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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 disabled, and sick.

The electric wheelchair is classified as class B and the maximum occupant mass is 120kg.

The Electric Wheelchair is a battery powered four wheeled vehicle.

It consists two Lithium batteries with an off-board battery charger, frame, controller, motors, seat with cushion, back support with cushion, control device (including the battery power indicator, power ON button, power OFF button, horn button, speed indicator, speed-up button, slow-l down button, joystick, charging port), arm supports, two rear wheels, two casters(front wheels), foot support, anti-tip devices, push handle.

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

The provided FDA 510(k) clearance letter for the Electric Wheelchair (F309) does not describe a study involving AI or human-in-the-loop performance measurement. This document pertains to a physical medical device (an electric wheelchair) and focuses on demonstrating its substantial equivalence to a predicate device through non-clinical performance and safety testing against established ISO standards.

Therefore, many of the requested points regarding acceptance criteria and study design for AI/human-in-the-loop performance cannot be extracted from this document, as they are not relevant to the clearance of this type of device.

However, I can extract information related to the non-clinical tests that were conducted to prove the device meets its design specifications and safety requirements.

Here's a breakdown based on the provided document, addressing the extractable information:

Acceptance Criteria and Device Performance for Electric Wheelchair (F309)

The acceptance criteria for the Electric Wheelchair (F309) are based on demonstrating compliance with a comprehensive set of ISO 7176 series standards for wheelchairs, as well as biocompatibility and electromagnetic compatibility (EMC) standards. The device performance is deemed acceptable if it meets the requirements outlined in these standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications" and that "The test results demonstrated that the proposed device complies with the following standards." For each standard, the acceptance criterion is implicitly "meets the requirements of the standard," and the reported performance is that the device did meet those requirements.

Note: Specific quantitative thresholds for "acceptance criteria" are generally detailed within the referenced ISO standards themselves, not typically in a 510(k) summary (unless there's a deviation or specific performance claim being made). The document generally confirms compliance.

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

• Sample Size: Not explicitly stated as a number of devices. For physical device testing against standards, it's typically one or a few representative units of the device that undergo the specified tests. The document implies that the "proposed device" (singular) was tested.
• Data Provenance: The tests are non-clinical (laboratory/engineering tests) performed to verify design specifications. The company, Changshu Pingfang Wheelchair Co., Ltd, is located in China. The tests would have been performed by or on behalf of the manufacturer, likely at a certified testing facility. The data is prospective in the sense that it's generated specifically for this submission to verify safety and performance.

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

Not applicable. For non-clinical device performance testing against ISO standards, "ground truth" is established by the test methodology and the physical properties of the device as measured by calibrated equipment and verified according to the standard protocols. There are no human experts establishing a "ground truth" in the clinical sense (e.g., radiologists interpreting images).

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

Not applicable. This is not a clinical study involving human interpretation or adjudication. The assessment is based on objective measurements against engineering 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 is for an electric wheelchair, not an AI-assisted diagnostic or therapeutic device. No human reader study (MRMC) was performed or required.

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

Not applicable. This device does not involve an algorithm for standalone performance evaluation in the medical imaging sense. Its performance is physical and mechanical.

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

The "ground truth" for this medical device is the adherence to the requirements and specifications outlined in the referenced international standards (primarily ISO 7176 series, ISO 10993-1, IEC 60601 series). This is verified through physical and electrical measurements and tests conducted in a laboratory setting. It is a technical/engineering standard conformance ground truth, not a clinical ground truth.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, so there is no "training set."

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

Not applicable, as there is no training set for this device.

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