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The Geriatric Products Restraints are for use by a responsible licensed healthcare professional to limit patient movement to the extent necessary for treatment, examination, protection of patient and others, or postural control.

Protective Restraint Models #302,440,750, 850, and 905

This prompt is about a 510(k) premarket notification for "Protective Restraint Models #302, 440, 750, 850, and 905" by Geriatric Products Incorporated.

The provided document is an FDA clearance letter and an Indications for Use statement. This type of document does not include information about acceptance criteria, study details, or performance data for a medical device. It primarily confirms that the FDA has reviewed the submission and found the device substantially equivalent to a legally marketed predicate device.

Therefore, I cannot fulfill your request for:

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

This information would typically be found in the 510(k) submission itself (e.g., in sections describing performance testing, clinical studies, or bench testing), which is not part of the provided text.

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