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The "eFOLDi Navigator Powerchair STPC-A" is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The eFOLDi Navigator Powerchair STPC-A is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. The wheelchair has two front wheels, two rear wheels, two electric motors with electromagnetic brake, and one rechargeable Lithium-Ion batteries with an off-board charger. The movement of the wheelchair is controlled by the joystick controller or attendant control. When attendant control is in use, the wheelchair no longer responds to the joystick controller. The device is installed with an electromagnetic brake that will engage automatically when the wheelchair is not in use and the brake cannot be used manually. The wheelchair only can be operated on the flat road for both outdoor and indoor use, hospital, senior center, family or similar circumstances use only. The Powerchair only can be operated on the flat road or slopes less than 6 degrees. The Powerchair is foldable.

The Powerchair has a physical dimension of 108 (depth) x 59 (width) x 89 (height) cm, with the seat itself has a dimension of 35 (depth) x 45 (width) x 50 (height) cm. The footrest is 10 cm in height. The Powerchair is foldable, and the folded dimension is 34 (Long) x 59 (width) x 89 (height) cm.

The device has a weight capacity of 120 kilograms, and weighs 14 kilograms with battery (12 kilograms without battery). The color is black.

The Powerchair consists of four wheels, a magnesium alloy mechanical main frame, seat, handle, and 100% polyester flame retardant cloth for upholstery that is ignition resistant.

The Powerchair uses solid Polyurethane wheels and the front wheel has a diameter of 20 cm (8 inch) and the back wheel has a diameter of 30 cm (11.5 inch). Both front wheel and back wheels use solid tires.

The Powerchair has two motors of 24V and 180 Watt, which allows a maximum speed of 5.6 kilometers per hour, and maximum travel range of 13 kilometers. It brakes in the form of electromagnetic force to apply mechanical resistance to the back wheels to force stop.

The wheelchair is equipped with anti-tipper device.

This FDA 510(k) clearance letter is for a physical medical device (eFOLDi Navigator Powerchair), not an AI/software as a medical device (SaMD). Therefore, the requested information regarding acceptance criteria, study details, ground truth, and expert involvement for AI performance is not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and compliance with relevant ISO and IEC standards for wheelchairs.

However, I can extract the acceptance criteria and study information related to the device's physical performance as detailed in the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size (number of units) used for each non-clinical performance test. It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is from non-clinical tests performed by the manufacturer (SunTech UK Ltd.) likely in a controlled laboratory or testing facility setting, rather than human data. There is no mention of country of origin for the data or whether it's retrospective or prospective in the context of data acquisition, as it's not human data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. For a physical device like a powerchair, "ground truth" as it relates to expert consensus for diagnostic accuracy or similar AI contexts is not relevant. Performance is determined by objective physical tests against established engineering standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human-AI studies (e.g., medical image interpretation). For physical device testing, the outcome is determined by whether the device passes or fails the specified standard criteria.

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

Not applicable. This is not an AI/SaMD device, so MRMC studies involving human readers or AI assistance are irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable, as this is not an AI/SaMD device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by compliance with internationally recognized engineering and safety standards for wheelchairs and their components (ISO 7176 series, ISO 10993-1, ISO 16840-10, IEC 62133-2). These standards define objective, measurable criteria that the device must meet.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/SaMD device. There is no "training set" in the context of a physical powerchair's mechanical and electrical performance.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is not an AI/SaMD device and has no training set.

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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.

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