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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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(111 days)
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(196 days)
The Electric Mobility Cavalier Scooter is intended to serve the needs of individuals who have limited mobility.
Not Found
This document is a 510(k) clearance letter from the FDA to Electric Mobility Corporation for their "Cavalier Scooters". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document only confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulations the company must follow.
Therefore, I cannot provide the requested information based on the provided text.
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(142 days)
The Electric Mobility RASCAL Power Wheelchair is intended to serve the needs of individuals who have very limited mobility and a reduced capacity to steer or maneuver a wheelchair without some type of power assistance. While this product is specifically targeted to the outdoor market, its design is adaptable for indoor use as well. It is substantially equivalent to several power chairs currently on the market as described later in this application. It is extremely stable and durable and it is designed to carry up to 250 pounds on our standard unit and 400 pounds on our heavy duty unit. It is capable of operating over smooth indoor surfaces, or moderately rough, moderately soft, and uneven outdoor surfaces. It is capable of negotiating small obstacles and its spring suspension provides for a smooth ride and easier handling.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a power wheelchair. It does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the format requested. The document primarily focuses on the FDA's determination of substantial equivalence to a predicate device and regulatory compliance.
Therefore, I cannot provide the requested information.
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