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The DeRoyal Industries, Inc. Pelvic Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movement thereby enabling examination or protection of the patient or others. The Pelvic Holder is a protective restraint which can be used with a bed or wheelchair.

The DeRoyal Industries, Inc. Pelvic Holder is a protective restraint device that is intended for medical purposes to limit patient moyement thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Pelvic Holder is designed similar to those marketed by other manufacturers. The Pelvic Holder is primarily comprised of either cotton cloth, flannel, cool knit, or cotton sheeting.

This looks like a 510(k) summary for a medical device called the "DeRoyal Industries, Inc. Pelvic Holder". However, it does not contain any information regarding acceptance criteria, a study proving device performance, sample sizes, expert involvement, or any of the other specific details requested in your prompt.

The document is a regulatory submission outlining:

• Submitter and Device Information: Name, address, contact, date, device names.
• Predicate Devices: Identifying similar devices already on the market.
• Device Description: What the device is made of (cotton cloth, flannel, cool knit, cotton sheeting) and its general design.
• Intended Use: To limit patient movement for examination or protection, usable with a bed or wheelchair.
• Technological Comparison: A table comparing characteristics of the DeRoyal Pelvic Holder to "Other Devices" (predicates), noting they are largely "Same" across materials, style, attachment vehicles, length of use, and level of patient activity.

In essence, this document is a justification of substantial equivalence to predicate devices based on design and intended use, not a performance study. It falls under the regulatory process where a new device is shown to be as safe and effective as an already legally marketed device, often without needing new clinical studies if the technological characteristics are similar enough.

Therefore, I cannot fulfill your request for the tables and details about acceptance criteria, study methodologies, sample sizes, and ground truth, as none of that information is present in the provided text.

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These products are intended to hinder egress of a patient and/or assist body alignment in a hospital bed, genatric chair, wheelchair, or gurney.

The devices included in this 510(k) submission support the torso and/or pelvic area. The product is closed around the patient by one or more of the following: a zipper, fabric alone, straps, or straps and buckles. The product is secured to the bed, geriatric chair, wheelchair, or gurney via straps. These straps are securely connected to the bed, geriatric chair, or wheelchair by one or more of the following: knots, or straps and buckles.

The provided text is a Safety and Effectiveness Summary for a 510(k) submission regarding protective restraints, specifically "Pelvic Holders" and "Protective Restraints." It outlines the device's purpose, classification, and regulatory context.

However, the document does not contain any information relevant to the acceptance criteria or a study proving the device meets those criteria, as requested in the prompt.

Here's why and what's missing:

• No Acceptance Criteria: The document describes the device's function and regulatory classification but does not list any quantitative or qualitative performance metrics (e.g., strength, durability, patient comfort scores, restraint effectiveness percentages) that would serve as acceptance criteria.
• No Study Details: There are no descriptions of any studies conducted to evaluate the device's performance against specific criteria. The text mentions "comparative purposes" and referencing "current products as legally marketed devices for comparison purposes," but this refers to regulatory comparison for the 510(k) process, not a performance study as typically understood in medical device validation.
• Missing Specifics for Performance Evaluation: All the sub-points requested in the prompt (sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, ground truth, training set size, training ground truth) are entirely absent because no such performance study is described.

Therefore, based on the provided text, I cannot complete the requested table or answer the questions. The document focuses solely on the regulatory process for a 510(k) submission for protective restraints.

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The Pelvic Holder is intended for patients who require both slider control and restraint while in the wheelchair.

The Pelvic Holder is a diaper-shaped device made from either woven polyester or polyester mesh. The device fits between the patient's legs and is secured by webbing around the waist. Webbing is 1 1/8-inch-wide polyester and secures to the wheelchair. The purpose of the device is to prevent patient from sliding down in the wheelchair. The edges are finished with bias cut binding that corresponds to a size chart included on the package insert. The device is intended for wheelchair use only.

The provided text is a 510(k) summary for a medical device called a "Pelvic Holder." It describes the device, its intended use, and compares it to a predicate device. However, it does not contain any information regarding acceptance criteria, performance studies, or ground truth establishment.

Therefore, I cannot provide the requested information in the format of a table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document focuses on regulatory compliance and device description, not on a detailed performance evaluation study.

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