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The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

The proposed device, Wheelchair model HM303, is traditional manually operated, user propelled, manual, mechanical wheelchairs. The device can be foldable easily for transport.

The main frame is made of magnesium alloy frame, which has a seat base with four-wheeled with a back cover. Upon the outside of this framework, and to the rear, are assembled two axle plates, wheels are connected to the stainless steel axle receivers via stainless steel axles. On the front end of the frame are assembled two caster housings. Caster forks are mounted to these housings via steel axles. On the front end of the frame, upon the caster, two footplates are assembled for foot holding. Two armrests are mounted on the frame for user's arm holding. Two grips mounted on the top end of the frame with a brake, and another brake is designed under the seat base. A folden set is on the frame, under the grips, for folding backrest.

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria in the context of a medical device with an AI component or a comparative effectiveness study.

The document is a 510(k) premarket notification for a Wheelchair, which is a mechanical device, not an AI-powered one. The submission focuses on demonstrating substantial equivalence to a predicate mechanical wheelchair through non-clinical performance and biocompatibility testing against established ISO standards.

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

• No AI Component: The device described is a "Mechanical Wheelchair" (Model HM303). There is no mention of any artificial intelligence, machine learning, or software algorithm components.
• No Clinical Study for Effectiveness: The document explicitly states "No Clinical Test conducted" in Section 8. The evaluation relies solely on non-clinical tests (physical performance and biocompatibility) and comparison to a predicate device.
• No Comparative Effectiveness Study: Since there's no AI component and no clinical study, there is no multi-reader multi-case (MRMC) comparative effectiveness study or analysis of human reader improvement with AI assistance.
• No Standalone Algorithm Performance: The concept of "standalone (algorithm only without human-in-the-loop performance)" is inapplicable because there is no algorithm or AI involved.
• No Ground Truth for AI Models: The establishment of ground truth for training or test sets is relevant for AI/ML models. For a mechanical wheelchair, performance is assessed against physical standards, not against expert labels or pathological outcomes for diagnostic accuracy.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them in the context of AI/ML or comparative effectiveness from the given document.

The document details the following regarding performance and acceptance for a mechanical wheelchair:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. For mechanical device testing against ISO standards, the "sample size" refers to the number of units tested, which is not specified but is typically a small number (e.g., 1-3 units) unless stress testing multiple units. The tests are non-clinical, likely performed in China (country of origin for the manufacturer).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical performance and biocompatibility is established by the specifications of international standards (ISO) and laboratory test results, not by expert interpretation in the medical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading). Mechanical and biocompatibility tests have objective pass/fail criteria based on standards.

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: Not applicable, as this is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this mechanical device is defined by international standards (ISO) for safety, performance, and biocompatibility, as well as FDA regulatory requirements for labeling.

8. The sample size for the training set: Not applicable. This is a mechanical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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The intended use of the Model STS Pediatric powered wheelchair is to provide mobility to children and young adults, weighing up to 150 pounds, with the ability to place themselves in a sitting position in the wheelchair and have the capacity to operate a standard joy stick hand control.

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This is a 510(k) premarket notification for a medical device called the "Innovative Products Pediatric Sit to Stand Wheelchair." This document is not a study report, but rather an FDA clearance letter. Therefore, it does not contain the detailed information about acceptance criteria and a study that proves the device meets those criteria, as typically found in clinical trial reports or performance evaluation summaries for AI/ML devices.

The information provided in this document primarily focuses on the FDA's decision regarding substantial equivalence to a predicate device.

However, based on the context of a 510(k) submission, we can infer some general aspects and state that the specific details you requested are not present in this document.

Here's an attempt to answer your questions based on what can be inferred or is explicitly missing from the provided text:

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

• Acceptance Criteria: Not explicitly stated in this document. For a physical medical device like a wheelchair, acceptance criteria would typically involve engineering specifications, safety standards (e.g., ISO standards for wheelchairs), durability tests, and performance metrics related to mobility, standing function, and control.
• Reported Device Performance: Not detailed in this document. The FDA letter confirms that the device is "substantially equivalent" to a legally marketed predicate device for its stated indications for use. This implies that its performance, as demonstrated by the manufacturer in their full 510(k) submission, was deemed comparable to the predicate.

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

• This information is not provided in the FDA clearance letter. For a physical device, this would typically refer to the number of units tested, the types of users involved in any user testing, and the methodology of such testing.

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)

• This information is not applicable or provided in this document. "Ground truth" and expert reviews are more relevant for diagnostic or AI/ML-based devices. For a physical device, "ground truth" would be established through objective measurements against engineering specifications and safety standards, rather than expert consensus on diagnostic interpretations.

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

• This information is not applicable or provided. Adjudication methods are typically used in clinical studies involving interpretation of data (e.g., medical images).

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

• This information is not applicable. MRMC studies and the concept of AI assistance for human readers are relevant to AI/ML-based diagnostic devices, not a physical pediatric sit-to-stand wheelchair.

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

• This information is not applicable. The device is a physical wheelchair, not an algorithm.

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

• As mentioned in point 3, the concept of "ground truth" in this context would refer to objective validation against engineering standards, safety regulations, and functional performance metrics (e.g., weight capacity, stability, maneuverability). The specific type of "ground truth" used for testing the wheelchair is not detailed in this FDA letter.

8. The sample size for the training set

• This information is not applicable or provided. "Training set" refers to data used to train AI/ML algorithms. For a physical device, there isn't a "training set" in this sense. Design and development are based on engineering principles and iterative testing.

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

• This information is not applicable.

Summary based on the provided document:

The provided document is an FDA 510(k) clearance letter for a physical medical device (Pediatric Sit to Stand Wheelchair). It confirms that the device is "substantially equivalent" to a legally marketed predicate device. This letter does not contain the detailed information about acceptance criteria and study results in the manner requested, as those details would be found within the full 510(k) submission, not the clearance letter itself. The questions you posed are largely relevant to AI/ML software as a medical device (SaMD) clearances, not directly to a physical device like a wheelchair.

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AIDC 8500-II Wheelchair is a tilt-in-space mobile positioning system for everyday indoor and outdoor use on flat terrain. They are available in a range of sizes to accommodate a particular fit to the user.

AIDC 8500-II Wheelchair can be an attendant propelled or self propelled device, its intended use is to enhance mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor or indoor. It has various options to control and/or support the user's specific needs.

AIDC 8500-II Wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor.

The AIDC 8500-II Wheelchair is manually operated mechanical wheelchair. It is designed to be light in weight with folding frame. The range of sizes and configurations are available to accommodate the needs of each user. The wheelchair is suitable to provide mobility to user for both indoors and outdoors with firm surface that is free of climbing obstacles.

The AIDC 8500-II Wheelchair consists of typical components found on most manual wheelchair. The wheelchair consists of aluminum alloy frame constructed of AA6061-T6 aluminum alloy tubing that is TIG-welded, removable seat and back upholsteries, flip-up available footrest and legrest, front castors and rear wheels.

The owner's manual of AIDC 8500-II Wheelchair provides information on warnings, cautions and operation instruction of the wheelchair.

The provided text describes a 510(k) summary for the AIDC 8500-II Wheelchair, focusing on its substantial equivalence to a predicate device through non-clinical testing. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of a medical AI device.

Therefore, I cannot fulfill your request for the tables and information outlined in your prompt, as the document is about a manual wheelchair and its non-clinical testing for regulatory approval, not about an AI-powered device or a study examining its performance against acceptance criteria.

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In order to transport patient(s) and/or disable people This particular wheel chair is manual,not electrical device. It is highly recommended that someone(nurse, assistant, nursing home staff or family member) operates this device to transport patient(s) and/or disable people on even surface like concerete road,pavement sudd floor for the safety and effectiveness.

WHEEL CHAIR(MANUAL,NOT ELECTRICAL)

The provided text is an FDA 510(k) clearance letter for a manual wheelchair, not a study report for an AI/ML medical device. Therefore, it does not contain any of the requested information regarding acceptance criteria or a study proving device performance for an AI-based system.

The document describes a manual wheelchair (not electrical) and states that its intended use is to "transport patient(s) and/or disable people." It specifies that "someone (nurse, assistant, nursing home staff or family member) operates this device to transport patient(s) and/or disable people on even surface like concrete road, pavement, sudd floor for the safety and effectiveness."

Since this is a clearance for a simple mechanical device, the concepts of acceptance criteria for an AI model, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to the information contained in these documents.

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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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The ES-125 Stair Platform Lift is intended to mechanically transport one person in a wheelchair up and down stairs in a private residence or public facility.

The ES-125 Stair Platform Lift is an unenclosed stair platform lift designed to carry a wheelchair and its occupant between floors in a residential or public facility. It is accessible via automatic dual access ramps (straight or 90 degree entry) and is driven by a cable/drum unit that incorporates a 3/16" aircraft cable with a breaking load of 4,200 lbs, a deviator pulley, and winding drum. It can be controlled from either end at a key-controlled station or from an on- board, hand-held control panel. The entire carriage unit is designed with ASTM 30 tubular steel, and the fold-away platform contains a non-skid surface. The unit travels at a rated speed of approximately 14 ft/min and possesses a mechanical emergency brake in case of drive cable failure. The lift can be used with stairways at an incline of up to 45 degrees and has a rated carrying load of up to 450 lbs. The power supply is 110 VAC, 1Ph, 60 Hz, 15 amp. The lift complies with ANSI-A17.1 Code specifications regarding elevating devices for the handicapped

The provided text is a 510(k) Summary for a medical device called the "Savaria ES-125 Stair Platform Lift." This document is a pre-market submission to the FDA to demonstrate that the device is as safe and effective as (substantially equivalent to) a legally marketed predicate device.

Crucially, a 510(k) summary does not typically contain information about clinical studies, acceptance criteria, or performance data in the same way a clinical trial report or a performance study for an AI/ML medical device would.

The "acceptance criteria" and "device performance" in this context refer to the device's design specifications and its compliance with industry standards, rather than statistical performance metrics against a defined ground truth. The study that "proves" the device meets the acceptance criteria is generally a bench test and verification of these design specifications against standards like ANSI-A17.1.

Therefore, many of the requested fields cannot be filled as they are not applicable to the type of information presented in this 510(k) summary.

Here's an attempt to answer the questions based only on the provided text, acknowledging its limitations for typical AI/ML device performance reporting:

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

Since this is a non-AI/ML device, the "acceptance criteria" are the design specifications and compliance with safety standards, and the "reported device performance" is the confirmation that the device meets these specifications.

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

This information is not provided in the 510(k) summary. For a mechanical device like this, testing would typically involve engineering validation and verification tests on prototypes or production units, not a "test set" or "data provenance" in the sense of clinical data.

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. The "ground truth" for a stair lift is its mechanical function and safety compliance, established through engineering specifications and adherence to standards like ANSI-A17.1, verified through testing, not expert consensus on medical images or patient outcomes.

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

Not applicable. This type of adjudication method is relevant for clinical studies, especially those involving human interpretation of medical images. For a mechanical device, performance is typically verified against design specifications and engineering standards.

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

Not applicable. This is a mechanical stair lift, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is a mechanical device, not an algorithm.

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

The "ground truth" for this device is its adherence to engineering specifications, safety standards (e.g., ANSI-A17.1 Code), and functional requirements for transporting a wheelchair and occupant. This is established through design documents, material specifications, and performance testing against those predefined criteria.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. No training set is involved for this mechanical device.

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