(197 days)
Sunrise powered wheelchairs empower physically challenged persons by providing a means of mobility.
The Quickie P190 R (or S525) is a medium duty, conventional, rear wheel drive, and rigid frame power wheelchair. The Quickie P190R Power Wheelchair consists of typical components found on most wheelchairs, such as push handles, armrests, backrest, seat frame, cushion, footrest and casters. Accessories that may be added after market include items such as positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc. As a motorized wheelchair, it also controller, a joystick, a motor, brakes, a drive wheel and 2 batteries. Like most power wheelchairs, the joystick is the user interface. It transfers intentions to command the chair. When the control is activated, or moved out of the center position, the motor brake is energized and released, allowing the chair to move in the direction of the activation. When the activation device (joystick or afternate input device) is released, the chair slows to a stop and the motor brake is automatically re-engaged. These dynamic "on command" brakes allow the user to stop by letting go of the activation device. If the chair loses power, the motor brake is automatically engaged and the chair comes to a stop. To prevent the rider from becoming stranded, the chair may be pushed. The chair incorporates a "free wheel" device motor lock disengagement option. This option allows the drive train to be manually disengaged, enabling the chair to be more easily pushed by an assistant. It should be noted that the chair would not have electronic brakes when in the "free wheel" mode. However, the manual wheel locks (also optional) will still function if engaged.
This 510(k) premarket notification for the Sunrise Medical S-525 Power Wheelchair is primarily focused on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and adherence to recognized performance standards. Itdoes not describe a study involving an AI/Machine Learning device or a diagnostic/screening medical device in the way typically expected by your request. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this document.
However, I will extract and present the information available that aligns with your request, interpreting "acceptance criteria" as the standards the device was tested against and "device performance" as its successful adherence to those standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Tested Against) | Reported Device Performance |
|---|---|
| ISO 7176 Wheelchair Standards: | Device tested to these standards |
| - Static Stability | Implied successful performance |
| - Dynamic Stability | Implied successful performance |
| - Effectiveness of Brakes | Implied successful performance |
| - Energy consumption | Implied successful performance |
| - Overall Dimensions | Implied successful performance |
| - Maximum Speed | Implied successful performance |
| - Acceleration and retardation | Implied successful performance |
| - Static Impact | Implied successful performance |
| - Fatigue Strength | Implied successful performance |
| - Climatic Test | Implied successful performance |
| - Obstacle Climbing Ability | Implied successful performance |
| - Testing of Power and Control System | Implied successful performance |
| - EMC Testing | Implied successful performance |
| ANSI/RESNA Wheelchair Standards: | Device tested to these standards |
| - Static Stability | Implied successful performance |
| - Dynamic Stability | Implied successful performance |
| - Effectiveness of Brakes | Implied successful performance |
| - Energy consumption | Implied successful performance |
| - Overall Dimensions | Implied successful performance |
| - Maximum Speed | Implied successful performance |
| - Acceleration and retardation | Implied successful performance |
| - Static Impact | Implied successful performance |
| - Fatigue Strength | Implied successful performance |
| - Climatic Test | Implied successful performance |
| - Obstacle Climbing Ability | Implied successful performance |
| - Testing of Power and Control System | Implied successful performance |
| - EMC Testing | Implied successful performance |
| Proposed Addition to ANSI/RESNA W/C 14 Electromagnetic Compatibility Requirements for Powered Wheelchairs and Motorized Scooters Version 1.5 Dated 1/11/94 | Device tested to this proposed standard |
| ISO EMC Draft Standard 7176-14 Rifled Draft ISO EMC Group Proposal Electromagnetic Compatibility Addition Dated 4/3/95 Regarding Electromagnetic Compatibility Requirements for Powered Wheelchairs and Motorized Scooters | Device tested to this proposed standard |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: This document does not specify a separate "test set" in the context of device performance data generation for a diagnostic/screening algorithm. The testing described refers to the physical device itself. It's implied that at least one S-525 Power Wheelchair was tested against the listed standards.
- Data Provenance: The testing was conducted internally by Sunrise Medical. The country of origin of the data is the United States, as Sunrise Medical is a US-based company, and the submission is to the FDA. The testing conducted is for prospective validation of the device's adherence to safety and performance standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This section is not applicable. The "ground truth" for a physical product like a power wheelchair is defined by its engineering specifications and its adherence to the published performance standards. There is no mention of human experts establishing ground truth for a diagnostic output.
4. Adjudication Method for the Test Set
- This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of data, typically in diagnostic studies. Here, the device's performance is objectively measured against technical standards.
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 section is not applicable. This document describes a physical medical device (power wheelchair), not an AI/ML-driven diagnostic tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This section is not applicable. The S-525 Power Wheelchair is a physical product operated by a user, not an algorithm. The performance described is of the complete physical device.
7. The type of ground truth used
- The ground truth for the S-525 Power Wheelchair's performance is established by conformance to internationally recognized and national engineering/performance standards (ISO 7176 and ANSI/RESNA). This is an objective, measurable "ground truth" based on predefined specifications and safety thresholds. It is not expert consensus, pathology, or outcomes data in the context of a diagnostic test.
8. The sample size for the training set
- This section is not applicable. This device is a physical product, not an AI/ML system that requires a "training set."
9. How the ground truth for the training set was established
- This section is not applicable, as there is no training set for this type of 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).