(28 days)
The intended use of the Pride Mobility Products Corporation Jazzy Frontie is to provide mobility to disabled persons having limited walking capabilities. The intended use of the Jazzy Frontie is to provide mobility to those who are limited to a seated position that have the capability of operating a Powered Wheelchair.
The Jazzy Frontie is a Powered Wheelchair having a digital controller, electrical 140 outly motors, batteries, seating, and frame. The Jazzy Frontie is equipped with electronic, regenerative disc brakes, off-board battery charger, removable 12 Volt U1 batteries, front anti-tip wheels, and rear caster wheels. The Jazzy Frontie has a depth adjustable fold flat seat that provides fast, simple adjustment for enhanced, personalized comfort that is removable.
The provided text is a 510(k) summary for a powered wheelchair, the Jazzy Frontie. It details the device's description, intended use, and comparison to a predicate device, as well as non-clinical testing performed. However, it explicitly states "N/A" for "Discussion of Clinical Testing Performed."
Therefore, based on the provided document, the following points regarding acceptance criteria and a study proving the device meets them cannot be answered:
- A table of acceptance criteria and the reported device performance: Not provided. The document focuses on regulatory compliance through non-clinical testing and substantial equivalence.
- Sample size used for the test set and the data provenance: Not applicable as no clinical study was performed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study was performed.
- Adjudication method for the test set: Not applicable as no clinical study was performed.
- 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 as no clinical study was performed, and the device is a powered wheelchair, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as the device is a powered wheelchair, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no clinical study was performed.
- The sample size for the training set: Not applicable as no clinical study that would require a training set was performed.
- How the ground truth for the training set was established: Not applicable as no clinical study that would require a training set was performed.
The document primarily relies on non-clinical testing and substantial equivalence to a predicate device (Pride Mobility Jet 1, K001970) to demonstrate safety and effectiveness.
Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing and Substantial Equivalence):
| Acceptance Criteria (Implied by Standards Compliance) | Reported Device Performance (Summary) |
|---|---|
| Safety and Performance Standards: | Compliance Demonstrated Through Testing: |
| RESNA WC Vol.1 2008 DRAFT - Requirements and Test Methods for Wheelchairs (Including Scooters) | "passed all the necessary testing" |
| RESNA WC Vol. 2 2008 DRAFT - Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems | "passed all the necessary testing" |
| ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility | "passed all the necessary testing" |
| IEC 601-1-1 Medical Electrical Equipment, General Requirements for Safety | "passed all the necessary testing" |
| CAL 117 - Flammability Testing | "passed all the necessary testing" |
| Substantial Equivalence to Predicate Device: | "The Jazzy Frontie is substantially equivalent to the Pride Mobility Jet 1 (K001970) when comparing performance, maneuverability, stability, and structure." |
| Similar intended use | "The Jazzy Frontie Powered Wheelchair has the same intended use." |
| Similar technological characteristics | "similar technological characteristics as the Jet 1 (K001970)" |
| No new questions of safety or effectiveness | "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." |
Study Proving Acceptance Criteria Met:
The study proving the device meets the acceptance criteria is non-clinical testing in conjunction with a substantial equivalence comparison to a predicate device.
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Non-Clinical Testing: The device underwent testing to comply with various standards including:
- RESNA WC Vol.1 2008 DRAFT
- RESNA WC Vol. 2 2008 DRAFT
- ANSI/RESNA WC Vol. 2-1998 Section 21
- IEC 601-1-1
- CAL 117
The document states the device "passed all the necessary testing."
-
Substantial Equivalence Study: A comparison was made to the predicate device, Pride Mobility Jet 1 (K001970), demonstrating that the Jazzy Frontie
- Has the same intended use.
- Has similar technological characteristics.
- Does not raise new questions of safety or effectiveness due to any differences in technological characteristics.
In summary, no clinical study was performed or required for the 510(k) clearance of the Jazzy Frontie powered wheelchair. The evidence supporting its safety and effectiveness is based on adherence to recognized non-clinical performance standards and a demonstration of substantial equivalence to an already legally marketed 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).