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The Equinoxe Reverse Shoulder System is indicated for use 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 proposed Equinoxe Reverse Shoulder System 36mm Glenosphere is a modification to the existing Equinoxe Reverse Shoulder System glenospheres previously cleared in K063569. The 36mm Glenosphere mates with previously cleared Equinoxe Reverse Shoulder glenoid baseplate and the glenosphere locking screw (K063569). The rationale for the modification of the devices is to offer a smaller glenosphere for patients in whom the 38mm glenosphere is too large. The only modifications to the predicate devices consist of a proposed dimensional change to decrease the radius of curvature on the articulating surfaces of the glenosphere to 36mm, as well as the removal of the extractor cavities on the side of the glenosphere due to size limitations.

The proposed Equinoxe Reverse Shoulder System 36mm Humeral Liners are a modification to the existing Equinoxe Reverse Shoulder System humeral liners previously cleared in K063569. The 36mm Humeral Liners mate with previously cleared Equinoxe Reverse Shoulder humeral tray (K063569). The rationale for the modification of the devices is to offer a smaller humeral liner for patients in whom the 38mm humeral liner is too large. The only modifications to the predicate devices consist of a proposed dimensional change to decrease the radius of curvature on the articulating surfaces of the humeral liners to 36mm.

This document is a 510(k) Summary of Safety and Effectiveness for the Exactech® Equinoxe® Reverse Shoulder System 36mm Glenosphere and Humeral Liners. It demonstrates substantial equivalence to a previously cleared predicate device rather than presenting a standalone study with acceptance criteria for a new device. Therefore, much of the requested information regarding acceptance criteria, human reader studies, and training set details are not applicable in this context.

However, I can extract information related to the non-clinical performance data and the conclusion of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a modification (dimensional change) to an existing device, the "acceptance criteria" are not framed as a specific set of target performance metrics but rather as demonstrating that the modified device performs comparably to the predicate device and meets established engineering standards. The reported device performance is presented as the findings from the non-clinical tests.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in terms of patient data or clinical images. The testing involved:
  • One 36mm Equinoxe Glenosphere for Finite Element Analysis.
  • Unspecified number of 36mm glenospheres and liners for the dynamic loading study.
  • Unspecified number of 36mm glenospheres and liners for geometric analysis.
  • Unspecified number of 36mm glenospheres and liners for polyurethane bone substitute validation.
• Data Provenance: The data is from non-clinical tests (Finite Element Analysis, dynamic loading study, geometric analysis, polyurethane bone substitute validation) conducted by the manufacturer, Exactech, Inc. It is not clinical data from patients.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth, in this context, would typically refer to clinical diagnoses or outcomes. This submission focuses on engineering analysis and mechanical testing, which rely on established engineering principles and measurements, not expert clinical consensus for a "ground truth" derived from patient data.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication of findings by human readers.

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 device is a shoulder prosthesis, not an AI-powered diagnostic or therapeutic tool. Therefore, MRMC studies involving human readers and AI are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

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

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was based on:

• Engineering principles and calculations (e.g., ASTM yield strength for FEA).
• Physical measurements and observations from mechanical and simulation studies (e.g., performance of devices in dynamic loading, proper articulation in bone substitute).
• Geometric analysis against the known dimensions and performance of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, and the submission does not describe a machine learning algorithm or a "training set" in that context. The design and testing are based on engineering principles and previous device performance.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a machine learning algorithm involved.

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