(177 days)
The intended use of the M300 & M400 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
M300 & M400 Powered Wheelchair is battery powered, center wheel motor driven and is controlled by the PG power wheelchair VR-2 90 amp or R-net 120 amp controller. The user interface is a joystick. M300 & M400 is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 25km (15,5 miles), depending on use and the terrain the chair is driven on. The chair frame is a rived nut and welded steel construction and includes two center drive wheels with drive units (motor, gear, brake), batteries and front and rear pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.
The Permobil M300 & M400 powered wheelchairs were assessed for substantial equivalence to the predicate device Permobil C350 (K071650). The performance data indicates that the M300 & M400 functioned as intended in all instances based on various ISO and RESNA standards.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" but lists various characteristics and their values for both the new device and the predicate device, implying these are the performance metrics against which substantial equivalence is judged. The "reported device performance" are the values for the M300 & M400.
| Characteristic | Acceptance Criteria (Predicate Permobil C350) | Reported Device Performance (Permobil M300 & M400) |
|---|---|---|
| Intended use | Provide indoor/outdoor mobility to persons restricted to a sitting position, capable of operating a powered wheelchair | Same |
| Type of base | Rear wheel driven | Mid wheel driven |
| Caster wheel dimension | 210x65 | 200x50 |
| Drive wheel dimension | 3.00-8 | 3.00-8 |
| Adjustable Anti-Tip Wheels | Anti tip device mounted in the rear, R100/32-2-v/4" | The front and rear castor wheels function as Anti-tip devices. |
| Overall dimension, l/w/h | 1065/625/1110 (42"/24½"/43¾") | 1256/620/1260 (49½"/24½"/49½") |
| Weight incl. batteries | 142 kg (313 lbs) (incl. PS-Seat and seat elevator) | 155 kg (342 lbs) (incl. PS-Seat and seat elevator, seat tilt) |
| Weight bearing capacity | 136 kg (300 lb) | 136 kg (300 lb) |
| Maximum speed | Up to 10 km/h (6.2 mph) | Up to 12 km/h (7.5 mph) |
| Brake system | Multiple brake system: 1. Electronic braking by drive motors. 2. Magnetic parking brakes that automatically stops the chair in case of power failure. | Same |
| Ground clearance/Obstacle-climbing | 70 mm/60 mm (2¾" /2⅓") | 77mm/70mm (3"/2¾") |
| Turning Radius | 954 mm (37") | 800mm (31.5") |
| Driving range | Up to 25 km (16 miles) | Up to 25 km (16 miles) |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size for a "test set" in the context of human subjects or a specific data set. The performance testing was based on compliance with various international and national standards for wheelchairs (ISO and RESNA). These standards typically involve testing a representative sample of the devices. The data provenance is derived from the testing conducted by Permobil AB, based in Timrå, Sweden. The testing described is likely prospective, as it's part of the premarket notification for a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided in the document. The device is a powered wheelchair; its performance is evaluated against engineering and safety standards, not against "ground truth" established by medical experts in diagnosing conditions.
4. Adjudication method for the test set:
This information is not applicable and not provided in the document. As mentioned above, the evaluation is against established engineering and safety standards, not expert consensus requiring adjudication.
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:
This information is not applicable and not provided in the document. The device is a powered wheelchair; it is not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided in the document. The device is a physical powered wheelchair, not an algorithm.
7. The type of ground truth used:
The "ground truth" in this context is the fulfillment of requirements outlined in the specified international and national standards (ISO 7176 series and RESNA WC-1/WC-2). These standards define objective performance thresholds and test methodologies for characteristics like climatic resistance, power and control systems, electromagnetic compatibility, weight bearing capacity, speed, braking, etc.
8. The sample size for the training set:
This information is not applicable and not provided in the document. The development of a powered wheelchair does not typically involve a "training set" in the way that machine learning algorithms do. The design and engineering process is iterative, based on established mechanical and electrical engineering principles, and validated through testing against standards.
9. How the ground truth for the training set was established:
This information is not applicable and not provided in the document for the reasons stated in point 8.
§ 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).