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Position and secure a patient in the prone or supine positions.

The Strap Wedge is an assembly of covered foam blocks to which five (5) restraining straps have been sewn.

The provided text describes a 510(k) summary for a medical device called "Strap Wedge." It outlines the device's description, intended use, and states that there have been no reports of death or serious injury. However, the document does not contain any information about acceptance criteria, a study proving the device meets those criteria, or any of the specific details requested in your prompt regarding performance metrics, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information from the given text.

The information you are asking for typically relates to the performance evaluation of diagnostic or AI-powered devices, which require specific metrics, a test dataset, and a rigorous evaluation process that includes ground truth and potentially expert involvement. The "Strap Wedge" appears to be a physical positioning and restraint device, and its 510(k) summary focuses on demonstrating substantial equivalence to pre-amendment devices and lack of reported adverse events, rather than quantitative performance metrics like sensitivity, specificity, or reader improvement.

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