(266 days)
The intended use of the Liberator™ is to provide mobility for those persons limited to a seated position, which are capable of operating a simple hand control.
The Liberator™ may be operated on internal DC batteries, which can be recharged by using a wall- charger and supplemented by using the detachable solar assisted battery maintaining device (Solar Companion).
The Liberator™ powered wheelchair is a six wheeled battery powered wheelchair. It has a controller system, which is used to operate the Liberator™ powered wheelchair. The one-piece base of the wheelchair is made of welded steel construction. The main frame also consists of a battery floor pan. The center drive wheels are mounted on the drive shafts of separate motor/gear assemblies, one on the left side of the wheelchair, the other on the right side of the wheelchair. The seat comes with ergonomic contoured comfort cushions, recliner, tilt-up adjustable arm rests, and patient can dial in their seating Position, can adjust the setting for air fan control, joy stick adjustments and table adjustments and settings. The Liberator™ powered wheelchair requires 2 NF22 batteries, has an on board charger, the Solar Companion, with solar panel and an assisted battery maintaining device (Solar Companion).
The Liberator™ powered wheelchair has a maximum load capacity of 300 lbs.
The Liberator™ can travel at ranges of 15-20 miles with maximum speed of 4.09 miles per hour on flat terrain under ideal conditions (RESNA testing). In order to achieve the maximum extended range of 20 miles the Solar Companion has the ability to maintain the batteries based on the intensity, angle, and availability of sunlight.
The Liberator™ has an air ride suspension system seat, cushion ventilation system (fan) for the seat and lumbar cushion with laser ported holes in fabric.
The Solar Companion is an onboard battery maintaining device that comes with the Liberator™. It has the ability to maintain the batteries based on availability sunlight intensity and angle. The solar panel assembly is affixed to the Liberator™ and the height can be adjusted to allow the user excellent visibility
Acceptance Criteria and Device Performance for Liberator Powered Wheelchair with Solar Companion
Based on the provided FDA 510(k) summary, the device is a powered wheelchair with a solar-assisted battery maintaining device. The study used to demonstrate substantial equivalence relies primarily on non-clinical testing according to RESNA standards.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for the device, but rather lists the RESNA test methods used and the conclusions drawn regarding performance. The "acceptance criteria" are implied to be the successful demonstration of compliance with these RESNA standards and the comparison of performance characteristics to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Demonstrated through successful completion of various RESNA tests. Any differences in technological characteristics from the predicate device (e.g., Solar Companion, air-ride suspension) do not raise new questions of safety and effectiveness, as confirmed by RESNA testing. |
| Static Stability | Complies with RESNA WC-1 Volume 1, Section 1. |
| Dynamic Stability | Complies with RESNA WC-2 Volume 2, Section 2 (for electrically powered wheelchairs). |
| Brake Effectiveness | Complies with RESNA WC-2 Volume 2, Section 3. |
| Energy Consumption & Theoretical Range | Theoretical range of 15-20 miles based on RESNA WC-2 Volume 2, Section 4. This compares favorably to the predicate device's advertised 15-mile range. The Solar Companion assists in maintaining battery charge to achieve the extended range. |
| Dimensions, Mass, & Maneuvering Space | Complies with RESNA WC-1 Volume 1, Section 5. Differences in wheelchair weight and overall height due to the Solar Companion were tested and found not to impact performance. |
| Maximum Speed | 4.09 miles per hour on flat terrain under ideal conditions (RESNA testing). Complies with RESNA WC-2 Volume 2, Section 6. |
| Seating & Wheel Dimensions | Complies with RESNA WC-1 Volume 1, Section 7. |
| Static, Impact & Fatigue Strengths | Complies with RESNA WC-2 Volume 1, Section 8. |
| Climatic Tests | Complies with RESNA WC-2 Volume 2, Section 9 (for electrically powered wheelchairs). |
| Obstacle-Climbing Ability | Complies with RESNA WC-2 Volume 2, Section 10 (for electrically powered wheelchairs). |
| Power and Control Systems | Complies with RESNA WC-2 Volume 2, Section 14. EMC testing was specifically performed for the Solar Companion to establish its safety. |
| Electromagnetic Compatibility (EMC) | Complies with RESNA WC-2 Volume 2, Section 21 and ISO 7176-21:2009 for the Solar Companion. |
| Load Capacity | Maximum load capacity of 300 lbs, identical to the predicate device. |
| Intended Use | "To provide mobility for those persons limited to a seated position, which are capable of operating a simple hand control." This is the same as the predicate device (Golden Spyder). The device may be operated on internal DC batteries, recharged by a wall-charger, and supplemented by the detachable solar assisted battery maintaining device (Solar Companion). The intended use of the Solar Companion features is also similar to the predicate device, AEU-14CF Expedition Dental System, in prolonging battery life using a solar panel. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for the individual tests (e.g., number of wheelchairs tested for each RESNA standard). The testing is described as occurring on "the Liberator™ powered wheelchair." It is implied that typical prototypes or production samples of the device were used for the non-clinical testing.
- Data Provenance: The data provenance is from non-clinical testing performed by or for the manufacturer (Solar Mobility LLC) and reported within the 510(k) submission. It is prospective in the sense that these tests were conducted to demonstrate compliance for this specific device. There is no mention of country of origin for the data beyond the US for the submitting company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the evaluation relies on established international and national standards (RESNA and ISO) for medical device performance (specifically for wheelchairs), not on expert consensus for "ground truth" as would be the case for diagnostic AI. The "ground truth" is defined by the objective measurement and performance requirements specified in these standards.
4. Adjudication Method for the Test Set
This is not applicable. The testing involves objective measurements against predefined acceptance criteria from RESNA and ISO standards. There is no mention or need for a subjective adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI systems in diagnostic tasks, especially how they impact human reader accuracy or efficiency. The Liberator Powered Wheelchair is a physical medical device, not a diagnostic AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical powered wheelchair, not an algorithm or AI system. The "standalone performance" refers to the device itself performing according to its specifications as determined by the RESNA tests.
7. The Type of Ground Truth Used
The "ground truth" used for this device is based on established objective performance standards outlined in RESNA (Rehabilitation Engineering and Assistive Technology Society of North America) and ISO (International Organization for Standardization) guidelines for wheelchairs. These standards dictate acceptable performance characteristics (e.g., stability, speed, braking effectiveness, energy consumption) for safe and effective operation. There is no pathology, expert consensus (in the diagnostic sense), or outcomes data used as "ground truth" in this context.
8. The Sample Size for the Training Set
This is not applicable. The Liberator Powered Wheelchair is a physical device and not an AI or machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this device.
§ 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).