Search Results

The Titan 4W is a mobility assistive device for indoor use on mild terrain. It is not used as a transportation vehicle on roads and freeways used by cars.

The Titan 4W scooter is an electrically powered scooter. It is intended to be used by individuals that are able to walk, but suffer from mobility limitations. The user must have sufficient arm and leg strength to get on and off the Titan 4W alone and to safely steer under all driving conditions. The Titan 4W is intended for indoor use and outdoor use. The Titan 4W has reflectors and lights, which should be used in the dark or in limited visibility conditions. The Titan 4W can be folded and disassembled into two parts. This allows for easy storage and enables portability of the Titan 4W.

The provided document is a 510(k) summary for the Titan 4W, a motorized three-wheeled vehicle (scooter). It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment relevant for an AI/ML medical device.

The "Performance Testing" section mentions that several standards were met and a "Usability Study validated the system's usability by the intended user." This implies testing was done, but the specifics requested in your prompt regarding acceptance criteria and performance metrics for a medical device are not provided in this document.

Therefore, I cannot fulfill your request for the specific details you've asked for, as they are not present in the provided text.

Specifically, I cannot extract:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics or thresholds are mentioned, other than compliance with general standards.
2. Sample sized used for the test set and the data provenance: No information on sample sizes for any tests, nor data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this document does not describe a study involving expert-established ground truth for a diagnostic or AI/ML output.
4. Adjudication method: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable; this device is a physical mobility aid, not an AI/ML interpretative tool.
6. Standalone (i.e. algorithm only without human-in-the-loop performance): Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device for a physical mobility aid, not an AI/ML-driven diagnostic or interpretative tool.

Ask a specific question about this device