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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 Press-Fit Humeral Components to the CSR Shoulder System. The press-fit humeral components have a non-spherical polished surface for articulation with the glenoid component or the glenoid cavity of the scapula. The humeral components incorporate 4 pegs which assist with alignment and provide rotational stability. The four plane geometry of the back side of the humeral component matches four cut surfaces on the humeral head to recreate the geometry and thickness of the removed bone. The CSR Press-Fit Humeral Components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The undersurface of the head and the proximal portion of the alignment pegs are coated with a plasma sprayed coating of CP Ti conforming to ASTM F1580.

The CSR humeral components are compatible with previously cleared CSR 3 Peg glenoid components.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Catalyst CSR Press-Fit Humeral Components:

Summary of Device and Context:

The document is an FDA 510(k) clearance letter and a 510(k) Summary for the Catalyst CSR Press-Fit Humeral Components, which are an addition to the existing Catalyst CSR Shoulder System. This device is a shoulder prosthesis intended for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint, where the humeral head, neck, and glenoid vault have sufficient bone stock, and the rotator cuff is intact or reconstructable. The key new feature here is the "Press-Fit" capability, allowing for uncemented or cemented use, and the device incorporates a plasma sprayed coating of CP Ti. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

Detailed Analysis of Acceptance Criteria and Study Information:

Based on the provided text, the focus is on non-clinical testing to demonstrate substantial equivalence, as clinical testing was deemed unnecessary.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

   • Static Shear Testing: The document states "Static shear testing was conducted," but it does not specify the sample size for this test.
   • Bacterial Endotoxin Testing: The document states "Bacterial Endotoxin Testing was performed," but it does not specify the sample size for this test.
   • Data Provenance: The document does not provide information on data provenance (e.g., country of origin, retrospective/prospective). Given these are non-clinical lab tests, it's implied they were conducted in a controlled lab environment by the manufacturer or a contracted lab.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • This question is not applicable as the document describes non-clinical engineering and bench tests, not studies requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set:

   • This question is not applicable for the same reasons as above. No human expert adjudication was involved in the non-clinical tests described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done.
   • The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst CSR Press-Fit Humeral Components to the predicate devices."
   • Therefore, there is no information on human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • This question is not applicable. The device is a physical shoulder implant, not an algorithm or AI system. The testing performed was related to its physical properties and biocompatibility.

7. Type of Ground Truth Used:

   • For the non-clinical tests mentioned:
     • Static Shear Testing: The "ground truth" would be the universally accepted principles of mechanical engineering and material science, measured against a pre-determined acceptance criterion (likely based on established standards for orthopedic implants).
     • Bacterial Endotoxin Testing: The "ground truth" is the predefined acceptable endotoxin limit (<10EU/component or <20EU/device construct), which is based on regulatory standards for medical devices to ensure safety.
     • Torque-out: "Ground truth" from an engineering analysis, likely based on established mechanical principles and data from the predicate device.

8. Sample Size for the Training Set:

   • This question is not applicable. The device is a physical implant, not an AI model requiring a training set. The term "training set" is typically used in the context of machine learning or AI development.

9. How the Ground Truth for the Training Set Was Established:

   • This question is not applicable for the same reasons as above.

Conclusion:

The FDA clearance for the Catalyst CSR Press-Fit Humeral Components relied on non-clinical testing demonstrating substantial equivalence to predicate devices. The key tests reported were static shear testing and bacterial endotoxin testing, both of which met pre-determined acceptance criteria. Clinical testing, which would involve human performance or outcomes, was explicitly stated as "not necessary." Therefore, many of the questions related to clinical study design, expert involvement, and AI performance are not relevant to this specific clearance document.

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