(70 days)
The Safety Poncho, Slider Poncho and the Pelvic Holder are intended for use to assist cooperative patients who require minimum support in wheelchair. The devices are labeled for prescription use and are not intended for lay use.
These devices are vest and pelvic holder style wheel chair accessories used to assist cooperative patients who require minimum support in a wheelchair. These devices are made of wolyester, cotton, nylon and vinyl configured into either a mesh or weave substrate. Each device utilizes straps for securing (tie) the patient in place.
This 510(k) summary (K96-3489) for the Smith & Nephew DonJoy "Safety Poncho, Slider Poncho and the Pelvic Holder" devices does not contain the information required to answer your request.
Here's why:
- Type of Device: This submission is for physical medical devices (wheelchair accessories) designed to assist cooperative patients with minimal support in a wheelchair. It is not an AI/ML-based diagnostic or imaging device.
- Nature of Evaluation: The summary states: "These devices have been commercially distributed for over four years and have not been associated with an MDR type complaint." This indicates that the regulatory clearance is based on a history of safe use and substantial equivalence to existing devices, rather than a performance study involving metrics like sensitivity, specificity, or accuracy that would be relevant for AI/ML devices.
Therefore, the following information is not present in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
§ 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.