(159 days)
The Merits Model P322 Powered Wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Model P322 Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the PG power wheelchair VR-2 50amp controller. The user interface is a joystick. P322 is powered by two 12 VDC 34ah (U1) batteries. The batteries are charged by 4A 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 28km (18mi). The chair frame is a rived nut and welded steel construction and includes two front drive wheels with drive units (including motor, gear, 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 upholstery of the device complies with EN 1021-1/-2:2006: Furniture: Assessment of the ignitability of upholstered furniture: Ignition source: Smouldering cigarette/ Match flame equivalent
The device can be operated on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
The document describes a 510(k) premarket notification for the Merits Model P322 Powered Wheelchair. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel efficacy. Therefore, the "acceptance criteria" discussed are primarily related to meeting established performance standards for powered wheelchairs, and the "study" is a series of non-clinical tests to show compliance with these standards.
Here's the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Standard/Test | Description/Purpose (Acceptance Criteria) | Reported Device Performance |
|---|---|---|---|
| Stability | ISO 7176-1:1999 | Determination of Static Stability | Meets specifications |
| ISO 7176-2:2001 | Determination of Dynamic Stability of electric wheelchairs | Meets specifications | |
| Braking | ISO 7176-3:2003 | Determination of effectiveness of brakes | Meets specifications |
| Range/Power | ISO 7176-4:2008 | Energy consumption for determination of theoretical distance range | Up to 28km (18mi) on fully charged batteries; Meets specifications |
| Dimensions/Maneuvering | ISO 7176-5:2008 | Determination of overall dimensions, mass and maneuvering space | Meets specifications |
| Acceleration/Deceleration | ISO 7176-6:2001 | Determination of maximum acceleration and deceleration of electric wheelchairs | Meets specifications |
| Seating/Wheel Dimensions | ISO 7176-7:1998 | Method of Measurement of Seating and Wheel Dimensions | Meets specifications |
| Strength/Durability | ISO 7176-8:1998 | Requirements and test methods for static, impact and fatigue strengths | Meets specifications |
| Environmental | ISO 7176-9:2009 | Climatic tests for wheelchairs | Meets specifications |
| Obstacle Climbing | ISO 7176-10:2008 | Determination of obstacle-climbing ability of electrically power wheelchairs | Meets specifications |
| Test Dummies | ISO 7176-11:1992 | Test dummies (Standard for test methodology) | N/A (Standard for test design) |
| Friction Coefficient | ISO 7176-13:1989 | Determination of coefficient of friction of test surfaces | Meets specifications |
| Control Systems | ISO 7176-14:2008 | Power control systems for electrically powered wheelchairs and scooters - Requirements and test methods | Meets specifications |
| Information/Labeling | ISO 7176-15:1996 | Requirements for Information Disclosure, Documentation and Labeling | Meets specifications |
| Electrical Safety | IEC 60601-1:1988 | General requirements for safety | Meets specifications |
| EMC | IEC 60601-1-2:2007 | Electromagnetic Compatibility Requirements and Tests | Meets specifications |
| Risk Management | ISO 14971:2007 | Application of risk management to medical devices | Meets specifications |
| Upholstery Ignitability | EN 1021-1:2006 | Ignition source: Smouldering cigarette | Complies |
| EN 1021-2:2006 | Ignition source: Match flame equivalent | Complies |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical testing of the Merits Model P322 Powered Wheelchair. This type of testing typically involves one or more physical units of the device being subjected to standardized tests in a laboratory setting. There is no specific sample size mentioned (e.g., "N=X wheelchairs tested"), nor is there information about data provenance in terms of country of origin or retrospective/prospective nature, as these concepts usually apply to clinical studies with human subjects or real-world data. The tests are prospective in the sense that they are performed on the device to demonstrate compliance.
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 section is not applicable to this type of device and submission. The "ground truth" for the performance tests of a powered wheelchair is defined by the technical specifications and requirements of the ISO, IEC, and EN standards listed. The "experts" involved would be the engineers and technicians performing the tests, qualified in understanding and executing these specific technical standards. Their qualifications are not detailed in the submission, as it's assumed they are competent to perform the standard tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices, to resolve disagreements among human readers or experts on ground truth determination. For engineering performance tests, the outcome is typically an objective measurement against a defined standard.
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 is not applicable. MRMC studies are relevant for diagnostic devices (often AI-assisted) where human interpretation of medical images or data is involved. This submission is for a powered wheelchair, which does not involve human readers interpreting AI outputs.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. A powered wheelchair is a physical device, not an algorithm. The "standalone performance" refers to the device's ability to meet the specified performance metrics (e.g., stability, braking, range) on its own, which is precisely what the non-clinical tests demonstrate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the Merits Model P322 Powered Wheelchair's performance is established by international and national engineering and safety standards (ISO, IEC, EN). Compliance with these standards serves as the objective measure of the device's technical performance and safety. There is no expert consensus, pathology, or outcomes data used as ground truth in this context.
8. The sample size for the training set
This is not applicable. This device is a physical product (a powered wheelchair) and does not involve AI or machine learning, which rely on training data sets.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this 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).