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The mobility scooter 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 mobility scooter 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 Mobility Scooter, Model N3473, has a base with magnesium alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a tiller console, an electric motor, an electromagnetic brake, 1 rechargeable Lithium Battery with an off-board charger, a remote control switch. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road.

The provided text is a 510(k) Summary for a Mobility Scooter (N3473), a medical device. It does not contain information about an AI/ML-driven medical device.

Therefore, I cannot provide information regarding:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample sizes, data provenance, number of experts, adjudication methods for training or test sets in the context of AI/ML.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used for AI/ML.
• How ground truth for training sets was established for AI/ML.

The document discusses the non-clinical testing performed for a physical device (mobility scooter) to demonstrate its substantial equivalence to a predicate device. This testing primarily involves adherence to ISO 7176 series standards related to wheelchairs and scooters, covering aspects like stability, brakes, speed, dimensions, strength, climatic tests, obstacle climbing, power/control systems, and electromagnetic compatibility.

Here's what can be extracted from the document regarding the mobility scooter's acceptance criteria and study:

1. Acceptance Criteria and Reported Device Performance (Non-AI Device)

The general acceptance criteria are that the subject device's performance meets the relevant ISO standards and exhibits no deleterious effect on safety and effectiveness compared to the predicate device, despite minor differences. The document asserts that "All test results meet the requirements" of the specified ISO standards for the subject device.

Here's a table based on the explicit comparisons provided, specifically focusing on measurable performance attributes mentioned in the "Comparison with the predicate device" section. While a direct "acceptance criterion" value isn't always given, the "Result" column implies acceptance if "Same" or if the difference is deemed non-deleterious after testing.

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

• Sample Size: Not specified in terms of number of units tested. This document refers to "non-clinical tests" and "test results" in a general sense, implying performance testing of the device itself rather than a dataset of patient cases. It's typical for device performance testing to use a small number of production or pre-production units.
• Data Provenance: The tests are performed by the manufacturer/sponsor (Zhejiang Innuovo Rehabilitation Devices Co., Ltd.) or a contracted testing facility, to demonstrate compliance with international standards (ISO, IEC). The location of the testing facility is not explicitly stated, but the manufacturer is based in China. The data would be prospective, as it's the result of specific tests conducted on the device.

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

• This is not applicable as this is not a study involving interpretation of medical images or patient data by human experts for AI/ML ground truth. The "ground truth" for this physical device is established by objective measurements and standardized test procedures defined by the ISO 7176 series and IEC 60601-1-2.

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

• Not applicable. Adjudication methods are relevant for subjective human interpretations, typically in clinical studies or AI algorithm validation against human consensus. For engineering performance tests like those conducted for a mobility scooter, compliance is determined by whether the measured parameters fall within the limits set by the relevant 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 not an AI/ML medical device. No MRMC study was conducted.

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

• Not applicable. This is not an AI/ML medical device. No standalone algorithm performance was assessed.

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

• The "ground truth" is established by objective measurements against the quantitative and qualitative requirements of the ISO 7176 series and IEC 60601-1-2 standards. Examples include measured brake distance, speed, static stability angle, and material compliance (e.g., biocompatibility testing per ISO 10993).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML medical device that requires a training set.

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

• Not applicable. This is not an AI/ML medical device.

In summary, the provided document details the regulatory submission for a physical medical device (mobility scooter) based on demonstrating substantial equivalence through non-clinical performance testing against established international standards, not an AI/ML-driven device.

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