(29 days)
The power wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The power wheelchair, model name:D26, is an indoor/outdoor, foldable, battery-operated 2-wheel (rear-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-Ion battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion.
The control system, including the controller handle (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop.
The power wheelchair, model name: D26, can be controlled by joystick or remote controller via Bluetooth Low Energy (BLE) wireless communication interface. The user can lock and unlock the device remotely via the BLE interface using the remote controller. For safety, controller rocker control is priority over the remote control by design.
The power wheelchair can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange.
This document is a 510(k) clearance letter for a Power Wheelchair (D26), not a software or AI-enabled medical device. Therefore, the provided information does not contain the details typically sought in an acceptance criteria and study report for AI/ML devices.
The 510(k) process for a physical device like a power wheelchair focuses on demonstrating substantial equivalence to a previously cleared predicate device, primarily through engineering and performance testing against recognized standards, rather than clinical studies with human subjects in the same way an AI-driven diagnostic tool would be evaluated.
Here's why the AI/ML-specific questions cannot be answered from this document:
- No AI/ML Component: The device description clearly indicates it's a "motor driven, indoor and outdoor transportation vehicle" with components like motors, brakes, joystick control, and Bluetooth remote control. There is no mention of artificial intelligence, machine learning, or algorithms that perform diagnostic or interpretative functions.
- Performance Evaluation Type: The "study that proves the device meets the acceptance criteria" in this context refers to various engineering and safety tests outlined in the ISO 7176 series and IEC 60601-1-2 standards (e.g., static ability, dynamic stability, brake performance, biocompatibility, EMC). These are objective, quantitative tests of the device's physical properties and functionality.
Therefore, it is not possible to fill out the table and answer the questions about AI/ML device performance, ground truth, expert adjudication, or MRMC studies based on the provided FDA 510(k) document.
This document demonstrates substantial equivalence for a physical medical device by comparing its technical specifications and performance against international standards for wheelchairs.
However, if you're looking for an example of how a 510(k) for a non-AI/ML device does define acceptance criteria and demonstrates compliance, here's an interpretation based on the provided text:
Acceptance Criteria and Study for Power Wheelchair (D26)
The device, a Power Wheelchair (D26), is primarily evaluated based on its adherence to established international standards for wheelchairs and its substantial equivalence to a predicate device (K242448, Power Wheelchair, D26 from the same manufacturer). The "acceptance criteria" are derived from these standards and the comparative analysis with the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (based on standards/predicate) | Reported Device Performance (Subject Device) | Discussion/Conclusion (from document) |
|---|---|---|---|
| General Characteristics | |||
| Device Classification Name | Class II | Class II | Same |
| Regulatory Class | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Indications for Use | Provide mobility to a disabled or elderly person limited to a seated position, for indoor & outdoor transportation. | "The power wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position." | Same |
| Key Performance Parameters | Note: All listed attributes below are explicitly stated as "Same" with the predicate device, or differences are explained as not raising new safety/effectiveness concerns. The acceptance criteria imply matching or exceeding predicate performance/standards. | ||
| Max Speed Forward | Up to 6 km/h (3.75 mph) | Up to 6 km/h (3.75 mph), continuously adjustable | Same |
| Minimum Braking Dist. (from max speed) | Forward: |
§ 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).