(107 days)
Quickie® and Zippie® power wheelchairs are battery-operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. The Zippie® power wheelchairs are specifically for people who are slightly smaller in stature-including children.
The Quickie® and Zippie® power wheelchairs are designed for indoor use at care facilities and private residences. The pediatric variant of the Quickie® Pulse 6, branded the Zippie® ZM-310, is intended to provide a slightly broader range of seating size options for people that are smaller in stature-including children. It varies from the Quickie® Pulse 6 only in having smaller seat options.
The Quickie® and Zippie® power wheelchairs are center-wheel-drive battery-powered wheelchairs which will perform optimally on firm even surfaces such as concrete, asphalt and indoor flooring.
The wheelchairs have steel and aluminum frame structure which is welded and utilizes standard foams and covers for the seat.
The braking system can be initiated by either automatic or electric means. The brakes are automatically on except when the wheelchair is turned on and the joystick has been moved away from the neutral position. When the joystick is released or moved back to neutral, the brakes engage again. If the electrical brake system fails, the brakes will default to the closed, or "brakes on" position, thereby stopping the wheelchair.
Actuators allow the seating to be adjusted to suit the user and activity.
A control system (i.e. controller and joystick) controls motor, brakes, drive wheel and batteries. This product is appropriate for use by any individual who has the ability to drive a power wheelchair without having to utilize the services of an attendant. In addition, the controls give the optional capability for attendant control. The optional drive controller R-net system provides further features. The controller is fully programmable.
This document is a 510(k) premarket notification from the FDA, approving a new powered wheelchair model as substantially equivalent to existing predicate devices. It does not contain information about acceptance criteria or a study proving that the device meets those criteria in the way typically seen for AI/ML medical devices. The performance data provided is for traditional medical device testing, not for AI algorithm performance.
Here's why the requested information cannot be fully provided based on the input:
- This is not an AI/ML device: The document describes powered wheelchairs, which are mechanical and electrical devices. There is no mention of any AI or machine learning components within these wheelchairs.
- The "study" referenced is standard medical device testing: The document describes performance data related to biocompatibility, electrical safety, EMC, software verification/validation, and mechanical testing, which are standard for non-AI medical devices. These are not "studies" in the context of proving AI algorithm performance.
- "Acceptance criteria" are for device functionality, not AI metrics: The document implies that the "acceptance criteria" are the successful completion of the described tests and adherence to relevant ANSI/RESNA Wheelchair standards, ensuring the device functions safely and effectively as a powered wheelchair. It does not relate to diagnostic performance metrics like sensitivity, specificity, or AUC, which would be relevant for an AI device.
Therefore, many of the specific fields requested about AI device performance (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance, type of ground truth for AI) are not applicable to the information contained in this FDA submission for a powered wheelchair.
However, I can extract the relevant information pertaining to the device's acceptance criteria and the tests performed to demonstrate its safety and effectiveness, interpreting them within the context of a non-AI medical device submission.
Acceptance Criteria and Device Performance (Interpreted for a Non-AI Device)
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria Met By | Reported Device Performance |
|---|---|---|
| Overall Equivalence | Demonstrated substantial equivalence to predicate devices (Quickie Rhapsody, MWD Series II Power Wheelchair, K062701; Quickie Rhythm Power Wheelchair, K083249). | "Testing carried out for the Quickie® and Zippie® power wheelchairs indicates that they meet design and performance functional requirements and function equivalently to the predicate devices meet the relevant ANSI/RESNA Wheelchair standards. This information indicates that the Quickie® and Zippie® power wheelchairs are equivalent to the predicate devices in terms of device safety and effectiveness." |
| Biocompatibility | Use of materials identical to those in the primary predicate device for patient contact. | "The materials used for the Quickie® and Zippie® power wheelchair components which have patient contact are the same as those used in the primary predicate device. Therefore, further testing was not required." |
| Electrical Safety & EMC | Compliance with relevant ANSI/RESNA Wheelchair standards for electrical safety and electromagnetic compatibility. Functional verification and device performance. | "Electrical safety and electromagnetic compatibility testing of Quickie® and Zippie® power wheelchairs was carried out... Testing established correct functionality of the wheelchairs according to the relevant ANSI/RESNA Wheelchair standards." |
| Software Verification & Validation | Software within the drive control units is identical to that of the predicate device, with a Letter of Authorization provided for the Master File access. | "The software in the two products is identical. A Letter of Authorization was provided by the supplier of the drive controller units in order access the medical device Master File for the controllers." (This implies the software meets established safety and functionality standards by being identical to a previously approved component). |
| Mechanical Testing | Compliance with relevant ANSI/RESNA Wheelchair standards for mechanical performance. Functional verification and device performance. | "Mechanical testing of Quickie® and Zippie® power wheelchairs was carried out to cover functional verification and device performance. Testing established correct functionality of the wheelchairs according to the relevant ANSI/RESNA Wheelchair standards." |
| (Non-Applicable) | Acoustic testing was not required to demonstrate device safety and effectiveness. Animal performance testing was not required to demonstrate device safety and effectiveness. Clinical testing was not required to demonstrate the safety and effectiveness. | "No acoustic testing was required to demonstrate device safety and effectiveness of the wheelchair." "Animal performance testing was not required to demonstrate device safety and effectiveness of the wheelchair." "Clinical testing was not required to demonstrate the safety and effectiveness of the wheelchair." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated as a "test set" in the context of an AI algorithm. The testing described (biocompatibility, electrical safety/EMC, mechanical) would typically involve a small number of physical samples of the manufactured device.
- Data Provenance: Not applicable in the context of AI data. The "data" here refers to the results of engineering and material tests performed on the physical wheelchairs, not patient data.
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 document pertains to the physical and functional safety of a powered wheelchair, not a diagnostic AI algorithm requiring expert-established ground truth from images or other clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This term relates to expert review for AI ground truth. For the physical device testing, adherence to standards and test protocols by qualified engineers and technicians would be the "adjudication" mechanism.
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, not applicable. This type of study is specifically for AI diagnostic/interpretive devices where human readers (e.g., radiologists) might use AI assistance. This document is about a powered wheelchair.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, not applicable. There is no standalone algorithm being evaluated as part of this device submission. The "software" mentioned controls the wheelchair's drive units, embedded in the device itself, and its functionality is assessed as part of the overall device's electrical and mechanical tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the AI sense. The "ground truth" for this device would be objective measurements and criteria defined by engineering standards (e.g., ANSI/RESNA Wheelchair standards for braking effectiveness, battery life, structural integrity, electrical safety parameters).
8. The sample size for the training set:
- Not applicable. There is no AI model that requires a training set for this device.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI model that requires a 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).