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The Power Wheelchair (N5515B) 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 Power wheelchair 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, pedal, battery box and charger.

The device is powered by Li-ion Battery pack (24V 12Ah) with 15 Km (9.32 miles) range, which can be recharged by an off-board 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, the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

This document is a 510(k) Premarket Notification for the Zhejiang Innuovo Rehabilitation Devices Co., Ltd. Power Wheelchair (N5515B). The purpose of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (K113463, Power wheelchair, PL00I by SUZHOU KD Medical Appliance Co. Ltd.).

Based on the provided text, the device in question is a power wheelchair, a device that does not typically use AI or require complex clinical studies for its clearance. Therefore, many of the requested criteria (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set information) are not applicable or not provided in the context of a medical device like a power wheelchair. The clearance relies heavily on engineering performance standards and bench testing.

Here's the information that can be extracted from the provided text:

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

The document does not explicitly present specific numerical acceptance criteria for each test alongside the reported device performance. Instead, it states that the device "complied with the requirements" of various ISO and IEC standards. The comparison table (Section VI) highlights attributes where the subject device differs from the predicate but doesn't quantify "reported performance" against a specific, numerical acceptance criterion for each different attribute.

However, the "Braking distance," "Maximum safe operational incline degree," "Maximum speed forward," "Max backward Speed," "Max loading weight," "Maximum distance of travel," "Turning Radius," and "Maximum obstacle climbing" are performance metrics with specific values for both the subject and predicate devices.

Let's synthesize a table based on the explicit performance values and the implicit acceptance of compliance with standards:

Regarding the study that proves the device meets the acceptance criteria:

The study is implicitly a non-clinical performance testing (bench testing) conducted by the manufacturer, Zhejiang Innuovo Rehabilitation Devices Co., Ltd.

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

• Sample Size: Not specified. For bench testing of physical products like wheelchairs against ISO standards, typically a representative number of units (often a small sample, e.g., 1-3 devices) are tested to demonstrate compliance and consistency in manufacturing processes. The document does not provide a specific number of devices tested.
• Data Provenance: The document states the tests were "provided to verify that the subject device met all design specifications." This indicates the testing was conducted by or for the manufacturer (Zhejiang Innuovo Rehabilitation Devices Co., Ltd.) to support their submission. The country of origin for the data is China, as the manufacturer is based there. The nature of the testing is prospective in the sense that the tests were performed specifically for this 510(k) submission to demonstrate compliance.

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 a power wheelchair, and its performance is evaluated against engineering standards (ISO, IEC) through bench testing, not against medical expert ground truth like in diagnostic imaging. The "ground truth" here is the established pass/fail criteria within the specified engineering standards.

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

Not applicable. This concept is relevant for studies involving human interpretation (e.g., radiologists assessing medical images) where discrepancies need to be resolved. For bench testing against engineering standards, the results are typically objectively measured and compared against predefined thresholds in the 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 type of study is relevant for AI-powered diagnostic or assistive devices involving human readers (e.g., physicians interpreting images). The Power Wheelchair is a physical mobility device that does not involve human "readers" or AI assistance in this context.

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

Not applicable. The device is a physical power wheelchair, not an algorithm. While it has an electronic controller and software, the "performance" is the mechanical and electrical function of the wheelchair itself, not an isolated algorithm. The software validation mentioned is part of the overall device performance verification.

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

The "ground truth" used is defined by the international engineering and safety standards (ISO 7176 series, IEC 60601-1-2, ISO 10993 series). The device's performance is measured against the specifications and test methods outlined in these standards. For biocompatibility, the ground truth is established by the tests themselves according to the ISO 10993 series.

8. The sample size for the training set:

Not applicable. There is no AI algorithm being "trained" in the typical sense for this device. The software validation is likely for embedded control software, which is traditionally developed, tested, and verified against functional requirements, not "trained" on a dataset.

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

Not applicable, as there is no training set for an AI algorithm in this context. The "ground truth" for embedded software validation would be its functional requirement specifications.

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