(6 days)
The Millennium Series Mechanical Wheelchair provides enhanced mobility to physically challenged persons limited to a sitting position.
The Millennium Series Wheelchair is manually operated mechanical wheelchair. It is designed to be durable with folding frame. The range of sizes and configurations are available to accommodate the needs of each user. The wheelchair is suitable to provide mobility to user for both indoors and outdoors with firm surface that is free of climbing obstacles.
The Millennium Series Mechanical Wheelchair consists of typical components found on most manual wheelchair. The wheelchair consists of metal frame constructed of round steel tubing that is welded, seat and back upholsteries, removable footrests/legrests, front casters and rear wheels. The upholstery fabric meets the California Technical Bulletin CAL 117 Standard for flame retardancy.
The provided text does not contain details about acceptance criteria, device performance, or a study that uses specific performance metrics (like accuracy, sensitivity, specificity, or AUC) to prove the device meets said criteria.
Instead, this document is a 510(k) submission for a mechanical wheelchair, focusing on substantial equivalence to a predicate device. Here's a breakdown of what is present and how it relates to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable. The submission does not define specific performance metrics like accuracy, sensitivity, or other quantitative measures typically found in studies for AI/software devices. For a mechanical wheelchair, "performance" is generally defined by meeting safety and functional standards, not diagnostic accuracy.
- The document states: "Required tests for mechanical wheelchair listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results are included in the subject 510(k) submission." This indicates that some testing was done, but the specific acceptance criteria and results are not detailed in this summary. They would be in the full submission, but not in a format suitable for the table requested for device performance in the context of an AI/diagnostic device.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. This is a hardware device (mechanical wheelchair). The concept of a "test set" for performance evaluation in the way it's used for AI or diagnostic devices does not apply here. There's no data (like images or patient records) being analyzed.
- Testing would likely involve physical trials on a limited number of wheelchair prototypes, but this is not a data-driven validation study for an AI algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a hardware device. There is no "ground truth" to be established by experts in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set:
- Not Applicable. As there's no "test set" in the diagnostic sense, there's no adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This directly indicates that no MRMC study or clinical comparative effectiveness study was performed or included.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not Applicable. This is a mechanical device, not an algorithm. There is no standalone algorithm performance to evaluate.
7. The Type of Ground Truth Used:
- Not Applicable. This is a mechanical device. The concept of "ground truth" as it applies to diagnostic or AI performance (e.g., pathology, clinical outcomes, expert consensus) is not relevant. The "truth" for a wheelchair would be its structural integrity, maneuverability, safety, and compliance with standards.
8. The Sample Size for the Training Set:
- Not Applicable. This is a mechanical device. There is no AI algorithm being trained, therefore no training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set.
Summary regarding your request:
The provided 510(k) summary for the Millennium Series Mechanical Wheelchairs is for a hardware (mechanical) device seeking market clearance based on substantial equivalence to a predicate device. It does not involve AI, diagnostics, or data-driven performance assessments in the way your questions are formulated. Therefore, most of the requested information (acceptance criteria for accuracy/performance metrics, sample sizes for test/training sets, expert ground truth, MRMC studies) is not applicable to this document. The "testing" mentioned refers to compliance with established standards for mechanical wheelchairs, not the type of performance evaluation relevant to AI or diagnostic software.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).