(31 days)
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.
§ 880.6760 Protective restraint.
(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.