(73 days)
The Morrison Medical Torso/Waist Restraint is intended to help secure a patient at the torso and waist in an ambulance or other emergency vehicle while in transport to a hospital or other critical care facility.
The Morrison Medical Torso/Waist Restraint is constructed by combining two adjustable. nylon, "over-the-shoulder" straps that secure the upper torso and two adjustable nylon straps that secure the waist. All four straps are joined at the waist and are secured with a metal push button buckle and metal connectors. The nylon webbing is available in multiple colors.
This document describes a 510(k) premarket notification for the Morrison Medical Products Torso/Waist Restraint. A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission generally does not require clinical studies or detailed performance data against specific acceptance criteria in the same way a novel device or a Premarket Approval (PMA) application would.
Therefore, many of the requested elements for describing specific acceptance criteria and a detailed study proving the device meets them are not applicable or explicitly stated in this 510(k) summary.
Here's an analysis based on the provided text, addressing the points where information is available or noting when it's not applicable (N/A) for a 510(k) submission of this nature.
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A table of acceptance criteria and the reported device performance
- Not Applicable (N/A) in the context of this 510(k) summary. This submission relies on substantial equivalence to a predicate device rather than presenting specific quantitative acceptance criteria and performance metrics from a new study. The "performance" is implicitly deemed equivalent to the predicate.
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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)
- Not Applicable (N/A). No new test set or data provenance from a device performance study is described as this is a substantial equivalence submission.
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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)
- Not Applicable (N/A). There is no mention of a test set requiring expert-established ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable (N/A). No test set requiring expert adjudication 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
- Not Applicable (N/A). This device is a physical medical restraint, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A). This device is a physical medical restraint and does not involve an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable (N/A). No ground truth for a novel performance study is mentioned. The "ground truth" for this submission is the accepted safety and effectiveness of the predicate device.
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The sample size for the training set
- Not Applicable (N/A). This device is a physical medical restraint and does not involve machine learning requiring a training set.
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How the ground truth for the training set was established
- Not Applicable (N/A). This device is a physical medical restraint and does not involve machine learning.
Summary of the 510(k) Submission:
The provided document is a 510(k) summary for the Morrison Medical Products Torso/Waist Restraint. The core of this submission is substantial equivalence to a previously legally marketed device, which is stated to be the same device (Morrison Medical Torso/Waist Restraint).
- Predicate Device: Morrison Medical Torso/Waist Restraint.
- Basis for Substantial Equivalence: The submitter declares the subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications, and issues of safety and effectiveness to the predicate devices. The only difference noted is a revision to product labeling to comply with agency requirements.
- No new performance data or acceptance criteria are presented because the device is identical to a predicate. The prior acceptance and approval of the predicate device serves as the basis for the current device's safety and effectiveness.
- Biocompatibility Assessment: A review indicated "little potential to evoke an adverse reaction" based on the components and materials being identical to the predicate device, for which there were no reported complaints of skin irritation.
In conclusion, this 510(k) summary does not describe a study proving the device meets specific acceptance criteria because it's asserting substantial equivalence to a predicate device, for which safety and effectiveness have already been established. The acceptance criteria effectively stem from the characteristics and performance of the predicate device 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.