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The Zip'r Mantis powered wheelchair is intended for an indoor/outdoor power wheelchair that provides transportation for disabled or elderly persons limited to a seated position.
To provide mobility to disabled or elderly persons limited to a seated position.

The Zip'r Mantis powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. By providing a powered wheelchair that breaks down into three manageable components (seat set, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.

Here's a breakdown of the acceptance criteria and study information for the Zip'r Mantis powered wheelchair, based on the provided 510(k) summary:

This device is a physical product (a powered wheelchair), not an AI/software device. Therefore, the questions related to AI/software performance metrics, ground truth, expert adjudication, MRMC studies, and training/test set details are not applicable in this context. The study performed is engineering and safety testing against recognized standards.

Acceptance Criteria and Reported Device Performance

The Zip'r Mantis powered wheelchair's acceptance criteria are based on compliance with several international and national standards for wheelchairs. The study performed was a summary of non-clinical testing demonstrating this compliance.

Explanation of the Study and Why Other Information is Not Applicable:

The provided document is a 510(k) summary for a physical medical device (a powered wheelchair). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through engineering and safety testing. It is not an AI/Software as a Medical Device (SaMD) submission.

Therefore, the following points are not applicable and cannot be answered from the provided text:

• Sample size used for the test set and data provenance: This refers to data used for AI model evaluation. For a physical device, testing involves physical prototypes or production units against specified standards. The document doesn't detail the number of wheelchairs tested, but it does state they "complied with the requirements."
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: "Ground truth" and "experts" in this context typically refer to clinical or diagnostic interpretation for AI/software. For a wheelchair, ground truth is defined by the objective pass/fail criteria of the engineering standards.
• Adjudication method for the test set: Not applicable to engineering compliance testing.
• 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: MRMC studies are specific to evaluating human reader performance with and without AI assistance in interpretation tasks. This is not relevant for a powered wheelchair.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no algorithm being evaluated in a "standalone" fashion.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" is defined by the objective, quantifiable requirements outlined in the cited engineering and safety standards.
• The sample size for the training set: Not applicable, as there is no AI model requiring a training set.
• How the ground truth for the training set was established: Not applicable, as there is no AI model requiring a training set.

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