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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 Mobility Scooter, Models: W3331F, has a base with Steal frame, one front wheel, two rear wheels, a seat, a tiller console, electromagnetic brake, 2 rechargeable Lead-acid Batteries with an off-board charger. 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 document is a 510(k) summary for a Mobility Scooter, Model W3331F, and focuses on demonstrating substantial equivalence to a predicate device (K220206). It primarily relies on non-clinical performance testing against established ISO standards rather than clinical studies or AI performance metrics.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are based on compliance with specifically cited ISO 7176 series standards for wheelchairs and scooters, and ISO 10993 for biocompatibility. The "reported device performance" is a statement of compliance with these standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document describes non-clinical testing against ISO standards for a single device model (Mobility Scooter, Model W3331F). It does not involve a "test set" in the context of a dataset for an AI algorithm. The testing is on the physical device itself.
• Data Provenance: Not applicable in the context of patient data. The "data" are the results of physical and electrical engineering tests performed on the device. No country of origin for the data is explicitly mentioned, but the manufacturer is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd in China, suggesting the testing likely occurred there. The tests are non-clinical, so the "retrospective or prospective" distinction does not apply.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the document describes physical device testing against engineering standards, not a clinical study requiring expert ground truth for interpretation of medical data.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." The device is a physical mobility scooter, not an AI diagnostic or assistance tool that would typically undergo such a study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. The device is a physical mobility scooter and does not involve an AI algorithm with standalone performance to be evaluated.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by compliance with internationally recognized engineering and safety standards (ISO 7176 series and ISO 10993 series). The test results demonstrate that the device meets the specifications outlined in these standards.

8. The Sample Size for the Training Set

This section is not applicable. The document does not describe an AI algorithm that requires a training set. The device is a physical product.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable as there is no AI algorithm or training set for this device.

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