(252 days)
The Velox power wheelchair is a battery operated device that is intended to provide mobility to individuals who lack mobility and who have the capability to operate a power wheelchair while being restricted to the seated position.
The Velox Power Chair is designed for everyday use for both indoor environments including care facilities and private residences. The subject device is intended to provide mobility to persons that are restricted or limited to a sitting position.
The Velox Power Chair is a battery powered, electric motor driven device that can be used on both indoor and outdoor surfaces, on soft/rough terrain. The user controls the speed and direction of the wheelchair using the joystick and hand control buttons mounted on the chair. The brakes of the wheelchair are electromagnetic.
The provided text describes the 510(k) summary for the Velox Power Chair, a powered wheelchair. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing specific acceptance criteria and a detailed study report for a novel AI/software medical device.
Therefore, many of the requested elements for an AI/software device performance study are not applicable to this document. The information provided is characteristic of a traditional medical device submission where equivalence is shown through comparison and adherence to recognized performance standards.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the format typically used for software performance metrics (e.g., sensitivity, specificity thresholds). Instead, it establishes "substantial equivalence" based on comparing characteristics to a predicate device and demonstrating compliance with recognized performance standards.
The table below summarizes the comparison to the predicate device, which implicitly defines the performance "acceptance" by showing that the Velox Power Chair's characteristics are either "Same" or "Equivalent" and do not raise new questions of safety or effectiveness.
| Characteristic | Proposed Device: Velox Power Chair (K231315) | Predicate Device: Quickie, Zippie (K142457) | Comparison (Implicit Acceptance) | Reported Performance (Velox Power Chair) |
|---|---|---|---|---|
| Indication for Use | To provide mobility to individuals who lack mobility and who have the capability to operate a power wheelchair while being restricted to the seated position. | To provide mobility to persons restricted to a sitting position. The Zippie® power wheelchairs are specifically for people who are slightly smaller in stature—including children. | Equivalent; the difference is that the predicate device has a different model for people who are slightly smaller in stature, whereas Velox has only one model. | The Velox Power Wheelchair is a battery-operated device that is intended to provide mobility to individuals who lack mobility and who have the capability to operate a power wheelchair while being restricted to the seated position. |
| Intended Use | Provide mobility to persons restricted to a sitting position. | Provide mobility to persons restricted to a sitting position. | Same. | Provide mobility to persons restricted to a sitting position. |
| Device Materials | Steel and aluminum. | Steel and aluminum. | Same. | Steel and aluminum. |
| Dimensions | 25" x 35" (length by width) | 24"x 34" (length by width) | Equivalent; difference in dimension is small and does not affect the safety or effectiveness. | 25" x 35" (length by width) |
| Maximum User Weight | 300 lbs | 300 lbs | Same. | 300 lbs |
| Regulation Description | Powered Wheelchair | Powered Wheelchair | Same. | Powered Wheelchair |
| Location for Use | Indoors, outdoors, soft/rough terrain. | Indoors, outdoors. | Equivalent; the difference in location for use does not affect the safety or effectiveness. | Indoors, outdoors, soft/rough terrain. |
| Maximum Speed | 5.64 mph | 6 mph | Equivalent; the slight difference in maximum speed does not affect the use of the device. No impact on safety and effectiveness. | 5.64 mph |
| Rolling Base Weight (lbs) | 145 | 130 | Equivalent; difference in weight does not affect the use of the device. No impact on safety and effectiveness. | 145 |
| Power Source | Batteries | Batteries | Same. | Batteries |
| Range (miles) | 15.38 | Not publicly available | No impact on safety and effectiveness. The difference in range, if any, would come down to the way the drive range is calculated based on various factors. Also, difference in range of miles has many factors, such as weight of the user, terrain, extra bags being carried etc. | 15.38 |
| Climbing Ability | 1.5" - 2" | Not publicly available | No impact on safety and effectiveness. The difference in climbing ability does not affect the use of the device. | 1.5" - 2" |
| Software / Controls | R-Net or VR2 from Curtiss Wright | VR2 from PGDT | Equivalent: Both use the same controller module (VR2). Velox powerchairs may be equipped with the alternative program R-Net from the same supplier, but both controllers are equivalent in functions and this difference does not affect safety or effectiveness of the device. | R-Net or VR2 from Curtiss Wright |
| Pivot Radius | 25.50" | Not publicly available | No impact on safety and effectiveness if there is any difference. The difference in pivot radius does not affect the use of the device. | 25.50" |
| Battery Details | 8G22NF Gel Cell or 8G24SS Gel Cell, Sealed lead acid or gel batteries | 22 NF, sealed lead acid or gel cell | Same. | 8G22NF Gel Cell or 8G24SS Gel Cell, Sealed lead acid or gel batteries |
| Drive Wheel Diameter (inches) | 13.5 | 13 | Equivalent. The slight difference in inches does not affect safety or effectiveness of the device. | 13.5 |
| Lift Range (inches) | 0-15" (from the top of the plastic to the top of the rehab seat) / 0-12" (the lift platform by itself) | 0-12" | Same. | 0-15" (from the top of the plastic to the top of the rehab seat) / 0-12" (the lift platform by itself) |
| Tilt Range | 0-50° | 0-50° | Same. | 0-50° |
| Suspension | Cloud suspension which reduces vibration with shock absorbers | Standard all wheel suspension with shock absorbers | Equivalent, suspension reduces vibration. | Cloud suspension which reduces vibration with shock absorbers |
| Folding mechanism | Yes (fold down backrest) | Yes (fold down backrest) | Same. | Yes (fold down backrest) |
| Armrest | Height adjustable, removable, flip up option, depth adjustable | Height adjustable and flip up option | Equivalent. Additional options do not affect the safety or effectiveness. | Height adjustable, removable, flip up option, depth adjustable |
| Footrest | Fixed, flip up, swing away, angle adjustable, rigid footplates or footboard | Swing away footrests with heel loops | Equivalent Additional options do not affect the safety or effectiveness. | Fixed, flip up, swing away, angle adjustable, rigid footplates or footboard |
| Anti-pitch Mechanism for Climbing | Six wheels provide pitch stabilization | Anti-pitch lock-out | Equivalent: Pitch is controlled to ensure appropriate stability. No impact on safety and effectiveness. | Six wheels provide pitch stabilization |
| Speed settings | Proportional. The braking settings are set according to the guidance of the therapist involved in setting up the chair with the client. | Not publicly available | No impact on safety and effectiveness if there is any difference. The difference in speed settings does not affect the use of the device. | Proportional. The braking settings are set according to the guidance of the therapist involved in setting up the chair with the client. |
| Minimum braking distance from maximum speed | Programmable. The minimum braking distance for a wheelchair depends on various factors, including the speed of the chair, road conditions, the reaction time of the braking, and the reaction time of the person operating the chair. Just like the speed settings the braking settings are set according to the guidance of the therapist involved in setting up the chair with the client. | Not publicly available | No impact on safety and effectiveness if there is any difference. The difference in minimum braking distance from maximum speed does not affect the use of the device. | Programmable. The minimum braking distance for a wheelchair depends on various factors, including the speed of the chair, road conditions, the reaction time of the braking, and the reaction time of the person operating the chair. Just like the speed settings the braking settings are set according to the guidance of the therapist involved in setting up the chair with the client. |
| Recline range | 0-170° | Not publicly available | No impact on safety and effectiveness if there is any difference. The difference in recline range does not affect the use of the device. | 0-170° |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This document does not refer to a "test set" in the context of an AI/software performance study involving patient data. The testing described is non-clinical performance testing of a physical device. There is no mention of data provenance, country of origin, or whether it was retrospective or prospective data, as these are not relevant to the type of testing conducted.
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):
Not applicable. Ground truth, in the context of expert review for medical image analysis or similar AI applications, is not relevant here. The "ground truth" for a physical device like a wheelchair is established through engineering specifications and objective measurements against recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no "test set" requiring adjudication by experts in this context.
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 a physical device, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The Velox Power Chair is a physical device, controlled by a human operator using a joystick. There is no standalone algorithm performance as described for AI devices. The intrinsic performance characteristics (speed, stability, etc.) are measured directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance of the Velox Power Chair is based on objective measurements and compliance with international consensus standards for powered wheelchairs. The document explicitly lists adherence to ISO 7176 series and RESNA sections for various performance metrics. This includes:
- Static stability
- Dynamic stability
- Effectiveness of brakes
- Energy consumption
- Dimensions, mass, and maneuvering space
- Maximum speed, acceleration, and deceleration
- Measurement of seat and wheel dimensions
- Static, impact, and fatigue
- Climatic test
- Obstacle climbing ability
- Test dummies
- Determination of coefficient of friction of test surfaces
- Power and control systems for power wheelchairs
- Documentation and labeling
- EMC testing
- Changing occupant posture
These standards define the benchmarks against which the device's performance is objectively measured.
8. The sample size for the training set:
Not applicable. This is a physical device, not an AI/ML model that requires a training set of data.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply here.
§ 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).