Search Results

Used as an indoor and outdoor mobility assistive device. Never used as a transportation tool on highways and freeways.

The Jupiter 50 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 50 consists of seven major components: chassis, body covers, transaxle, seat, controller, batteries, and battery charger.

The provided text describes a 510(k) summary for the Jupiter 50 Scooter, a mobility assistive device. It focuses on demonstrating substantial equivalence to a predicate device (Pride Health Care Legend Scooter) rather than establishing novel acceptance criteria or conducting studies as would be performed for a new, high-risk medical device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or explicitly stated in this type of submission. The information provided is primarily for regulatory clearance based on substantial equivalence.

Here's the breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The submission does not define "acceptance criteria" in the typical sense of a clinical or performance study with pre-specified thresholds. Instead, it presents a comparison of the Jupiter 50's features and performance against a predicate device (Legend SC 300) to demonstrate substantial equivalence. The "performance" is reported by comparing specifications.

The device was also tested against and passed several ISO 7176 standards (1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 14, and 16) and British Standard BS5852 (equivalent to California Bulletin 116 and 117 for fire retardantness). These standards represent performance and safety criteria, and passing them serves as evidence of meeting acceptance criteria for specific technical aspects.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission references "The testing and comparative study" but does not detail the methodology, sample sizes, or data provenance for these studies beyond stating the device has been sold in China for over a year "with no safety problems".

3. 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 as this is a mechanical device, not an AI or diagnostic device requiring expert interpretation for ground truth.

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

This information is not applicable as this is a mechanical device, not an AI or diagnostic device requiring expert interpretation for ground truth.

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. This is not an AI-based diagnostic device.

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

This information is not applicable. This is not an AI-based device.

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

For the technical specifications, the "ground truth" is measured physical and performance characteristics against established engineering specifications and predicate device performance. For safety and standards compliance, the ground truth is adherence to the requirements of the specified ISO standards and fire retardantness standards. The claim of "no safety problems" in China over a year could be considered a form of real-world outcomes data, though not a formal "ground truth" for a specific test set.

8. The sample size for the training set

This information is not applicable. This is not an AI-based device that requires a training set.

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

This information is not applicable. This is not an AI-based device that requires a training set.

Ask a specific question about this device

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:

1. A table of acceptance criteria and reported device performance in that format.
2. Details about a test set sample size, data provenance, number of experts for ground truth, or adjudication methods for a specific performance study.
3. Information about an MRMC comparative effectiveness study or specific effect sizes.
4. Details about a standalone algorithm performance (as this is a mechanical device, not an algorithm).
5. The type of ground truth used in a formal study.
6. 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.

Ask a specific question about this device