Search Results

To provide mobility to people who are unable to walk and are capable of operating a powered wheelchair.

The Cajun Commando 4x4 is an electric indoor/outdoor wheelchair. The Cajun Commando is similar in design, composition and function to the Magic Mobility Extreme 4x4-8. The Cajun Commando 4x4 does not introduce any new technology or material that departs from current industry standard or practice. The Cajun Commando 4x4 is a four wheel drive wheelchair with a controller attached to the armrest allowing the rider to control the movement of the chair.

I am sorry, but all the information that you have requested is not available in the document. The provided text is a 510(k) premarket notification for a powered wheelchair (Cajun Commando 4x4). This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparison tables and adherence to recognized standards for performance and safety. It does not contain information about the detailed acceptance criteria and study proving device meets acceptance criteria.

Specifically, the document does not contain:

• A table of acceptance criteria and reported device performance in the format you requested, although a comparison chart of specifications with a predicate device is provided.
• Sample sizes, data provenance, number of experts, adjudication methods, or ground truth details for a test set.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Details about a training set or how its ground truth was established.

What the document does provide, which is relevant to performance and safety, is:

• A comparison chart (on page 6) between the Cajun Commando 4x4 and its predicate device, the Extreme 4x4-X8 (K090350). This chart lists various specifications and characteristics like dimensions, weight, speed, range, and safety features. This indirectly serves as a set of performance specifications that the device aims to meet or be comparable to the predicate.
• A list of non-clinical data standards (on pages 8-9) to which the device was tested for safety and effectiveness. These are American National Standards for Wheelchairs (WC-1:2009 and WC-2:2009) covering aspects like:
  • Static Stability
  • Dynamic Stability
  • Effectiveness of Brakes
  • Energy Consumption (for theoretical distance range)
  • Dimensions, Mass, and Maneuvering Space
  • Maximum Speed, Acceleration, and Deceleration
  • Measurement of Seating and Wheel Dimensions
  • Static, Impact, and Fatigue Strengths
  • Climatic Tests
  • Obstacle-Climbing Ability
  • Power and Control Systems
  • Electromagnetic Compatibility

The document states that "the results of performance testing demonstrate that these differences [between the subject and predicate devices] do not raise any questions of safety or effectiveness" and that "The nonclinical data demonstrate that the Commando 4x4 is as safe, as effective, and performs as well as the Extreme X8." However, it does not provide the raw performance data or detailed study reports from these tests within this 510(k) summary. These would typically be detailed in separate test reports submitted alongside the 510(k) application, but not included in the public summary.

Ask a specific question about this device