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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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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 and A30" x 30" Belt)

The provided document is a 510(k) premarket notification letter for a Protective Restraint device (Models #302, 440, 750, and A30" x 30" Belt) from Geriatric Products Incorporated. This type of document, particularly from 1997, does not typically contain information about objective acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment in the detailed manner that a modern regulatory submission for an AI/ML medical device would.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device's clearance was based on demonstrating substantial equivalence to a predicate device, not on meeting specific, pre-defined quantitative acceptance criteria through a formal study as would be required for a novel or high-risk device today. The substantial equivalence pathway often relies more on comparisons of technological characteristics and intended use rather than rigorous performance metric studies against acceptance criteria.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth types, training set details) from this document, as it is not present. This document is a regulatory clearance letter, not a detailed study report or performance specification document.

Ask a specific question about this device