(97 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 provided document is a 510(k) Summary for a Permobil M300 & M400 Powered Wheelchair. It is a regulatory filing for a medical device that establishes substantial equivalence to a legally marketed predicate device, rather than a study demonstrating clinical performance or acceptance criteria in the context of diagnostic accuracy or similar AI/algorithm-driven devices.
Therefore, many of the requested elements (like acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of regulatory submission for a powered wheelchair.
However, I can extract the relevant information from the document as requested, interpreting "acceptance criteria" and "device performance" in the context of device function and regulatory equivalence.
Acceptance Criteria and Device Performance (Permobil M300 & M400 Powered Wheelchair)
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence and Intended Use) | Reported Device Performance |
|---|---|
| Intended Use: Provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair. | The M300 & M400 functioned as intended, providing mobility. It is battery-powered, motor-driven, and controlled by a joystick. Features include automatic braking upon joystick release. |
| Safety and Effectiveness: Demonstrate safety and effectiveness comparable to the predicate device (C350, K071650). | "Performance data demonstrate that the M300 & M400 is as safe and effective as the C350." The submission asserts that minor technological differences from the predicate device "raise no new issues of safety or effectiveness." |
| Technological Characteristics: Similar technological characteristics and principles of operation to the predicate device. | The M300 & M400 shares the same intended uses and similar indications, technological characteristics, and principles of operation as the C350. Both are powered wheelchairs with joystick control, automatic braking, and likely similar frame constructions and power systems (though specific comparisons beyond "similar" are not detailed in the summary). The M300 & M400 uses PG power wheelchair VR-2 90 amp or R-net 120 amp controllers and two 12VDC 60Ah batteries, offering a driving range of up to 25km (15.5 miles). The chair frame is a riveted nut and welded steel construction. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This is a regulatory submission for a physical device, not an AI/algorithm. Performance data is mentioned generally ("In all instances, the M300 & M400 functioned as intended"), but no specific test set sample size (e.g., number of units tested, number of user trials) or data provenance for such a test set is provided in this summary.
- Data Provenance: Not applicable in the context of "country of origin of the data, retrospective or prospective." The manufacturer, Permobil AB, is located in Timrå, Sweden.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is a physical product (powered wheelchair). Ground truth in the sense of expert annotation or clinical diagnosis is not relevant here.
4. Adjudication method for the test set
- Not applicable. No adjudication method for a test set (e.g., consensus among experts) is mentioned or relevant for this type of device submission.
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/diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a powered wheelchair; it does not have a "standalone algorithm performance" in this context.
7. The type of ground truth used
- The "ground truth" for a device like this would be its functional performance against engineering specifications, safety standards, and its intended use. The document states "In all instances, the M300 & M400 functioned as intended," which implies it met its design and functional requirements. Substantial equivalence relies on comparing these functional and safety aspects to a predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning 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).