(84 days)
The devices included in this 510(k) submission facilitate attachment of protective restraint devices to vehicles. These devices provide anchor points for tying quick release knots and/or adapts protective restraints with quick release buckles. The products are then secured to the bed, geriatric chair, or wheelchair via the accessory device. The accessory devices attach directly to the vehicle.
These products are facilitate attachment of devices that are intended to hinder egress or aid in positioning of a patient in a wheelchair, hospital bed, geriatric chair, or gumey.
The devices included in this 510(k) submission facilitate attachment of protective restraint devices to vehicles. These devices provide anchor points for tying quick release knots and/or adapts protective restraints with quick release buckles. The products are then secured to the bed, geriatric chair, or wheelchair via the accessory device. The accessory devices attach directly to the vehicle.
This document is a 510(k) premarket notification for "Protective Restraints" by the Posey Company, dated November 22, 1996. It states that the submission is in response to a new FDA final rule requiring 510(k)s for these devices, which were previously exempt. The core of the submission revolves around demonstrating substantial equivalence to devices already legally marketed by the Posey Company itself.
Therefore, the document does not contain information about acceptance criteria or a study that proves a device meets specific performance criteria in the way a diagnostic or treatment device might. Instead, it focuses on the regulatory framework of demonstrating equivalence to existing products.
Here's why the requested information cannot be fully provided from this document:
- Acceptance Criteria & Device Performance: This document is about regulatory classification and equivalence for restraint accessories (which facilitate attachment of restraints), not about performance metrics like sensitivity, specificity, accuracy, or other measurable clinical outcomes.
- Study Details: There is no clinical or technical performance study described in this document to evaluate the "effectiveness" of these restraint accessories in the sense of a medical device clinical trial. The "comparative purposes" mentioned refer to comparing the device itself to an already marketed version of the same device for regulatory purposes, not a performance study against a ground truth.
Based on the provided text, here's what can be extracted and why other points are not applicable:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Not Applicable (The submission focuses on substantial equivalence to legally marketed devices, not specific performance criteria for these restraint accessories.) Not Applicable (No performance metrics are reported as no performance study was conducted in the context of this submission.) -
Sample size used for the test set and the data provenance:
- Not Applicable. No "test set" in the context of a performance study is described. The comparison is against the company's own legally marketed devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No ground truth for device performance is established in this document, as it's not a performance study.
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Adjudication method for the test set:
- Not Applicable. No performance study or test set requiring 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. This document is about physical restraint accessories, not an AI-enabled diagnostic or imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm-based device.
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The type of ground truth used:
- Not Applicable. No ground truth for device performance is established. The "ground truth" in this context is the regulatory status of "legally marketed" predicate devices.
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The sample size for the training set:
- Not Applicable. There is no "training set" as this is not a machine learning or AI device.
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How the ground truth for the training set was established:
- Not Applicable.
In summary: This document is a regulatory submission demonstrating substantial equivalence for previously exempt physical restraint accessories. It does not describe a performance study with acceptance criteria, sample sizes, ground truth definitions, or expert evaluation as the basis for its claim. The "effectiveness" mentioned in the summary title refers to a general regulatory requirement for all medical devices, but the demonstration of it in this specific submission is through comparison to already marketed predicate devices, not through a new performance study.
§ 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.