Search Results

The Extreme X8 Power Wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair.

The Extreme X8 Power Wheelchair is designed for everyday use for both indoor and outdoor environments including care facilities and private residences. The subject device is intended to provide mobility to persons who are restricted or limited to a sitting position. The Extreme X8 Power Wheelchair is a battery powered, electric motor driven device that can be used on both indoor and outdoor surfaces (i.e., concrete, asphalt, indoor flooring such as carpet, gravel, grass, and bark/woodchips).The Extreme X8 Power Wheelchair offers two basic seating options: MPS and Rehab. The MPS option is more static and does not allow for additional aftermarket cushions. The Rehab option is more adjustable to adhere to recommendations from the user's physician or physical therapist.

The provided text is a 510(k) summary for a powered wheelchair, not an AI/ML medical device. Therefore, the information requested in the prompt, which is specific to AI/ML device studies (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set sample size), is not applicable and cannot be extracted from this document.

The document discusses the substantial equivalence of the "Extreme X8 Power Wheelchair" to a predicate device, focusing on non-clinical testing for performance, EMC and electrical safety, biocompatibility, and software in the context of general medical device safety and effectiveness.

Here's a breakdown of the relevant information provided, tailored to the context of a non-AI/ML medical device for which the prompt's questions are not appropriate:

1. Acceptance Criteria and Reported Device Performance:

The acceptance criteria are implicitly defined by compliance with various ISO standards for wheelchairs. The reported device performance is that the "Extreme X8 Power Wheelchair has undergone testing to ensure that any differences in technological characteristics (i.e., battery, castor wheels, and no anti-pitch mechanism) do not affect safety and effectiveness when compared to the predicate device."

The study proving the device meets these criteria is the non-clinical testing summarized in the "Summary of Non-Clinical Testing" section. This testing demonstrated that the Extreme X8 Power Wheelchair does not raise new issues of safety or effectiveness compared to the predicate device, leading to a conclusion of substantial equivalence.

The following numbered points from the prompt cannot be answered as they pertain to AI/ML device studies, and this document is for a physical medical device (powered wheelchair):

2. Sample sizes used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Ask a specific question about this device