(36 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The COMFORT SCOOTER, LY-EW408 is an indoor / outdoor Electric Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
The provided text describes the submission of a 510(k) premarket notification for a medical device, the COMFORT SCOOTER, LY-EW408. This document focuses on demonstrating substantial equivalence to a predicate device, not on presenting a study with specific acceptance criteria and detailed performance metrics as one might find for an AI/ML medical device.
Therefore, many of the requested elements for acceptance criteria and study design are not applicable to this type of regulatory submission. The goal here is to show the new device is as safe and effective as a legally marketed one, not to quantify its performance against pre-defined accuracy thresholds using a clinical study involving experts and ground truth.
Here's an attempt to address your request based on the provided text, highlighting what is (and isn't) present:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
The "acceptance criteria" in this context refer to the demonstration of substantial equivalence to a predicate device (COMFORT SCOOTER LY-EW415 (K063032)). The criteria are broad comparisons of features, safety, and functionality rather than specific statistical performance thresholds.
| Acceptance Criteria Category (Implied by Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use | Met: The device is intended for medical purposes to provide mobility to persons restricted to a seated position, which is the same as the predicate. |
| Technological Characteristics (Overall Dimensions & Appearance) | Met (with minor differences): Overall dimensions and visual appearance are similar. The new device has smaller dimensions, which is presented as an improvement (can fit into most ordinary car trunks, more convenient for moving and turning). This difference is not presented as a compromise in safety or effectiveness. |
| Technological Characteristics (Electronic Systems) | Met: Electronic systems (controller, batteries, recharger) are from the same suppliers and are UL certificated, ensuring safety and performance equivalent to the predicate. |
| Technological Characteristics (Materials) | Met: Back upholstery is made of the same material and passed the resistance ignition test by SGS, ensuring material safety is equivalent to the predicate. |
| Technological Characteristics (Mechanical Design) | Met: Suspension of cross brace, footplates, incline degree (12°), armrest type, and warranty are all the same, ensuring mechanical stability and user experience are equivalent to the predicate. |
| Performance (Safety & Functions) | Met: "The safety and performance functions of two systems are assured and validated." (This is a general statement rather than specific metrics, relying on the equivalence of components and design.) |
| Performance (Maximum Speed) | Met (with minor differences): 1.0 mph difference in maximum speed. This difference is deemed not significant because the throttle allows continuous adjustment, and operators can set adequate speeds for indoor/outdoor use. This difference is not considered to impact overall performance or safety negatively. |
| Performance (Battery Charger) | Met (with minor differences): Battery charger types are "almost the same," with a difference in output electric current (4A for new, 5A for predicate). This difference relates to charging period or battery capacity, not safety aspects, and is therefore considered substantially equivalent. The chargers are UL certificated as part of the overall electronic system. |
| Compliance with Standards | Met: Performance testing included EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (for Electrically Powered Wheelchairs, controller, and their chargers). These standards demonstrate compliance with recognized safety and performance requirements for such devices. |
Regarding the other desired information points:
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Sample size used for the test set and the data provenance:
- N/A. This submission is for a physical medical device (Electric Scooter) and does not involve an AI/ML algorithm or a "test set" of data in the manner implied by the question. Performance testing involved compliance with engineering standards (e.g., EMC, wheelchair standards) on the device itself, not on a dataset.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No "ground truth" establishment by experts on a test set of data is described. Device performance testing is against established engineering and safety standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No test set or adjudication method as described is applicable here.
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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:
- N/A. This is a physical mobility device, not an AI-assisted diagnostic or clinical decision support tool. No human reader studies are described.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This does not involve an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. The "ground truth" for this device's performance is adherence to recognized engineering standards for safety and functionality, and verification of components' certifications (e.g., UL, SGS).
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The sample size for the training set:
- N/A. This is a hardware device, not an AI/ML algorithm requiring a training set.
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How the ground truth for the training set was established:
- N/A. Not applicable for this type of device.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).