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The Equinoxe Shoulder System is indicated for use individuals with degenerative diseases or fractures of the glenolumeral joint where total or hemi-arthroplasty is determined by the preferred method of treatment.

• The cemented primary humeral stem, longrevision stems, and all Equinoxe glenoids are intended for cemented fixation.
• The press-fit humeral stems are intended for press-fit applications but may be used with bone cement at the surgeon.
• . The reverse humeral components are intended to be used in cemented applications or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
• . Humeral Heads are intended for use in cemented and press-fit applications.

Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:

The Equinoxe Reverse Shoulder System is in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

The Equinoxe Platform Fracture Stem is in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures (hemi-athroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximation with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superil head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.

The proposed Exactech Equinoxe Reverse Humeral Liners and Humeral Adapter Trays are intended for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where reverse total arthroplasty is determined by the surgeon to be the preferred method of treatment.

This document is a 510(k) summary for medical device clearance, not a study report. It describes the device, its intended use, and claims substantial equivalence to existing predicate devices. It does not contain information about a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study for a diagnostic AI device would.

Therefore, many of the requested fields cannot be populated from the provided text because they pertain to a type of performance study (e.g., AI algorithm performance, human-in-the-loop studies, ground truth establishment) that is not included in this regulatory submission for a physical orthopedic implant.

Here's a breakdown of what can and cannot be extracted:

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

This information is not explicitly provided in the format of acceptance criteria and reported performance metrics in the context of device function (e.g., accuracy, sensitivity, specificity). Instead, the document lists various non-clinical testing performed and states that the proposed device conforms to "the same recognized performance standards" as the predicate devices. This implies that the acceptance criteria are adherence to these standards, and the reported performance is simply that the device passed these tests.

2. Sample size used for the test set and the data provenance:

• Sample size for test set: Not applicable in the context of this document. The "tests" are non-clinical, mechanical, and biological evaluations, not a test set for an algorithm. The non-clinical testing likely involved a certain number of physical device samples for each test, but those numbers are not specified here.
• Data provenance: Not applicable. The "data" pertains to the results of biomechanical and material tests, not clinical patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is a physical device clearance, not an AI or diagnostic device requiring ground truth established by experts for a test set.

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

• Not applicable for the same reason as above.

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:

• Not applicable. This is not an AI device.

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

• Not applicable. This is not an AI algorithm.

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

• Not applicable. For a physical orthopedic implant, "ground truth" generally refers to physical measurements, material properties, and biomechanical responses validated against established engineering and medical standards, rather than clinical diagnostic ground truth.

8. The sample size for the training set:

• Not applicable. The device is a physical implant, not an AI model requiring a training set.

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

• Not applicable.

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