(76 days)
The devices included in this 510(k) submission provide anterior postural support, The products are inserted into the arms of the wheelchair compressing the foam and releasing it once in position. If the patient cannot easily self release the product, it may be considered a restraint. These products are intended to provide postural support and a surface for activities,
The devices included in this 510(k) submission provide anterior postural support, The products are inserted into the arms of the wheelchair compressing the foam and releasing it once in position. If the patient cannot easily self release the product, it may be considered a restraint.
The provided text is a Safety and Effectiveness Summary for a medical device (Posey® Hugger) submitted to the FDA in 1996. It focuses on device classification, intended use, and substantial equivalence to legally marketed predicate devices, primarily for regulatory purposes.
Crucially, this document does not contain information about a study that measures the device's performance against specific acceptance criteria in the context of typical AI/software-as-a-medical-device (SaMD) performance evaluations. The "Safety and Effectiveness Summary" in this context refers to regulatory compliance and demonstrating substantial equivalence to existing devices, not a clinical performance study with statistical metrics.
Therefore, I cannot provide the requested information, such as acceptance criteria, reported device performance metrics (like sensitivity, specificity, AUC), sample sizes, ground truth methodology, or details about expert involvement, because these types of studies were not conducted or described in this document.
The relevant information from the document related to "effectiveness" pertains to its function as a postural support and a surface for activities, and its regulatory status as an exempt device. The "comparison" mentioned is purely for demonstrating substantial equivalence to existing, legally marketed J.T. Posey Co. huggers, not for evaluating a new device's performance against clinical endpoints.
§ 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.