(95 days)
The LANDLEX S403X 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 S403X 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 document is a 510(k) premarket notification for a motorized scooter (LANDLEX S403X). It does not contain information about acceptance criteria or a study that rigorously tests the device's performance against such criteria. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance studies with ground truth establishment or expert involvement.
Here's a breakdown of why the requested information cannot be provided from this document:
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A table of acceptance criteria and the reported device performance: This document does not list specific acceptance criteria for the device's performance (e.g., speed, range, safety features quantified metrics). It only states "minor differences in performance specifications" between the new device and the predicate. Without explicit acceptance criteria defined and corresponding test results, such a table cannot be constructed.
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Sample size used for the test set and the data provenance: No test set or study data is described. The submission relies on a comparison to a predicate device and does not involve a specific test set of patients or conditions.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Since there is no test set or performance study described, there is no mention of experts or ground truth establishment.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no test set or adjudication process is described.
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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 question is related to AI-assisted diagnostic or interpretive devices. The LANDLEX S403X is an electrical scooter and does not involve AI or human readers for interpretation. Therefore, an MRMC study is not relevant to this device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a motorized scooter, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no ground truth is established for a performance study.
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The sample size for the training set: Not applicable. This is not an AI/machine learning device, so there is no training set.
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How the ground truth for the training set was established: Not applicable as there is no training set.
Summary based on the provided document:
The 510(k) submission for the LANDLEX S403X electric scooter relies on demonstrating substantial equivalence to a previously cleared device (LANDLEX S400X, K050793). The document explicitly states: "There are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness."
This type of submission typically confirms that the new device meets the same safety and performance profile as the predicate through design comparison and, perhaps, basic engineering tests, rather than comprehensive clinical performance studies against defined acceptance criteria. Therefore, the detailed information requested regarding clinical study design, ground truth, and expert evaluation is not present in this document.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).