(39 days)
Used as an indoor and outdoor mobility assistive device. Never used as a transportation tool on highways and freeways
The Jupiter 50F electric scooter is a mobility assistive device for physically challenged people and elderly people. It is motorized by a 24V DC motor. Two or four 12 volt batteries supply electrical power. Jupiter 50F consists of seven major components: chassis, body covers, transaxle, seat, controller, batteries, and battery charger.
This document is a 510(k) summary for the JUPITER 50F SCOOTER, a motorized 3-wheeled scooter, by ACEME Technologies International, submitted to the FDA in 1998. It describes the device, compares it to a predicate device, and seeks substantial equivalence. However, it does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria.
Here's an explanation of why the requested information cannot be extracted from the provided text:
- Medical Device vs. Mobility Device: The Jupiter 50F Scooter is classified as a "Motorized 3-wheeled Scooter" and a "mobility assistive device." While submitted to the FDA, the submission is focused on demonstrating substantial equivalence to a predicate device (Pride Health Care Legend Scooter) rather than presenting a performance study with specific acceptance criteria in the way a diagnostic or therapeutic medical device might. The "study" mentioned ("Our study has demonstrated that the Jupiter is substantially equivalent to the Legend 4-wheeled scooters.") refers to the comparative analysis presented in the 510(k) itself, not an experiment with a test set and ground truth.
- Focus on Substantial Equivalence: The primary goal of a 510(k) submission is to show that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics, intended use, and performance data to the predicate, rather than establishing de novo acceptance criteria and then proving those through a new, large-scale clinical study as would be expected for novel or high-risk medical devices.
- Lack of Specific Performance Metrics and Study Details: The document lists several performance characteristics (e.g., maximum speed, slope capability, travel distance on a charge) and highlights specific improvements over the predicate device (e.g., headlight, turning lights, four-battery option, bigger front wheels). However, it does not present these as "acceptance criteria" with defined thresholds that were then quantitatively proven in a formal study with a defined sample size, ground truth, or expert adjudication. The statement "Our 4-wheeled Jupiter 50F did not show tip-over during its performance test" is the closest it gets to a "performance test," but it lacks any detail about the methodology, sample size, or formal acceptance criteria for "no tip-over."
Therefore, I cannot populate the table or answer the specific questions because the provided text does not include:
- A table of acceptance criteria and reported device performance in that format.
- Details about a test set sample size, data provenance, number of experts for ground truth, or adjudication methods for a specific performance study.
- Information about an MRMC comparative effectiveness study or specific effect sizes.
- Details about a standalone algorithm performance (as this is a mechanical device, not an algorithm).
- The type of ground truth used in a formal study.
- The sample size or ground truth establishment method for a training set (as this document describes a physical product, not a machine learning model).
The document is a regulatory submission for a physical product, not a clinical study report for an AI/ML device, which is what the provided template questions seem designed for.
§ 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).