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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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