Search Results

The e-Throne Folding Wheelchair, Model : ET-12F22 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 e-Throne Folding Wheelchair, Model: ET-12F22 is a powered wheelchair that is designed to fold when not in use so it can be more easily transported in a car trunk or similar space. It uses rechargeable lithium batteries and is controlled by a joystick and a few other simple controls which are located on the end of the armrest. The joystick assembly may be installed on either side of the chair to accommodate both right-handed and left-handed users.

The e-Throne Folding Wheelchair consists of two foldable armrests, a back rest, a seat cushion, a foldable frame, two rear drive wheels with hub motor and electromagnetic brake assemblies, two pivoting casters, a single Li-ion battery pack, an off-board battery charger, a control panel (joystick) with connect cables and an electric motor controller. The device is powered by one Li-ion battery pack (24V, 15 Ah), which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.

This document is a 510(k) Premarket Notification for a powered wheelchair, the e-Throne Folding Wheelchair, Model: ET-12F22. As such, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing against recognized standards, rather than providing a detailed clinical study demonstrating the device meets specific acceptance criteria in the manner of a new diagnostic or AI-driven medical device.

Therefore, many of the requested criteria for describing an AI/diagnostic device study (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of submission. This document describes a traditional medical device (a powered wheelchair) and its performance is assessed through compliance with established international standards for wheelchairs.

Here's a breakdown of the available information regarding "acceptance criteria" and "proof" within the context of this document:

1. A table of acceptance criteria and the reported device performance:

The acceptance criteria are generally established by the international standards themselves, and the reported "performance" is compliance with those standards. The document states that the device "complied with the requirements" of several ISO and IEC standards. It doesn't present specific quantitative acceptance criteria in a table with corresponding measured performance values, but rather indicates a qualitative "compliance."

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

• Sample Size: Not explicitly stated as a number of devices. "Bench testing" or "non-clinical testing" implies testing on one or more physical units manufactured according to design specifications. For compliance with standards, often a representative sample or specific test units are used. This is not a study on a data "set" in the way an AI model is evaluated.
• Data Provenance: The testing was "lab bench testing or other non-clinical way." The location of the testing facilities is not specified, but the manufacturer is based in China. This is not "retrospective or prospective" in the sense of a clinical data collection.

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 a study requiring expert ground truth for interpretation (e.g., medical image interpretation). The "ground truth" is defined by the requirements of the international engineering standards themselves, and the testing is performed by accredited laboratories or qualified engineers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. See point 3.

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 a hardware medical device, not an AI-assisted diagnostic tool or reader study.

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

• Not Applicable. See point 5.

7. The type of ground truth used:

• Engineering Standards and Specifications: The "ground truth" is adherence to established international performance and safety standards (ISO and IEC series for wheelchairs, electrical safety, biocompatibility, and risk management). For example, a brake system's effectiveness is "proven" by meeting the stopping distance requirements outlined in ISO 7176-3.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning model; therefore, there is no "training set."

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

• Not Applicable. See point 8.

In summary:

This document is a 510(k) submission for a powered wheelchair, demonstrating substantial equivalence through compliance with recognized performance and safety standards. The "acceptance criteria" are the thresholds or requirements defined within these standards, and "proof" is provided through non-clinical bench testing confirming the device meets these requirements. It does not involve AI, image interpretation, or clinical trials with human readers/experts to establish ground truth in the way a diagnostic AI device would.

Ask a specific question about this device