(220 days)
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
| Acceptance Criteria (Test Standard) | Reported Device Performance (Reference Standard Results) |
|---|---|
| Biocompatibility: All user directly contacting materials compliant with ISO10993-1 requirements | Compliance with ISO10993-1 requirements |
| Static Stability: ISO 7176-1 | Compliant with ISO 7176-1 |
| Dynamic Stability: ISO 7176-2 | Compliant with ISO 7176-2 |
| Brake Effectiveness: ISO 7176-3 | Compliant with ISO 7176-3 |
| Energy Consumption/Range: ISO 7176-4 | Compliant with ISO 7176-4 |
| Overall Dimensions, Mass, Maneuvring Space: ISO 7176-5 | Compliant with ISO 7176-5 |
| Max Speed, Acceleration, Deceleration: ISO 7176-6 | Compliant with ISO 7176-6 |
| Seating & Wheel Dimensions: ISO 7176-7 | Compliant with ISO 7176-7 |
| Static, Impact & Fatigue Strengths: ISO 7176-8 | Compliant with ISO 7176-8 |
| Climatic Tests: ISO 7176-9 | Compliant with ISO 7176-9 |
| Obstacle-Climbing Ability: ISO 7176-10 | Compliant with ISO 7176-10 |
| Test Dummies: ISO 7176-11 | Compliant with ISO 7176-11 |
| Power and Control Systems: ISO 7176-14 | Compliant with ISO 7176-14 |
| Resistance to Ignition of Postural Support Device: ISO 16840-10: 2021 | Compliant with ISO 16840-10: 2021 |
| Safe Operation of Portable Sealed Secondary Lithium Cells and Batteries: IEC 62133-2 | Compliant with IEC 62133-2 |
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.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).