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This 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.

The product is intended only carry one person and used as a means of transportation for people with disabilities or incomplete walking ability (excluding obesity).

The electric wheelchair is classified as class A, which is suitable for use on flat walking paths indoors and near buildings.

The maximum occupant mass is 100kg.

The Electric Wheelchair is a battery powered four wheeled vehicle.

It consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back support, control device (including the battery power indicator, ON/OFF button, horn button, speed indicator, speed control button, joystick, lighting switch, USB interface), arm supports, two rear wheels, two casters(front wheels), Foot support, anti-tip devices.

The wheelchair can easily fold and unfold for transportation or storage.

The controller handle (joystick) is equipped on the control pad that attaches to the right arm rest. While there is a bluetooth music play function equipped on the left arm rest. The bluetooth function does not connect to the controller, so it will not affect the normal operation of the wheelchair at all.

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The intended use of the Electric Wheelchair (Robooter E80), Model name: BBR-E80-01 and BBR-E80-02 is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

The Electric Wheelchair (Robooter E80), Models name: BBR-E80-01,BBR-E80-02, is an indoor/outdoor, battery- operated, 2-wheel drive (rear-wheel drive) powered wheelchair.

It consists of four modules: seat system, control system, braking system, and drive system. The user sits in the wheelchair seat and uses the control system.

The control pad positioned on the right armrest, user can turn the wheelchair on, control the speed, and direct the movement.

The braking system employs an electromagnetic brake, when release the controller rocker, the electromagnetic brakes will be actuated, and the electric wheelchair will stop in several seconds. Electromagnetic brake will not take effect immediately, it will take effect after the wheel rotates for 1/2 cycle.

The wheelchair is powered by a 24V DC,12Ah or 20Ah rechargeable lithium-ion battery charged by an offboard lithium-ion battery charger. The wheelchair is driven by two DC motors.

The Electric Wheelchair (Robooter E80), Models name: BBR-E80-01,BBR-E80-02, contains Bluetooth 4.1 BLE technology. The device can be controlled by the controller rocker or remote control by a smartphone app via Bluetooth 4.1 Low Energy (BLE) wireless communication interface. The smartphone app is used to drive the chair remotely. For safety, controller rocker control is priority over the remote control by design. The smartphone app can also view the battery's status, adjust the speed gear level and lock/unlock the unattended device.

The wheelchair can be folded/expanded manually. The Left and right handrails (joystick) can be interchange.

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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 Electric Wheelchair 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 Electric Wheelchair are 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 flat path near buildings, but not on grass, gravel roads, large slopes or motorway, neither on muddy, rugged, soft, narrow, icy road, bad roads such as dangerous roads without guardrails or waterways.

The DH01126 Electric Wheelchair consists of two parts, the wheelchair main body and the electrical part. The main body includes a main foldable frame, two armrests, a backrest, a seat cushion, two rear driving wheels and two front wheels. The electrical part is composed of two 24V DC motors, two brakes, lithium battery, a controller and an off-board charger.

The device is powered by Li-ion battery, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet 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 DC brushless motor and brake system are fixed on the rear wheels.

The max loading of both models is 100KG. Only for one person sit.

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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.

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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 battery, motivated by DC motor, driven by user controlling joystick controller and adjusting speed. Products for adult use.

The Electric Wheelchair is a battery powered four wheeled vehicle. It consists lithium-ion battery with an off-board battery charger, Push handle, Seat, Back support, Joystick controller, Control panel (including: Speed light, ON/OFF button, Horn, Joystick, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Front 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 Joystick can control the wheelchair to travel in any direction, the operation of the Joystick movement will determine the wheelchair in that direction speed of movement. The farther the Joystick is moving from 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 Electric 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 8 inch front wheel and 12.5 inch rear tire.

Max. distance of travel on the fully charged battery is 11 km and Max. speed forward is 6.48 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 and friction plate to lock the motor, so as to brake.

The braking time is about 2s, and the braking distance is ≤1.5m.

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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.

The Electric wheelchair, Model P2, is an indoor/outdoor, foldable, battery-operated 2-wheel (rear-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-Ion battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion.

The control system, including the controller handle (joystick), is equipped on the control board that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop.

The electric wheelchair can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange.

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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 battery, motivated by DC motor, driven by user controlling joystick controller and adjusting speed, products for adult use.

The Electric Wheelchair is a battery powered four wheeled vehicle. It consists Lithium battery with an off-board battery charger, Push handle, Seat, Back support, Joystick controller, Control panel (including: Speed light, ON/OFF button, Horn, Joystick, Accelerated button, Decelerated button), Arm support (Anti-tip wheel, Front 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 Joystick can control the wheelchair to travel in any direction, the operation of the Joystick movement will determine the wheelchair in that direction speed of movement. The farther the Joystick is moving from 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 Electric 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 wheel and 12 inch rear tire.

Max. distance of travel on the fully charged battery is 12.4 km and Max. speed forward is 6.48 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 and friction plate to lock the motor, so as to brake.

The braking time is about 2s, and the braking distance is <=1.5m.

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The power 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.

The subject device, Electric Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick controller and adjusting speed. Products for adult use.

The Electric Wheelchair is a battery powered four wheeled vehicle. It consists lead-acid battery with an off-board battery charger, Push handle, Seat, Back support, Joystick controller, Control panel (including: Speed light, ON/OFF button, Horn, Joystick, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Front 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 Joystick can control the wheelchair to travel in any direction, the operation of the Joystick movement will determine the wheelchair in that direction speed of movement. The farther the Joystick is moving from 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 Electric 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 wheel and 12 inch rear tire.

Max. distance of travel on the fully charged battery is 13.3 km and Max. speed forward is 5.76 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 and friction plate to lock the motor, so as to brake.

The braking time is about 2s, and the braking distance is ≤1.5m.

The provided FDA 510(k) clearance letter and summary are for an Electric Wheelchair (HG-630). This document specifies performance criteria based on engineering and safety standards (ISO 7176 series), not on AI/algorithm performance. Therefore, the questions related to AI/algorithm performance, such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, and standalone performance, are not applicable to this device.

The study proves the device meets acceptance criteria through a comparison to a predicate device and adherence to established international standards for wheelchairs.

Here's a breakdown of the acceptance criteria and proof of performance based on the provided text:

Acceptance Criteria and Device Performance for the Electric Wheelchair (HG-630)

The acceptance criteria for the Electric Wheelchair (HG-630) are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (K240913) and compliance with relevant international performance and safety standards, specifically the ISO 7176 series and ISO 10993 series. The "performance" of the device is assessed against a set of engineering and safety specifications that ensure it functions safely and effectively as a powered wheelchair.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the adherence to a comprehensive set of ISO standards for wheelchairs and by demonstrating that the device's technical specifications are comparable to or meet the safety requirements outlined by the predicate device and those standards.

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

• Sample Size: Not explicitly stated as a "test set" in the context of a dataset for AI/algorithm validation, as this is an electro-mechanical device. The performance is based on physical testing of the device itself.
• Data Provenance: The tests are conducted according to international standards (ISO series) which specify the methodologies. The manufacturer is Zhejiang Automwheel Tech Co., Ltd. from China. The testing would have been conducted in a laboratory environment, likely by the manufacturer or a third-party testing facility, to certify compliance with the stated ISO standards. This is akin to prospective testing on a manufactured unit.

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

• Not Applicable. For an electric wheelchair, "ground truth" is established by adherence to engineering performance metrics and safety standards defined by organizations like ISO. There are no human "experts" establishing subjective "ground truth" in the way one would for diagnostic AI. The performance metrics are objective and measurable (e.g., braking distance, stability angles, dimensions).

4. Adjudication Method for the Test Set

• Not Applicable. As objective engineering parameters and safety standards are being met, there is no need for adjudication in the context of multiple human interpretations as there would be in, for example, medical image analysis. The tests either pass or fail the defined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• Not Applicable. This is not an AI/algorithm-assisted diagnostic device. Therefore, a comparative effectiveness study involving human readers' improvement with or without AI assistance is irrelevant.

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

• Not Applicable. This device is an electro-mechanical product. It does not have a "standalone algorithm" in the typical sense of AI/ML. Its performance is inherent to its design and functionality, which is then tested against industry standards.

7. The Type of Ground Truth Used

• Engineering and Safety Standard Compliance: The "ground truth" for this device's performance relies on objective, measurable physical parameters and functionalities as defined by established international standards (ISO 7176 series for performance, ISO 10993 series for biocompatibility, etc.). These standards set the benchmarks for what constitutes safe and effective operation for a powered wheelchair.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires machine learning training data.

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

• Not Applicable. No training set for AI/ML was used. The "ground truth" (i.e., compliance with performance and safety standards) is established through established test procedures defined by the ISO standards themselves.

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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.

This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design.The wheelchair can easily fold and unfold for transportation or storage.The armrest can be flipped backward, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device.

The QDWP-A01 uses lithium batteries as its power source, The QDWP-B02 uses lead acid batteries as its power source.The controller controls the drive left/right motor to realize the wheelchair forward, backward and turn functions.

The frame of QDWP-A01 is aluminum,the frame of QDWP-B02 is steel. The front wheels are driven wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels. The rear wheels are driving wheels to control the speed and direction. When in use, the operator drives the motor of the rear wheel by operating the joystick to achieve the rear wheels movement.

The motor and brake system are fixed on the rear wheels.

The max loading of the device is 120KG. Only for one person sit.

This document is a 510(k) clearance letter for an electric wheelchair, not an AI/ML medical device. Therefore, the information typically requested regarding acceptance criteria and study designs for AI/ML devices (e.g., sample size, expert ground truth, MRMC studies, standalone performance) is not available or applicable in this context.

The 510(k) letter focuses on demonstrating substantial equivalence to a predicate device based on:

1. Indications for Use: The current device has the same intended use as the predicate (to provide mobility to disabled or elderly individuals).
2. Technological Characteristics: Comparison of physical and operational specifications (e.g., motor, battery, dimensions, speed, braking).
3. Performance Benchmarking: Validation through adherence to widely accepted international standards for wheelchairs (ISO 7176 series) and biocompatibility (ISO 10993 series), rather than a clinical study comparing human performance with and without AI assistance.

Here's an attempt to structure the available information, acknowledging that many requested fields are not relevant for this type of device clearance:

Device: Electric Wheelchair (QDWP-A01, QDWP-B02)

Study Purpose (Implied from 510(k) clearance): To demonstrate substantial equivalence of the proposed device to legally marketed predicate devices, ensuring it meets established safety and performance standards for powered wheelchairs.

1. Table of Acceptance Criteria and Reported Device Performance

For an electric wheelchair, acceptance criteria are typically compliance with relevant ISO standards and specific performance thresholds based on comparative data with predicate devices. The document highlights "Analysis" remarks for minor differences and states that numerous ISO standards were met.

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

• Test Set Sample Size: Not specified in terms of a "sample size" of individual devices, as this is typically based on testing a representative number of units to demonstrate compliance with standards. Testing would involve a few prototypes/production units.
• Data Provenance: The device manufacturer is Jinhua Qidian Vehicle Co. Ltd. in China. The testing would have been conducted by the manufacturer or accredited testing laboratories, likely in China, to the specified ISO standards. The data is prospective in the sense that it's generated for the clearance submission.

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

• Not applicable. For a physical medical device like an electric wheelchair, "ground truth" is established by direct physical measurements, engineering tests, and adherence to objective performance standards (e.g., braking distance, speed, stability under load). It does not involve expert interpretation of medical images or clinical outcomes that require medical experts to establish a "ground truth."

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, particularly in image interpretation or clinical diagnosis. This device's performance is objectively measured against engineering and safety standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is an electric wheelchair, not an AI-assisted diagnostic or therapeutic device. No human-in-the-loop clinical study comparing human performance with and without AI assistance would be conducted for this product.

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

• Not applicable. There is no "algorithm only" performance for an electric wheelchair in the sense of an AI/ML model. The device operates mechanically and electronically, with its "performance" being its ability to move, brake, and maintain stability.

7. The Type of Ground Truth Used

• Engineering Standards and Objective Measurements: The "ground truth" for this device's performance is established by recognized international engineering, safety, and quality standards (e.g., ISO 7176 series for wheelchairs, ISO 10993 series for biocompatibility). Performance is measured directly against these benchmarks and compared to a predicate device. This includes physical measurements (dimensions, speed), mechanical tests (strength, stability, braking), electrical tests (battery, motor, EMC), and material tests (biocompatibility, flammability).

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI/ML system that requires training data. The "training" for the device would be its design and manufacturing processes.

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

• Not applicable. As above, there is no AI/ML training set for this device. The design specifications and performance objectives are based on engineering principles and regulatory requirements for powered wheelchairs.

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This 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.

The product is intended only carry one person and used as a means of transportation for the old and infirm who have difficulty in moving.

The maximum occupant mass is 100kg.

The Electric Wheelchair is a battery powered four wheeled vehicle. It consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back support, control device (including the battery power indicator, ON/OFF button, horn button, speed indicator, speed control button, joystick, Battery charger socket), arm supports, two rear wheels, two casters(front wheels), Foot support, anti-tip devices.

The wheelchair can easily fold and unfold for transportation or storage.

The provided text describes the FDA 510(k) clearance for an Electric Wheelchair. However, it does not include information about acceptance criteria for a device performance study in the typical sense of a clinical or analytical performance study with specific metrics like sensitivity, specificity, or accuracy.

Instead, the "acceptance criteria" for this device are demonstrated through adherence to a comprehensive set of international standards for wheelchairs. The study that proves the device meets these criteria is a series of non-clinical tests conducted against these standards.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Electric Wheelchair are largely defined by compliance with a comprehensive set of ISO and IEC standards related to wheelchairs. The reported device performance is demonstrated by its successful adherence to these standards.

Study Details:

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

   • The document states "Non-clinical tests were conducted to verify that the proposed device met all design specifications." This typically implies testing of a representative sample of the manufactured device models. Specific numbers for each test (e.g., how many units were tested for static stability) are not provided.
   • Data provenance: The tests were performed by the manufacturer, Ningbo Baichen Medical Devices Co., Ltd., which is located in China. The data would be considered retrospective in the sense that the testing was completed prior to the 510(k) submission, but it's prospective in relation to the design validation process.

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

   • This question is not applicable in the context of this device and study type. The "ground truth" for non-clinical performance (e.g., static stability, brake effectiveness) is defined by the technical specifications and limits set forth in the international standards (ISO, IEC). The testing involves objective measurements rather than expert interpretation of data like in an image-based diagnostic study.

3. Adjudication method for the test set:

   • This question is not applicable. Adjudication typically refers to resolving discrepancies in expert interpretations (e.g., 2+1 means 2 out of 3 experts agree, 3+1 means 3 out of 4 agree, with a fourth to resolve ties). Since these are objective physical performance tests against established numerical standards, there is no expert adjudication process. The results are either within the standard's limits or they are not.

4. 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 is not applicable. This is an Electric Wheelchair, a physical medical device, not an AI software intended for interpretation by human readers. Therefore, an MRMC study is not relevant.

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

   • This is not applicable. This is a physical medical device. While it contains an "Electronic controller" (SYC-PM30), the performance described (e.g., speeds, stability, braking) is a property of the integrated physical device, not a standalone algorithm. Software validation was performed for the control system, as mentioned under the difference D#11, but this is part of the overall device's non-clinical testing, not a standalone algorithm performance study in the context of diagnostic AI.

6. The type of ground truth used:

   • The "ground truth" for this device's performance is established by international consensus standards (ISO and IEC). These standards define the acceptable performance parameters and test methods for electric wheelchairs to ensure their safety and effectiveness.

7. The sample size for the training set:

   • This question is not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI algorithms for this type of device. The design and validation are based on engineering principles and compliance with established standards.

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

   • This question is not applicable, as there is no training set for this device.

In summary, the provided document details a non-clinical performance study demonstrating substantial equivalence through rigorous adherence to internationally recognized safety and performance standards for electric wheelchairs. The specific metrics are defined by these standards, and the device's performance met these criteria through objective physical testing.

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