(244 days)
Quickie Powered Wheelchairs empower physically challenged persons by providing a means of mobility.
Quickie powered wheelchairs consist of typical features found on any wheelchair, such as push handles, adjustable armrests, backrest, seat frame and cushion, footrests, and casters. Because these are motorized wheelchairs, they also consist of joy stick controller, motors, brakes, batteries and drive wheels.
The provided text describes a 510(k) submission for a change in the controller of a powered wheelchair. This is a medical device submission, but it primarily focuses on engineering and performance testing related to the wheelchair's functionality and safety, rather than a clinical study evaluating diagnostic or therapeutic efficacy.
Therefore, many of the typical acceptance criteria and study details relevant to AI/diagnostic medical devices (such as sample size for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, training sets, etc.) are not applicable or not provided in this document.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maximum and minimum forward/reverse speeds are within acceptable range. | Performs as predicate device. |
| Maximum turn speeds are within acceptable range. | Performs as predicate device. |
| Maximum and minimum acceleration/deceleration are within acceptable range. | Performs as predicate device. |
| Maximum and minimum turn acceleration/deceleration are within acceptable range. | Performs as predicate device. |
| Brake distance is comparable to predicate device. | Performs as predicate device. |
| Electromagnetic compatibility (EMI) standards are met. | Passes the 20 V/m EMI test. |
| Controller software meets requirements, design, development, and verification/validation. | Software validation information includes requirements, design, V&V, hazards, and mitigation. |
| Overall performance is substantially equivalent to predicate devices. | Demonstrated substantial equivalence to previous Quickie wheelchairs and other P&G 8 controller models. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The testing described is likely on a limited number of physical units of the Quickie Power Wheelchair with the new P&G controller.
- Data Provenance: The testing was conducted on the Quickie Power Wheelchair with the P&G Controller. The data would be prospective, as it was generated from testing the new configuration. The country of origin is not explicitly stated but can be inferred as the US, given the submission to the FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is not a study requiring expert interpretation of diagnostic images or data. Ground truth here refers to engineering specifications and measurements, which are established by engineers and adherence to industry standards, not medical experts.
4. Adjudication method for the test set
- Not Applicable. Not a clinical study requiring adjudication of expert opinions. Performance is measured against predefined engineering specifications.
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
- No. This type of study is not relevant to a powered wheelchair controller change.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. The "device" here is a physical wheelchair system, not an AI algorithm. Its performance is inherent in its physical operation.
7. The type of ground truth used
- Engineering Specifications and Predicate Device Performance: The "ground truth" for this submission is established by:
- Predefined engineering parameters (e.g., speed ranges, acceleration limits).
- The performance characteristics of the previously approved Quickie wheelchair with the Dynamics controller (predicate device).
- The performance characteristics of other commercially available wheelchairs using the P&G 8 controller (other predicate devices).
8. The sample size for the training set
- Not Applicable. This submission does not involve an AI algorithm that requires a "training set" in the machine learning sense. The controller's software is developed and validated, not "trained" on a dataset.
9. How the ground truth for the training set was established
- Not Applicable. (See point 8)
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APR 2 8 1997
Appendix F
Summary of Safety and Effectiveness for Quickie Powered Wheelchair with Penny and Giles Controller
August 22, 1996
Quickie Designs Inc. Powered Wheelchair
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Submitter Quickie Designs Inc. 2842 Business Park Ave. Fresno, CA 93727 209-292-2171 Fax-209-292-2741 Dave Counts
Date summary was prepared 8/21/1996
Name(s) of the device
P300
Identification of predicate device(s) P100, P110, P190, P500, P500, P200, P210, P320, P300 Earnest and Jennings Lancer 2000, Sabre, Sabre ES Prode Health Care Inc. Jazzy
Description of the device
Quickie powered wheelchairs consist of typical features found on any wheelchair, such as push handles, adjustable armrests, backrest, seat frame and cushion, footrests, and casters. Because these are motorized wheelchairs, they also consist of joy stick controller, motors, brakes, batteries and drive wheels.
Intended Use
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Quickie Powered Wheelchairs empower physically challenged persons by providing a means of mobility.
Comparison of device characteristics to predicate
This 510(k) is for a change in the wheel chair controller. The power wheelchair specifications have not been changed due to this modification. The New controller subject to this 510(k) is the P&G Controller that has been available on other lines of power wheelchairs, including Pride Health Care's Jazzy, Everst and Jennings Lancer 2000 and Sabre, and Hoveround Personal Mobility Vehicles.
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Everest and Jennings recently made the same switch in controllers as Quickie; replacing the Dynamics Controller with a P&G 8 controller.
The P&G controller is based on Hitachi's H8/532 microprocessor while Dynamics is based on Motorola's 68HC705C8. The power wheelchair specifications have not been changed due to this modification.
Non clinical testing
Testing of all programmable parameters has been performed. These parameters include the following: maximum and minimum forward and reverse speeds, maximum turn speeds, maximum and minimum acceleration and deceleration, and maximum and minimum turn acceleration and deceleration. Comparative testing regarding speed, acceleration, brake distance demonstrate that the wheelchair performs as the predicate device with the Dynamics controller. Results demonstrate the wheelchairs perform according to specification. Electromagnetic compatibility testing was also performed on Quickie Power Wheelchairs, and results demonstrate that the wheelchairs pass the 20 Software validation information includes the software requirements, design, V/m EMI test. development and verification and validation of the controller as well as a hazards and mitigation associated with the safety of the controller.
K963381 510(k) Number
Not Known at the writing of this summary.
Conclusion
The Quickie Power Wheelchair is Substantially Equivalent to the previous versions of the Quickie Wheelchairs which utilize the Dynamics controller as well as other power wheelchair models which already incorporate the P&G 8 controller.
§ 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).