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The DeRoyal Industries, Inc. Wheelchair Belt is indicated for use, at the discretion of a responsible licensed healtheare professional, to limit patient movements thereby enabling examination or protection of the DeRoyal Industries, Inc. Wheelchair Belt is intended to be used with a wheelchair only.

The DeRoyal Industries, Inc. Wheelchair Belt is a protective restraint device that is intended for medical purposes to limit patient movements thereby helping prevent the patient from sliding in a wheelchair.

Device Design/Materials Used/Physical Properties: The DeRoyal Wheelchair Belt is designed similar to those marketed by other manufacturers. The Wheelchair Belt is primarily comprised of nylon or polyester seat belt webbing,

This is a 510(k) summary for a medical device (wheelchair belt) rather than a study report for a diagnostic or AI-powered device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, study design, expert involvement, and ground truth establishment.

The provided document describes a device that is a physical restraint, and the 510(k) process for such devices typically focuses on demonstrating substantial equivalence to a legally marketed predicate device based on design, materials, intended use, and performance without requiring a clinical study with acceptance criteria in the way a diagnostic algorithm would.

Here's why the requested information cannot be extracted from the given text:

1. Acceptance Criteria and Reported Device Performance: This document doesn't define quantitative acceptance criteria for performance; instead, it compares the DeRoyal Wheelchair Belt's characteristics (materials, size, vehicles for attachment, length of use, level of patient activity) to "Other Devices" (predicate devices) and states they are the "Same." This is a qualitative comparison for substantial equivalence.
2. Sample Size and Data Provenance: No clinical study or performance data is mentioned. The comparison is based on device characteristics.
3. Number of Experts and Qualifications: No experts were used to establish ground truth because there's no diagnostic task or outcome being measured in a clinical study.
4. Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not an AI-assisted diagnostic device.
6. Standalone Performance: Not applicable.
7. Type of Ground Truth Used: Not applicable.
8. Sample Size for Training Set: Not applicable, as there's no algorithm being trained.
9. How Ground Truth for Training Set Was Established: Not applicable.

In essence, the provided text does not describe a study that would generate the kind of data you are asking for. It's a regulatory submission demonstrating substantial equivalence for a physical medical device.

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Medline Wheelchair Safety Belt Restraints are intended for use with patients or residents that need a "gentle reminder" for the patient to stay in their wheelchair or to remind them to seek assistance before standing. These products are also intended to help prevent falls or to help the patient feel safer in their wheelchair. Several of the designs are intended to enable the user to release them, per O.B.R.A. regulations. These products are designed for use with a carefully defined medical treatment program which addresses (but is not limited to) restorative nursing, patient release, and pressure sore prevention. Aggressive, agitated or restless patients require increased monitoring and a systematic review and evaluation of both their physical and psychological status.

Medline Patient Safety Products are intended to be used for those patients suffering from temporary medical related cognitive deficits, for agitated patients, for patients that are at risk for a life threating fall or fall that may cause serious injury or re-injury, or to help patients feel safer in wheelchair.

Medline Wheelchair Safety Belt Restraints are not intended for use with stretchers, on toilets or shower chairs or in the shower or tub.

Medline Patient Safety Products are not intended for use in a motorized vehicle, as they are not designed to withstand the force of a crash.

Medline Patient Safety Products are not intended for home use.

These devices are for use in hospitals and/or nursing homes to help maximize patient safety and are not intended to preclude good nursing care and common sense.

Medline's Wheelchair Safety Belts are intended to be utilized as a "gentle reminder" for patients to stay in their wheelchair or not to attempt to stand without assistance. They are intended to help the patient feel safer or more secure in their wheelchair. Two of the items are designed to be able to be released by the patient.

The first two items are not designed to be released by the wearer:

• A. Wheelchair Waist Belt
  Made of 2" nylon web. Belt circles patient's waist and passes through a slid buckle in front for individual fit. Belt criss-crosses in back and attaches to kick spurs at rear of wheelchair.

• B. Economy Wheelchair Belt
  Made of 2" nylon web. Similar to the Wheelchair Waist Belt except this item does not have the slide buckle in front. Belt goes around wearer's waist and attaches to the kick spurs using an adjustable loop.

The following three items are designed to be released by the wearer:

• C. Two-Piece Safety Soft Belt
  Hook and Loop (Velcro) closure enables the wearer to release the belt by themselves as required by the O.B.R.A. regulations. Padded belt made of blue knit material for extra comfort.

• D. Wheelchair Belt with Buckle
  Made of 2" nylon web. Quick release buckle enables the wearer to release the belt by themselves as required by the O.B.R.A. regulations.

• ய் Wheelchair Belt with Hook & Loop
  Made of 2" nylon web. Hookk and Loop closure in the front enables the wearer to release the belt by themselves as required by the O.B.R.A. regulations.

This documentation describes a medical device, specifically Medline Wheelchair Safety Belts, and details their intended use and safety considerations, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The provided text is a "SAFETY AND EFFECTIVENESS SUMMARY" for a 510(k) submission (K963569) to the FDA. This type of submission is for devices substantially equivalent to legally marketed predicate devices, and often relies on existing literature and comparisons rather than new clinical trials with acceptance criteria.

Here's a breakdown of why the requested information cannot be extracted from the given text:

• No acceptance criteria are defined: The document lists potential complications and benefits but does not quantify performance metrics or set thresholds for success (e.g., "The device must reduce falls by X%").
• No specific study is described that tests performance against acceptance criteria: The document mentions reviewing "thirteen articles" for safety and efficacy data, but these are general literature reviews, not a specific study conducted by Medline Industries with defined acceptance criteria and methods to evaluate its own device against them.
• No details on sample size, data provenance, ground truth establishment, MRMC studies, or standalone performance are provided.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor details about a study proving device acceptance, as this information is not present in the provided text.

The document primarily focuses on:

• Device Description: Discusses different types of wheelchair belts (e.g., Wheelchair Waist Belt, Two-Piece Safety Soft Belt).
• Intended Use: Specifies who can use the belts ("gentle reminder" for patients to stay in their wheelchair, prevent falls, help feel safer) and who cannot (stretchers, motorized vehicles, home use). It also highlights the importance of use within a defined medical treatment program and increased monitoring for aggressive patients.
• Safety and Effectiveness Summary: Reviews potential complications from the literature (e.g., emotional desolation, fractures, decubitus ulcers, death) attributed to incorrect use or patient selection of restraints in general. It also mentions benefits when used correctly.
• Regulatory Context: Indicates that these devices were legally marketed prior to the submission date and that their features have not changed. It also references O.B.R.A. regulations regarding patient release mechanisms.

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