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The Proasia L3402 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

The Proasia L3402 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.

The provided text is a 510(k) Summary for a medical device, specifically an electrical scooter named Proasia L3402. This document is a regulatory submission to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

Key takeaway: 510(k) summaries do not typically contain detailed acceptance criteria and study results in the way a clinical trial report or a performance study for a novel device would. Instead, substantial equivalence is often established by comparing design, materials, and performance specifications to the predicate device, emphasizing that any differences do not raise new questions of safety or efficacy.

Based on the provided text, a formal study demonstrating specific acceptance criteria with performance metrics is not described. The submission relies on establishing substantial equivalence to a predicate device.

Therefore, many of the requested fields cannot be directly answered from the given text.

Here's an attempt to answer based on the information available, and explicitly stating when information is not provided:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not provided. The document does not describe a performance study with a test set.
• Data Provenance: Not provided, as no specific performance study data is presented.

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. No explicit test set or ground truth establishment by experts is described for this type of regulatory submission. The assessment is primarily based on comparing specifications and design to a predicate device.

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

• Not Applicable. No test set or adjudication process is described.

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

• No. This device is an electrical scooter and does not involve "readers" or "AI assistance" in the context of diagnostic interpretation. Therefore, an MRMC comparative effectiveness study is not relevant and was not performed.

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

• Not Applicable. This is an electrical scooter, not an algorithm, so "standalone" performance in this context is not relevant.

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

• Not Applicable. No ground truth, in the typical sense for diagnostic or prognostic devices, is established or used for this submission. Substantial equivalence relies on comparing the device's design and intended use to an already legally marketed device.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this device is not an AI/ML algorithm or diagnostic tool that requires training data.

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

• Not Applicable. No training set or ground truth for it is relevant or described.

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