(84 days)
These products are intended to limit movement in a hospital patient.
The devices included in this 510(k) submission limit movement. The product is closed around the patient by encircling the wrists, hands, or ankles. The product is secured around the patient via straps. These straps are secured behind the patient with either heavy duty corset buckles or heavy duty standard buckles.
I am sorry, but the provided text does not contain the necessary information to describe the acceptance criteria and the study proving the device meets them. The document is a 510(k) submission for "Straight Jackets" and primarily focuses on regulatory classification, common names, and a historical context of their marketing and exemption status.
Specifically, the text is a "SAFETY AND EFFECTIVENESS SUMMARY" but it does not include any performance data, clinical study results, or explicitly stated acceptance criteria for the device. It discusses the device's purpose (limiting patient movement) and its comparison to legally marketed devices (the manufacturer's own current products), but it does not detail any studies proving its safety or effectiveness in terms of measureable outcomes or performance metrics.
Therefore, I cannot provide any of the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or expert details for test sets.
- Adjudication methods.
- MRMC study details or effect sizes.
- Standalone performance studies.
- Types of ground truth used.
- Training set sample sizes or ground truth establishment methods.
The document is purely a regulatory statement about the device's status and comparison within the 510(k) framework, not a summary of performance studies.
§ 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.