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The DVO™ Extended Articulation Humeral Heads for use in hemi-shoulder replacement are indicated for:

1. Ununited humeral head fractures;
2. Avascular necrosis of the humeral head.
3. Rotator cuff tear arthropathy.
   Humeral stems and glenoids labeled "for cemented use only" are indicated only for use with bone cement. Humeral stems are also indicated for press-fit uncemented use or for use with bone cement. These are sterile, single use devices.

The Extended Articulation Humeral Heads are an addition to the previously cleared modular DVO Total and Hemi Shoulder System. The cobalt chrome alloy, semispherical heads mate with the previously cleared humeral stems through a locking taper. The heads are highly polished. They do not articulate with the previously cleared glenoids as they are intended to be used in hemi-arthroplasty applications only.
The heads are available in four sizes, 44 to 56mm, in 4mm increments, and in heights of 18 and 21 mm.

The provided text is for a 510(k) premarket notification for a medical device called "Extended Articulation Humeral Heads." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on detailed performance studies with acceptance criteria in the way AI/ML devices typically present them.

Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving the device meets those criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies, as described in your prompt.

Instead, the submission states:

• Comparison to Predicates: "The DVO Extended Articulation Humeral Heads are similar to the listed predicate devices in intended use for hemi shoulder replacement, indications for use, design, materials of construction (cobalt chrome alloy), methods of sterilization (gamma irradiation), packaging, and manufacturing methods."

This means the device's acceptance is based on its similarity to previously approved devices, not on a new, explicit performance study against pre-defined acceptance criteria as would be typical for a novel diagnostic or AI-powered solution.

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