(19 days)
The intended use of the K450 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 K450 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.
K450 Powered Wheelchair is battery powered, rear wheel motor driven and is controlled by the PG power wheelchair R-net PM120 amp controller. The user interface is a joystick. The K450 is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 26,9 km (16,7 miles), depending on use and the terrain the chair is driven on. The chair frame is a welded steel construction and includes two rear drive wheels with drive units (motor, gear, brake), batteries and front 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.
This is a 510(k) summary for a powered wheelchair (K450). The document states that the K450 functioned as intended in all instances but does not provide specific acceptance criteria or details of a study to prove conformance. It primarily focuses on demonstrating substantial equivalence to a predicate device (C350, K071650).
Here's an breakdown based on the provided text, highlighting what is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated in terms of quantitative metrics or specific pass/fail thresholds) | "In all instances, the K450 functioned as intended." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document doesn't detail any specific clinical or non-clinical testing data beyond a general statement of functioning as intended.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This device is a powered wheelchair and the submission does not involve an AI/imaging diagnostic device requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set:
- Not applicable. This device is a powered wheelchair and the submission does not involve an AI/imaging diagnostic device requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is not an AI/imaging diagnostic device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/imaging diagnostic device. The device itself is a powered wheelchair that a human operates.
7. The Type of Ground Truth Used:
- Not explicitly defined in the context of "ground truth" as it would be for an AI diagnostic device. For a powered wheelchair, "ground truth" would typically refer to objective performance standards (e.g., speed, range, stability, braking distance) and user functionality, but the document only states "functioned as intended."
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
Summary of what is missing/not applicable for an AI device:
The provided document is a 510(k) summary for a powered wheelchair, not a medical imaging or AI diagnostic device. Therefore, many of the requested criteria (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of device submission.
The submission primarily relies on demonstrating substantial equivalence to an existing predicate device (C350, K071650) by stating that the K450 has "the same intended uses and similar indications, technological characteristics and principles of operation." The "performance data" mentioned is very high-level: "In all instances, the K450 functioned as intended." This suggests that internal testing was conducted that validated its functionality, likely against a set of engineering and safety specifications, but these specific criteria and the detailed data are not provided in this summary.
§ 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).