(206 days)
The intended use of the Freedom Sciences Motion Control Module is to allow for remote motion control of a powered wheelchair while the wheelchair is unoccupied. It is not intended for use when a person is seated in the wheelchair.
The Freedom Sciences Motion Control Module for powered wheelchairs is a wireless, remote control product designed for use with powered wheelchairs. Its intended function and use is to allow for remote motion control of a powered wheelchair only while the wheelchair is unoccupied. It is not intended for use when a person is seated in the wheelchair.
The MCM allows for remote motion control of a differential drive power wheelchair using high level motion control commands. It interfaces to the power wheelchair using the host wheelchair attendant control interface on the motor controller. This method of interfacing with the powered wheelchair retains all configured safety interlocks inherent to the host motor controller itself and is the standard means for integrating auxiliary input devices.
The provided 510(k) Premarket Notification for the Freedom Sciences LLC Motion Control Module (K073330) indicates that the device's performance was evaluated against a specific FDA guidance document. However, it does not provide specific quantitative acceptance criteria or reported device performance metrics in a table format. Instead, it states that the device "met the applicable required performance criteria and functioned as intended."
Based on the provided document, here's an analysis of the study and the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Overall Performance | "Met the applicable required performance criteria" as outlined in FDA's July 26, 1995, draft publication: "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles." | "Functioned as intended" and "met the applicable required performance criteria." |
Note: The document only provides a high-level statement that the criteria were met, without detailing the specific criteria or quantitative results.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that the MCM "was tested as required" by the FDA guidance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The document does not provide information on the number of experts, their qualifications, or how ground truth was established for any test set. Given the nature of the device (a remote control for an unoccupied wheelchair), it is unlikely that "expert ground truth" in the clinical imaging sense would be applicable. The testing would likely involve engineering and functional performance evaluations.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. This type of method (e.g., 2+1, 3+1) is typically relevant for studies involving human interpretation or subjective assessments, which do not appear to be central to the performance testing of this device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported. This type of study is relevant for evaluating human performance (e.g., radiologists interpreting images) with and without AI assistance, which is not applicable to this device.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
The device itself is designed for standalone operation (remote control of an unoccupied wheelchair by a human operator, but the device itself is "standalone" in automating the control signals) without human-in-the-loop performance in the sense of an AI assisting human decision-making. The performance data section refers to general compliance with a guidance document for wheelchairs, implying a standalone functional assessment of the device's ability to control the wheelchair remotely. However, the document does not explicitly describe a "standalone" algorithmic performance study in the context of typical AI/software device submissions.
7. Type of Ground Truth Used
The document does not explicitly state the "type of ground truth" used. For this type of device, "ground truth" would likely be defined by the successful execution of remote control commands, adherence to safety protocols (e.g., not allowing control while occupied), and compliance with electrical and mechanical safety standards specified in the referenced FDA guidance. This would be functional verification rather than clinical "ground truth" like pathology or outcomes data.
8. Sample Size for the Training Set
The document does not provide any information about a training set. This is not an AI/machine learning device, so the concept of a "training set" is not applicable in the typical sense.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/machine learning device, there is no training set mentioned, and therefore, no ground truth establishment for a training set.
§ 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).