(29 days)
The Ruike 3421 powered wheelchair 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 3421 powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market. But the Ruike 3421 is kind oh a new class of lightweight powered wheelchair. By providing a powered wheelchair that breaks down into two manageable components (seat frame, body frame with motors and battery pack), a user can have a more practical alternative when traveling long distances by bus, train, etc.
This document is a 510(k) summary for the Ruike 3421 powered wheelchair. It does not contain information about acceptance criteria or a study proving device performance in the way typically found for AI/ML-driven medical devices.
Instead, this submission is for a physical medical device (a powered wheelchair) and relies on demonstrating "substantial equivalence" to a predicate device already on the market. Therefore, the questions related to AI/ML device evaluation (like sample sizes for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable here.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not provide a table of acceptance criteria or reported device performance in the traditional sense for an AI/ML device. For a physical device like a powered wheelchair, acceptance criteria would typically involve engineering specifications, safety standards (e.g., ISO or ANSI standards for wheelchairs), durability tests, and performance metrics like speed, range, turning radius, weight capacity, etc. The document only mentions "minor differences in performance specifications" compared to the predicate, implying that the Ruike 3421's performance is largely comparable while potentially being "a new class of lightweight powered wheelchair." However, no specific performance metrics or acceptance criteria are detailed.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable: This is a physical device, not an AI/ML diagnostic or prognostic tool that uses data for testing. The evaluation focused on substantial equivalence to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable: Ground truth establishment by experts is relevant for diagnostic accuracy studies of AI/ML algorithms. This document does not pertain to such a study.
4. Adjudication Method for the Test Set:
- Not Applicable: Adjudication is used in studies with multiple readers/experts. This document describes a traditional medical device submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC study was not done. This type of study is for evaluating the impact of AI assistance on human reader performance, which is not relevant for a physical device like a powered wheelchair.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable: "Standalone performance" refers to the performance of an algorithm without human intervention. This device is a powered wheelchair, not an algorithm.
7. The Type of Ground Truth Used:
- Not Applicable: The concept of "ground truth" (expert consensus, pathology, outcomes data) is for validating diagnostic or predictive algorithms. For this device, the "ground truth" for regulatory approval is primarily its safety and effectiveness being substantially equivalent to a legally marketed predicate device. This involves demonstrating compliance with relevant standards and functional requirements for a wheelchair.
8. The Sample Size for the Training Set:
- Not Applicable: "Training set" refers to data used to train an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable: As above, this concept applies to AI/ML algorithm development.
Summary of what the document does provide regarding the device's acceptance and study:
The acceptance of the Ruike 3421 powered wheelchair by the FDA is based on its substantial equivalence to a predicate device, the CWD01 (K062888) / EMG Technology Co. Ltd.
- Acceptance Criteria (Implied by Substantial Equivalence): The device is considered acceptable because it performs its "intended function and use" without raising "any new questions pertaining to safety or effectiveness" compared to the predicate device. This essentially means it meets the safety and basic performance expectations already established for powered wheelchairs on the market.
- Study/Evidence: The "study" for this type of submission is the 510(k) Premarket Notification itself, where the manufacturer (Shanghai Ruike Sports Goods CO., LTD.) presents a detailed comparison between their device (Ruike 3421) and the predicate device (CWD01). This comparison would typically include:
- Intended Use: Both devices are intended for indoor/outdoor transportation for disabled or elderly persons limited to a seated position.
- Technology/Design: The Ruike 3421 is "basically similar to other powered wheelchairs," but designed to be lightweight and break down into two components.
- Performance Specifications: The document states "minor differences in performance specifications" but asserts these do not alter function, safety, or effectiveness. (Specific performance data is not provided in this summary, but would have been part of the full 510(k) submission).
- Materials: (Not explicitly mentioned in the summary, but usually part of a full submission).
- Labeling and Controls: The device must comply with general controls provisions of the Act (registration, listing, GMP, labeling, etc.).
In essence, the document serves as evidence that the manufacturer has presented sufficient information to the FDA to demonstrate that their new device is as safe and effective as a legally marketed device, thus allowing it to be marketed.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).