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510(k) Data Aggregation
(68 days)
The device is intended to provide mobility to persons restricted to a seated position or who are mobility impaired.
The Rascal "We Go 250" Powered Wheelchair is an indoor/outdoor use battery operated wheelchair. It has a frame with four (4) wheels, a seat, two (2) arm rests and a seat belt. The primary technology advantage of this device is that the movement of the wheelchair can be controlled by the rider or an attendant using hand controls located at the top of steering column to adjust the speed and direction of the wheelchair with occupant therein. These hand controls for the attendant are the same controls used for most electric scooters (Motorized Three Wheeled Vehicles - Regulation Number 890.3800). We currently market electric scooters with that same technology (510k K002616). The brake mechanism is activated or deactivated dependant upon the use of the hand controls located at the top of the steering column.
The base of the wheelchair is same base currently used on 510k approved device (K013788)
This document describes the 510(k) submission for the Rascal "We Go 250" Powered Wheelchair. Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Requirement | Reported Device Performance |
|---|---|
| Conformance to FDA Recognized Consensus Standards for Powered Wheelchairs | "All testing indicates that the Rascal 'We Go 250' meets its performance requirements." |
| Substantial Equivalence to Predicate Device (Merits K011687) in Intended Use | "The Rascal 'We Go 250' has the same intended use as the legally marketed device(s)" |
| Substantial Equivalence to Predicate Device (Merits K011687) in Technological Characteristics (no new safety/effectiveness questions) | "Technological characteristics that do not raise questions on the safety and effectiveness during use." "non-clinical testing and the predicate comparisons... demonstrate that any differences in their technological characteristics do not raise any questions as to safety and effectiveness." |
2. Sample Size for Test Set and Data Provenance
The document does not specify a quantitative "test set" in terms of number of units or patients. The testing appears to be focused on meeting recognized consensus standards for powered wheelchairs (Product Code ITI, Regulation Number 890-3860). This implies a series of engineering and performance tests on the device itself.
The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a country of origin for patient data. Given the nature of a powered wheelchair, the "test set" most likely refers to the manufactured device(s) undergoing physical and functional testing, not data from human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. For a powered wheelchair, "ground truth" would relate to the performance specifications and safety standards, which are established by regulatory bodies and engineering standards, not typically by clinical experts in the same way as, for example, diagnostic imaging. The "experts" involved would likely be engineers, quality assurance personnel, and regulatory specialists.
4. Adjudication Method for the Test Set
This information is not provided. Given that the testing is centered on meeting recognized consensus standards, the adjudication method would likely be compliance verification against those standards through direct measurement, inspection, and functional testing, not a consensus-based adjudication as seen in clinical studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or mentioned. This type of study is typically relevant for diagnostic or interpretive devices where human reader performance is a key metric. For a powered wheelchair, the focus is on safety, functionality, and performance in meeting established engineering standards.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study was not performed in the context of an "algorithm only" or AI system. This device is a physical powered wheelchair, not an AI-driven system that would have an "algorithm only" performance. The performance testing refers to the physical device's capabilities.
7. Type of Ground Truth Used
The "ground truth" used for this device is compliance with FDA Recognized Consensus Standards for Powered Wheelchairs. This means the device's performance was measured against established safety, functionality, and durability benchmarks defined by these standards, not against pathology, expert consensus on clinical cases, or long-term outcomes data in the typical sense.
8. Sample Size for the Training Set
This information is not applicable and therefore not provided. The "We Go 250" is a physical medical device (powered wheelchair), not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided, for the same reasons as point 8.
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