(260 days)
For the prevention and treatment of pressure ulcers.
The PressureGuard SelectCare is a powered air flotation mattress which provides pressure-reducing support within a range of adjustable firmness to meet individual comfort needs. The system also includes a CPR mode, providing a firm surface for performing CPR.
This document is a 510(k) summary for a medical device called "PressureGuard: SelectCare Mattress System". It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or MRMC studies that would be relevant to evaluating AI/ML-based medical devices.
Therefore, I cannot provide the requested information for the following reasons:
- No acceptance criteria or device performance data: The document does not specify any quantitative or qualitative acceptance criteria for the device's performance (e.g., pressure reduction percentages, incidence of pressure ulcers, etc.). Consequently, it does not report any device performance against such criteria.
- No study information: This is a pre-market notification (510(k)) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on presenting detailed clinical study results or performance metrics in the way an AI/ML device would.
- Irrelevance to AI/ML device evaluation: The device described is a physical mattress system, not an AI/ML-based diagnostic or prognostic tool. Therefore, concepts like "test set," "training set," "ground truth experts," "adjudication methods," or "MRMC studies" are not applicable in this context.
In summary, the provided text does not contain the type of information needed to answer your request, which is geared towards evaluating the performance of AI/ML medical devices.
§ 880.5550 Alternating pressure air flotation mattress.
(a)
Identification. An alternating pressure air flotation mattress is a device intended for medical purposes that consists of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.