(63 days)
Medline's Limb holders are intended to be utilized as a patient safety device when limited movement of the limb is deemed necessary.
Medline's Limb holders are intended to be utilized as a patient safety device when limited movement of the limb is deemed necessary. The limb holders are all of the same basic design, some with different linings on the cuff, others utilize buckles, hook and loop closures ("velcro") or D-rings. They may be used either at the wrist or ankle and may tie to the bed frame or wheelchair.
The provided document is a Safety and Effectiveness Summary for Medline's protective limb restraints. It describes the devices, their intended use, and a literature review conducted to support their safety and effectiveness. However, it does not contain any information regarding specific acceptance criteria for a device's performance, nor does it describe a study conducted by Medline to prove the device meets such criteria.
The document primarily focuses on:
- Description of various Medline limb holders: detailing their design, materials, and adjustment mechanisms.
- General statement of their intended use: as a patient safety device to limit limb movement.
- Discussion of general safety and effectiveness in the context of protective restraints: outlining potential complications found in literature (e.g., emotional desolation, agitation, fractures, nerve damage, circulatory impairment, etc.) and noting the benefits when used correctly.
- Emphasis on proper use: highlighting the importance of patient monitoring, appropriate patient and restraint selection, correct application, and physician/trained professional advice.
- A list of thirteen articles reviewed: to establish the safety and efficacy of protective restraints in general, rather than providing specific performance data for Medline's products.
Therefore, I cannot fulfill the request for information on acceptance criteria and a study proving device performance because that data is not present in the provided text.
To reiterate:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample sized used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not provided. (This question is also irrelevant as the device is a physical restraint, not an AI imaging or diagnostic tool).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. (Again, irrelevant for a physical restraint).
- The type of ground truth used: Not provided.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
§ 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.