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The Equinoxe Stemless Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment.

Clinical indications for anatomic total shoulder arthroplasty are as follows:

• 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 Stemless Shoulder humeral components are indicated for press-fit, uncemented use.

The Equinoxe Stemless Shoulder System is intended to be used with the cemented Equinoxe glenoid components.

The Equinoxe Stemless Shoulder is intended to be used with Exactech glenoid components for use in Total Shoulder Arthroplasty. The Exactech glenoid components are indicated for cemented use. The Equinoxe Stemless Shoulder includes humeral components and humeral heads. The proposed Equinoxe Stemless Humeral Components are additively manufactured from Ti-6Al-4V, and have porous regions. The Equinoxe Stemless Humeral Heads are manufactured from Cobalt Chrome. The Equinoxe Stemless Humeral Components are available in two types, Caged and Non-Caged, with each type available in three sizes, with lengths between 17mm and 24mm. The Equinoxe Stemless Humeral Heads are available in 12 sizes, with diameters between 38mm and 53mm and two height options (Extra Short, Short).

This FDA 510(k) premarket notification for the Exactech® Equinoxe® Stemless Shoulder device does not describe an AI/ML-based medical device. Therefore, the questions related to acceptance criteria, AI/ML study design, ground truth, and sample sizes for training/testing sets are not applicable in this context.

This submission is for a medical implant (a shoulder prosthesis) and focuses on demonstrating substantial equivalence to previously approved predicate devices through non-clinical (mechanical) testing, material comparisons, and similar indications for use.

Instead of AI/ML performance metrics, the document presents mechanical performance criteria.

Here's a breakdown of the relevant information provided:

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

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

• Not applicable for AI/ML device. The "test set" here refers to mechanical test samples, not clinical data for an algorithm. The document does not specify the number of mechanical samples used for each test. Data provenance is not relevant as it's mechanical testing of a physical device.

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):

• Not applicable for AI/ML device. Ground truth, in the context of AI/ML, refers to labels or diagnoses. For a physical implant, ground truth would be established through engineering specifications and standards.

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

• Not applicable for AI/ML device. Adjudication methods are used to resolve disagreements in expert labeling for AI/ML ground truth.

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/ML device, so no MRMC studies or human reader improvement with AI assistance were performed.

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

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

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

• Not applicable for AI/ML device. For this physical device, "ground truth" equates to the established engineering specifications, performance standards (e.g., ISO, ASTM for fatigue, pull-out strength), and material properties that the device must meet to function safely and effectively.

8. The sample size for the training set:

• Not applicable for AI/ML device. There is no training set for a physical implant.

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

• Not applicable for AI/ML device. There is no ground truth or training set in the AI/ML sense for this device.

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