Search Results

The intended use of the Model DX Micro-Computer Control is to activate and control power wheelchair motion.

The Model Dx Controller is a series of electronic, microcomputer based, motion control devices for use with power wheelchairs. Their intended function and use is to activate and control power wheelchair motion. Additionally, they provide a method of adjusting, selecting and programming the type of power wheelchair performance characteristics which best suit the specific control needs of the wheelchair user. The Dx product line includes a motor controller power module with microprocessor, and a variety of joystick options and accessories which are used to perform various functions. The power module, which contains the system microprocessor, is housed in a pressure die cast aluminum enclosure. The power module stores preprogrammed operating functions, processes user inputs and issues commands to the wheelchair motors. The joystick options are used to engage wheelchair motion and to steer the chair. The options and accessories are used to program the wheelchair performance parameters and to perform additional functions as needed by the wheelchair user.

This submission does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the way a diagnostic or AI-driven device would. The Invacare Model Dx Micro-Computer Controls for Power Wheelchairs is a control system for mobility, and the provided document focuses on its substantial equivalence to previously cleared predicate devices and its compliance with a relevant ISO standard for safety and performance in its operational context.

Here's an analysis based on the provided text, addressing the requested points where applicable, and noting when the information is not present:

1. A table of acceptance criteria and the reported device performance
   • Acceptance Criteria: The primary acceptance criterion mentioned is compliance with ISO 7176:1993(E) "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs." Specific quantitative criteria within this standard are not listed in the provided text (e.g., maximum speed deviation, response time, etc.).
   • Reported Device Performance: The document states: "Results indicate that the Dx Controller meets the requirements of this standard." No specific performance metrics or values are reported beyond this general statement of compliance.

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 text. The document mentions "tested for compliance," but does not detail the nature of the test set (e.g., how many wheelchairs, how many controllers, data 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 question is more applicable to diagnostic devices or those requiring expert interpretation of results. For a power wheelchair control system tested against an ISO standard, "ground truth" would typically refer to objective measurements of the device's performance against the standard's specifications, not human expert consensus on interpretations. Therefore, this information is not applicable/not provided in the context of this device and study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   • Similar to point 3, adjudication methods are typically used for expert review and consensus in studies involving subjective interpretation (e.g., medical image assessment). For compliance testing against a technical standard, objective measurement and verification are expected, not expert adjudication. This information is not applicable/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 device is not an AI-assisted diagnostic tool. An MRMC study is not applicable to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   • This concept is typically relevant for AI algorithms. While the Dx Controller is a "microcomputer-based" system, its function is inherently "human-in-the-loop" as it takes user input (joystick) to control wheelchair motion. The compliance testing would assess the system's performance as a control system, which inherently involves its interaction with the wheelchair and a user's input, even if testing is automated to simulate user input. A "standalone" performance without the concept of user interaction or the wheelchair it controls is not applicable in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   • For this device, the "ground truth" is defined by the specifications and test methods outlined in ISO 7176:1993(E). Performance measurements were taken and compared against the defined thresholds and requirements of this international standard.

8. The sample size for the training set
   • This question pertains to machine learning models. The Dx Micro-Computer Control is a deterministic, pre-programmed control system, not a device that learns from a training set. Therefore, a "training set" is not applicable.

9. How the ground truth for the training set was established
   • As there is no training set for this type of device, this information is not applicable.

Ask a specific question about this device