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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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QbTest provides clinicans with objective measurements of hyperactivity, and inatention to aid in the clinical assessment of ADHD (Attention Deficit Hyperactivity Disorder) an interentions in patients with ADHD. QbTest results should be interpreted only by qualified professionals.

QbTest 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. QbTest 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 QbTest is a computer-assisted attention and impulse control task and simultaneous recording of activity using an infrared camera for motion measurements.

The system consists of the following components:

• · Client software
• · Responder button (also referred to as responder unit)
• · Infrared camera
• · Reflective motion marker
• · User manual
• Technical manual
• · Stimulus card
• · Camera stand
• · Measuring tape
• · QbTest Behavior Rating Scale
• · In addition, the user must have access to a remote server that generates test reports

Here's a breakdown of the acceptance criteria and the study information for the QbTest device, based on the provided 510(k) summary:

QbTest Acceptance Criteria and Performance Study Summary

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state formal "acceptance criteria" in terms of predefined thresholds for performance metrics. Instead, it presents the results of clinical studies to demonstrate the device's ability to measure treatment effects in ADHD. The key performance indicators used are Effect Size (ES) and Agreement (NPA, PPA) with established clinical rating scales.

Important Note: The document explicitly states: "Although the ES in the above studies all show large treatment effects they must be interpreted with caution since two of the studies did not include a concurrent control arm." It also mentions, "The registry study showed statistically significant but low correlations between QbTest and the clinically validated rating scales (RS)." This suggests that while effects are detectable, agreement is not perfect, necessitating clinical evaluation alongside QbTest results.

2. Sample Sizes Used for the Test Set and Data Provenance

The "test set" in this context refers to the data used for the clinical performance evaluation for the expanded intended use (evaluation of treatment interventions).

• Registry Study (comparing QbTest with Rating Scales):

  • Pooled Cohort: 115 patients (42 children/adolescents + 73 adults)
  • Child Cohort: 42 children/adolescents (mean age 11.5, 35 male, 7 female)
  • Adult Cohort: 73 adults (mean age 35, 41 male, 32 female)
  • Data Provenance: Retrospective, from clinical centers. The child cohort consisted of Swedish children, and the adult cohort consisted of Dutch adults.

• Other Published Clinical Studies (evaluating responsiveness/effect size):

  • Study 5 (Atomoxetine vs. Placebo): 128 children with ADHD (mean age 9.0)
  • Study 6 (Methylphenidate, Dexamphetamine vs. Placebo): 36 medication-naïve children (aged 9-14 years)
  • Study 7 (Methylphenidate in Adults): 23 adults

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• The ground truth for the Effect Size (ES) was based on the change from baseline in QbTest metrics itself or in the ADHD Rating Scales (RS). The clinical diagnosis of ADHD and assessment of treatment response using rating scales would have been performed by "qualified professionals" as stated in the intended use.
• For the Agreement with Rating Scales, the "ground truth" for the rating scales (RS) was implicitly established by the application of those scales by clinicians.
• The document does not specify the number or specific qualifications (e.g., number of years of experience) of the experts/clinicians who established the diagnoses or administered the rating scales in these studies. It only refers to "qualified professionals."

4. Adjudication Method for the Test Set

• The document does not describe an explicit adjudication method for establishing ground truth from multiple experts for the clinical studies mentioned.
• For the comparison between QbTest and Rating Scales, the methods are compared directly, meaning the "ground truth" for each is independently derived (QbTest metrics vs. RS scores). The agreement (NPA/PPA) is essentially a comparison rather than an adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not described. The QbTest is described as a diagnostic aid that provides "objective measurements" to supplement clinical assessment, not as an AI system assisting human readers/clinicians in interpreting other data. The studies focused on the device's standalone ability to detect treatment effects and its correlation with traditional rating scales.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a standalone performance assessment was done in the sense that QbTest's measurements and the derived "Q-scores" are direct outputs of the device's algorithms based on patient behavior and performance during the task. The effect sizes reported for QbTest are based solely on these objective measurements, demonstrating its standalone capacity to detect changes due to treatment.
• The comparison with Rating Scales in the registry study also assesses the standalone performance of QbTest against another established standalone method (RS).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The primary "ground truth" in these studies consists of clinical diagnoses of ADHD (DSM-IV criteria mentioned) and changes in symptoms and behavior due to treatment, as measured by:
  • QbTest's objective metrics (Time active, Distance, Area, Microevents, Reaction Time Variation, Omission Errors, Commission Errors).
  • Clinically validated Rating Scales (RS) for ADHD, with a specific, clinically-derived threshold for "meaningful response" (-30% change).
  • In placebo-controlled studies, the "ground truth" for treatment effect is the difference in outcomes between the active treatment group and the placebo group.

8. The Sample Size for the Training Set

• The document does not explicitly describe a "training set" for the QbTest device's core algorithms. The QbTest is presented as a system that provides quantitative measurements based on standardized tasks and infrared motion tracking.
• The studies mentioned are for the validation of the device's ability to measure treatment effects, not for training a machine learning model. The algorithms for calculating QbTest metrics and Q-scores are expected to be established during the device's development, prior to these clinical validation studies.

9. How the Ground Truth for the Training Set Was Established

• As no explicit training set for a machine learning model is mentioned, there is no information provided on how ground truth for a training set was established.

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QbTest is indicated to be used to aid in the clinical assessment of ADHD. QbTest results should be interpreted by qualified health care professionals only.

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.

QbTest is a non-invasive test that has been developed to provide precise quantitative assessment of the capacity for 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. QbTest 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 QbTest is a computer-assisted attention and impulse control task and simultaneous recording of activity using an infrared camera for motion measurements.

The system consists of the following components:

• Client software
• Responder button (also referred to as responder unit)
• Infrared camera
• Reflective motion marker
• User manual
• Technical manual
• Stimulus card
• Camera stand
• Measuring tape
• QbTest Behaviour Rating Scale
• In addition, the user must have access to a remote server that generates test reports

The provided FDA 510(k) summary for QbTest v3.5 is a predicate device comparison, rather than a typical AI/ML medical device submission with specific performance acceptance criteria for an algorithm. Therefore, the information typically found for AI/ML device validation studies (like sensitivity/specificity, ROC curves, MRMC studies, precise ground truth establishment for a test set, etc.) is largely absent.

The submission focuses on demonstrating substantial equivalence to a previously cleared device (QbTest K040894) and the Gordon Diagnostic System (K854903) by showing similar intended use, technological characteristics, and safety/performance based on normative data collection and prior published clinical studies of the device and its predecessor.

Here's an attempt to answer your questions based on the provided text, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Strict "acceptance criteria" as you'd find in an AI/ML device validation (e.g., minimum sensitivity or specificity) are not stated in this 510(k) summary. The performance is demonstrated through:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Clinical Validation/Normative Data:
  • "Normative tests have been gathered from several different cohorts resulting in a normative database of 1307 individuals between 6 and 60 years with an even age and gender distribution." This 1307-individual dataset serves as the primary "reference" or "test set" against which individual patient performance is compared. It's not a "test set" in the sense of an independent validation set for algorithm performance, but rather a normative reference.
  • The submission also mentions "four published studies which have evaluated the clinical validity of the QbTest for its intended use population" and "two test-retest studies." The individual sample sizes for these specific studies are not provided in this summary.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the general nature of normative data collection often implies a prospective or at least a systematic retrospective collection from a defined population. The submitter is Swedish (Qbtech AB, Stockholm, Sweden), which might suggest some data from that region, but this is speculative.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

• Ground Truth for QbTest: The QbTest itself generates the objective measurements of hyperactivity, impulsivity, and inattention. The "ground truth" for ADHD diagnosis isn't established by individual experts reviewing test data; rather, the test aids qualified healthcare professionals in making the diagnosis.
• The "normative database" would have been collected from individuals (both with and without diagnosed ADHD, presumably) where their diagnostic status would have been established by qualified clinicians, but the number and qualifications of these clinicians are not specified.
• The "four published studies" and "two test-retest studies" would have involved clinical professionals to manage and interpret the data, but no specific count or qualifications are provided in this summary.

4. Adjudication Method for the Test Set

• Not applicable in the typical sense of expert review for an algorithm's output. The QbTest itself produces quantitative output. Any diagnostic "ground truth" used in the underlying clinical studies (if those studies involve comparing QbTest outputs to clinical diagnoses) would likely follow standard clinical diagnostic procedures, which may involve adjudication, but this is not described in the 510(k) summary.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No, an MRMC study is not mentioned or described. This type of study (human readers with and without AI assistance) is typically performed for imaging or diagnostic algorithms that directly influence a human reader's interpretation. QbTest provides quantitative data that aids a clinician, rather than directly modifying their interpretation of, for example, an anatomical image.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, in essence. The QbTest itself is a standalone device that measures parameters (hyperactivity, impulsivity, inattention). Its performance is assessed by how well these measurements are collected and how consistently they reflect a person's behavior/performance. The "clinical validity" studies assess the utility of these measurements in aiding ADHD assessment, which is analogous to a standalone performance evaluation of the device's output. The summary refers to "four published studies which have evaluated the clinical validity of the QbTest for its intended use population."

7. Type of Ground Truth Used

• Clinical Diagnosis/Phenotype (implicit): For the "clinical validity" studies, the "ground truth" would likely be a clinical diagnosis of ADHD (or lack thereof) made by qualified professionals, following established diagnostic criteria (e.g., DSM criteria). The QbTest's output is then correlated with or assessed for its ability to discriminate based on this clinical "ground truth."
• Observed Behavior/Performance (inherent): For the test-retest reliability studies, the ground truth is the inherent stability of an individual's performance and behavior on the test over time.
• Normative Data: The "normative database" itself serves as a "ground truth" for what is considered typical performance for a given age and gender.

8. Sample Size for the Training Set

• Not Applicable / Not Explicitly Stated. The QbTest described is a direct measurement system, not a machine learning algorithm that is "trained" on a dataset in the conventional sense. The "normative database" of 1307 individuals functions more like a reference set rather than a "training set" for an AI model.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable / Not Explicitly Stated. As it's not an ML training set, the concept of establishing ground truth for training doesn't apply directly. The "normative database" was established by collecting data from "several different cohorts" of individuals between 6 and 60 years old. The methods for this collection are described as being in the "technical manual," but not detailed here. Presumably, these were "healthy" or "typically developing" individuals to establish the "norm."

Summary of Limitations based on the provided text:

This 510(k) summary is typical for a non-AI/ML device that is seeking clearance based on substantial equivalence to an existing predicate. It heavily relies on prior clearance and existing clinical literature demonstrating the utility of the type of device. It does not provide the detailed information about AI/ML validation studies that are now common in submissions for software as a medical device (SaMD) utilizing AI/ML algorithms.

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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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