Search Results

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 Mobility Scooters, Models: W3431Q, W3431R, have a base with Steal frame, two front wheel, two rear wheels, a seat, a tiller console, electric motor, electromagnetic brake, 2 rechargeable Lead-acid Batteries with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. 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 Scooter only can be operated on the flat road.

The provided document is a 510(k) Summary for a Mobility Scooter (Models: W3431Q, W3431R). This type of regulatory submission is for a medical device that aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or significant improvements over existing technology through clinical studies.

Therefore, the acceptance criteria and study that proves the device meets those criteria are not related to a traditional clinical trial or AI/imaging performance metrics. Instead, the "acceptance criteria" here refer to demonstrating that the new device meets established safety and performance standards relevant for a mobility scooter and is substantially equivalent to a previously cleared device.

Here's an analysis based on the provided document, addressing the prompt's points where applicable for this type of submission:

Acceptance Criteria and Device Performance (for a Mobility Scooter)

The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to a predicate device (K220206) and compliance with relevant international standards for wheelchairs and mobility scooters (ISO 7176 series and ISO 10993 for biocompatibility). The study undertaken to prove this involved non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a number of devices tested. The non-clinical tests typically involve testing one or more units of the device to confirm compliance with each specified standard. Given the nature of mechanical/electrical testing, typically a representative sample or even a single unit is sufficient if it demonstrates compliance.
• Data Provenance: The testing was non-clinical (laboratory/bench testing) performed by the manufacturer, Zhejiang Innuovo Rehabilitation Devices Co.,Ltd in China. The data would therefore be prospective from these tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. For this type of device and submission, "ground truth" as it relates to expert consensus or clinical diagnosis (e.g., in AI/imaging) is not relevant. The "truth" is established by adherence to the engineering and performance standards (ISO series) and comparison to the predicate device. The experts involved would be engineers and technicians proficient in conducting these specific ISO tests.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1 or 3+1) are for resolving discrepancies in expert interpretations of clinical data, which is not part of this 510(k) submission for a mobility scooter. The "results" are objective measurements and compliance statements against defined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is not relevant for this device. It is a method used to evaluate diagnostic performance (e.g., of an AI algorithm or a new imaging modality) involving multiple human readers interpreting cases. This submission focuses on the mechanical, electrical, and safety performance of a mobility scooter against established engineering standards and comparison to a predicate device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This is not an AI/algorithm-based device. "Standalone performance" is relevant to AI's diagnostic accuracy without human intervention. This device is a mobility scooter.

7. The Type of Ground Truth Used

• Engineering/Performance Standards and Predicate Device Specifications. The "ground truth" for this submission is defined by the technical specifications and performance requirements outlined in the ISO 7176 series of standards (e.g., static stability must meet ISO 7176-1) and the demonstrated performance of the legally marketed predicate device (e.g., maximum speed, braking distance). The tests confirm that the new device's performance aligns with or is sufficiently similar to the predicate and meets safety standards.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/machine learning device, so there is no training set in the context of data used to train an algorithm. "Training" for this device would refer to the manufacturing processes and quality control, not data training.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no "training set" in the context of AI, this question is not applicable. The design and manufacturing of the device would follow established engineering principles and quality management systems to meet the desired performance characteristics.

Ask a specific question about this device