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ProVest should only be used with proper medical authorization. The licensed medical practitioner will determine when a restraint is indicated, the type of device needed, and the duration and frequency of use of the device. ProVest is intended to be used as a gentle reminder to remain in the bed or wheelchair and for postural support.

ProVest - Protective Restraint

This document is a 510(k) clearance letter from the FDA for the "ProVest - Protective Restraint" device. It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, the provided text DOES NOT contain any information regarding:

• Acceptance criteria or reported device performance.
• Any study details (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details).

The document primarily focuses on:

• The FDA's decision of substantial equivalence.
• Regulatory classifications and requirements.
• Indications for Use for the ProVest device, which state: "ProVest should only be used with proper medical authorization. The licensed medical practitioner will determine when a restraint is indicated, the type of device needed, and the duration and frequency of use of the device. ProVest is intended to be used as a gentle reminder to remain in the bed or wheelchair and for postural support."

Therefore, I cannot provide the requested table and study details based on the input text. The document is a regulatory approval, not a performance study report.

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