Search Results

The "eFOLDI Scooter, Lite" is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The eFoldi Scooter. Lite is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk but suffer from mobility limitations. It has a base with metal alloy frame, one front wheels, two rear wheels, a seat, an adjustable steering column, a tiller console, an electric motor, an electromagnetic brake, 2 rechargeable Lithium-Ion Battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road or slopes less than 6 degrees. The scooter is foldable.

This document describes the regulatory approval for the eFOLDi Scooter, Lite, a motorized three-wheeled vehicle. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for a novel AI device or diagnostic.

Therefore, many of the requested items (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, ground truth establishment for AI models) are not applicable to this type of regulatory submission for a physical medical device like an electric scooter. The "acceptance criteria" here are defined by compliance with recognized standards and a comparison against a predicate device.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing and Predicate Comparison):

The acceptance criteria for this device are primarily demonstrated through compliance with recognized international standards (ISO 7176 series for wheelchairs and scooters, ISO 10993-1 for biocompatibility, and ISO 7176-21 for EMC) and by showing that any differences from the predicate device do not raise new safety or effectiveness concerns.

Table of Acceptance Criteria and Reported Device Performance:

Detailed Responses to Specific Questions:

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

   • Please see the table above. The "acceptance criteria" for this device are demonstrated by its compliance with various ISO standards for safety and performance (the non-clinical tests) and by showing that its specifications are substantially equivalent to a legally marketed predicate device, even with some differences that are deemed not to raise new questions of safety or effectiveness.

2. Sample sizes used for the test set and the data provenance:

   • N/A. This is a physical medical device (electric scooter), not an AI/software device requiring a "test set" of data in the typical sense. Performance is verified through engineering tests on the physical product and comparison to specifications and a predicate device. There is no mention of a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. Ground truth as defined for diagnostic AI models (e.g., radiologist reads, pathology) is not relevant for this device. The "ground truth" here is established by engineering standards, physical measurements, and compliance testing performed by qualified test labs/engineers.

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

   • N/A. No multi-reader or adjudication process for a "test set" is applicable.

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:

   • N/A. This is not an AI-assisted diagnostic device. No MRMC study was conducted or relevant.

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

   • N/A. Not an algorithm-only device.

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

   • The "ground truth" for this device's safety and effectiveness is established by:
     • Compliance with recognized international performance and safety standards (ISO 7176 series, ISO 10993-1, ISO 7176-21).
     • Engineering specifications and test results of the physical device.
     • Demonstrated substantial equivalence to a predicate device, meaning its performance falls within acceptable parameters compared to a device already deemed safe and effective.

8. The sample size for the training set:

   • N/A. No training set for an AI model.

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

   • N/A. No training set for an AI model.

Conclusion from the Document (Section 9.0):
"The conclusions drawn from the nonclinical tests that demonstrate is that the subject device is as safe, as effective, and performs as well as the legally marketed device." This statement summarizes the "proof" that the device meets its regulatory acceptance criteria for substantial equivalence.

Ask a specific question about this device