(27 days)
The intended function and use is to provide mobility to persons limited to a sitting position that have the capability of operating a powered wheelchair.
The purpose of this pre-market notification is to request marketing clearance from FDA to change the controller of certain power wheelchairs models, manufactured by Invacare Corporation, which have already been granted marketing clearance by FDA under separate submissions.
The controller change applies to the Invacare Pronto Powered Wheelchair Series (K012927, 9/19/2001), and the Nutron Powered Wheelchair Series (K900565, 2/15/1990). Each of these devices are battery powered, motorized mobility vehicles. Their intended function and use, which has not changed, is to provide mobility and transportation to physically challenged persons that may be restricted to a seated position.
The controller for the Nutron and Pronto Series of Wheelchairs is being modified from the Invacare MKIV-RII controller to the Invacare MKV-NX controller. The Invacare MKV-NX controller, which is the subject of this premarket notification, is an electronic, microcomputer based. motion control device designed for use with Invacare powered wheelchairs. The intended function of the controller is to activate and control powered wheelchair motions. Additionally, it provides a method of adjusting, selecting and programming certain powered wheelchair performance characteristics to better suit the specific control needs of the user.
Two versions of the controller will be available. These are the MKV-NX and the MKY-NX LP. The MKV NX version has full programming capability, while the MKV-NX LP version has limited programming capability. Programming capability for the LP version is limited to forward speed, turning speed, and reverse speed only. Otherwise the controllers are identical.
The Invacare MKV-NX and MKV-NX LP controllers are programmed using the Invacare MIV remote programmer, previously cleared with the Model MCC-MKIV Micro Computer Control (K940972, 6/2/1994). The controller software and electronics will not allow wheelchair operation during programming.
The provided text describes a 510(k) premarket notification for a modification to power wheelchairs, specifically a change in the controller. The document primarily focuses on establishing substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and performance data for the modified device.
Therefore, many of the requested details about acceptance criteria, sample sizes, expert ground truth, and comparative effectiveness studies are not present in the provided text.
Here's a breakdown of what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document states:
"The Invacare Elevating Seat meets the applicable requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991) and ISO Standard ISO 7176: 1993(E), 'ISO Standard, Wheelchairs -Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs.'"
This indicates the types of standards against which performance was assessed. However, specific numerical acceptance criteria (e.g., maximum speed, minimum turning radius, battery life) and the actual reported performance values are not provided in this summary.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC/14 (1991) | Met |
| ISO 7176: 1993(E) | Met |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "the Invacare Elevating Seat" meeting standards, but doesn't specify if this refers to the new controller or a separate component, nor does it detail a specific test set, its size, or provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided and is not relevant to this type of device submission, which references engineering standards rather than diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This information is not provided and is not applicable to a power wheelchair controller. This type of study is relevant for diagnostic AI devices, not mobility devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a physical controller for a power wheelchair. The "performance data" refers to its ability to meet engineering safety and functional standards. The concept of "standalone" performance in the context of an algorithm's diagnostic accuracy is not applicable to this device. The controller functions as an integral part of the human-in-the-loop system (the user operating the wheelchair).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this type of engineering device, "ground truth" would be established by objective measurements against the specified performance parameters in the ANSI/RESNA and ISO standards (e.g., speed measurements, control response times, stability tests). The specific method for establishing these ground truths (e.g., specific test equipment, calibrated sensors) is not detailed in this summary.
8. The sample size for the training set
9. How the ground truth for the training set was established
These questions are typically relevant for machine learning algorithms. While the controller is "electronic, microcomputer based," the document does not describe it as an AI/ML device that requires a "training set" in the conventional sense. Therefore, this information is not provided and likely not applicable to this type of device submission.
§ 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).