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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.

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The provided document is a 510(k) clearance letter from the FDA for a Mobility Scooter. It is a regulatory document and does not contain any information regarding acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information based on the given input. This document is a clearance letter, confirming that the device is substantially equivalent to legally marketed predicate devices, not a study report detailing performance metrics.

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The mobility scooter is intended for providing assistance to people restricted to a sitting position.

The mobility scooter mainly consists of steal frame, two front wheels, two rear wheels, a seat, a tiller console, an electric motor, an electromagnetic brake, front lights, two rechargeable Lead-acid Batteries, and a battery charger. The product is intended to be used for assisting people restricted to a sitting position. It is driven by the end users for movement. It is compact, maneuverable but not necessarily able to overcome obstacles. The maximum load is 150 kg. It is powered by rechargeable batteries with 25.3 km theoretical distance range which maximum speed up to 10.5 km/h (tested value).

This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for a Mobility Scooter (C4+) seeking 510(k) clearance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on meeting the requirements of various ISO 7176 series standards for wheelchairs and motor scooters, as well as EMC and biocompatibility standards. The document explicitly states that the device met all these requirements.

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

• Performance Testing: The document does not specify the exact sample size for each performance test (e.g., number of scooters tested for static stability). It implies that the test was conducted on the device (Mobility Scooter C4+).
• Biocompatibility Testing: The document does not specify the sample size for the materials tested.
• Package Validation: The document does not specify the sample size (number of packages tested).
• Usability and Human Factor Testing: The document does not specify the sample size (number of users) for this testing.
• Data Provenance: The document does not explicitly state the country of origin of the data for these tests. However, the manufacturer is in China (YONGKANG YILE VEHICLE CO., LTD., Zhejiang, PRC) and the submission correspondent is with a consulting company in Shanghai, China, suggesting the testing was likely conducted in China or by labs recognized by the manufacturer. The nature of these tests (performance, biocompatibility, package validation, usability) generally implies they are prospective tests conducted specifically for this submission.

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

This type of information is generally not applicable to the non-clinical testing performed for a mobility scooter. "Ground truth" established by experts is more relevant for diagnostic or AI-driven devices where human interpretation is a key component. For this device, the "ground truth" is defined by the objective pass/fail criteria of the specified engineering and safety standards (e.g., whether the brake engages within a certain distance, or if a material causes a cytotoxic reaction).

4. Adjudication method for the test set:

Not applicable. The performance, biocompatibility, and package validation tests rely on objective measurements against predetermined standard thresholds, not on subjective expert consensus or adjudication. For usability testing, it's mentioned that observations and questionnaires were used, which would typically involve user feedback and possibly expert review of the results, but no formal adjudication method (like 2+1) is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or similar devices where different readers interpret cases, often with and without AI assistance. This device is a mobility scooter, which does not involve diagnostic interpretation.

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

Not applicable. This device is a physical product (mobility scooter), not an algorithm or AI system that would have a "standalone" performance.

7. The type of ground truth used:

• Performance Testing: The ground truth is defined by the objective pass/fail criteria specified in the various ISO 7176 series standards, IEC standards, and ASTM standards. These are engineering specifications and safety thresholds.
• Biocompatibility Testing: The ground truth is determined by the objective results of standard biological assays (cytotoxicity, intracutaneous reactivity, sensitization) as per ISO 10993-1, with clear pass/fail criteria.
• Package Validation: The ground truth is whether the packaging successfully protects the product under simulated shipping conditions, as defined by ASTM D4169-16.
• Usability and Human Factor Testing: The "ground truth" here is user feedback and observed user behavior aligning with safe and effective operation, and the absence of newly identified risks. This is derived from user questionnaires and observations based on FDA guidance.

8. The sample size for the training set:

Not applicable. This device is a physical product and not an AI/ML algorithm that requires a 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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