Search Results

The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.

The Model XW-LY001 Electric wheelchair is powered by Li-ion battery, driven by DC motor. Users control direction and adjust speed by controller. It is suitable to be used in low speed, good road condition and small slope. The electric wheelchair consists of two foldable armrests, a backrest, a seat cushion, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, a Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. The subject device has 8 inch front wheel and 12.5 inch rear wheel. The motor of electric wheelchair is DC24V 200W; the battery is 25.2V 10.4Ah Li-ion battery; the charger is DC 24V, 2A. Max. loading can not be over than 125Kgs, and its maximum speed is 6km/h. The braking time is about 2-3s,and the braking distance is ≤1.5m

The provided FDA 510(k) summary (K200423) for the Electric Wheelchair (XW-LY001) details non-clinical tests to demonstrate substantial equivalence to a predicate device (K170787). This document does not describe a study involving an AI device or a comparative effectiveness study with human readers. Therefore, several aspects of your request related to AI performance, human reader improvement, and ground truth establishment for AI models cannot be addressed from the given text.

Based on the provided information, here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are its compliance with various ISO and IEC standards for wheelchairs and the demonstration of substantial equivalence to a predicate device. The reported device performance is presented as compliance with these standards and a comparison of its characteristics to the predicate device.

The "study that proves the device meets the acceptance criteria" is described as "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." (page 5, "7.0 _Non-Clinical Test Conclusion"). These tests demonstrated compliance with the listed ISO and IEC standards.

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

The document does not specify a "test set" in the context of data or AI model evaluation. The tests conducted were non-clinical performance and safety tests of the physical wheelchair device. The provenance of the data is not applicable in this context as it refers to physical testing results against engineering standards.

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

Not applicable. This is not an AI device or a diagnostic device where expert ground truth would be established for image or data interpretation. The "ground truth" here is the pass/fail criteria defined by the ISO and IEC standards.

4. Adjudication method for the test set

Not applicable, as there is no human adjudication of a test set in the context of this device's non-clinical safety and performance testing.

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

Not applicable. This is not an AI-assisted diagnostic or interpretation device. No MRMC study was performed or is relevant to this submission.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

The "ground truth" for the device's performance is adherence to the specifications and performance metrics outlined in the various international standards (ISO and IEC) for wheelchairs and medical devices. These standards define the acceptable range or criteria for parameters like static stability, dynamic stability, braking effectiveness, energy consumption, dimensions, maximum speed, strength, climatic performance, obstacle climbing, power/control systems, electromagnetic compatibility, battery safety, and biocompatibility.

8. The sample size for the training set

Not applicable, as this is not an AI device that requires a training set.

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

Not applicable, as this is not an AI device that requires a training set or ground truth establishment for AI models.

Ask a specific question about this device

It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The Scooter (Models: R-100) is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk, but suffer from mobility limitations. It has a base with aluminum alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a control panel, an electric motor, an electromagnetic brake, a rechargeable battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the direction control lever, speed control switch and handle on the control panel. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually.

The provided document is a 510(k) premarket notification from the FDA for a scooter (motorized three-wheeled vehicle). It is not an AI/ML medical device submission. Therefore, the information required to address the acceptance criteria for an AI/ML device, such as acceptance criteria in terms of performance metrics (sensitivity, specificity, AUC), sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, or MRMC studies, is not present in this document.

The document discusses the regulatory process for clearing a non-AI medical device and demonstrates its substantial equivalence to a predicate device based on non-clinical performance testing against established international standards for wheelchairs and scooters.

Here's a breakdown of why I cannot fulfill the request with the provided text:

• Device Type: The device is a "Scooter, Model: R-100," a motor-driven transportation vehicle, not an AI/ML-driven diagnostic or analytical tool.
• Study Type: The "study" refers to non-clinical performance tests conducted to verify compliance with standards and demonstrate substantial equivalence to a predicate device. There is no mention of clinical studies, AI algorithm performance evaluation, or human reader studies.
• Acceptance Criteria for AI: The concept of sensitivity, specificity, AUC, or other AI performance metrics, as well as the methodology for evaluating AI (e.g., test/training sets, ground truth, expert adjudication, MRMC) are completely absent because they are irrelevant to this type of device.
• Ground Truth: The "ground truth" for a physical device like a scooter is its physical performance and safety characteristics as measured against engineering standards (e.g., static stability, dynamic stability, brake effectiveness, speed, range, weight capacity). It's not a diagnostic "truth" established by experts.
• Sample Size: "Sample size" in this context would likely refer to the number of scooters tested, not data samples for an AI algorithm. This information is not explicitly provided, only that "Non clinical tests were conducted to verify that the proposed device met all design specifications."

To reiterate, the document contains no information that would allow me to populate the requested table or answer the questions related to AI/ML device acceptance criteria and study methodology.

Ask a specific question about this device