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The Equinoxe Humeral Augmented Tray is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in skeletally mature individuals with an intact medial calcar for whom the rotator cuff is irreparable or grossly deficient, a functional deltoid muscle is present, and proximal humeral bone loss is present in cases of:

· Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
· Congenital abnormalities in the skeletally mature
· Primary and secondary necrosis of the humeral head
· Humeral head fracture with displacement of the tuberosities
· 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 humeral stem fixation can be achieved)
· Displaced three- and four-part upper humeral fractures
· Failed ORIF requiring rTSA with an absent or deficient greater tuberosity
Revision of failed previous reconstructions when distal anchorage is required
· Treatment of unplanned proximal bone loss during a revision
· To restore mobility from previous procedures (e.g. previous fusion)

The Equinoxe Humeral Augmented Tray can be used in either primary or revision arthroplasty procedures.

Device Description

The Exactech Equinoxe Humeral Augmented Trays are intended for use in total shoulder arthroplasty in skeletally mature patients with proximal humeral bone loss. Specifically, Equinoxe Humeral Augmented Trays are used in combination with Equinoxe Reverse Shoulder System components to compensate for proximal humeral bone loss in presence of an intact medial calcar, irreparable or grossly deficient rotator cuff and a functional deltoid muscle. One of the overall goals of the anatomically designed Equinoxe Humeral Augmented Trays is to improve joint mechanics and stability by providing increased deltoid muscle wrapping and adequate soft tissue tensioning in patients with proximal humeral bone loss.

The Equinoxe Humeral Augmented Trays are consisted of a humeral tray component, a modular extension (augment) and a universal locking screw for use in primary and revision cases. To accommodate patients' various anatomical needs. Equinoxe Humeral Augmented Trays are anatomically designed with two offsets/thicknesses and multiple lateralizations of left and right humeral trays and left and right modular extensions. Per surgeon evaluation, the modular extension secured with a locking screw is used to replace greater and more severe proximal humeral bone loss than can be adequately addressed with use of humeral tray component alone. When the modular extension is used, the locking screw must be used to secure it to the humeral tray component. All three components of the Equinoxe Humeral Augmented Trays are manufactured from Titanium Alloy (Ti-6Al-4V).

AI/ML Overview

The provided text describes a medical device submission (K191561) for Exactech® Equinoxe® Humeral Augmented Trays. This document is a regulatory filing, and as such, it does not contain acceptance criteria or study results in the manner typically associated with AI/ML device performance. The device described is a physical implant for shoulder arthroplasty, not an AI or software device that would have performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested points are not applicable to this document. I will extract the relevant information from the provided text.

Here's an analysis based on the assumption that the request is looking for "acceptance criteria" and "study results" related to the mechanical performance and regulatory clearance of this physical implant, rather than an AI/ML diagnostic system.

1. A table of acceptance criteria and the reported device performance

The document describes non-clinical testing performed to demonstrate substantial equivalence, but it does not explicitly state quantitative "acceptance criteria" with numerical targets and then report performance against those targets. Instead, it lists the types of tests done to ensure the product performs as intended and is comparable to previously cleared devices.

Acceptance Criteria (Implied)	Reported Device Performance (Non-Clinical Testing)
Mechanical Performance:
- Sufficient fatigue strength under worst-case lateral loading	- Fatigue strength testing under worst-case lateral loading was performed. (Result: Demonstrates substantial equivalence)
- Sufficient fatigue strength under worst-case medial loading	- Fatigue strength testing under worst-case medial loading was performed. (Result: Demonstrates substantial equivalence)
- Maintain acceptable Range of Motion	- Range of Motion Analysis was performed. (Result: Demonstrates substantial equivalence)
- Biomechanical compatibility and functional performance in situ	- Cadaveric evaluation was performed. (Result: Demonstrates substantial equivalence)
Biocompatibility/Sterility:
- Meet pyrogen limits for sterile devices	- Pyrogen testing was conducted in accordance with USP , USP , and ANSI/AAMI ST72. (Result: Meets recommended limits per FDA's Guidance Document Submission and Review of Sterility Information in Premarket (510(k)) Submission for Devices Labeled as Sterile, demonstrating substantial equivalence)
Overall substantial equivalence to predicate devices	- Results of these non-clinical tests (mechanical testing, engineering analysis, and cadaveric evaluation) demonstrate that the proposed device is substantially equivalent to the previously cleared Humeral Adapter Trays (K063569, K082702).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in a quantifiable manner typical for clinical trials or AI/ML studies. The device underwent non-clinical testing, which includes:

Mechanical testing: Likely involved a specified number of devices tested on a test rig, but the specific sample size for each test (e.g., how many augmented trays underwent fatigue testing) is not detailed.
Engineering analysis: This is a computational/design review rather than a "sample."
Cadaveric evaluation: This would involve a certain number of cadaver specimens, but the exact count is not specified in the document.

The provenance (country of origin, retrospective/prospective) is not relevant for these types of non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable. The device is a physical implant, and its performance is assessed through mechanical tests and cadaveric evaluation, not through interpretation by human experts to establish "ground truth" for a diagnostic purpose.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like "2+1" are used in diagnostic consensus for things like image interpretation, which is not relevant to the mechanical and cadaveric testing of a shoulder implant.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. An MRMC study is designed for evaluating diagnostic devices, particularly AI/ML systems that assist human readers. This document concerns a physical orthopedic implant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical testing mentioned:

Mechanical Testing: The "ground truth" would be the engineering standards for fatigue, strength, and range of motion.
Cadaveric Evaluation: The "ground truth" would relate to anatomical fit, surgical procedure, and biomechanical function as observed by the evaluating surgeons/researchers in the cadaver models.

8. The sample size for the training set

This is not applicable. This is a physical medical device; there is no "training set" in the context of machine learning. The design and manufacturing process would involve iterative development and testing, analogous to "training" in an engineering sense, but not a data-driven training set.

9. How the ground truth for the training set was established

This is not applicable for the same reason as point 8.

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