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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 larger, standard (non-spherical) humeral components to the CSR Shoulder System. Like the previously cleared CSR humeral components, the Size H and Size I CSR standard humeral components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. They 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 humeral components are compatible with previously cleared CSR 3 Peg glenoid components.

The provided text is a 510(k) premarket notification for a medical device called the "Catalyst CSR Shoulder System." This document does not describe acceptance criteria for an AI/ML powered device, nor a study proving a device meets such criteria. Instead, it details the indications for use, device description, and a summary of substantial equivalence for a physical shoulder prosthesis, with non-clinical testing performed on its components.

Therefore, I cannot provide the information requested in your prompt based on the provided text, as it pertains to an entirely different type of medical device submission.

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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.
The Catalyst CSR glenoid components are manufactured from UHMWPE conforming to ASTM F648. Three sizes of glenoid components are available, with right and left sides. 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. Two backside anchoring elements are engineered to match the shape of the glenoid vault and provide implant fixation within the dense cortical and subchondral bone. The triangular shape of the anchoring elements combines attributes of both peg and keel designs to resist loosening forces.
The Catalyst CSR humeral components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75 and have a polished surface for articulation with the glenoid component or the glenoid cavity of the scapula. The humeral components are designed with standard (non-spherical) and spherical geometries. The standard humeral components have seven sizes and the spherical humeral components have six sizes. 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 provided text is a 510(k) Summary for the Catalyst CSR Shoulder System. It describes the device, its intended use, and substantial equivalence to predicate devices, but does not contain information related to acceptance criteria, a specific study proving it meets acceptance criteria, or any details about a study with a test set, expert ground truth, training set, or MRMC analysis.

Therefore, I cannot fulfill your request with the provided input. The document explicitly states:

"Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst CSR Shoulder System to the predicate devices."

This indicates that clinical studies, which would typically involve the kind of data you're asking for, were not performed or submitted for this 510(k) clearance. The clearance was based on non-clinical testing and substantial equivalence to previously cleared devices.

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