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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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The DeRoyal Industries, Inc. Poncho Vest Restraint is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit movements thereby enabling examination or protection of the patient or others. The Poncho Vest Restraint is a protective restraint that is intended to be used with a bed or wheelchair.

The DeRoyal Industries, Inc. Poncho Vest Restraint device that is intended for medical purposes to limit movements thereby enabling examination or protection of the patient or others.
Device Design/Materials Used/Physical Properties: The DeRoyal Poncho Vest Restraint is designed similar to those marketed by other manufacturers. The Poncho Restraint is primarily comprised of cool knit or cotton with polyester straps. The fasteners are made of a nylon hook and loop or steel nickel plated buckles.

This document describes a medical device called the "DeRoyal Industries, Inc. Poncho Vest Restraint," which is a physical restraint. The provided text is a 510(k) summary for this device, seeking clearance from the FDA.

Based on the information provided, this is not a device that involves artificial intelligence (AI), machine learning (ML), or any form of digital diagnostics/analysis. Therefore, the concepts of acceptance criteria related to algorithmic performance, test sets, ground truth establishment, expert readers, MRMC studies, or standalone algorithm performance are not applicable here.

The document discusses equivalence to predicate devices based on:

• Materials: "Principally comprised of cool knit or cotton with polyester straps. The fasteners are made of a nylon hook and loop or steel nickel plated buckles."
• Design: "designed similar to those marketed by other manufacturers."
• Intended Use: "to limit movements thereby enabling examination or protection of the patient or others."

To provide an answer that aligns with the spirit of your request (even though AI/ML is not involved), I will reinterpret the "acceptance criteria" and "study" in the context of a traditional medical device submission like this.

This medical device is a physical restraint and thus the concepts of "device performance" in the context of AI/ML metrics (like accuracy, sensitivity, specificity, AUC) and associated studies (like MRMC, standalone performance) are not applicable. The documentation focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use.

Here's an interpretation based on the provided text, using the structure you requested, even though it deviates significantly from an AI/ML context:

1. Table of "Acceptance Criteria" and the Reported "Device Performance"

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable. This is not a study involving a "test set" of data in the AI/ML sense. The "test" is a comparison to existing, legally marketed predicate devices.
• Data Provenance: Not applicable. No specific data provenance (country, retrospective/prospective) is involved in this type of comparison for a physical restraint.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not applicable. Ground truth for a physical restraint is typically established through engineering design principles, material testing (not detailed in this summary), and clinical experience with predicate devices, rather than expert consensus on diagnostic data.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" requiring adjudication in the context of this device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No. MRMC studies are used for diagnostic accuracy and reader performance, which are not relevant for a physical restraint device of this nature.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

• In this context, the "ground truth" for demonstrating safety and effectiveness would be established through:
  • Predicate Device Performance: The known performance and safety profiles of the legally marketed predicate devices.
  • Engineering Standards/Material Specifications: Adherence to established standards for textiles, fasteners, and overall design integrity (though specific standards are not detailed in this summary).
  • Clinical Experience: The general understanding and experience of healthcare professionals regarding the safe and effective use of patient restraints.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" for an AI/ML model.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. There is no "training set" or AI/ML model for which ground truth would be established in this manner.

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The DeRoyal Industries, Inc. Multi-Purpose Utility Restraint/ Body Holder is indicated for use, at the discretion of a responsible licensed healthcare professional, to limit patient movements thereby enamination or protection of th patient or others. The Multi-Purpose Utility Restraint can be used with an OR table, gurney, bed, or stretcher. The Bod Holder is a protective restraint which can be used with a bed or wheelchair.

The DeRoyal Industries, Inc. Multi-Purpose Utility Restraint / Body Holder is a protective restraint device that is intend medical purposes to limit patients thereby enabling examination or protection of the patient or others.

Device Design/Materials Used/Physical Properties: The DeRoyal Multi-Purpose Utility Restraint/ Body Holde designed similar to those marketed by other manufacturers. The Multi-Purpose Utility Restraint Body Holder is prima - comprised of nylon or cotton.

This document is a 510(k) Summary for the DeRoyal Industries, Inc. Multi-Purpose Utility Restraint/Body Holder. It describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

The purpose of a 510(k) Summary is to demonstrate substantial equivalence to a legally marketed predicate device, not to present performance data against specific acceptance criteria. The document lists characteristics of the device and compares them to "Other Devices" (predicate devices), noting they are "Same". This comparison implicitly serves as the "proof" for the 510(k) pathway – that because it is similar to already marketed devices, its safety and effectiveness are established.

Therefore, I cannot provide the requested information from the given text. The input does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size for test set or data provenance.
3. Number and qualifications of experts.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study or effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The Support Vest is intended to provide restraint and upper body support for patients in wheelchairs and restraint for patients in bed.

The Support Vest is a sleeveless, upper body device that has a poncho-style front bib and vest-style rear wings. These wings have 1 1/8-inch-wide polyester webbing sewn to them and brought around to the front of the device, and passed through two slots on the front bib. This closes the vest and causes the wings to criss-cross over the patient's middle chest thus providing posture support. The webbing secures to the wheelchair kickspurs or to the bed frame. The device is edged in bias cut binding in colors that correspond to a size chart included on the package insert. The device is intended for use in the bed or wheelchair.

This 510(k) premarket notification describes a Support Vest, a physical restraint for patients in wheelchairs or beds. The submission does not include a study to prove the device meets specific acceptance criteria based on performance metrics. Instead, it relies on a comparison to an already marketed predicate device and current regulatory frameworks.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable. No test set or clinical study data is presented.
• Data Provenance: Not applicable. The submission refers to a currently marketed predicate device and regulatory guidelines, rather than new clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. No ground truth establishment for a test set is discussed, as no performance study was conducted.

4. Adjudication Method for the Test Set

• Not applicable. No test set or adjudication process is mentioned.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. The submission focuses on comparing the proposed device to a predicate device already on the market and regulatory compliance, not on comparing human readers' performance with and without AI assistance. The device itself is a physical restraint, not an AI-powered diagnostic tool.

6. Standalone Performance Study

• No, a standalone (algorithm only without human-in-the loop performance) study was not done. The device is a physical product, not an algorithm.

7. Type of Ground Truth Used

• Not applicable. No ground truth derived from clinical data, pathology, or outcomes data is used to establish the device's performance. The basis for safety and effectiveness is primarily through substantial equivalence to a predicate device and adherence to regulatory guidance for medical device labeling and use.

8. Sample Size for the Training Set

• Not applicable. There is no training set mentioned, as this is not an AI/ML device requiring training data.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. No training set or associated ground truth establishment is described.

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The Safety Poncho is used for restraint. The Shoulder Strap Poncho provides restraint and posture support.

Safety Poncho: A poncho-style, upper body device made from either woven polyester or polyester mesh. A waist strap secures the device to the wheelchair kickspurs. The strap is 1 1/8-inch-wide polyester webbing. The edges of the garment are finished with a bias cut binding, the color of which corresponds to a size chart included on the package insert. The device is intended for wheelchair use only. Shoulder Strap Poncho: The Shoulder Strap Poncho has the same configuration as the above with the addition of a strap sewn on the shoulder area. This strap ties to the wheelchair pushhandles to provide posture support. Strap is 1 1/8-inch-wide polyester webbing.

This document describes a 510(k) submission for the "Safety Poncho" and "Shoulder Strap Poncho" by Skil-Care Corporation. It's important to note that this submission is from 1996, and modern medical device submissions, especially for AI/ML-driven devices, look vastly different and require significantly more rigorous data and study details.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria in the way one would expect for an AI/ML device. This is because the devices described are physical restraints, not AI-powered diagnostics or therapeutics.

Therefore, I cannot populate the requested table or answer most of your detailed questions, as they pertain to the evaluation of AI/ML device performance.

However, I can extract the relevant information from the document as it pertains to the nature of the submission:

1. A table of acceptance criteria and the reported device performance

• No acceptance criteria or reported device performance metrics are provided in the document. The submission is not for a device requiring performance evaluation against quantitative metrics like sensitivity, specificity, or F1 score.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. There is no "test set" in the context of evaluating a physical restraint device's performance. The submission refers to 18 years of commercial distribution of the predicate devices.

3. 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. There is no "ground truth" establishment in the context of this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable.

5. 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

• No. This is a physical device, not an AI or diagnostic tool, so an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable.

8. The sample size for the training set

• Not applicable.

9. How the ground truth for the training set was established

• Not applicable.

Summary of the K96346 submission relevant to its context:

The core of this 510(k) submission (K96346) is a substantial equivalence claim for two physical restraint devices: the "Safety Poncho" and the "Shoulder Strap Poncho."

• Device Description:
  • Safety Poncho: A poncho-style upper body device made of woven polyester or polyester mesh with a waist strap to secure it to wheelchair kickspurs.
  • Shoulder Strap Poncho: Same as the Safety Poncho but with an additional strap on the shoulder area to tie to wheelchair pushhandles for posture support.
• Indications for Use:
  • Safety Poncho: Used for restraint.
  • Shoulder Strap Poncho: Provides restraint and posture support.
• Predicate Device: The predicate devices are the "Safety Poncho" and "Slider Poncho" already marketed by Skil-Care Corporation.
• Basis for Equivalence: The submission states that the devices used for comparative purposes (the predicate devices) are currently marketed and have been for approximately 18 years. The only difference mentioned is a change in labeling to incorporate suggestions from an FDA draft guidance document for protective restraints.
• Regulatory Context: The document highlights that such restraints are subject to HCFA (Health Care Financing Administration, now CMS) regulations and accreditation standards, which govern their appropriate use and personnel training. This implies that the safety and effectiveness are managed through existing clinical practice guidelines and regulatory oversight for restraint use, rather than through a device-specific performance study presented in this 510(k).

In essence, this is a notification for minor labeling changes to existing, legally marketed devices, rather than a submission for a new device requiring extensive performance data validation in the modern sense, especially as it relates to AI/ML.

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The sleeved jacket is intended for patients who require support while seated in a wheelchair.

The sleeved jacket with slider control is intended for patients who require support and additional support to prevent sliding forward while seated in a wheelchair.

Both are intended for patients who have a history of removing vest-style and poncho-style restraints.

Sleeved Jacket: The sleeved jacket is a polyester upper body garment, designed to be worn over clothing, with short sleeves, a brass back zipper, and 1 & 1/8 inch polyester webbing ties sewn across the back at the shoulder area and across the front at the waist. The ties are tied to the wheelchair push handles and kick spurs, respectively, to provide patients with postural support. The edges of the garment are finished with bias cut binding in a color to correspond with the garment size as described in the insert labeling.

Sleeved Jacket with Slider Control: The Sleeved Jacket with Slider Control has the same features as the sleeved jacket with the addition of a crotch pad sewn to the bottom center front. The pad is lined with 1/4 inch polyurethane foam and has a 1 & 1/8 inch polyester webbing strap sewn on that is either placed directly under the patient or under the seat of the wheel chair and secured to the wheelchair cross brace to prevent the patient from sliding down.

This document is a 510(k) summary for a medical device (Sleeved Jacket and Sleeved Jacket with Slider Control), which describes the device, its indications for use, and comparative information to a predicate device. It does not contain information about a study that assesses the device's performance against specific acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the provided text lacks this information.

Specifically, the document:

• Does not present a table of acceptance criteria.
• Does not report device performance data.
• Does not mention any studies conducted to evaluate the device's efficacy or safety against quantitative metrics.
• Does not discuss sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

The document primarily focuses on:

• Identifying the device and its manufacturer.
• Describing the device's physical characteristics and intended use.
• Stating that the device is a predicate device already legally marketed and exempt from certain regulations.
• Mentioning a change in labeling to align with FDA draft guidance.
• Discussing regulatory context regarding the use of restraints in healthcare settings.

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