(41 days)
The AVANTICARE SA4022 scoter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated po lition.
The AVANTICARE SA4022 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 the AVANTICARE SA4022 scooter, a motorized three-wheeled vehicle. The document explicitly states that there are minor differences in performance specifications between the AVANTICARE SA4022 scooter and its predicate device, the Bewell SC 20 (K043326). However, the submission asserts that "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."
Crucially, the provided document does not contain explicit acceptance criteria or a detailed study demonstrating that the device meets specific performance criteria. The basis for substantial equivalence is the assertion that any differences in performance specifications are minor and do not impact safety or effectiveness.
Therefore, many of the requested details cannot be extracted from this document.
Here's an attempt to answer based on the provided text, with clear indications where the information is not present:
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A table of acceptance criteria and the reported device performance
Acceptance Criterion Reported Device Performance Not explicitly stated in the document. The submission focuses on substantial equivalence to a predicate device rather than specific performance metrics. "minor differences in performance specifications" compared to Bewell SC 20 (K043326). These differences are asserted not to alter intended function/use or raise new safety/effectiveness questions. -
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 specified.
- Data provenance: Not specified.
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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)
- This information is not applicable and not present in the document. The substantial equivalence argument is based on comparing device specifications and intended use against a legally marketed predicate device, not on clinical performance evaluated by experts against a ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable and not present.
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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
- Not applicable and not present. This device is a mobility scooter, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable and not present.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" in this context is the predicate device's established safety and effectiveness, implied by its legal market status.
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The sample size for the training set
- Not applicable and not present. This device is not an AI/machine learning model that requires a training set.
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How the ground truth for the training set was established
- Not applicable and not present.
§ 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).