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Each Osteonics Shoulder Humeral Component consists of a humeral stem component and a mating humeral head component. Each device is a single-use device. The Osteonics® Shoulder Humeral Components are intended for cementless applications.

The Osteonics Shoulder Humeral Components may be used as a hemi- or as a total shoulder replacement device. If used as a hemi-shoulder replacement device, the Osteonics Shoulder Humeral Components are intended to articulate directly with the anatomic glenoid. If used as a total shoulder replacement device, the Osteonics" Shoulder Humeral Components are intended to articulate with the legally marketed Osteonics All Polyethylene Glenoid Shoulder Component.

The specific indications for the use of the Osteonics" Shoulder Humeral Components are as follows:

• . Aseptic necrosis of the humeral head.
• . Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
• Proximal humeral fracture and/or dislocation.
• Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure. ●
• Clinical management problems where arthrodesis or alternative reconstructive techniques are ● less likely to achieve satisfactory results.

Each Osteonics Shoulder Humeral Component consists of an Osteonics Shoulder Humeral Stem and a mating Osteonics Shoulder Humeral Head.

The Osteonics" Shoulder Humeral Stems:
The Osteonics" Shoulder Humeral Stems are available in a range of sizes, and are manufactured from Ti6Al4V alloy. They are characterized by the following features:

• Male Taper: The humeral stem components are affixed to the modular humeral head ー components by means of a male/female taper lock.
• Flanges: There are flanges on the anterior, posterior and lateral sides. -
• -Collar: The collar seats flush with the prepared proximal humerus. There are two collar designs.
• Proximal surface roughening: The surface of the proximal portion of the stem is grit blasted to enhance the cement/prosthesis interface.
• Distal Flats: The distal flats provide rotational stability. -

The Osteonics Shoulder Humeral Heads:
The Osteonics" Shoulder Humeral Heads feature a female taper design. The heads are available in a range of sizes and thicknesses. The heads feature a circular groove in the non-articulating underside of the component to prevent the components from being unnecessarily heavy. The humeral head components, which are manufactured from cobalt chromium alloy, will be available with or without nitrogen ion implantation.

This 510(k) Premarket Notification is for the Osteonics® Shoulder Humeral Components. It's a submission for a medical device, and as such, it does not involve the types of studies that would typically have acceptance criteria, statistical analysis of performance, or ground truth establishment in the way that an AI or diagnostic device would.

The document focuses on demonstrating substantial equivalence to existing predicate devices already cleared by the FDA. This means the primary "study" is a comparison of the new device's features, materials, and intended use against those of legally marketed devices.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and statistical performance analysis is not applicable to this type of regulatory submission for a orthopedic implant.

Here's an explanation based on the provided document:

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

• Not Applicable. This submission is for an orthopedic implant (shoulder humeral components), not a diagnostic or AI device that generates specific performance metrics like sensitivity, specificity, or AUC against a ground truth.
• The "acceptance criteria" for a 510(k) for a device like this are primarily demonstrating substantial equivalence in terms of:
  • Intended Use: The device is for the same indications as predicate devices.
  • Technological Characteristics: The materials, design principles, and mechanical aspects are similar to or equivalent to predicate devices.
  • Safety and Effectiveness: There are no new questions of safety or effectiveness raised by the differences from predicate devices.
• "Reported device performance" in this context refers to the description of the device's design and materials, which are deemed safe and effective if they are substantially equivalent to existing cleared devices.

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. No "test set" in the context of performance evaluation for a diagnostic or AI device was used. The submission relies on a comparison to existing, legally marketed devices.

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. No "ground truth" establishment by external experts was required for this type of device submission. The FDA reviews the submitted documentation for substantial equivalence.

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

• Not Applicable. No "adjudication" in the context of expert review of a test set.

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 an orthopedic implant, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is an orthopedic implant, not an algorithm.

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

• Not Applicable. Ground truth in the sense of a medical truth for performance evaluation is not relevant for this 510(k) submission. The "ground truth" that matters is the established safety and effectiveness of the predicate devices cleared by the FDA.

8. The sample size for the training set:

• Not Applicable. No "training set" was used as this is not an AI or machine learning device.

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

• Not Applicable. No "training set" or establishment of ground truth for it.

In summary, the provided document is a 510(k) summary for an orthopedic implant, which operates under the principle of substantial equivalence, rather than a data-driven performance study common for AI or diagnostic devices.

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