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The Comprehensive Humeral Fracture Stems are indicated for 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Revision where other devices or treatments have failed; 4) Correction of functional deformity; 5) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate; and 6) Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

The Interlok® finish Comprehensive Humeral Fracture Stems are intended for cemented use and the MacroBond™ coated Comprehensive Humeral Fracture Stems are intended for press-fit or cemented application.

The Comprehensive Humeral Fracture Stems consists of various lengths and can be provided with an Interlok® finish for cement fixation or with a thin layer of plasma spray coating known as MacroBond™ for press-fit. The device is fluted distally which allows for a cement mantle and an increase in anti-rotational stability. The proximal body of the stem incorporates a reverse Morse taper for the Bio-Modular Heads and 4 fins, three of which include suture holes to facilitate multiple attachment sites for the bone. A collar also exists to minimize subsidence.

The provided document is a 510(k) premarket notification for a medical device, the "Comprehensive Humeral Fracture Stems." It outlines the device description, classification, predicate devices, indications for use, and a summary of testing.

Crucially, the document explicitly states:

• "No clinical testing was provided as a basis for substantial equivalence."
• "Non-Clinical Testing: Mechanical Testing and a Finite Element Analysis determined that the Comprehensive Humeral Fracture Stems presented no new risks and were, therefore, substantially equivalent to the predicate devices."

Therefore, based on the provided text, there is no study detailing acceptance criteria and device performance in the context of an AI/algorithm-based system. The regulatory clearance was based on substantial equivalence to predicate devices through non-clinical mechanical testing and finite element analysis, not on clinical performance data or AI model validation.

Because no clinical or AI-related study was performed, I cannot provide information for the following points:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and data provenance
• Number of experts used to establish ground truth
• Adjudication method
• MRMC comparative effectiveness study
• Standalone performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

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