(81 days)
These products are intended to hinder egress of a patient and/or assist body alignment in a hospital bed, genatric chair, wheelchair, or gurney.
The devices included in this 510(k) submission support the torso and/or pelvic area. The product is closed around the patient by one or more of the following: a zipper, fabric alone, straps, or straps and buckles. The product is secured to the bed, geriatric chair, wheelchair, or gurney via straps. These straps are securely connected to the bed, geriatric chair, or wheelchair by one or more of the following: knots, or straps and buckles.
The provided text is a Safety and Effectiveness Summary for a 510(k) submission regarding protective restraints, specifically "Pelvic Holders" and "Protective Restraints." It outlines the device's purpose, classification, and regulatory context.
However, the document does not contain any information relevant to the acceptance criteria or a study proving the device meets those criteria, as requested in the prompt.
Here's why and what's missing:
- No Acceptance Criteria: The document describes the device's function and regulatory classification but does not list any quantitative or qualitative performance metrics (e.g., strength, durability, patient comfort scores, restraint effectiveness percentages) that would serve as acceptance criteria.
- No Study Details: There are no descriptions of any studies conducted to evaluate the device's performance against specific criteria. The text mentions "comparative purposes" and referencing "current products as legally marketed devices for comparison purposes," but this refers to regulatory comparison for the 510(k) process, not a performance study as typically understood in medical device validation.
- Missing Specifics for Performance Evaluation: All the sub-points requested in the prompt (sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, ground truth, training set size, training ground truth) are entirely absent because no such performance study is described.
Therefore, based on the provided text, I cannot complete the requested table or answer the questions. The document focuses solely on the regulatory process for a 510(k) submission for protective restraints.
§ 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.