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The Ascend Shoulder System consists of a humeral stem, a mating humeral head, and an optional polyethylene glenoid. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Ascend Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.

The Ascend Shoulder System is indicated for use as a replacement of shoulder joints disabled bv:

• Rheumatoid arthritis with pain .
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) .
• Correction of functional deformity ●
• Fractures of the humeral head .
• Traumatic arthritis .
• Revision of other devices if sufficient bone stock remains .

All components are single use. The humeral stem is intended for cementless use, while the all polyethylene glenoid is intended for cemented use only.

The Ascend Shoulder System consists of a humeral stem Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a mating humeral head and an optional all polyethylene glenoid. The stem and head may be used alone, as a hemiarthroplasty if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total shoulder replacement system.

The present device submission corresponds to changes made to the version of the device cleared in 510(k) K113413.

This document is a 510(k) premarket notification for the Tornier Inc. Ascend Shoulder System. It describes modifications to an already cleared device. As such, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not include information about acceptance criteria or a study proving the device meets those criteria in the context of AI/software performance metrics (e.g., sensitivity, specificity, accuracy).

Therefore, I cannot provide the requested information from the given text. The provided document is for a physical medical device (shoulder prosthesis) and evaluates its safety and effectiveness through mechanical and material testing, not through AI/software performance studies.

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