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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 Electric Wheelchair, models: HBLD3-B, HBLD3-E, is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people. The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, seatbelt, pedal, battery box and charger. The device is powered by Li-ion Battery pack with 20 Km range, which can be recharged by an offboard battery charger that can be plugged into an AC socket outlet (100-240V. 50/60Hz) when the device is not in use. The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electronic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

The provided text describes a 510(k) premarket notification for an Electric Wheelchair. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing against various ISO standards. There is no information within the document about the acceptance criteria or a study that proves a device meets specific clinical performance acceptance criteria related to AI or diagnostic accuracy. The document is for a physical medical device (Electric Wheelchair) and not an AI-enabled diagnostic tool.

Therefore, for your request, I can only extract information related to the non-clinical testing performed to show substantial equivalence.

Here's a breakdown of the available information based on your request, with the understanding that it pertains to non-clinical performance and not the type of clinical or AI-related study you might be expecting:

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

The document states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." The acceptance criteria are implicit in meeting the requirements of the standards listed, and the reported performance is simply that the device "meets its design specification" or "meet the requirements." Specific numerical performance data or acceptance criteria are not provided in detail beyond the summary statements.

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

The document is for a medical device (Electric Wheelchair) and describes non-clinical performance testing. It does not refer to a "test set" in the context of data for an AI algorithm. The testing was conducted on the physical device itself. The provenance of the testing data is that it was performed by/for Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd. (China) to demonstrate compliance with international standards. Details on specific test sample sizes (e.g., number of wheelchairs tested) are not provided. The testing is inherently prospective for the device being submitted.

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 section is not applicable as the document is about non-clinical testing of a physical device against engineering standards, not an AI algorithm requiring expert-established ground truth.

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

This section is not applicable for the same reasons as above.

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 section is not applicable as the document is about an Electric Wheelchair and does not involve AI or human reader studies.

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

This section is not applicable as the document is about an Electric Wheelchair and does not involve an algorithm.

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

This section is not applicable. The "ground truth" for the non-clinical tests is defined by the technical specifications and requirements outlined in the ISO standards, which are objective engineering measurements and performance criteria.

8. The sample size for the training set

This section is not applicable as the document is about an Electric Wheelchair and does not involve an AI algorithm with a training set.

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

This section is not applicable for the same reasons as above.

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