(189 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.
Quickie and Zippie wheelchairs are battery-powered, user-controlled, electric wheelchairs. All models of these wheelchairs will be offered with an optional wireless pointer control feature. This option entails adding a Bluetooth Mouse Module (BMM)—a small Bluetooth transmitter—mounted to the chair and wired into its control bus. With BMM in place, the wheelchair's controller can then use the pointer-control feature built into the BMM hardware and software. Pointer control can only be activated when the wheelchair is stationary and not actively performing wheelchair functions. The BMM lets users use the chair's joystick, or other input device, to control the pointer functions of Bluetooth-enabled devices (such as personal or tablet computers) while the chair is not in operation. The wireless pointer control feature will be offered on all models of the Quickie Pulse and Zippie ZM-310 series chairs. Technologically, all of these chair designs are identical. Model designations relate to widths and heights of their seats and various components: such as seating, wheels, and other options available. Quickie Pulse chairs are sized to fit medium to large size individuals Zippie ZM-310 chairs fit individuals of smaller stature—including children. These chairs, along with the BMM, are meant for use in healthcare facilities, in the home, outdoors, and other places of individual activity for the disabled.
The provided text is a 510(k) summary for the Quickie Pulse and Zippie ZM-310 power wheelchairs with an optional wireless pointer control feature (Bluetooth Mouse Module - BMM). It describes the device, its intended use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.
Regarding your request for "acceptance criteria and the study that proves the device meets the acceptance criteria," it's important to note that this document is for a medical device (powered wheelchair) and not an AI/ML-driven diagnostic tool. Therefore, the questions related to AI/ML performance metrics (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training set) are not applicable in this context.
The "acceptance criteria" for this device are implicitly tied to safety and functional performance, particularly regarding the added Bluetooth Mouse Module (BMM) and its impact on the wheelchair's operation and electromagnetic compatibility. The "study" that proves the device meets these criteria is the non-clinical performance testing.
Here's a breakdown of the relevant information from the document, tailored as much as possible to your request, while acknowledging that it's not an AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implicit from Testing) | Reported Device Performance |
|---|---|---|
| Operational Performance | Wireless pointer function operates without detriment to wheelchair function or features. | "Operational performance of wireless pointer function without detriment to wheelchair function or features" was achieved. |
| Wheelchair's electrical braking holds on maximum slope during BMM operation. | "Chair's electrical braking continued to hold on a maximum slope during BMM operation." | |
| Wireless pointer function properly executes on typical external Bluetooth-enabled electronic devices from wheelchair inputs. | "Wireless pointer function properly executed on typical external Bluetooth-enabled electronic device from wheelchair inputs." | |
| Electromagnetic Compatibility (EMC) | Immunity of the total chair system with BMM mounted and connected. | "Immunity of total chair system with BMM mounted and connected" was demonstrated during EMC testing. |
| No effect on chair operation during BMM activation. | "No effect on chair during BMM activation" was demonstrated during EMC testing. | |
| Software Qualification | Wireless pointer function demonstrated while the chair is not in operation. | "Wireless pointer function demonstrated while chair not in operation, qualifying the BMM and its software by successful device performance." |
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: The document does not specify a numerical sample size for the test set. The performance data section describes types of tests conducted on the device itself (e.g., "chair's electrical braking," "BMM operation," "EMC testing"). This implies testing was done on the physical device, likely prototypes or production samples, rather than a "data set" in the AI/ML sense.
- Data Provenance: Not explicitly stated, but standard practice for medical device testing like this would be in a controlled laboratory or testing facility within the manufacturer's operational region. It is not "retrospective or prospective" data in the clinical study sense; it's non-clinical engineering and functional testing.
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 an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is the physical reality of the device's function (e.g., brakes holding, wireless signal working without interference). This is typically established by engineers, technicians, and potentially regulatory compliance specialists following established test protocols.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for interpreting medical images or diagnoses where inter-reader variability exists. This document describes non-clinical performance and safety testing.
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. An MRMC study is relevant for comparing diagnostic performance, often with AI assistance in clinical settings. This device is a powered wheelchair with an added Bluetooth feature; it is not a diagnostic tool requiring human reader performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This refers to AI/ML algorithm performance. The "BMM" has software, but its "performance" is evaluated as part of the overall wheelchair system's function and electromagnetic compatibility, not as a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device is based on engineering standards and physical measurements of performance. For example:
- Brake holding capability is verified against a specific angle/load (engineering spec).
- EMC is verified against international standards (e.g., ANSI/RESNA WC2, extended frequency ranges) using proper measurement equipment.
- Wireless pointer function is verified by observing its actual function with compatible external devices.
8. The sample size for the training set
- Not Applicable. This device does not use machine learning, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for machine learning, this question is not relevant.
In summary, the provided document describes a medical device in the context of a 510(k) submission, confirming its substantial equivalence to a predicate device. The "acceptance criteria" and "studies" are focused on engineering performance, safety, and electromagnetic compatibility for the physical device system, not on AI/ML diagnostic performance metrics.
§ 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).