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The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total arthroplasty, anatomic hemi-arthroplasty, or reverse total arthroplasty is determined by the surgeon to be the preferred method of treatment.

Clinical indications for anatomic total arthroplasty and anatomic hemi-arthroplasty are as follows:

• · Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
• · Congenital abnormalities in the skeletally mature
• · Primary and secondary necrosis of the humeral head.
• · Pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
• · Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved)
• · To restore mobility from previous procedures (e.g. previous fusion)

The Equinoxe Preserve Stems are additionally indicated for use in reverse total arthroplasty in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff or a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Equinoxe Preserve Stems are intended for press-fit applications but may be used with bone cement at the discretion of the surgeon.

The Exactech Equinoxe Preserve Stem is a line extension to the range of humeral stems marketed by Exactech under the Equinoxe brand name. The subject device is intended to provide surgeons with a short-stem, distal bone preserving option that is compatible with minimally invasive surgical techniques. The proposed device is manufactured from Ti-6Al-4V and has Titanium Plasma Spray, grit blasted, and polished regions. The stems are available in 10 sizes, with distal stem diameters between 6mm and length of 70mm.

This document is a 510(k) premarket notification for a medical device called the Exactech® Equinoxe® Preserve Stem, a humeral stem for shoulder replacement surgery. It establishes substantial equivalence to previously marketed predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the context of AI/algorithm performance. Therefore, I cannot extract the requested information regarding acceptance criteria and studies in the way you've outlined, as this document pertains to a physical orthopedic implant and its regulatory clearance process based on substantial equivalence, not an AI/software as a medical device.

The document discusses:

• Indications for Use: What the device is intended for.
• Technological Characteristics: How the device is similar to predicate devices (materials, design, dimensions, sterilization).
• Non-Clinical Testing: Engineering analyses performed to demonstrate performance (Fatigue Testing, Subsidence and Pull-out Testing, Pyrogen testing).

It does not contain information about:

1. A table of acceptance criteria and reported device performance (in terms of AI metrics).
2. Sample size for a test set, data provenance, or ground truth.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone (algorithm only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory submission for a physical medical device, not an AI/ML-driven diagnostic or therapeutic device that would require the specific types of studies and acceptance criteria you're asking about.

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