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510(k) Data Aggregation
(141 days)
The DeRoyal Industries, Inc. Disposable Limb Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit limb movements thereby enabling examination of the patient or others. The Disposable Limb Holder can be used with a gurney, bed, or stretcher.
The DeRoyal Industries, Inc. Disposable Limb Holder is a protective restraint device that is intended for medical purposes to limit limb movements thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Disposable Limb Holder is designed similar to those marketed by other manufacturers. The Disposable Limb Holder is primarily comprised of a kodel, nylon, flannel or blue purr material. The straps are made of white webbing. The fasteners are made of hook and loop or steel nickel plated buckles.
This document is a 510(k) premarket notification for a medical device called the "DeRoyal Industries, Inc. Disposable Limb Holder." It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices.
This document describes a physical medical device (a limb holder), not a software or AI-driven diagnostic device. As such, many of the requested categories (e.g., acceptance criteria for algorithms, sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone algorithm performance) are not applicable to this type of submission.
Therefore, I cannot provide a table of acceptance criteria and device performance in the context of an algorithm or AI system, nor can I provide information on studies related to AI performance from this document.
However, I can extract the relevant information pertaining to the device's characteristics and its comparison to predicate devices, which serves a similar function to demonstrating that the device "meets" the functional requirements for its intended use.
Here's the closest analogous information based on the provided text:
1. A table of acceptance criteria and the reported device performance
For a physical device like a limb holder, "acceptance criteria" are typically defined by demonstrating substantial equivalence to predicate devices in terms of materials, intended use, and performance characteristics for its intended purpose. The reported "performance" is implicitly that it functions similarly to existing, legally marketed devices.
| Characteristic | Acceptance Criteria (Implied "Same" as Predicate Devices) | Reported Device Performance (DeRoyal Device) |
|---|---|---|
| Materials | Materials used should be equivalent to or demonstrate comparable safety/efficacy to predicate devices. | Primarily comprised of kodel, nylon, flannel or blue purr material. The straps are made of white webbing. Fasteners include hook and loop or buckles. |
| Size | Should offer a size range comparable to predicate devices for intended patient population. | Universal |
| Vehicles for Attachment | Should be attachable to standard medical vehicles like predicate devices. | Gurney, Bed, or Stretcher |
| Length of use | Usage protocols should align with accepted medical practice for such devices. | Doctor must prescribe every 24 hours |
| Level of Patient Activity | Intended for similar patient agitation/disorientation levels as predicate devices. | Mildly to moderately agitated or disoriented |
Explanation of "Acceptance Criteria" in this context: The acceptance criteria for a 510(k) submission like this are generally met by demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics, or if it has different technological characteristics, the information submitted demonstrates that the device is as safe and effective as the legally marketed device and does not raise different questions of safety and effectiveness. The table above shows the device meets these criteria by being "Same" as Other Devices for all listed characteristics.
2. Sample sized used for the test set and the data provenance
Not applicable. This is a physical device submission, not a study involving a test set of data for an algorithm. There is no information about data provenance.
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 described.
4. Adjudication method for the test set
Not applicable. No test set or adjudication method is described.
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 limb holder, not an AI or diagnostic imaging device.
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. Ground truth as typically defined for algorithms or diagnostic studies is not relevant here. The "ground truth" for a physical device like this is its physical properties, materials, and functional performance in its intended use, which are compared against predicate devices.
8. The sample size for the training set
Not applicable. No training set is described for this physical device.
9. How the ground truth for the training set was established
Not applicable. No training set is described.
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