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The DeRoyal Industries, Inc. Restraint Net is indicated for use, at the discretion of a responsible licensed healthcare professional, to restrict patient body movements thereby enabling protection of the patient or others. The Restraint Net/Bed is intended to be attached to a bed. The Restraint Net/Stretcher is intended to a stretcher.

The DeRoyal Industries, Inc. Restraint Net is a protective restraint device that is intended for medical purposes to restrict patient body movements thereby enabling protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Restraint Net is designed similar to those marketed by other manufacturers. The Restraint Net is primarily comprised of white mesh.

This submission describes a medical device, the DeRoyal Industries, Inc. Restraint Net, for which a 510(k) premarket notification was filed in 1996. The document is primarily focused on demonstrating substantial equivalence to predicate devices already on the market, rather than proving performance against specific acceptance criteria through a formal study with statistical targets.

Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert ground truth, MRMC study, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission from that era.

Here's an analysis based on the provided text, indicating where information is present and where it's absent:

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

• Not Applicable. This document does not describe acceptance criteria in the sense of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) typically associated with AI/software device studies or clinical trials with predefined endpoints. The "acceptance criteria" for a 510(k) of this nature involve demonstrating that the device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use, technological characteristics, and safety/effectiveness profiles.
• Reported Device Performance: The document implicitly "reports" performance by stating that the DeRoyal Restraint Net's design, materials, size, attachment vehicles, length of use, and level of patient activity it addresses are "Same" as other legally marketed predicate devices. This implies it performs equivalently to those predicates for its intended use. There are no quantitative performance metrics reported.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided. No formal "test set" and associated sample size are described. The equivalence is based on a comparison of device characteristics, not on a study involving patients or data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable / Not Provided. There is no "ground truth" establishment in the context of a clinical study or performance evaluation for this type of submission. The ground truth for this submission essentially relies on the established safety and effectiveness of the predicate devices as accepted by the FDA.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable / None. No adjudication method is described as there is no test set or expert evaluation of device performance.

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 device is a physical restraint net, not an AI or software-based diagnostic or assistive device. Therefore, an MRMC study is irrelevant.

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

• Not Applicable. This is a physical device, not an algorithm.

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

• Not Applicable. As noted above, there's no "ground truth" derived from patient data or clinical outcomes in this submission. The "truth" is established by demonstrating equivalence to devices already cleared by the FDA, implying their safety and effectiveness are accepted.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is a physical device and not an AI/ML algorithm.

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

• Not Applicable. As there's no training set, this question is not relevant.

Summary of the Study (as presented in a 510(k) context):

The "study" presented here is a comparison of technological characteristics between the proposed DeRoyal Industries, Inc. Restraint Net and identified predicate devices (J.T. Posey Company and other DeRoyal Industries, Inc. products).

• Objective: To demonstrate substantial equivalence to legally marketed predicate devices.
• Methodology: Direct comparison of device specifications:
  • Materials: Both the DeRoyal device and predicate devices use "Primarily comprised of white mesh, white webbing straps (100% polyester), and steel nickel plated fasteners." -> "Same"
  • Size: Both are "Universal." -> "Same"
  • Vehicles for Attachment: Both can attach to beds and stretchers. -> "Same"
  • Length of use: Both are for "Short term use." -> "Same"
  • Level of Patient Activity: Both are for "Highly Agitated or Disoriented," "Aggressive," or "Patient requires physical control." -> "Same"
• Conclusion (Implicit): Based on these comparisons, the sponsor asserts that the DeRoyal Industries, Inc. Restraint Net is substantially equivalent to the predicate devices in terms of materials, design, and intended use, and therefore is as safe and effective.

This type of submission focuses on demonstrating that the new device does not raise new questions of safety or effectiveness when compared to an already cleared device. It does not involve performance studies with quantitative metrics against predefined acceptance criteria like a clinical trial for a novel drug or a performance study for an AI-powered diagnostic device would.

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