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

WT-T4QP2 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-T4QP2 is driven by two PU solid rear wheels (7.28" x 1.96") and steered by two PU solid castors (6.49" 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-T4QP2 is 250 lbs. (115 kg). Its maximum forward speed is 4 mph (6.4 km/h), and its maximum safe climbing incline angle is 6 degrees.

This FDA 510(k) summary describes a new medical device, the Electrical Scooter, model WT-T4QP2, and compares it to a predicate device, the i3 Foldable Mobility Scooter (K191356), to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: This 510(k) is for a medical mobility scooter. The "acceptance criteria" discussed are primarily related to safety and performance standards for wheelchairs and motorized scooters, with a strong emphasis on demonstrating equivalence to a previously cleared predicate device. There is no AI component in this device, so questions related to AI performance, such as MRMC studies, human reader improvement with AI, or standalone AI performance, are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not present a formal "acceptance criteria" table in the way one might expect for a diagnostic device with specific performance metrics (e.g., sensitivity, specificity). Instead, the acceptance criteria are implicitly defined by compliance with a set of international and national performance standards for wheelchairs and motorized scooters, and by demonstrating substantial equivalence to the predicate device across various specifications.

The "reported device performance" is primarily the device's adherence to these standards and a comparison of its specifications with the predicate.

Similar or Different but not raising new S&E concerns in: Overall Dimensions, Wheel sizes, Battery, Charger type & rating, Battery weight, Motor, Max Forward Speed, Height adjustable tiller (difference mitigated by safety claim), Back upholstery (difference mitigated by ISO 7176-16 pass), Maximum safe operational incline (difference mitigated by labeling), Weight w/ Battery and w/o Battery (difference mitigated by no S&E concerns), Cruising Range (difference mitigated by labeling), Max Loading (difference mitigated by labeling), Turning Radius (advantage to subject device), Electronics controller (difference mitigated by RESNA WC-2:2019 Section 14 pass), Ground clearance (difference mitigated by labeling), Curb climbing (difference mitigated by labeling). |

Studies and Information Provided:

Since this is a filing for a non-AI medical device (an electric scooter), the typical questions about AI performance metrics (sensitivity, specificity, AUROC, MRMC, etc.) are not applicable. The "study" here refers to non-clinical performance and safety testing.

2. Sample size used for the test set and the data provenance:

• The document describes performance testing against various ISO and RESNA standards. This testing is typically conducted on a limited number of manufactured units, rather than a "test set" from a patient population. The exact sample size (number of scooters tested) is not specified, but it would align with standard engineering and regulatory testing practices for device robustness and functionality.
• Data provenance: This would be prospective testing conducted by the manufacturer or accredited labs on the actual device units. The country of origin for the data is implicitly Taiwan, where the manufacturer is located, or potentially international testing labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This concept is not directly applicable. "Ground truth" for an electric scooter is defined by whether it successfully meets the specified performance parameters of the ISO and RESNA standards (e.g., "does it stop within X distance?" "does it maintain stability at Y incline?"). This is determined through objective measurements and test protocols, not expert consensus in a clinical sense. The "experts" would be the engineers and technicians conducting the tests and interpreting the results against the standard's requirements.

4. Adjudication method for the test set:

• Not applicable in the context of objective engineering performance testing. Compliance is determined by direct measurement against quantitative thresholds defined in the standards.

5. 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:

• No, this device does not involve AI. Therefore, an MRMC study or any assessment of AI assistance is not relevant or performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No, this device does not involve AI. Therefore, standalone algorithm performance is not relevant.

7. The type of ground truth used:

• For the performance tests: Objective measurements against defined thresholds in international and national engineering standards (ISO 7176 series, RESNA WC-2 series).
• For biocompatibility: Laboratory test results (Cytotoxicity, Sensitization, Irritation) against biological endpoints defined by ISO 10993 standards.

8. The sample size for the training set:

• Not applicable. This is a hardware device without an AI component that would require a "training set" of data.

9. How the ground truth for the training set was established:

• Not applicable. No training set exists for this device.

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