(12 days)
The intended use of the Pride Mobility Products Corp. Jazzy 600 Powered Wheelchair is to provide mobility to persons limited to a seated position.
The intended use of the Pride Mobility Products Corp. Jazzy 600 Power Wheelchair is to provide mobility to persons limited to a seated position, that have the capability of operating a powered wheelchair.
The Jazzy 600 is a battery-operated power wheelchair featuring Mid-Wheel Drive technology, rear casters, front anti-tip casters, and a standard 75 amp Pride Flight controller. The Jazzy 600 is designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.
The Jazzy 600 Power Wheelchair consists of the same basic components found on the Jazzy (K945936), such as a rigid steel frame, upholstered seat, amrests, football drive wheels, rear caster wheels and front anti-tip devices. As a motorized wheelshair substantially equivalent to the Jazzy (K945936) it also offers 2 motors for operational purposes, electronic regenerative disc brakes, suspension, onboard hattery charger, a fully programmable controller, and requires two batteries. Accessories include lap bett, rear basket, cane or crutch holder, oxygen holder, walker holder, flag holder, cup holder, saddle bag, and dust cover.
The Jazzy 600 is designed with ultimate safety, stability, and performance in mind. It features rear casters, and front anti-tip casters which allow for surface contact all times and prevents pitching on sloped terrain.
The provided document is a 510(k) premarket notification for a powered wheelchair, the Jazzy 600. It focuses on demonstrating substantial equivalence to a predicate device and includes information on non-clinical testing. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics in the way a clinical study for an AI/algorithm-based medical device would.
Therefore, I cannot fulfill your request for the specific acceptance criteria and study details as they are not present in the provided text. The document refers to "Non-Clinical Testing" which details compliance to various ANSI/RESNA WC standards. These are likely performance and safety standards for wheelchairs, not clinical efficacy metrics for an AI.
Here's a breakdown of why each numbered point of your request cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present. The document lists "Compliance to applicable Testing Standards" for non-clinical aspects like static stability, dynamic stability, brakes, dimensions, etc., but it doesn't provide specific numerical acceptance criteria or performance metrics in a table format. For example, it lists "ANSI/RESNA WC/01 Determination of Static Stability" but doesn't state what the acceptable static stability angle is or what the Jazzy 600 achieved.
- Sample sized used for the test set and the data provenance: Not applicable. The testing described is non-clinical, likely involving physical prototypes and testing equipment, not human subjects or data sets.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/algorithm performance is not relevant here.
- Adjudication method for the test set: Not applicable.
- 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. This is a powered wheelchair; it does not involve human readers or AI assistance in data interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical powered wheelchair.
- The type of ground truth used: Not applicable. The "ground truth" for a physical device like a wheelchair is compliance with engineering and safety standards, determined by physical measurements and tests.
- The sample size for the training set: Not applicable. This device is not an AI/algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary based on the provided document:
The provided document describes the non-clinical testing performed for the Jazzy 600 Powered Wheelchair to demonstrate substantial equivalence to a predicate device for its physical and mechanical performance and safety. It is not a document describing the validation of an AI or algorithm.
The non-clinical testing focuses on compliance with the following ANSI/RESNA WC standards:
- ANSI/RESNA WC/01 Determination of Static Stability
- ANSI/RESNA WC/02 Determination of Dynamic Stability
- ANSI/RESNA WC/03 Effectiveness of Brakes
- ANSI/RESNA WC/05 Overall Dimensions, Mass & Turning Space
- ANSI/RESNA WC/08 Test methods for Static, Impact and Fatigue Strengths
- ANSI/RESNA WC/09 Climatic Tests
- ANSI/RESNA WC/10 Obstacle Climbing
- ANSI/RESNA WC/15 Documentation and Labeling
- ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility.
- ANSI/RESNA WC/93 Maximum overall Dimensions
- CAL 117 - Flammability Testing
The conclusion states that the Jazzy 600 "has passed all the necessary testing procedures and is considered to be safe for user operation." This implies that the device met the requirements of these standards, but the document does not further elaborate on specific numerical acceptance criteria or performance results within these standards.
§ 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).