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It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The subject device, Electric Wheelchair, mainly powered by DC motor, driven by user controlling joystick controller and adjusting speed. The Electric Wheelchair is a battery powered four wheeled vehicle. It consists Li-ion battery with an off-board battery charger, Push handle, Seat, Back support, Joystick control panel (including: Speed light, ON/OFF button, Horn, Joystick, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Rear wheels.

The operation of the Controller: Use the On/Off button to turn on or turn off the power, The main function of the Joystick is to control the speed and direction of the wheelchair, the loystick can control the wheelchair to travel in any direction, the Joystick movement will determine the wheelchair in that direction speed of movement. The farther the center, the faster the wheelchair runs. When you release the Joystick, the wheelchair is automatically braked. Use the speed control button to reduce or increase the speed setting. The Electric manual model change lever underneath the seat will allow for the brakes to engage or disengage. When adjusted to the manual model, the assistant can easily push the wheelchair. The Electic Wheelchair has a structure for quick assembly and disassembly that is convenient to be stored or placed in the trunk of your vehicle while traveling.

The Electric Wheelchair has 7 inch front wheels and 12 inch rear tires.

Max. distance of travel on the fully charged battery is 15 km and Max. speed forward is 6.5 km/h.

When the wheelchair needs to stop, release the joystick. After a set period of time, the controller disconnects the solenoid brake power supply, and the internal spring squeezes the suction plate to lock the motor, so as to brake.

This is a 510(k) summary for an Electric wheelchair (KR-8807), not an AI/ML powered device. As such, the requested information regarding AI/ML specific acceptance criteria, study methodologies, and ground truth establishment is not applicable to this document. The document describes the device's adherence to various engineering and safety standards for wheelchairs.

However, I can extract and present the information available in the document regarding the device's performance based on the provided engineering standards:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Electric wheelchair (KR-8807) are primarily defined by adherence and successful testing against a comprehensive set of ISO 7176 series standards, as well as ISO 16840-10 and ISO 10993 series for biocompatibility. The reported performance confirms compliance with these standards.

2. Sample size used for the test set and the data provenance

The document does not specify a "sample size" in the context of clinical studies for a human-in-the-loop or AI/ML evaluation. The evidence for compliance comes from non-clinical tests performed on the device itself (likely a prototype or production sample) to verify it meets the specifications outlined in the various ISO standards. The data provenance is implied to be from laboratory testing against established engineering standards. There is no information on the country of origin of this testing data beyond the applicant's location in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The "ground truth" for this device's performance is established by engineering standards and their associated test methodologies, not by expert consensus in an AI/ML context. The tests are designed to objectively measure physical and electrical properties of the wheelchair against predefined limits or characteristics.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based studies where expert interpretation is involved. For engineering specifications tested against ISO standards, the results are typically quantitative measurements that either meet or fail the specified criteria.

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 question is not applicable. The document describes an electric wheelchair, which is a physical device, not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this submission.

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

This question is not applicable for the reasons stated above.

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

For this device, the "ground truth" is defined by international engineering and safety standards (ISO 7176 series, ISO 16840-10, ISO 10993 series). The device's performance is compared against the requirements and test methods stipulated within these standards.

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device.

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

This question is not applicable as this is not an AI/ML device.

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The Electric wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Not Found

I apologize, but the provided text from the FDA 510(k) clearance letter for the "Electric wheelchair (YHWL002, YHWL003)" (K240331) does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically associated with AI/ML-driven medical devices.

This document is a standard FDA clearance letter for a Class II medical device (Powered Wheelchair). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must adhere to. It does not include details about clinical performance studies or specific metrics that would be relevant for answering your detailed questions about acceptance criteria and study methodologies for an AI device.

Therefore, I cannot provide the requested information based on the given input.

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The Electric wheelchair is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The subject Electric wheelchair(C001) is a wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk designed to be propelled by power from electric motors. The electronic control of speed and direction can be performed by the occupant with the help of controlling joystick. The device can be quickly folded and disassembled, which makes it convenient to be stored or placed at the trunk of vehicles while traveling. The subject device is intended to provide mobility to a disabled or elderly limited to a seated position. It is of indoor and outdoor type, suitable for the use indoor and outdoor road like flat stone road and so on. The subject device consists of two parts, the wheelchair main body and the electrical part. The main body includes a main foldable Carbon fiber frame, two armrests, a backrest, a seat cushion, a safety belt, two rear driving wheels(8" / PU solid tire) and two front wheels(6"/ PU solid tire). The electrical part is composed of two motors, two brakes, a lithium battery, a controller and an off-board charger. The device is powered by a Li-ion battery with 14.8km range, which can be recharged by an off-board battery charger that can be plugged into an AC socket when the device is not in use. The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair. The further the joystick is pushed from its central position, the faster the wheelchair moves, when it is released, it will automatically reset and brake. The device can convered between electric driving and manual push.

This is not an AI/ML device, so elements of the request regarding AI/ML tests are not applicable.

The device in question, the Electric Wheelchair (C001), is a powered medical device. The acceptance criteria and the study that proves the device meets these criteria are primarily based on non-clinical performance testing against a series of ISO 7176 standards relevant to wheelchairs and IEC 60601-1-2 for electromagnetic compatibility.

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

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

The document does not explicitly present a table of "acceptance criteria" versus "reported device performance" in a quantitative manner for each specific parameter. Instead, it states that the device "complied with the requirements" of various ISO and IEC standards. The comparison table in Section VI outlines differences between the subject device and the predicate but doesn't explicitly state quantitative performance acceptance criteria for the subject device beyond the general statement of compliance with standards.

However, based on the non-clinical testing performed, the acceptance criteria are implicitly the successful adherence to the requirements outlined in the cited ISO and IEC standards. The "reported device performance" is the statement of this compliance. For certain parameters where the subject device differs from the predicate, the document asserts that these differences do not impact safety or effectiveness.

Below is a table summarizing the implicit acceptance criteria (compliance with standards) and the reported performance (compliance achieved).

2. Sample size used for the test set and the data provenance

The document describes bench performance testing according to international standards (ISO and IEC). For such tests, the "sample size" is typically not described in terms of patients or data records, but rather in terms of the number of devices or components tested. The document does not specify the exact number of electric wheelchairs (C001) or their components that underwent each of these tests.

The data provenance is laboratory testing data, presumably collected at the manufacturer's facility or a certified testing laboratory, as implied by the phrase "performance data were provided to verify that the subject device met all design specifications." The country of origin of the device is China (Zhejiang Hfizer Medical Equipment CO.,LTD.). Since these are bench tests, they are inherently prospective in relation to the current device's design and manufacturing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as the device is a physical medical device, not an AI/ML system requiring expert-established ground truth for its performance evaluation. The "ground truth" for this device is the established technical specifications and safety requirements set forth in the international standards (ISO and IEC) to which it was tested for compliance.

4. Adjudication method for the test set

Not applicable for a physical device undergoing bench testing. The evaluation is based on objective measurements and compliance with predefined standard requirements, not on human interpretation or adjudication of outputs.

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 device is not an AI-assisted diagnostic or interpretive tool.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

The "ground truth" for the performance evaluation of this electric wheelchair is compliance with the technical specifications and safety criteria defined by the cited international standards (ISO 7176 series and IEC 60601-1-2). These standards provide objective, measurable criteria for various aspects of wheelchair safety and performance.

8. The sample size for the training set

Not applicable. This device is not an AI/ML system and does not have a training set.

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

Not applicable. This device is not an AI/ML system and does not have a training set with associated ground truth.

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The Electric wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Electric wheelchair (W3902)

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for an "Electric wheelchair (W3902)". This document does not contain information about the acceptance criteria and study details for an AI/ML device. It focuses on regulatory approval based on substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

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The Electric wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Electric wheelchair (N3901)

This document is an FDA 510(k) clearance letter for an electric wheelchair. It does not contain information about acceptance criteria or a study proving that a device meets such criteria, as it is not a technical report for the device's performance, but rather a regulatory approval document.

Therefore, I cannot provide the requested information. The concepts mentioned (acceptance criteria, test sets, ground truth, MRMC studies, training sets) are relevant to the evaluation of certain types of medical devices, particularly those involving AI or diagnostic capabilities, which is not the case for an electric wheelchair as described here. An electric wheelchair would typically be evaluated based on safety standards, maneuverability, battery life, weight capacity, etc., rather than the type of criteria you've listed.

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The Electric wheelchair is a motor driven transportation vehicle with the intended use to provide mobility to a disabled or elderly limited to a seated position.

Electric wheelchair (S7018)

I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Electric wheelchair (S7018)" does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets them.

The document is a standard FDA clearance letter, which primarily states that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory requirements. It does not include information about:

• Specific acceptance criteria in a tabled format.
• The results of any performance studies against those criteria.
• Sample sizes for test sets or data provenance.
• Details about expert involvement in establishing ground truth.
• Adjudication methods.
• MRMC studies or effect sizes.
• Standalone algorithm performance.
• Types of ground truth used.
• Training set details (size or ground truth establishment).

The letter indicates that the device is an "Electric wheelchair" for "mobility to a disabled or elderly limited to a seated position." For such a device, performance criteria typically relate to safety, durability, speed, battery life, weight capacity, maneuverability, and electromagnetic compatibility, often tested against established industry standards (e.g., ISO, ANSI/RESNA). However, these specific test results and acceptance criteria are not detailed in this FDA clearance letter. They would typically be found in the full 510(k) submission, which is not publicly available in this format.

Therefore, I cannot populate the table or provide the requested details based on the provided text.

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The Electric wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Electric wheelchair

This document is an FDA 510(k) clearance letter for an electric wheelchair. It does not contain information about acceptance criteria or a study proving that a device (medical or otherwise) meets specific performance criteria through a study involving AI or human readers, ground truth, or sample sizes.

The information you are asking for (acceptance criteria, study details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in documentation for AI/ML-enabled medical devices, often in their 510(k) summary, clinical study reports, or specific performance reports submitted to the FDA.

Since the provided text is solely an FDA clearance letter for a physical medical device (an electric wheelchair) and not a software/AI-driven diagnostic or therapeutic device, it does not describe the kind of performance study you are asking about.

Therefore, I cannot fulfill your request based on the provided text. The document is about the regulatory clearance process for an electric wheelchair, not its performance validation through a study as described in your prompt.

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The Electric wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Electric wheelchair (YHW001-C;YHW001-D;YHW001-E;YHW001-F)

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, studies, ground truth, or sample sizes related to the Electric Wheelchair (YHW001-C; YHW001-D; YHW001-E; YHW001-F).

The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as product classification, general controls, quality system regulations, adverse event reporting, and other compliance requirements.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the input provided.

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The device is a power wheelchair intended to provide mobility to persons restricted to a sitting position.

The Electric wheelchair (Model S7204, S7205) is a power wheelchair intended to provide mobility to persons restricted to a sitting position. The Electric wheelchair (Model S7204, S7205) is about 136 kg weight capacity. It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists primarily of a welded-aluminum frames, sealed transaxle motors drive system, electromagnetic braking system, electric motor controller and Li-ion batteries with an off-board battery charger. It is powered by rechargeable batteries with 45 km which maximum speed up to 7 km/h. The controller with a joystick attaches to either armrest and allows the rider to control the movement and velocity of the powered wheelchair. When the joystick is released. the electromagnetic brake will be actuated and the power wheelchair is slow to stop. It consists of three parts which are chair part, control part and drive part. Overall it mainly has a basic aluminum alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a footrest, an controller, an electric motor, an electromagnetic brake and a Lithium battery with an off-board charger. The result of "tiltover" tests performed laterally (12° ), posteriorly (16° ), and anteriorly (12° ) with a user of maximum allowable weight in the least stable configuration: No overturn performed laterally, posteriorly, and anteriorly with 136kg in the least stable configuration.

The provided text is a 510(k) summary for an Electric Wheelchair, Models: S7204, S7205. It describes the device, its intended use, and comparative testing against predicate devices to establish substantial equivalence.

However, the document does not describe an AI medical device or a study involving human readers or AI assistance. It focuses on the physical and functional characteristics of an electric wheelchair and its compliance with various ISO and IEC standards relevant to wheelchairs and medical electrical equipment.

Therefore, many of the requested criteria cannot be extracted from this document, as they pertain to AI/ML device performance and clinical studies involving expert readers, which are not present here.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance Study (Electric Wheelchair)

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a typical table format for an AI device. Instead, it refers to compliance with various international standards for wheelchairs and medical electrical equipment. The "reported device performance" is mainly a comparison of the subject device's specifications against those of two predicate devices, with notations on substantial equivalence.

Key Performance & Safety Standards (implicit acceptance criteria by compliance):

2. Sample size used for the test set and the data provenance

Not applicable. The "test set" here refers to the device itself and components undergoing engineering and safety tests, not a dataset for an AI model. Testing was performed on the electric wheelchair models S7204 and S7205. The provenance of the data is from specific tests conducted by the manufacturer/laboratories against established international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI/ML device requiring expert ground truth for a diagnostic or prognostic task. The "ground truth" is established by the specifications defined in the international standards (e.g., how to measure static stability, speed, brake performance).

4. Adjudication method for the test set

Not applicable. This concept typically applies to expert review of data for AI model training or evaluation, which is not relevant here. The evaluation is based on compliance of physical and functional tests with established 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 an electric wheelchair, not an AI-assisted diagnostic or prognostic device. No MRMC study or evaluation of human readers with/without AI assistance was performed.

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

Not applicable. This is an electric wheelchair. There is no standalone algorithm being evaluated.

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

For this device, the "ground truth" is defined by the objective performance criteria and methodologies outlined in the referenced ISO and IEC standards. For example, static stability is measured according to ISO 7176-1, brake performance according to ISO 7176-3, and biocompatibility according to ISO 10993. These are engineering and safety standards, not clinical ground truth of a diagnostic nature.

8. The sample size for the training set

Not applicable. This is not an AI/ML device relying on a training set.

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

Not applicable. This is not an AI/ML device.

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The Electric wheelchair is a motor driven transportation vehicle with the intended use to provide mobility to a disabled or elderly limited to a seated position.

The Electric wheelchair (Model S7012) is to provide mobility to adults, limited to a seated position that have capability to operate a few simple controls and the ability to control a powered wheelchair. The device and accessories (remote controller, AC power wire, charger, and battery) are reusable. The Electric wheelchair (Model S7012) is about 125 kg weight capacity and size is about 840mm x 640mm x 930mm if unfold and about 700mm x 640mm x 370mm if fold. It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists primarily of a foldable welded-aluminum frames, sealed transaxle motors drive system, electromagnetic braking system, electric motor controller and Li-ion batteries with an off-board battery charger. It has some components as two front wheels, two rear wheels, two anti-tip wheels, a seat, a footrest, and has a remote for folding/unfolding the device. Its basic function is powered by rechargeable batteries with 15 km which has a maximum speed up to 6 km/h. The controller with a joystick attaches to either armrest and velocity of the powered wheelchair. When the joystick is released, the electromagnetic brake will be actuated and the power wheelchair is slow to stop. The joystick can move up and down, left and right. There is a speed button to adjust the speed, and the speed indicator can display the speed. In addition, there is a remote control to control the folding and unfolding of the device. And no any new features of the device.

The provided text is a 510(k) Summary for an Electric Wheelchair (Model: S7012). It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical studies against acceptance criteria in the manner one might expect for a novel AI/software as a medical device.

Therefore, the requested information regarding detailed acceptance criteria, study design for proving those criteria, sample size for test sets, expert involvement, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment does not apply in the context of this traditional medical device submission. The submission relies on adherence to established international standards for wheelchairs and a comparison of technical specifications to a predicate device.

However, I can extract the closest analogous information from the document:

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

The acceptance criteria are generally implied by conformity to the listed ISO and IEC standards and demonstrating substantial equivalence to the predicate device in terms of specifications. The "reported device performance" is given by the subject device's specifications.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. The "tests" mentioned are conformity to international standards (e.g., ISO 7176 series, IEC 62304) for a physical device, not statistical performance evaluations against a test set of data. These standards typically involve testing a single or a small number of physical units to verify specifications and safety features.
• Data Provenance: Not applicable in the context of data used for statistical evaluation of a test set. The provenance of the tested device itself is Dongguan Prestige Sporting Goods Co., Ltd., China.

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. This device is an electric wheelchair, not an AI/diagnostic device that generates an output needing expert "ground truth." The "truth" is established by direct physical measurement, engineering tests, and adherence to performance specifications outlined in the international standards cited (e.g., measuring speed, stability, brake effectiveness).

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

Not applicable for this type of device submission. Adjudication methods are typically used in clinical studies where expert consensus is needed to define a ground truth for a diagnostic outcome.

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. MRMC studies are specific to evaluating the effectiveness of AI-assisted diagnostic tools on human reader performance. This device is a physical mobility aid.

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

Not applicable. This device is a physical product (electric wheelchair), not an algorithm or AI system.

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

The "ground truth" for this device's performance relies on:

• Direct Physical Measurements: E.g., dimensions, weight, speed, range, turning radius.
• Engineered Safety Standards: Compliance with ISO 7176 series (static stability, dynamic stability, brakes, strength, climatic tests, EMC, etc.), IEC 62304 (software life-cycle), IEC 60601-1-6 (usability), IEC 62366 (usability engineering), and ISO 10993 series (biocompatibility).
• Comparison to a Predicate Device: Demonstrating that any differences in specifications do not raise new questions of safety or effectiveness.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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