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The Aequalis Adjustable Reverse Shoulder System is indicated for patients with a functional deltoid muscle and a massive and non-repairable rotator cuff tear as a replacement of Shoulder joints disabled by:

• 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 the devices if sufficient bone stock remains

The Aequalis Adjustable Reverse Shoulder system is a modular Reverse version of the Aequalis Shoulder System (K100142, K081059). The Aequalis Adjustable Reverse Shoulder system is supplied in separate, sterile packages which will be assembled in the operating room. The components provided will be: Metaphysis, Stem Spacers, Stems, Assembly Screw, Securitization System: Securitization Bracket and Screw. The Aequalis Adjustable Reverse Shoulder is a modular version of the Aequalis Reverse shoulder system. The Aequalis Adjustable Reverse Shoulder system has the same indications as Tornier Aequalis® Ascend™ Modular Reverse Shoulder System K110599. The Aequalis Adjustable Reverse Shoulder system contains a set of anatomically sized metaphyseal, spacers, and tapered stems that will be used in conjunction with the existing Aequalis Reverse glenosphere and polyethylene inserts for reversed total shoulder arthroplasty. The device will have a series of modular stems and spacers to accommodate a varied patient population. The system will include 10 stems: Five 90mm length (9, 11, 13, 15, 17mm diameter) and five 110mm length stems with 3 options: Uncoated, Hydroxylapatite (HAP) coated, HAP over titanium plasma spray (HAP/Ti PS) coated. The Aequalis Adjustable Reverse Shoulder assembly must be used in association with the Aequalis Reversed or Aequalis Reversed II glenoid implants, screws and fracture inserts (K030941, K061439, K081059, K050316, and K082120).

The provided document is a 510(k) premarket notification for a medical device (Aequalis Adjustable Reverse Shoulder System). It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or diagnostic accuracy.

The document discusses the substantial equivalence of this new device to previously marketed predicate devices based on material, design, sizing, indications for use, and non-clinical mechanical testing (e.g., fatigue, fretting corrosion). It's a regulatory submission for a physical orthopedic implant, not a software-driven diagnostic or prognostic tool.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance using the details from this document, as those types of studies and criteria are not applicable to the content provided.

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