(72 days)
The DeRoyal Industries, Inc. Super Security Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patients thereby providing postural support or enabling examination or protection of the patient or others. The Super Security Restraint is a protective restraint which can be used with a bed or wheelchair.
The DeRoyal Industries. Inc. Super Security Restraint device that is intended for medical purposes to limit patient movements thereby providing postural support or enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Super Security Restraint is designed similar to those marketed by other manufacturers. The Super Security Restraint is primarily comprised of cool knit material.
This 510(k) summary describes a medical device, the DeRoyal Industries, Inc. Super Security Restraint, but it does not contain the information needed to fill out a table of acceptance criteria and the results of a study proving the device meets those criteria.
The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, a common pathway for medical device clearance in the US, rather than a performance study against specific acceptance criteria.
Here's why the requested information cannot be extracted from the provided text:
- Acceptance Criteria & Device Performance: The document does not define quantitative or qualitative acceptance criteria (e.g., "device must withstand X force for Y duration," or "device reduces patient falls by Z%"). Instead, it describes the device's materials, design, and intended use as being "similar" or "same" as predicate devices. There are no performance metrics reported in terms of safety or effectiveness.
- Study Details (Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): The document references no formal study with a test set, experts, or ground truth. The comparison made is a technological comparison based on materials, design, and intended use, not a clinical or performance evaluation.
- Training Set Details: Similarly, there's no mention of a training set or how ground truth for such a set would have been established, as no AI/algorithm is described.
In summary, the provided text is a 510(k) summary focused on establishing substantial equivalence to existing devices, not a report of a study designed to prove the device meets specific acceptance criteria through performance testing.
Therefore, I cannot provide the requested table and study details based on the given input.
§ 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.