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The Catalyst F1x Shoulder System is intended for use as a replacement of shoulder joints in anatomic or reverse arthroplasty. Should the need arise for a conversion from an anatomic total shoulder to a reverse total shoulder, the humeral stem can remain in place, while the articulating surfaces are exchanged.

ANATOMIC TOTAL SHOULDER OR HEMI-SHOULDER

The Catalyst F1x 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 F1x 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

REVERSE TOTAL SHOULDER

The Catalyst F1x 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;
• 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

Catalyst F1x press-fit stems are intended for cementless press-fit applications.

The Catalyst F1x cemented stems are intended for cemented fixation.

The Catalyst F1x stem is compatible with the implants from the Catalyst CSR System, Catalyst EA Convertible Shoulder System and R1 Shoulder Systems.

The Catalyst F1x Shoulder System is intended for use as a replacement of shoulder joints in anatomic or reverse arthroplasty. The stems can be used in conjunction with the Catalyst R1 Reverse Shoulder humeral articulating poly inserts and glenoid implants for use in reverse shoulder arthroplasty. The stems can also be used in conjunction with the Catalyst Convertible System and CSR System for use in total or hemi-shoulder arthroplasty. The design intent of the Catalyst F1x Shoulder System is to offer a unique solution for revision shoulder arthroplasty and for securing and immobilizing the greater and lesser tuberosities in the repair of proximal humerus fractures.

This submission for the Catalyst F1x Shoulder System is to add anatomic indications for the Catalyst F1x Shoulder System. This submission consists of proximal bodies, distal stems and locking screws. The fracture specific proximal bodies have asymmetric, right- and left-sided finned geometry to provide specific locations to reattach the greater and lesser tuberosities for a stable reconstruction of the proximal humerus. The proximal bodies will have a porous titanium structure on the bone engaging regions to enhance the mechanical fixation. The distal stems shall be provided in varying diameters to accommodate varying bone geometries. The distal stems will be offered in press-fit and cemented versions. The press-fit distal stems shall have a tapered, splined proximal geometry with an HA (hydroxyapatite) coating. The cemented stems shall have a smooth stem geometry. The proximal bodies and distal stems shall be secured together using a mechanical taper interface that is supplemented with a locking screw.

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The Catalyst F1x 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;

• Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural head and/or glenoid;

· Inflammatory arthritis including rheumatoid arthritis;

· Correction of functional deformity

The Catalyst F1x press-fit stems are intended for cementless press-fit applications.

The Catalyst F1x cemented stems are intended for cemented fixation.

The Catalyst F1x stem is compatible with the implants from the R1 Shoulder Systems.

The Catalyst F1x Shoulder System is intended for use as a replacement of shoulder joints in reverse arthroplasty. The stems can be used in conjunction with the Catalyst R1 Reverse Shoulder humeral articulating poly inserts and glenoid implants for use in reverse shoulder arthroplasty.

This submission for the Catalyst F1x Shoulder System consists of proximal bodies, distal stems, locking screws and spacers. The fracture specific proximal bodies have asymmetric, right- and left-sided finned geometry to provide specific locations to reattach the greater and lesser tuberosities for a stable reconstruction of the proximal humerus. The proximal bodies have a porous titanium structure on the bone engaging regions. The distal stems shall be provided in varying diameters to accommodate varying bone geometries. The distal stems will be offered in press-fit and cemented versions. The press-fit distal stems shall have a tapered, splined proximal geometry with an HA (hydroxyapatite) coating. The cemented stems shall have a smooth stem geometry. The proximal bodies and distal stems shall be secured together using a mechanical taper interface that is supplemented with a locking screw. Spacers shall be provided to offer additional options for restoring the appropriate humeral height.

I am sorry, but the provided text is a 510(k) Premarket Notification letter from the FDA regarding a medical device, the "Catalyst F1x Shoulder System." This document does not contain any information about acceptance criteria or a study that proves a device meets specific acceptance criteria, particularly not for AI/Software as a Medical Device (SaMD) performance.

The document states:

• "Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst F1x Shoulder System to the predicate devices."
• "The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, as the legally marketed predicate identified in this 510(k) Summary."

This indicates that the submission relied on non-clinical testing (like biocompatibility, fatigue testing, etc.) and comparison to predicate devices, rather than a clinical study evaluating AI performance against acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text, as this information is not present.

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