(83 days)
Great Hands Mitts hand restraints are worn like gloves. The mitts are intended to prevent patients from grasping or pulling out catheters, I.V. tubes and other vital lines. The mitts also prevent patients from scratching themselves or inflicting other injuries to themselves or others.
Great Hands Mitts are hand restraints that are worn like gloves. The cotton covered mitt is filled with polyester and is covered with a mesh material on one side. The glove-like finger lanes are sewn into the mesh material and a Velcro wrist strap with a D-Ring loop fastener helps secure the glove in place.
This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. Instead, it describes a medical device called "Great Hands Mitts" and provides a "Safety and Effectiveness Summary" for a 510(k) submission.
The document focuses on:
- Device Description: What the Great Hands Mitts are, their components, and how they function.
- Intended Use: To prevent patients from grasping or pulling out medical lines and to prevent self-inflicted injuries.
- Technological Characteristics: Emphasizing that the "subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications and issues of safety and effectiveness to the devices prior to the submission of this notification." The only change mentioned is revised labeling to comply with agency requirements.
- Biocompatibility Assessment: Stating that the materials have a history of safe use in the clothing and garment industry and that there are no known skin irritation reports.
- Conclusion: That the device is safe, effective, and substantially equivalent to a predicate device.
There is no mention of:
- Specific performance metrics or quantitative acceptance criteria.
- Any study, trial, or testing methodology used to assess performance against such criteria.
- Information regarding sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and study details based on the provided text.
§ 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.