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Vest Restraint: The body of the vest restraint is constructed from two main pattern pieces, a front and a back which are cut from light weight polyester mesh fabric. The back is split down the center which results in there being two identical back pieces. The back opening facilitates the application of the garment to the patient. It contains a hook and loop closure which extends from the neck through to the bottom of the vest comes equipped with long straps attached just below waist level for securing the patient to the chair, wheelchair or bed; ties at the waist to adjust for proper fit: underarm loops to which the optional 54" long straps can be attached if additional support is required: and a modified v-neck. It 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.

Wrist/Ankle Restraints: The wrist/ankle restraints are simply constructed from a polyester pile fabric with a knitted backing. They are secured to the wrist or ankle with a hook and loop closure and are supplied with a long strap which is used to secure the wrist/ankle restraint to a chair, wheelchair or bed. The wrist/ankle restraints are available with two types of buckles on the long straps; sliding metal buckle or a white (nylon acetal) quick-release buckle. Both styles are provided in one universal adult size. They may be hand washed in warm water and air dried.

This submission, K963393, is for a Class I protective restraint and does not include performance data typically found in studies for diagnostic or AI-driven medical devices. The submission relies on substantial equivalence to predicate devices rather than clinical performance studies with acceptance criteria, sample sizes, or ground truth.

Therefore, most of the requested information cannot be extracted directly from the provided text.

Here is what can be inferred or stated based on the given information:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the 510(k) summary. The submission is based on substantial equivalence, meaning it argues that the new device is as safe and effective as a legally marketed predicate device without requiring new performance data against specific acceptance criteria.

2. Sample sized used for the test set and the data provenance:

Not applicable. No "test set" in the context of a performance study is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No ground truth establishment for a test set is mentioned.

4. Adjudication method for the test set:

Not applicable. No test set requiring adjudication is mentioned.

5. 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 is not an AI-driven device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI-driven device, and no standalone algorithm performance is mentioned.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable. No ground truth in the context of a performance study is mentioned. The "ground truth" for this 510(k) submission is the regulatory acceptance of the predicate devices for their safety and effectiveness.

8. The sample size for the training set:

Not applicable. No training set for an algorithm is mentioned.

9. How the ground truth for the training set was established:

Not applicable. No training set for an algorithm is mentioned.

Summary of Device Acceptance:

The device's "acceptance criteria" through the 510(k) pathway is substantial equivalence to predicate devices. The study proving this acceptance is the comparison of the DePuy Mesh Vest Restraint with Sleeves and the DePuy Wrist/Ankle Restraints to existing protective restraints marketed by the J. T. Posey Co.

The basis for this substantial equivalence is stated as their "similarities in design, construction, materials, fasteners, and intended uses." This type of submission relies on demonstrating that the new device does not raise new questions of safety and effectiveness compared to the legally marketed predicate devices, rather than proving efficacy against specific performance metrics through a clinical study.

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