(22 days)
The Merits P335 Powered Wheelchair is intended to provide indoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.
The Merits P335 Powered Wheelchair is to provide indoor and outdoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.
The Merits P335 Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the PG power wheelchair R-net 120 amp controller. The user interface is a joystick. P335 is powered by two 12 VDC 60ah batteries. The batteries are charged by 6A off-board charger connect with 3-pin Microphone Connector to charging socket on joystick. The approximate driving range on fully charged batteries is up to 30km (19mi). The chair frame is a welded steel construction and includes two front drive wheels with drive units (including motor, gear, and brake), batteries and rear 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 wheelchair 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.
The device is equipped with a Power Seating System consists of a power tilt unit, a power recline module and an optional power elevating seat module. The tilt, reclining and elevating systems are actuated by 24V DC motorized linear actuator. The tilt system includes one motorized linear actuator caused the seat frame to shift forward. This enhances stability since the center of gravity is kept substantially in place while the user is tilting. The recline system include one motorized linear actuator change the position of the backrest with respect to the seat pan. The optional elevating seat module use one motorized linear actuator which allows the user to elevate the seat pan for easy accessing things stored in higher places.
The upholstery of the device complies with ISO 7176-16:2012: Wheelchairs -- Part 16: Resistance to ignition of postural support devices.
The device can be operated on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
The provided document is a 510(k) premarket notification for a powered wheelchair (Merits P335). It does not describe an AI/ML powered medical device, an imaging device, or diagnostic software. Therefore, the requested information about acceptance criteria for an AI/ML device, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or data provenance is not applicable to this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Permobil F3 FWD Powered Wheelchair). The acceptance criteria described are in the form of compliance with various ISO and IEC standards related to powered wheelchairs, and the "study" is the non-clinical testing performed to confirm adherence to these standards.
Here's the relevant information based on the document:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are implicitly meeting the requirements of the listed international standards (ISO and IEC). The reported device performance is that the "results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device."
| STD No. | Title of Standard | FDA Rec. No. | Reported Device Performance |
|---|---|---|---|
| ISO 7176-1:2014 | Determination of Static Stability | 16-195 | Passed |
| ISO 7176-2:2017 | Determination of Dynamic Stability of electric | ||
| wheelchairs | 16-202 | Passed | |
| ISO 7176-3:2012 | Determination of effectiveness of brakes | 16-192 | Passed |
| ISO 7176-4:2008 | Energy consumption of electric wheelchairs and | ||
| scooters for determination of theoretical distance | |||
| range | 16-162 | Met | |
| ISO 7176-5:2008 | Determination of overall dimensions, mass and | ||
| maneuvering space | 16-163 | Met | |
| ISO 7176-6:2018 | Determination of maximum speed, acceleration and | ||
| deceleration of electric wheelchairs | 16-204 | Met | |
| ISO 7176-7:1998 | Method of Measurement of Seating and Wheel | ||
| Dimensions | 16-196 | Met | |
| ISO 7176-8:2014 | Requirements and test methods for static, impact and | ||
| fatigue strengths | 16-197 | Passed | |
| ISO 7176-9:2009 | Climatic tests for wheelchairs | 16-167 | Met |
| ISO 7176-10:2008 | Determination of obstacle-climbing ability of | ||
| electrically power wheelchairs | 16-164 | Met | |
| ISO 7176-11:2012 | Test dummies | 16-190 | Used as specified |
| ISO 7176-13:1989 | Determination of coefficient of friction of test surfaces | 16-25 | Met |
| ISO 7176-14:2008 | Power and control systems for electrically powered | ||
| wheelchairs and scooter- Requirements and test | |||
| methods. | 16-165 | Met | |
| ISO 7176-15:1996 | Requirements for Information Disclosure, | ||
| Documentation and Labeling | 16-27 | Met | |
| ISO 7176-16:2012 | Resistance to ignition of postural support devices | 16-191 | Met |
| ISO 7176-21:2009 | Requirements and test methods for electromagnetic | ||
| compatibility of electrically powered wheelchairs and | |||
| scooters, and battery chargers. | 16-166 | Met | |
| ISO 7176-25:2013 | Batteries and charger for powered wheelchairs | 16-194 | Passed |
| ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: | ||
| Evaluation and testing within a risk management | |||
| process | 2-258 | Compliant | |
| IEC60601-1-2:2020 | Medical electrical equipment - Part 1-2: General | ||
| requirements for basic safety and essential | |||
| performance - Collateral Standard: Electromagnetic | |||
| disturbances - Requirements and tests | 19-36 | Met |
2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device, and testing is performed according to the specified standards (e.g., durability cycles, static/dynamic stability tests), not on a "test set" of data in the AI/ML sense. Data provenance is not specified beyond "non-clinical testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical medical device meeting performance standards is established by adherence to the objective criteria and methodologies outlined in the international standards, not by expert consensus on a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI-powered device or a diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is compliance with established international performance and safety standards for powered wheelchairs (e.g., ISO 7176 series, IEC 60601-1-2) which involve objective measurements and tests.
8. The sample size for the training set: Not applicable. There is no AI/ML component; therefore, 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).