(73 days)
The DePuy OrthoTech Heavy Duty Vest Restraint is intended to limit body movement and provide support for patients in chairs, wheelchairs and beds who (a) may be susceptible to lifethreatening falls, (b) may be suicidal, or (c) are aggressive.
The body of the vest restraint is constructed from three main pattern pieces, two front panels and a back panel which are cut from polyester mesh fabric. The vest comes equipped with four pairs of long straps which are used for securing the patient to the chair, wheelchair or bed. The subject vest restraint is supplied in five sizes from X-small to X-large to fit chests from 28" to 56". It may be hand washed in warm water and air dried.
The provided document K971742 is a 510(k) premarket notification for a medical device (DePuy OrthoTech Heavy Duty Vest Restraint). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical studies with acceptance criteria in the same way a Premarket Approval (PMA) application would.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, device performance studies, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance.
The "Basis of Substantial Equivalence" section explicitly states that the device is considered substantially equivalent based on similarities in design, construction, materials, and intended uses to previously cleared devices. This means the device's "performance" is implicitly considered acceptable because it is similar to other devices already on the market.
Here's a breakdown of why each point of your request cannot be fulfilled by this document:
- A table of acceptance criteria and the reported device performance: Not applicable. The document doesn't define specific performance criteria for the device beyond its intended use, nor does it report any testing against such criteria.
- Sample sized used for the test set and the data provenance: Not applicable. No test set or study data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert review process is described.
- Adjudication method for the test set: Not applicable.
- 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 applicable. This device is a physical restraint, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical restraint, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. No machine learning or algorithm training is involved.
- How the ground truth for the training set was established: Not applicable.
In summary, the K971742 document is a regulatory submission for a physical medical device based on substantial equivalence, and it does not involve the type of performance data and study methodologies typically associated with digital health technologies or AI/ML devices that would require the information outlined in your request.
§ 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.