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Modular Neer 3 Humeral Stems and Humeral Heads are indicated for use as orthopedic implants for the partial or total replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glenoid component, respectively. Modular Neer 3 Humeral Stems and Humeral Heads are intended for use with bone cement (cemented fixation) and for single use only. Modular Neer 3 Humeral Stems and Humeral Heads are intended for the following indications:

Proximal Humeral Prosthesis – (1) complex, acute fractures or fracture-dislocations of the humeral head (e.g. trauma -- three and four-part injuries in the Neer classification, or head impression fractures); (2) complex, chronic fracture-dislocations of the humeral head with malunion, nonunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures; (3) avascular necrosis with intact glenoid cartilage; and (4) selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or must engage in moderately heavy activities.

Total Shoulder Arthroplasty (when used in conjunction with a compatible glenoid component) – severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, osteourthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures.

The subject devices are modular humeral stems and humeral heads. They are designed for use with existing Neer II, Neer III, and Cofield2 Total Shoulder System glenoid components.

This document describes a 510(k) premarket notification for a medical device, specifically orthopaedic implants (Modular Neer 3 Humeral Stems and Humeral Heads). It does not contain information about an AI/ML powered medical device, an acceptance criteria table, or a study that proves the device meets specific performance criteria in the context of an AI/ML product.

The document states: "The safety and effectiveness for the subject devices is adequately supported by test data, material information, and substantial equivalence information provided in this Special 510(k) Premarket Notification. Design Verification Test results indicate that the subject devices meet the requirements of the applicable FDA guidance documents."

However, it does not provide the specific acceptance criteria or the details of the "test data" or "Design Verification Test results" that would be necessary to complete the requested table and study information. The determination of substantial equivalence for this device is based on its similarity to existing legally marketed predicate devices, rather than a specific performance study with acceptance criteria as one might see for an AI/ML diagnostic tool.

Therefore, I cannot fulfill the request as the provided text pertains to a traditional orthopedic implant and does not contain the necessary information regarding:

1. Acceptance criteria and reported device performance (table format): No quantitative performance metrics or acceptance thresholds are provided.
2. Sample size for the test set and data provenance: Not applicable in the context of this 510(k).
3. Number and qualifications of experts for ground truth: Not applicable.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not done/applicable.
6. Standalone (algorithm only) performance: Not applicable as it's not an algorithm.
7. Type of ground truth used: Not applicable for this type of device submission.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

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