(72 days)
The DeRoyal Industries, Inc. Mittens are indicated for use, at the discretion of a responsible licensed healthcare professional, to limit limb movements thereby enabling examination or protection of the patient or others. The Mittens are intended to be attached to a bed.
The DeRoyal Industries, Inc. Mittens are a protective restraint device that are intended for medical purposes to control hand and finger movements and/or limit limb movements thereby enabling examination or protection of thers.
Device Design/Materials Used/Physical Properties: The DeRoyal Mittens are designed similar to those marketed by other manufacturers. The Mittens are primarily comprised of 100% cotton or polyester with hook and loop or buckle fasteners.
Here's an analysis of the provided text regarding the DeRoyal Industries, Inc. Mittens, specifically addressing your request for acceptance criteria and study information.
Crucially, the provided document is a 510(k) Summary for a medical device (mittens) and does not contain the acceptance criteria or a study proving the device meets those criteria in the way you're asking about for AI/software-based devices.
The K96-3469 document is focused on establishing substantial equivalence to predicate devices for regulatory clearance, not on presenting performance data from a clinical trial or algorithm validation study. Therefore, most of the information you requested (sample size, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training sets) is not applicable or not present in this type of submission for this type of device.
However, I will extract what can be inferred or directly stated from the document in relation to your questions, and explicitly state where information is missing or not applicable.
1. A table of acceptance criteria and the reported device performance
For a physical restraint device like mittens, "acceptance criteria" and "reported device performance" are assessed differently than for, say, an AI diagnostic algorithm. The acceptance criteria here are implicitly met if the device is substantially equivalent to legally marketed predicate devices in terms of its materials, design, intended use, and mechanisms of action, and does not raise new questions of safety or effectiveness.
| Acceptance Criteria Category (Inferred from 510(k) process) | Specific Criteria (Inferred/Stated) | Reported Device Performance (From 510(k)) |
|---|---|---|
| Intended Use | To limit limb movements thereby enabling examination or protection of the patient or others. Attached to a bed. Used at discretion of a licensed healthcare professional. | "The DeRoyal Industries, Inc. Mittens are indicated for use... to limit limb movements thereby enabling examination or protection of the patient or others. The Mittens are intended to be attached to a bed." (Matches predicate) |
| Device Design/Materials | Similar to predicate devices; comprised of 100% cotton or polyester; hook and loop or buckle fasteners. | "The DeRoyal Mittens are designed similar to those marketed by other manufacturers. The Mittens are primarily comprised of 100% cotton or polyester with hook and loop or buckle fasteners." (Matches predicate) |
| Functional Characteristics | Same materials, size (S,M,L,XL), attachment vehicles (bed), length of use (doctor must prescribe every 24 hours), and level of patient activity (mildly agitated/limb interference by patient) as predicate devices. | Materials, Size, Vehicles for Attachment, Length of Use, and Level of Patient Activity are all stated as "Same" when compared to "Other Devices" (predicates). |
| Safety and Effectiveness | No new questions of safety or effectiveness are raised compared to predicate devices. (Implicit in 510(k) process for substantial equivalence) | The document concludes that the device is "substantially equivalent" to predicate devices, implying no new safety/effectiveness concerns. No specific performance metrics (e.g., prevention of self-harm rate) are provided or generally required for this type of device in a 510(k). |
Regarding a "study that proves the device meets the acceptance criteria":
For this type of device and submission (510(k) for a restraint), a formal clinical performance study with quantitative metrics, as one would conduct for an AI algorithm or a diagnostic test, is typically not required if substantial equivalence to a predicate can be demonstrated through design, material, and intended use comparison.
The "study" in this context is the comparison to legally marketed predicate devices. The document itself is the evidence for meeting its "acceptance criteria" by demonstrating that it is fundamentally the same as devices already on the market.
Specific Questions & Answers:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This document does not describe a test set or data derived from studies in the context you're asking. It relies on a comparison to existing predicate devices.
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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)
- N/A. No test set or ground truth in the context of expert review for performance evaluation is described. The "ground truth" for this 510(k) is the regulatory acceptance and safe market use of the predicate devices.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No test set or adjudication process is described.
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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
- N/A. This is a physical restraint device, not an AI or diagnostic tool. No MRMC study was conducted or would be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implicit ground truth: The regulatory acceptance and established safe and effective use of the identified predicate devices (J.T. Posey Company restraint, and other DeRoyal Industries, Inc. restraints mentioned implicitly). The "ground truth" is that devices with these characteristics are understood to be safe and effective for their intended use.
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The sample size for the training set
- N/A. No training set for an algorithm is applicable or described.
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How the ground truth for the training set was established
- N/A. No training set or associated ground truth establishment is applicable or described.
In summary: The provided 510(k) document is a regulatory submission for a physical medical device (mittens) establishing substantial equivalence. It is not a clinical study report for an AI or software device, and therefore the types of performance criteria and study details you've requested are largely absent or not applicable in this context. The "acceptance criteria" are met by demonstrating the device is essentially the same as already cleared devices, and the "study" is the comparative analysis presented in the 510(k) itself.
§ 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.