(77 days)
QbTest provides clinicians with objective measurements of hyperactivity, impulsivity, and inattention to aid in the clinical assessment of ADHD. QbTest results should be interpreted only by qualified professionals.
The QbTest is a 15 minute, non invasive test that has been developed to provide precise quantitative assessment of the capacity of children to pay attention to visual stimuli while inhibiting their loco motor activity and controlling their urge to respond impulsively. There are three cardinal disturbances in Attention-Deficit Hyperactivity Disorder (ADHD) impaired attention, hyperactivity and impulsivity. QbTest provides an accurate and reproducible measure of a child's capacity in each of these three domains by utilizing a consistent challenge paradigm coupled with detailed real-time measurements of behavior and performance. The fundamental core of QbTest is a computer-administered go/not-go vigilance response task combined with motion capture.
The system consists of the following components;
• Client PC software
• Connection box
• Responder button
• Camera for motion measurement
• Reflective marker
• USB and serial cable
The provided 510(k) summary for the QbTest device does not contain a detailed study demonstrating acceptance criterion, or tables of acceptance criteria and reported device performance. It focuses on establishing substantial equivalence to a predicate device (OPTAx System K020800) and outlines the device's intended use and technical characteristics.
However, based on the information provided, we can infer some details and highlight the missing information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the given 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device by stating that the QbTest "provides the same or similar functions and has a similar design" and that "The new characteristics do not affect safety or effectiveness." It also mentions "Performance Testing" for the camera (EN60825-1:1994) and the system (EN 60601-1 and EN 60601-1-2), which are safety and electrical compatibility standards, not clinical performance acceptance criteria for ADHD assessment.
To completely answer this question, a clinical study summary with specific performance metrics (e.g., sensitivity, specificity, accuracy, precision for hyperactivity, impulsivity, and inattention measurements) and their corresponding acceptance thresholds would be required.
2. Sample Size Used for the Test Set and Data Provenance
This information is not explicitly provided in the given 510(k) summary. The document does not describe a specific clinical performance test set, its sample size, or the provenance (country of origin, retrospective/prospective) of any clinical data used to support the device's effectiveness.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given 510(k) summary. Since no specific clinical performance test set or ground truth establishment method is described, details about experts or their qualifications are absent.
4. Adjudication Method for the Test Set
This information is not provided in the given 510(k) summary. Given the absence of a described clinical test set, an adjudication method would not be detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
This information is not provided in the given 510(k) summary. The document does not mention any MRMC studies or a comparison of human reader performance with and without AI assistance. The QbTest described is an objective measurement tool for ADHD, not an AI-assisted diagnostic aid for human readers in the context of image interpretation, which is typical for MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The QbTest, as described, is a standalone algorithm/device for objective measurement. The "Intended use" states, "QbTest provides clinicians with objective measurements...to aid in the clinical assessment of ADHD." It's an independent diagnostic aid, not a component meant to be integrated into a human's judgment process during real-time interpretation. Therefore, its performance would inherently be "standalone." However, a specific study detailing its standalone performance independent of human interpretation for making a diagnosis is not described here. The provided text refers to the device itself as providing the objective measurements.
7. The Type of Ground Truth Used
This information is not explicitly provided in the given 510(k) summary. For a device like QbTest, ground truth for "hyperactivity, impulsivity, and inattention" would typically involve:
- Clinical diagnosis of ADHD (or absence of ADHD) made by qualified clinicians using established diagnostic criteria (e.g., DSM-IV, DSM-5).
- Behavioral observations or other psychometric assessments.
The document implicitly suggests that the QbTest measurements aid in this clinical assessment, implying that the clinical assessment itself (likely expert consensus based on established criteria) serves as the ground truth against which the QbTest's utility is evaluated, but no study details are given.
8. The Sample Size for the Training Set
This information is not provided in the given 510(k) summary. There is no mention of a "training set" or a description of machine learning model development, which would typically involve such a set. The QbTest is described as utilizing a "consistent challenge paradigm coupled with detailed real-time measurements of behavior and performance," suggesting its output is based on pre-defined algorithms rather than a trained machine learning model in the modern sense.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (see point 8), the method for establishing its ground truth is also not provided.
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