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The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

WT-T4SU is for indoor or outdoor uses, and it is Lithium-ion battery powered and configured with four solid wheels, a seat, a turning tiller, and a control panel.

WT-T4SU is driven by two PU solid rear wheels (7.28" x 1.96") and steered by two PU solid castors (7.28" x 1.96"). The user can control the turning tiller to control the castors to steer the scooter's direction. Control panel has 3 functions of battery level indication, speed lever and forward/reverse selector. The user can pull the speed lever to drive forward or drive backward. Release the speed lever completely and the electromagnetic brake in the motor will be activated automatically, and the scooter will stop.

The maximum weight capacity of WT-T4SU is 264 lbs. (120 kg). Its maximum forward speed is 4 mph (6.4 km/h), and its maximum safe climbing incline angle is 6 degrees. The cruising range is 6.61 miles (10.58 km).

The provided document is a 510(k) premarket notification for an Electrical Scooter (WT-T4SU). It focuses on demonstrating substantial equivalence to a predicate device (WT-T4QP2), rather than providing detailed acceptance criteria and performance data for an AI/ML-driven medical device. Therefore, the requested information regarding acceptance criteria, study design for AI/ML performance, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in this document.

The document primarily describes the physical characteristics, intended use, and non-clinical performance tests (e.g., electrical safety, stability, mechanical strength) conducted to ensure the new scooter meets established standards for motorized wheelchairs and scooters. It compares the specifications of the new device to its predicate and discusses why differences do not raise new safety or effectiveness concerns.

To answer your request, here's what can be extracted and what cannot:

What can be extracted:

• Device Name: Electrical Scooter, WT-T4SU
• Predicate Device Name & 510(k) number: Electrical Scooter, model WT-T4QP, K222729
• Indications for Use: The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
• Type of Ground Truth (for non-clinical tests): Testing against established medical device standards (e.g., ISO, ANSI AAMI ES).
• Sample Size for Test Set: Implicitly, the test set for non-clinical performance tests would be the device itself or test units, not a patient population. The document lists numerous standards for testing.
• Data Provenance: Not explicitly stated as "retrospective" or "prospective" in the context of an AI study, but the tests are likely conducted in a controlled lab environment. The manufacturer is Wu's Tech Co., Ltd. from Taiwan.

What cannot be extracted from this document:

• A table of acceptance criteria and reported device performance related to AI/ML. This document pertains to a physical medical device (an electrical scooter), not an AI/ML-driven diagnostic or therapeutic device. The "performance" discussed refers to physical attributes like speed, range, and loading capacity, and compliance with various safety and performance standards for scooters.
• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) for an AI/ML algorithm evaluation.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience) for an AI/ML algorithm evaluation.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set for an AI/ML algorithm evaluation.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
• The sample size for the training set (for an AI/ML algorithm).
• How the ground truth for the training set was established (for an AI/ML algorithm).

In summary, this document is a regulatory submission for a physical medical device (an electrical scooter) and does not contain the information requested about AI/ML device acceptance criteria and study design.

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