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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 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 re sectional 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)

In the USA, the Equinoxe Stemless Shoulder is only indicated for total shoulder arthroplasty.

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

When used in total shoulder arthroplasty, the Equinoxe Stemless Shoulder System is intended to be used with the cemented Equinoxe glenoid components.

The Equinoxe Stemless Humeral Components are intended to be used with Exactech Equinoxe Stemless Humeral Heads and the Equinoxe glenoid components for use in Total Shoulder Arthroplasty. The Exactech glenoid components are indicated for cemented use. The proposed Equinoxe Stemless Humeral Components are additively manufactured from Ti-6Al-4V and have porous regions. The Equinoxe Stemless Humeral Components are available in in three sizes, with lengths between 17mm and 24mm.

This FDA 510(k) K192097 premarket notification is for a medical device called the Exactech® Equinoxe® Stemless Humeral Components. It is an orthopedic implant for shoulder arthroplasty.

It's important to note that this document describes a traditional 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device through engineering analyses and non-clinical testing. It does not involve studies with human subjects, AI algorithms, or deep learning models. Therefore, many of the requested fields (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone AI performance, training set sample size) are not applicable to this type of device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail numerical sense for each test. Instead, it states that the devices "perform as intended and are substantially equivalent to the identified predicate devices" based on the non-clinical testing. The "reported device performance" is the conclusion that the device passes these tests, thereby demonstrating substantial equivalence.

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

• Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., number of units tested for fatigue). These would typically be determined by relevant ASTM or ISO standards for testing orthopedic implants, but are not detailed in this summary.
• Data Provenance: Not applicable in the context of this device. The "data" comes from engineering and laboratory testing of the physical device components, not from patient data or clinical images. It's not retrospective or prospective in the clinical sense.

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

Not applicable. "Ground truth" in this context is established by physical measurement against engineering specifications and industry standards for material properties, mechanical performance, and sterilization. It doesn't involve clinical experts establishing diagnoses or observations.

4. Adjudication Method for the Test Set

Not applicable. There's no "test set" in the sense of clinical cases requiring adjudication. The tests are physical and chemical evaluations.

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 a physical orthopedic implant, not an AI-powered diagnostic or assistive device for human readers.

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

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

7. The Type of Ground Truth Used

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

• Established mechanical engineering principles.
• Relevant ASTM/ISO International Standards for orthopedic implants.
• FDA Guidance Documents (e.g., for sterility).
• Material specifications (e.g., for Ti-6Al-4V).
• Functional requirements for shoulder replacement devices.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is a physical implant, not a machine learning model.

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

Not applicable, as there is no training set.

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