(155 days)
The Magic 360 Power Wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair.
The Magic 360 Power Wheelchair is designed for everyday use for both indoor and outdoor 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 Magic 360 Power Wheelchair is a battery powered, electric motor driven device that can be used on both indoor and outdoor surfaces (i.e. concrete, asphalt, indoor flooring, gravel, grass, and bark). The subject device has two seat options: MPS and rehab. The rehab seat option has more built-in adjustments (i.e., width and depth adjustments) and allows for aftermarket cushions. All the wheelchairs include the same power seating options including lift, tilt, recline, and leg elevation to ensure the user to find a position that is comfortable.
The Magic 360 Power Wheelchair includes the following accessories:
- Extra spreader bar
- Slide in table
- Lights
- Luggage rack
- Accessory charger ●
- Posture belt
- Roho cushion
- Jay cushion
- MPS push rail
- MPS peg push handle
- Scooter stopper ●
- Retractable docking pin
- Fold forward kit
Please note, the fold forward kit is an accessory which allows the user to fold the wheelchair and put the wheelchair in a car. To fold the wheelchair the user pulls the red release handle located at the back of the Magic 360 Power Wheelchair. To unfold the wheelchair the user pulls the frame back into place using the armrests.
The provided text is a 510(k) summary for the Magic 360 Power Wheelchair. This document is a regulatory submission to the FDA for medical device clearance, not a study evaluating an AI algorithm's performance. Therefore, most of the requested information regarding acceptance criteria and a study proving device meets acceptance criteria is not directly applicable in the AI/ML context.
However, I can extract the closest analogous information from the document as it pertains to a traditional medical device (power wheelchair).
Here's an interpretation based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific acceptance criteria with quantitative performance metrics for the Magic 360 Power Wheelchair in the way one would for an AI algorithm (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by adherence to recognized ISO standards for wheelchairs and demonstrating substantial equivalence to predicate devices. The "reported device performance" is inferred from the successful completion of these tests.
The comparison table provided in the document (pages 6-7) highlights the characteristics of the Magic 360 Power Wheelchair against predicate devices. The "Statement of Equivalence" column implicitly indicates that the device's performance characteristics are either identical or substantially equivalent to the predicate devices, thus meeting regulatory expectations.
| Category | Acceptance Criteria (Implied) | Reported Device Performance (Implied from "Statement of Equivalence") |
|---|---|---|
| Indications for Use | Must be identical or substantially similar to predicate device(s) without raising new questions of safety or effectiveness. | "Identical to primary predicate. No impact on safety or effectiveness." |
| Product Codes / Regulation No. | Must align with predicate device(s). | "Identical to primary and secondary predicate. No impact on safety and effectiveness." |
| Regulation Description | Must align with predicate device(s). | "Identical to primary and secondary predicate. No impact on safety and effectiveness." |
| Maximum User Weight (lbs) | Must be within acceptable limits compared to predicate(s) and demonstrate safety and effectiveness for stated weight. | "Identical to primary predicate. No impact on safety and effectiveness." (300 lbs) |
| Storage Temperature (°C) | Must meet relevant standards for safe storage. | "Identical to primary predicate and reference devices. No impact on safety and effectiveness." (-40 to 70 °C) |
| Location for Use | Must be comparable to predicate(s) or justified through testing for safety and effectiveness. | "Identical to predicate and reference devices. No impact on safety and effectiveness." (Indoors and outdoors including care facilities, residences, and soft/rough terrain) |
| Frame Material | Must be biocompatible and structurally sound. | "Identical to primary predicate and reference devices. No impact on safety and effectiveness." (Steel and aluminum) |
| Biocompatibility | Materials must be common to many wheelchairs and pass relevant ISO standards. | "Identical to predicate and reference devices. No impact on safety and effectiveness." (Uses materials common to many wheelchairs and passed ISO 10993 tests) |
| Maximum Speed (mph) | Must be comparable to predicate(s) and safe. | "Identical to primary predicate. No impact on safety and effectiveness." (6 mph) |
| Base Overall Dimensions | Must be within a range that demonstrates substantial equivalence and does not negatively impact safety or effectiveness. | "Substantially equivalent to the predicate and reference devices. No impact on safety and effectiveness." (26"x38.7") |
| Rolling Base Weight (lbs) | Must be comparable to predicate(s) and demonstrate safety and effectiveness. | "Identical to primary predicate. No impact on safety and effectiveness." (130 lbs) |
| Power Source | Must be safe and effective. | "Identical to predicate and reference devices. No impact on safety and effectiveness." (Batteries) |
| Battery Details | Must be safe and effective, and comparable to predicate(s). | "Identical to secondary predicate and reference devices. No impact on safety and effectiveness." (24V (2x12V) / 73 Ah/20h, similar to K181908 and K172384) |
| Drive Wheel Diameter (inches) | Must be comparable to predicate(s) and not negatively impact safety or effectiveness. | "Identical to reference device. No impact on safety and effectiveness." (14 inches) |
| Castor Wheel Size (inches) | Must be comparable to predicate(s) and not negatively impact safety or effectiveness. | "Substantially equivalent to the primary predicate and reference devices. No impact on safety and effectiveness." (Front 8", Rear 8") |
| Anti-pitch Mechanism | Functionality should be comparable to predicate(s) or justified for safety and effectiveness without one. The subject device has "None" but is deemed substantially equivalent based on testing for differences in technological characteristics. | "Substantially equivalent to the primary predicate and reference devices. No impact on safety and effectiveness." (None, despite predicates having additional anti-pitch lock out; testing justifies this difference) |
| Range (miles) | Must be comparable to predicate(s). | "Substantially equivalent to the predicate and reference devices. No impact on safety and effectiveness." (22.5 miles) |
| Lift Range (inches) | Must be comparable to predicate(s). | "Identical to primary predicate and reference devices. No impact on safety and effectiveness." (0-12 inches) |
| Tilt Range (degrees) | Must be comparable to predicate(s). | "Identical to primary predicate and reference devices. No impact on safety and effectiveness." (0-50 degrees) |
| Recline Range (degrees) | Must be comparable to predicate(s). | "Identical to primary predicate and reference devices. No impact on safety and effectiveness." (0-170 degrees) |
| Suspension | Must provide equivalent safety and effectiveness to predicate(s). | "Substantially equivalent to the primary predicate and reference devices. No impact on safety and effectiveness." (Independent drive wheel suspension with shock absorbers) |
| Type of Braking System | Must be safe and effective. | "Identical to the primary predicate. No impact on safety and effectiveness." (Electromagnetic, regenerative brakes with a free-wheeling mode) |
| User Controller | Must be safe and effective and provide appropriate control. | "Identical to primary predicate and reference devices. No impact on safety and effectiveness." (Joystick and hand control buttons) |
| Joystick Mount | Must be safe and provide appropriate adjustability. | "Identical to primary predicate and reference devices. No impact on safety and effectiveness." (Fixed mount, height adjustable, swing-away) |
| Folding mechanism | Must be safe and effective, and comparable to predicate(s). | "Substantially equivalent to the primary predicate. No impact on safety and effectiveness." (Yes, with fold forward kit accessory) |
| Software | Must be safe and effective, and comparable to predicate(s). | "Identical to reference device. No impact on safety and effectiveness." (R-Net from PGDT) |
| Seat Height (minimum, inches) | Must be within a range that demonstrates substantial equivalence and does not negatively impact safety or effectiveness. | "Substantially equivalent to the predicate and reference devices. No impact on safety and effectiveness." (17.1 inches) |
| Seat Width (inches) | Must be within a range that demonstrates substantial equivalence and does not negatively impact safety or effectiveness. | "Substantially equivalent to the primary predicate and reference devices. No impact on safety and effectiveness." (12-22 inches) |
| Armrest | Must provide equivalent safety and effectiveness to predicate(s). | "Identical to the primary predicate. No impact on safety and effectiveness." (Height adjustable, removable, flip up option) |
| Footrest | Must provide equivalent safety and effectiveness to predicate(s). | "Substantially equivalent to the predicate devices. No impact on safety and effectiveness." (1 or 2 pieces, fixed or flip up, angle and height adjustable rigid footplates) |
| ISO Standards Compliance | Must meet all relevant ISO standards for wheelchairs. | "The results of these tests indicate that the Magic 360 Power Wheelchair are substantially equivalent to the predicate devices." (Passed 20+ ISO tests and biocompatibility tests as listed in "SUMMARY OF NON-CLINICAL TESTING") |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided because this is a submission for a physical medical device (power wheelchair) and not an AI/ML algorithm. The "test set" in this context refers to physical units of the wheelchair undergoing standardized engineering and performance tests, not a dataset for an algorithm. There is no mention of "data provenance" in the sense of patient data. The manufacturer is based in Australia ("3 International Court, Scoresby, VIC, 3179 Australia").
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)
This is not applicable to this type of device submission. "Ground truth" in this context would implicitly be the established engineering specifications and performance requirements defined by ISO standards and regulatory guidelines, confirmed through physical testing by qualified engineers or technicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept relates to human review of data, which is not described for the performance testing of this physical device. The testing described (e.g., Static stability, Dynamic stability, EMC testing) are objective engineering measurements against defined standards.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this medical device's performance is established by international consensus standards (ISO standards) for wheelchairs regarding functionality, safety, and durability, as well as the performance characteristics of legally marketed predicate devices. The testing verifies that the device performs according to these objective standards and is comparable to equivalent devices already on the market.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set." The device is designed, manufactured, and tested to engineering specifications.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned in the context of an AI/ML algorithm.
§ 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).