(143 days)
The intended use of the F3 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 F3 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
F3 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 F3 is powered by two 12VDC 60Ah or tow 12VDC 73Ah. Group M34 batteries or 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 wheels with 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 is a 510(k) premarket notification for a powered wheelchair (Permobil F3) and does not involve a diagnostic AI/ML device. Therefore, the specific information requested about acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, is not applicable to this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Permobil M300 & M400) by comparing intended use, technological characteristics, and conformance to recognized standards.
However, I can extract information related to the device's performance based on the non-clinical testing:
1. Table of acceptance criteria and the reported device performance:
The document states that "The F3 complies to the below standards." This implies that the device met the requirements outlined in each standard, which serve as the acceptance criteria for those specific performance aspects. The document does not explicitly list numerical acceptance criteria or reported device performance values for each standard but asserts compliance.
| Standard | Name | Compliance Status (Reported Performance) |
|---|---|---|
| ISO 7176-1 | Determination of static stability | Complies |
| ISO 7176-2 | Determination of dynamic stability of electric wheelchairs | Complies |
| ISO 7176-3 | Determination of efficiency of brakes | Complies |
| ISO 7176-4 | Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range | Complies (up to 25km (15.5 miles) driving range reported separately) |
| ISO 7176-5 | Determination of dimensions, mass and maneuverings space | Complies |
| ISO 7176-6 | Determination of maximum speed, acceleration and deceleration of electric wheelchairs | Complies (no changes in speed reported relative to predicate) |
| ISO 7176-8 | Requirements and test methods for static, impact and fatigue strengths | Complies |
| ISO 7176-9 | Climatic tests for electric wheelchairs | Complies |
| ISO 7176-10 | Determination of obstacle-climbing ability of electrically powered wheelchairs | Complies (states "improved results" compared to predicate) |
| ISO 7176-11 | Test Dummies | Complies |
| ISO 7176-14 | Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods | Complies |
| ISO 7176-15 | Requirements for information disclosure, documentation and labelling | Complies |
| ISO 7176-16 | Resistance to ignition of postural support devices | Complies |
| ISO 7176-19 | Wheeled mobility devices for use in motor | Complies |
| ISO 7176-21 | Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters | Complies |
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 non-clinical performance testing of a physical device like a wheelchair, the "sample size" would typically refer to the number of units tested, and the "data provenance" would relate to the testing facility and methodology. These details are not elaborated upon beyond stating compliance with international standards.
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)
Not applicable. This is not an AI/ML device requiring expert ground truth for classification. The "ground truth" for a physical device is derived from the objective physical and functional measurements performed according to the specified test methods in the ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device involving human interpretation needing adjudication.
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 medical device, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" is established by adherence to the objective measurements and protocols defined within the referenced international standards (e.g., ISO 7176 series). It relies on physical testing and measurement rather than expert consensus or pathology.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
§ 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).