(97 days)
The Ruike 3331 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.
The Ruike 3331 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
The Ruike 3331 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
The provided text is a 510(k) summary for the Ruike 3331 scooter. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance. Medical devices, especially those like electric scooters, are often evaluated against established performance standards and demonstrated substantial equivalence through detailed comparisons of specifications and intended use.
Therefore, the requested information components related to acceptance criteria, specific study designs (like MRMC or standalone performance), ground truth, and expert evaluation are not present in this type of regulatory submission. The 510(k) process primarily relies on comparing the new device to a legally marketed predicate device.
Here's an analysis based on the information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document states:
"There are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness."
This suggests that the "acceptance criteria" are implicitly met by demonstrating that any performance differences between the Ruike 3331 and the predicate device (LANDLEX P100X) are minor and do not impact safety or effectiveness. No specific quantitative performance metrics or acceptance criteria are listed.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is not a study reporting on a test set in the traditional sense of a clinical or performance study with a sample size. It's a regulatory submission demonstrating substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth establishment with experts is not part of a substantial equivalence submission for this type of device.
4. Adjudication Method for the Test Set
Not applicable.
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 physical medical device (an electric scooter), not an AI/software-as-a-medical-device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used
Not applicable. The "ground truth" in this context is the predicate device's established safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that involves a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary based on the document:
The regulatory submission for the Ruike 3331 scooter aims to demonstrate substantial equivalence to a previously cleared device, the LANDLEX P100X (K060042). The core "study" (or comparison) for this type of device involves:
- Comparison of Intended Use: Both devices are "intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position."
- Comparison of Device Description: Both are battery-operated, controlled by a tiller handle and thumb-operated throttle.
- Comparison of Performance Specifications: The document states "minor differences in performance specifications," but crucially, these differences "do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness." This implies that while specific numbers aren't given, the differences were assessed and deemed not to negatively impact safety or effectiveness compared to the predicate.
Therefore, the "acceptance criteria" for the Ruike 3331 were met by demonstrating that it is as safe and effective as its predicate device, the LANDLEX P100X, based on a direct comparison of features and performance, rather than a clinical trial with specific performance metrics and acceptance thresholds.
§ 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).