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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

The Catalyst CSR humeral and glenoid implants are intended for cemented use.

The Catalyst CSR Press-Fit humeral implants are intended for uncemented or cemented use.

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 augmented glenoid components to the CSR Shoulder System. The CSR Augmented Glenoids are nearly identical to the previously cleared CSR 3 Peg Glenoids, except that additional material has been added to the fixation surface creating a 10 degree posterior wedge. Like the previously cleared CSR 3 Peg glenoid components, the CSR Augments are manufactured from UHMWPE conforming to ASTM F648. Also like the previously cleared CSR 3 Peg Glenoid components, three sizes of augmented 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 bone 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.

The CSR Augmented Glenoid components are compatible with previously cleared CSR Press-Fit humeral components.

This document describes a 510(k) premarket notification for the Catalyst OrthoScience CSR Shoulder System, specifically focusing on the addition of augmented glenoid components. This is a medical device submission, and as such, it does not involve the type of AI/ML device performance criteria, studies, or ground truth establishment typically requested in your prompt.

Therefore, many of the requested fields are not applicable to this document. The existing information pertains to the non-clinical testing performed to demonstrate the device's safety and effectiveness for its intended use, rather than a clinical study evaluating diagnostic accuracy or similar AI model performance.

Here's a breakdown based on the provided text, indicating where information is not applicable:

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

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

• Sample size for test set: Not applicable for non-clinical testing. The "test set" here refers to physical devices or materials tested.
• Data provenance: Not applicable. The testing is non-clinical/laboratory-based.

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. Ground truth as typically defined for AI/ML performance evaluation (e.g., expert consensus on images) is not relevant to this type of non-clinical device testing.

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

• Not applicable. This concept is for clinical ground truth establishment, not for non-clinical device testing.

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. This is not an AI/ML device. Clinical testing was explicitly stated as not necessary to demonstrate substantial equivalence.

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

• Not applicable. This is not an AI/ML device.

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

• For the non-clinical tests described:
  • Glenoid stability: Ground truth is defined by the passing criteria of ASTM F2028-14 (a standardized test method).
  • Bacterial Endotoxin Testing: Ground truth is defined by the passing criteria of an endotoxin limit of <1.2 EU/device.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. There is no training set for this type of device.

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