(86 days)
The intended use of the ELECTRO powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
The intended use of the Electro series of the powered wheelchair is to provide indoor and outdoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.
Electro Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the PG power wheelchair VSI 70 amp controller. The user interface is a joystick. The Electro is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 25 km (16 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 front drive wheels with drive units (motor, gear, brake), batteries and back 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 powered wheelchair, the Permobil Electro. It does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria and a study proving the device meets those criteria, as typically found in submissions for AI/ML-enabled medical devices.
Here's why and what information is missing:
This 510(k) submission is for a traditional medical device (a powered wheelchair) and precedes the widespread adoption and specific regulatory requirements for AI/ML-enabled devices. Therefore, the performance data section is very brief and focuses on the device functioning as intended and its substantial equivalence to a predicate device, rather than quantitative performance metrics against specific acceptance criteria.
Missing Information:
- A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, precision, etc.) or report detailed performance metrics for the Electro powered wheelchair in this format. The "Performance Data" section simply states, "In all instances, the Electro functioned as intended."
- Sample size used for the test set and the data provenance: Not applicable. Performance for a powered wheelchair typically involves engineering testing for safety and functionality, not a "test set" of data in the AI/ML sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of an AI/ML device, refers to a verified label or diagnosis. For a powered wheelchair, this is not relevant.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable. MRMC studies are specific to image interpretation or diagnostic aid effectiveness, not powered wheelchairs.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The Electro is a physical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. The Electro is not an AI/ML algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable.
What the document does state about performance and equivalence:
- Performance Data: "In all instances, the Electro functioned as intended." This is a qualitative statement indicating that engineering and functional tests showed no failures.
- Substantial Equivalence: The primary method for demonstrating safety and effectiveness in this 510(k) is through substantial equivalence to a predicate device: the Chairman 2k (K991658).
- The Electro has the "same intended uses and similar indications, technological characteristics and principles of operation" as the predicate device.
- "The minor technological differences between the Electro and its predicate device raise no new issues of safety or effectiveness."
- "Performance data demonstrate that the Electro is as safe and effective as the Chairman 2K." This performance data would typically be in the form of engineering tests, bench testing, and potentially some limited user testing to confirm basic functionality, stability, braking, speed, etc., rather than clinical study data with specific quantitative metrics.
§ 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).