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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 consists of a frame, wheels, a seat, an armrest, a lithium battery, a motor, and a controller with a lightweight and compact design. The entire wheelchair can be folded, allowing it to be easily carried or rolled after folding. The seat cushion is detachable. The armrest can be flipped upside down, which is convenient for the elderly to move. Users can drive the wheelchair independently by controlling the device.

It uses lithium batteries as its power source. The controller controls the drive left/right motor, enabling the wheelchair to move forward, backward, and turn.

The frame of the device is made of Aluminum Alloy, the same as previously specified in PL001 of K113463. The front wheels are driven wheels that are suitable for rotation, acceleration, and retrograde motion, as well as other actions of the wheelchair. The front wheels' movement will be achieved by the thrust generated from the rear wheels. The rear wheels serve as the driving wheels, controlling speed and direction. The wheels are PU Solid tires. When in use, the operator drives the motor of the rear wheel by operating the controller's joystick to achieve movement of the rear wheel.

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

The maximum loading capacity of the device is 136 kg. Only one person can 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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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 product is intended only carry one person and used as a means of transportation for the disabled, the sick and the infirm. The electric wheelchair is classified as class A and the maximum occupant mass is 120kg. The Electric Wheelchair is a battery powered 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 light, ON/OFF button, horn button, speed indicator, speed increase button, speed decrease button, joystick, battery charger socket), arm supports, push handle, two rear wheels, two casters(front wheels), foot supports, anti-tip devices. The wheelchair can easily fold and unfold for transportation or storage.

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

The Power 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 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 Power 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 Power Wheelchair has 7 inch front wheel and 12 inch rear tire.

Max. distance of travel on the fully charged battery is 7.5 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.

Based on the provided FDA 510(k) clearance letter for the Vive Health LLC Power Wheelchair (MOB1107), here's an analysis addressing the acceptance criteria and study proving the device meets those criteria:

The document describes a Class II medical device (Powered Wheelchair, Product Code: ITI) undergoing a 510(k) premarket notification process. This process focuses on demonstrating substantial equivalence to a predicate device rather than proving clinical efficacy or superiority through extensive clinical trials. Therefore, the "study that proves the device meets the acceptance criteria" primarily refers to non-clinical performance testing against established international standards for wheelchairs, rather than AI/software performance metrics often seen in other medical device clearances.

Crucially, this document is for a physical medical device (power wheelchair), NOT a software/AI medical device. Many of the points you requested (e.g., number of experts, adjudication method, MRMC study, standalone AI performance, ground truth for training) are not applicable to this type of device clearance. The "performance" being evaluated here is mechanical, electrical, and safety performance of the wheelchair itself.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this power wheelchair are derived from international ISO standards for wheelchairs. The "reported device performance" is essentially a statement of compliance with these standards, indicating that various tests were conducted and the device met the specifications within those standards.

Table of Acceptance Criteria and Reported Device Performance:

Inapplicable/Not Provided Information for a Physical Wheelchair 510(k):

The following points are standard for AI/ML device submissions but are not applicable and therefore not provided in this traditional medical device 510(k) for a power wheelchair:

2. Sample sizes used for the test set and the data provenance: Not relevant for physical device performance testing against engineering standards. The "samples" would be the manufactured wheelchairs tested. Data provenance typically refers to patient/clinical data, which isn't used for this type of device's "performance" evaluation.
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 a physical device's performance (e.g., brake effectiveness, stability) is established by physical measurement against engineering standards, not expert consensus on medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are for human interpretation of data, typically medical images or clinical outcomes.
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 for AI/software devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/software devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" is defined by the technical specifications and testing methods outlined in the ISO 7176 series and IEC 60601-1-2 standards, confirmed by laboratory testing.
8. The sample size for the training set: Not applicable. There is no AI/ML model for this device that requires training data.
9. How the ground truth for the training set was established: Not applicable, as there is no training set for an AI/ML model.

Summary of the "Study" Proving Substantial Equivalence and Meeting Criteria:

The "study" proving the Vive Health LLC Power Wheelchair (MOB1107) meets acceptance criteria and is substantially equivalent to its predicate device (K242791) is based entirely on non-clinical laboratory performance testing and technical comparisons.

• Study Design: The manufacturer performed a series of tests on the subject device according to the rigorous requirements of various international ISO 7176 series standards (for wheelchairs) and IEC 60601-1-2 (for electromagnetic compatibility/electrical safety).
• Measurement: These tests involve direct physical measurements of parameters like static stability, dynamic stability, brake effectiveness, theoretical distance range, dimensions, weight, maximum speed, obstacle-climbing ability, as well as evaluating material biocompatibility and electrical safety.
• Assessment of Compliance: The results of these tests were expected to "meet its design specification" or "meet the requirements" of the respective ISO standards. The submission asserts that the subject device's performance did meet these requirements.
• Substantial Equivalence Argument: The core of the 510(k) submission is that because the subject device demonstrates comparable technical characteristics and achieves equivalent performance (as verified by these standard tests) to a legally marketed predicate device, it is considered "substantially equivalent" in terms of safety and effectiveness. The document explicitly states: "All these tests have corresponding requirements/ acceptance criteria following above mentioned standards. And the test results show that the subject device is within acceptable performance specifications and thus substantially equivalent to the predicate device in performance."
• No Clinical Studies: The document explicitly states, "No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the power wheelchair to its predicate device." This reinforces that the safety and performance were established through non-clinical, engineering-based testing.

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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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