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The Nexa Orthopedics Total Shoulder System consists of a humeral stem, a mating humeral head, and an optional all polyethylene glenoid. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement shoulder system. The Nexa Total Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.

The Nexa Orthopedics Total Shoulder System is indicated for use as a replacement of shoulder joints disabled by the following:

• . Rheumatoid arthritis with pain
• . Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• . Correction of functional deformity
• . Fractures of the humeral head
• . Traumatic arthritis
• Revision of other devices if sufficient bone stock remains .

All components are single use. The humeral stem is intended for cementless use while the all polyethylene glenoid is intended for cemented use only.

The Nexa Orthopedics Total shoulder system is comprised of a line of humeral stems, humeral heads, and all polyethylene glenoid components. The humeral stems are sized and shaped to provide proximal fixation and optimal fixation area. Their variable length and proximally filling shape, are designed to accommodate the natural humeral geometry and provide stable fixation, proximal bone loading, and proper head placement with 0 to 3 mm of head adjustment possible. The humeral heads are offered with both spherical and non-spherical articulating surfaces and allow both neutral and offset head positioning via offset taper. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the Nexa all polyethylene, cemented glenoid. The glenoid has two or three pegs, depending on size, and is designed to function with both the spherical and non-spherical heads of the Nexa system.

The provided text describes a 510(k) summary for the Nexa Orthopedics Total Shoulder System. However, it does not include detailed acceptance criteria or a study proving device performance against such criteria in the format requested.

The document lists various ASTM standards to which the device components have been evaluated. These standards define test methods and specifications, which imply certain performance requirements, but the specific acceptance criteria values and the results showing the device meets them are not provided in this summary.

Therefore, I cannot fully complete the table or answer all sub-questions based solely on the provided text. I will fill in what can be inferred and explicitly state where information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided document. The listed ASTM standards typically define test methodologies, including sample size recommendations, but the specific number of units tested for this device is not reported here.
• Data Provenance: Not specified. This would typically be from laboratory testing as per the ASTM standards.

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

• Not applicable. This device is an orthopedic implant and its performance is evaluated through mechanical testing against established engineering standards (ASTM), not through expert clinical review of data for "ground truth" in the way a diagnostic AI might be.

4. Adjudication method for the test set

• Not applicable for mechanical testing of an orthopedic implant. Adjudication methods like "2+1" are relevant for clinical or imaging studies involving human interpretation or consensus.

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/diagnostic device.

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

• Not applicable. This is not an AI/diagnostic device.

7. The type of ground truth used

• Not applicable in the typical sense of "ground truth" for clinical or diagnostic devices. The "ground truth" for this device's performance is defined by its adherence to established engineering specifications and material properties as outlined in the ASTM standards.

8. The sample size for the training set

• Not applicable. This is an orthopedic implant, not a machine learning model. There is no "training set."

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

• Not applicable. As noted above, there is no "training set" or "ground truth" in the context of training a model for this device.

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