(147 days)
The intended use of the Pride Mobility Products Corporation device is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.
The Jazzy Elite 6 is a Powered Wheelchair having a digital controller, electrical system, motors, batteries, seating, and frame. The Jazzy Elite 6 is equipped with electronic regenerative disc brakes, 3A off-board battery charger, removable 12 volt batteries, drive wheels, and front and rear caster wheels.
The Jazzy Elite 6 is designed with ultimate safety, stability, and performance in mind. The Powered Wheelchair is designed for, but not limited to Pride Mobility Products Corporation, providers/retailers and their consumers.
The provided document describes the Jazzy Elite 6 Powered Wheelchair and its substantial equivalence to a predicate device, the Jazzy Frontie (K092961). The information focuses on non-clinical testing and comparison rather than a study involving human readers or a standalone algorithm.
Here's a breakdown based on your request, highlighting what is and isn't available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance to applicable Testing Standards: | Jazzy Elite 6 passed all necessary testing. (No specific numerical performance metrics are provided in this document beyond compliance.) |
| - RESNA WC Vol.1 2009 - Requirements and Test Methods for Wheelchairs (Including Scooters) | Compliant |
| - RESNA WC Vol. 2 2009 - Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems | Compliant |
| - ANSI/RESNA WC Vol. 2-2008 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility. | Compliant |
| - CAL 117 - Flammability Testing | Compliant |
| - ISO 10993 - Biocompatibility Testing | Compliant |
| Substantial Equivalence to Predicate Device (Jazzy Frontie K092961) in terms of: | Determined to be substantially equivalent. |
| - Performance | Similar |
| - Maneuverability | Similar |
| - Stability | Similar |
| - Structure | Similar |
| - Position of electronics and drive mechanisms | Similar to achieve the same intended use function that enables the user to maintain optimum stability without hindering performance. |
| - Intended Use | Same |
| - Technological Characteristics | Similar; differences do not raise any new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance:
This document describes non-clinical testing of a powered wheelchair, not a test set for an AI/algorithm-based device. Therefore, the concept of "sample size for the test set" and "data provenance" in the context of clinical data is not applicable. The testing involves physical tests on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document describes physical testing and compliance with engineering standards, not a study requiring expert-established ground truth for an algorithm.
4. Adjudication method for the test set:
This information is not applicable for the reasons stated above.
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. The device is a powered wheelchair, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device itself is a physical product (a powered wheelchair), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the Jazzy Elite 6 is established through compliance with recognized industry standards and regulatory requirements (e.g., RESNA, ANSI/RESNA, CAL 117, ISO 10993). This involves objective measurements and evaluations against specified criteria for safety, performance, and functionality of the physical device. It is not based on expert consensus for a diagnostic outcome or pathology.
8. The sample size for the training set:
This is not applicable as the document does not describe the development or testing of an AI algorithm that would require a training set.
9. How the ground truth for the training set was established:
This is not applicable for the reasons stated above.
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is referred to as "Non-Clinical Testing" and the "Comparison to Predicate Devices."
The document states:
- "Compliance to applicable Testing Standards is as follows (See 7F for FDA-3654 forms):" followed by a list of RESNA, ANSI/RESNA, CAL 117, and ISO 10993 standards.
- "The Jazzy Elite 6 Powered Wheelchair has the same intended use and similar technological characteristics as the Jazzy Frontie (K092961), moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Jazzy Elite 6 is substantially equivalent to the predicate device, has passed all the necessary testing, and is considered to be safe for user operation."
In essence, the "study" is a series of engineering and safety tests conducted on the physical device to ensure compliance with established standards, and a direct comparison of its design and performance against a previously cleared predicate device (Jazzy Frontie K092961). The specific details of these tests (e.g., how many units tested, exact results for each parameter within the standards) are not provided in this summary but are referenced as having been performed and demonstrating compliance.
§ 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).