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The LANDLEX P100X 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 LANDLEX P100X 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.

This 510(k) summary (K060042) describes a motorized scooter, the LANDLEX P100X. It is a Class II medical device, classified as a "Motorized three-wheeled vehicle."

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

1. Table of acceptance criteria and the reported device performance

The provided document does not explicitly define specific performance acceptance criteria or report detailed performance metrics for the LANDLEX P100X. Instead, it relies on demonstrating "substantial equivalence" to predicate devices. The "minor differences in performance specifications" are mentioned but not detailed, and no specific numerical criteria are given.

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

The document does not describe a specific "test set" or data provenance in the context of typical device performance studies (e.g., clinical trials, bench testing with quantified results). The substantial equivalence claim is made based on the device's design and intended use compared to predicates, rather than a prospective study with a defined test set.

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

This information is not applicable or provided in the document. The substantial equivalence argument for this type of device does not typically involve expert review of a "test set" for ground truth establishment in the way it would for, say, an AI-powered diagnostic tool.

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

This information is not applicable or provided in the document.

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

This information is not applicable or provided in the document. This device is an electrical scooter; it does not involve human readers interpreting images or data, nor does it incorporate AI in the sense of a diagnostic or assistive technology for human readers.

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

This information is not applicable or provided in the document. The LANDLEX P100X is a physical device, not an algorithm.

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

Ground truth, in the context of demonstrating performance against a standard, is not explicitly mentioned or described for this device. The basis for approval is substantial equivalence to legally marketed predicate devices, meaning that if the predicates were deemed safe and effective, and the new device is sufficiently similar, it can also be considered safe and effective.

8. The sample size for the training set

This information is not applicable or provided in the document. The device is a physical product, not a machine learning model that requires a training set.

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

This information is not applicable or provided in the document for the reasons stated above.

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