(156 days)
The intended use of the F5 powered wheelchair is to provide indoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.
The intended use of the F5 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
F5 Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the R-net 120 amp controller. The user interface is a joystick.
The F5 is powered by two 12VDC 73Ah. Group M24. 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 steel construction and includes two front drive units (motor, gear and brake), two batteries and two rear pivoting casters. Depending on the user's 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 joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically reengaged. The solenoid electromechanical brakes allow the user to stop by letting go of the joystick.
This document is a 510(k) premarket notification for the Permobil F5 Powered Wheelchair. It does not describe a study involving an AI/ML device, but rather a traditional medical device (a powered wheelchair). Therefore, most of the questions relating to acceptance criteria, ground truth, expert adjudication, and AI performance metrics are not applicable.
However, I can extract information related to the device's performance based on the provided safety and performance standards.
Here's the relevant information based on the provided text:
1. Table of acceptance criteria and the reported device performance
For a traditional medical device like a powered wheelchair, "acceptance criteria" are typically defined by compliance with recognized performance standards. The "reported device performance" is implicitly that the device met these standards, as indicated by the statement "The F5 complies to the below standards" and "The submitted device are tested and having same or improved results as the already predicated device."
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 7176-1: Determination of static stability | Complies (tested and same/improved results as predicate) |
| ISO 7176-2: Determination of dynamic stability of electric wheelchairs | Complies (tested and same/improved results as predicate) |
| ISO 7176-3: Determination of efficiency of brakes | Complies (tested and same/improved results as predicate) |
| ISO 7176-4: Energy consumption for determination of theoretical distance range | Complies (tested and same/improved results as predicate) |
| ISO 7176-5: Determination of dimensions, mass and maneuverings space | Complies (tested and same/improved results as predicate) |
| ISO 7176-6: Determination of maximum speed, acceleration and deceleration | Complies (tested and same/improved results as predicate) |
| ISO 7176-8: Requirements and test methods for static, impact and fatigue strengths | Complies (tested and same/improved results as predicate) |
| ISO 7176-9: Climatic tests for electric wheelchairs | Complies (tested and same/improved results as predicate) |
| ISO 7176-10: Determination of obstacle-climbing ability | Complies (tested and same/improved results as predicate) |
| ISO 7176-11: Test dummies | Complies (used in testing as per standard) |
| ISO 7176-14: Power and control systems - Requirements and test methods | Complies (tested and same/improved results as predicate) |
| ISO 7176-15: Requirements for information disclosure, documentation and labeling | Complies |
| ISO 7176-16: Resistance to ignition of postural support devices | Complies (tested and same/improved results as predicate) |
| ISO 7176-19: Wheeled mobility devices for use in motor vehicles | Complies (if applicable to this device; not specified otherwise) |
| ISO 7176-21: Electromagnetic compatibility (EMC) | Complies (tested and same/improved results as predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. For a physical device like a wheelchair, "test set" would typically refer to the specific units or prototypes of the device that underwent testing. The document states "The submitted device are tested," implying testing was performed on at least one F5 unit, but the exact number is not specified. The manufacturer, Permobil AB, is based in Timrå, Sweden, so the testing would likely have been conducted there or by a certified testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as this is a physical device, not an AI/ML diagnostic tool requiring expert interpretation for ground truth. The "ground truth" for a wheelchair's performance is determined by meeting objective engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical device compliance testing.
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 a physical device, not an AI/ML-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the F5 Powered Wheelchair is defined by its compliance with internationally recognized safety and performance standards (ISO 7176 series). This involves objective measurements and tests rather than subjective expert consensus.
8. The sample size for the training set
Not applicable. This is not an AI/ML device so there is no training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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).