(474 days)
QbCheck provides health care professionals with objective measurements of hyperactivity, and inattention to aid in the clinical assessment of ADHD and in the evaluation of treatment interventions in patients with ADHD. Q6Check results should be interpreted only by qualified health care professionals.
QbCheck is a non-invasive test that has been developed to provide precise quantitative assessment of the capacity of an individual to pay attention to visual stimuli and inhibit impulses. There are three cardinal disturbances in Attention-Deficit Hyperactivity Disorder (ADHD); impaired attention, hyperactivity and impulsivity. QbCheck provides an accurate and reproducible measure of an individual'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 QbCheck is a computer-assisted attention and impulse control task and simultaneous recording of activity. QbCheck is an online solution and no extra hardware is needed as the test is performed on the user's own computer. For the activity tracking analysis QbCheck uses the built in camera in the user's laptop or a separate web camera on the user's desktop computer. QbCheck consists of the following;
● QbCheck client and server software
. Online test with instructions, a continuous performance task (CPT) and motion measurement technology through web camera.
- Access to a remote server which generates test results .
- Secure access to a result report
- User manual ●
- Technical manual
- QbCheck Behavior Observation Form .
The QbCheck device provides objective measurements of hyperactivity, impulsivity, and inattention to aid in the clinical assessment and treatment evaluation of ADHD.
Here's a breakdown of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical acceptance criteria in a dedicated table format with reported performance. However, it states that QbCheck is substantially equivalent to its predicate device, QbTest (K133382). This implies that its performance is considered comparable to the predicate for its intended use. The primary difference highlighted is the use of a webcam for motor activity tracking instead of an infrared camera and reflective marker, and the use of the spacebar instead of a responder button.
The substantial equivalence determination is the "acceptance criterion" in this context, demonstrating that the device performs as intended and is as safe and effective as a legally marketed device.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for a specific "test set" solely to demonstrate performance against acceptance criteria for this K143468 submission. However, it references a comparison to the predicate device, QbTest (K133382). Clinical studies for the predicate would contain this information.
Regarding data provenance for QbCheck, the document states: "For the activity tracking analysis QbCheck uses the built in camera in the user's laptop or a separate web camera on the user's desktop computer." This implies the data is generated from users performing the test. The document does not specify country of origin or whether studies were retrospective or prospective for this specific submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not detail the number or qualifications of experts used to establish ground truth for a test set for the QbCheck device itself. The interpretation of QbCheck results is stated to be "only by qualified health care professionals," which implies that clinical judgment from trained professionals would form the basis of actual ADHD diagnosis and evaluation.
4. Adjudication Method for the Test Set:
Given the information provided, there is no mention of an adjudication method (like 2+1, 3+1) for a test set directly comparing QbCheck's output against a "ground truth" established by experts. The focus of this 510(k) summary is on demonstrating substantial equivalence to the predicate device through technological comparison and intended use similarity.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The submission focuses on substantial equivalence based on technical characteristics and intended use similar to the predicate QbTest.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The document describes QbCheck as a "computer-assisted attention and impulse control task and simultaneous recording of activity." Its results are intended to "aid in the clinical assessment," and "QbCheck results should be interpreted only by qualified health care professionals." This structure implies it is a tool to be used with human interpretation, not a standalone diagnostic that makes decisions without human-in-the-loop performance. Therefore, a standalone study without human interpretation of results would not be appropriate for its indicated use.
7. The Type of Ground Truth Used:
The document makes no explicit mention of the type of ground truth (e.g., expert consensus, pathology, outcomes data) used in a study to establish the diagnostic accuracy of QbCheck itself. The predicate device, QbTest, and by extension QbCheck, provide "objective measurements of hyperactivity, impulsivity, and inattention," which aid in clinical assessment of ADHD. The "ground truth" for ADHD diagnosis typically involves a comprehensive clinical evaluation by qualified healthcare professionals based on diagnostic criteria (e.g., DSM-5), which may include parental/teacher reports, clinical interviews, and behavioral observations, in addition to objective measures like those provided by QbCheck.
8. The Sample Size for the Training Set:
The document does not specify the sample size used for any training set for QbCheck.
9. How the Ground Truth for the Training Set Was Established:
The document does not specify how ground truth for any training set was established.
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