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The intended use of the WIN-2TM Tango Elite NP is to provide mobility for a person restricted to a sitting position.

The WIN-2 Tango Elite NP is a powered wheelchair for use both indoors and outdoors. It is battery powered, has two 0.25 horsepower motors, and a controller unit with joystick. It is designed for a single rider who controls the speed and direction of the chair's movement with the joystick. It can be disassembled for transport, and a battery charger is supplied as an accessory. The only difference between the WIN-1 and the WIN-2 wheelchairs is the controller.

This device, the WIN-2™ Tango Elite NP, is a powered wheelchair. The submission is a 510(k) modification, indicating that it is largely similar to a previously cleared device. Therefore, the information provided focuses on the differences and how the new device remains substantially equivalent.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for the test set. The tests conducted were primarily related to product standards and functional aspects. The data provenance is not explicitly stated as country of origin, nor whether it was retrospective or prospective. Given the nature of wheelchair testing (mechanical, electrical, safety standards), it would typically involve physical testing of prototypes rather than human subject data in the conventional sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. Ground truth in the context of a powered wheelchair would likely be based on engineering specifications, safety standards (ANSI/RESNA), and functional performance measures. It wouldn't involve expert clinical assessment for "ground truth" in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set

This information is not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments, which are not relevant for the type of testing described here (mechanical, electrical, and safety standards for a wheelchair).

5. Multi-Reader-Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." Therefore, no MRMC study, human reader improvement effect size, or human-AI interaction was assessed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable in the context of this device. This device is a powered wheelchair; it does not involve an algorithm with "standalone" diagnostic or image analysis performance. The "algorithm" could be considered the controller's internal logic, but its performance is assessed via functional and safety tests, not as a standalone AI model.

7. Type of Ground Truth Used

The "ground truth" for this device's testing is implicitly based on:

• Engineering specifications and design requirements.
• Relevant industry standards (e.g., ANSI/RESNA Wheelchairs Vol. 2 Standard).
• Functional performance criteria (e.g., maximum speeds, maneuverability).
• Safety requirements for electromagnetic compatibility, upholstery flammability, and charger operation.

8. Sample Size for the Training Set

This information is not applicable as this device is a physical product (a powered wheelchair) and does not involve AI or machine learning models that require a "training set" of data in the typical sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

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