulder prosthesis. It details the device, its intended use, and substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for an AI/ML medical device.

The document discusses non-clinical testing for the glenoid components (static lever-out, static torque-out, dynamic shear testing, and Bacterial Endotoxin Testing) and concludes that "the performance of the Catalyst CSR Shoulder System is adequate for its intended use." However, it does not provide specific quantitative acceptance criteria or detailed results of these tests.

It explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst CSR 3 Peg Glenoids to the predicate devices." This means a clinical study to establish performance against acceptance criteria in a human population, or a comparative effectiveness study, was not performed for this submission.

Therefore, many of the requested sections regarding AI/ML device performance are not applicable based on the provided text.

Here's a breakdown of what can and cannot be answered based on the provided document:

1. A table of acceptance criteria and the reported device performance

• Cannot be created. The document states that non-clinical tests (static lever-out, static torque-out, dynamic shear testing, bacterial endotoxin testing) were performed and indicated "adequate performance for its intended use." However, it does not provide specific quantitative acceptance criteria (e.g., minimum load for lever-out, maximum endotoxin level) nor does it report the specific performance values achieved by the device in these tests.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable for clinical performance. Clinical testing was not deemed necessary. For the non-clinical tests, the sample sizes and data provenance are not detailed in this summary document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No clinical test set or ground truth establishment by experts was performed for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical test set or adjudication was performed.

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

• No. An MRMC comparative effectiveness study was not performed. This device is a shoulder prosthesis, not an AI/ML diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical device (shoulder prosthesis), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. No clinical ground truth was established for this submission. The "ground truth" for the non-clinical tests would be the established engineering standards or physical properties being measured.

8. The sample size for the training set

• Not applicable. This device is a physical prosthesis, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

• Not applicable. This device is a physical prosthesis, not an AI/ML algorithm requiring a training set or its associated ground truth establishment.

Summary of relevant information from the document related to "acceptance criteria" and "study":

The document focuses on establishing substantial equivalence to predicate devices for a shoulder prosthesis, rather than demonstrating performance against novel acceptance criteria in a clinical study.

Non-Clinical Testing:

• Tests Conducted:
  • Static lever-out
  • Static torque-out
  • Dynamic shear testing (per ASTM F2028-14)
  • Bacterial Endotoxin Testing
• Reported Performance: "The results of these tests indicate that the performance of the Catalyst CSR Shoulder System is adequate for its intended use." (Specific quantitative results or formal acceptance criteria are not provided in this summary.)
• Bacterial Endotoxin: "endotoxin limit of 20EU/device was met." (This is the only explicit acceptance criterion given, and the device met it for the predicate component, with the new glenoids not creating a new worst case).
• Clinical Testing: Explicitly stated as "Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst CSR 3 Peg Glenoids to the predicate devices."

In essence, the "study" proving the device met "acceptance criteria" for this 510(k) was a set of non-clinical, mechanical, and biocompatibility tests intended to show that the new components perform similarly to the predicate devices and meet basic safety and performance requirements for the indicated use, without requiring new clinical data.

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