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510(k) Data Aggregation
(27 days)
The intended use of Travel Ease Electric Scooter, Pioneer 5 is to provide mobility to adult persons limited to a sitting position and capable of operating a few simple controls.
Travel Ease Electric Scooter, Pioneer 5
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a "Travel Ease Electric Scooter, Pioneer 5," confirming its substantial equivalence to previously marketed devices. It details the regulatory classification, general controls, and the process for marketing the device, but it does not include specific performance criteria or scientific study results.
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(61 days)
The intended use of the MERITS Pioneer 3 Powered Scooter is to provide mobility to adults, limited to a siting position and have the capability to operate a simple hand control.
MERITS Pioneer 3 Electric powered four wheel drive scooter
Due to the nature of the provided document, which is an FDA 510(k) clearance letter for a powered scooter, the requested information about acceptance criteria and a study proving a device meets acceptance criteria using AI/ML methodologies is not present.
This document pertains to a physical medical device (MERITS Pioneer 3 Electric Powered Four Wheel Drive Scooter) and its clearance through the 510(k) pathway, which focuses on demonstrating substantial equivalence to a predicate device. It does not involve AI/ML performance studies, ground truth establishment, or multi-reader multi-case studies typically associated with AI/ML-driven medical devices.
Therefore, I cannot extract the requested information as it is not contained within the provided text.
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(58 days)
The intended use of Travel Ease Electric Scooter, Pioneer 4 is to provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.
Travel Ease Electric Scooter, Pioneer 4
I am sorry, but the provided text from the FDA 510(k) summary for the "Travel Ease Electric Scooter, Pioneer 4" does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details regarding a medical device's performance evaluation as requested in your prompt.
The document is a clearance letter from the FDA, confirming that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It discusses regulatory matters such as the device's classification, general controls, and compliance with regulations, but it does not include performance data or studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.
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(16 days)
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