(90 days)
The OPTAx System provides clinicians with objective measurements of hyperactivity, impulsivity and inattention to aid in the clinical assessment of ADHD. OPTAx results should be interpreted only by qualified professionals.
OPTAx (Optical Tracking and Attention test) is a 15 minute non-invasive, office-based test that was developed to provide precise quantitative assessment of the capacity of children to pay attention to visual stimuli, while inhibiting their locomotor activity and controlling their impulsive responses. The three core symptoms of Attention-Deficit Hyperactivity Disorder (ADHD) are : impaired inattention, hyperactivity, and impulsivity. OPTAx 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 OPTAx is a computer-administered GO/NO-GO vigilance response task.
The OPTAx System consists of the following components:
- . IMac computer and peripherals (printer and adapters)
- Pre-installed OPTAx software program ●
- . Motion analysis camera and peripherals
- Data analysis software on the OPTAx secure server .
Unfortunately, the provided text does not contain detailed information about the acceptance criteria or the specific clinical study that proves the OPTAx System meets such criteria.
The document is a 510(k) summary for the OPTAx System, primarily focusing on its substantial equivalence to a predicate device (Gordon Diagnostic System, K854903) for the purpose of aiding in the clinical assessment of ADHD.
Here's a breakdown of what is available and what is missing based on your request:
What is Available:
- Device Description: OPTAx is a 15-minute non-invasive, office-based test for quantitative assessment of attention, inhibition of locomotor activity, and control of impulsive responses in children. It uses a computer-administered GO/NO-GO vigilance response task.
- Intended Use: To provide clinicians with objective measurements of hyperactivity, impulsivity, and inattention to aid in the clinical assessment of ADHD.
- Comparison to Predicate: Both OPTAx and the Gordon System aid in ADHD assessment by providing objective measurements of impulsivity and inattention; OPTAx additionally provides objective measurements of hyperactivity. Both are microprocessor-based vigilance task recorders.
- Performance Testing Mention: "Bench testing of the camera to EN 60825-1-1994, safety standards has been performed. Clinical testing has also been performed on the OPTAx System." This statement acknowledges clinical testing but provides no details about it.
What is Missing (and thus cannot be provided in the requested format):
- Table of Acceptance Criteria and Reported Device Performance: This information is not present. The document does not define specific performance metrics (e.g., sensitivity, specificity, accuracy, precision for different symptoms) or the targets for these metrics that would constitute "acceptance criteria." Consequently, no "reported device performance" against such criteria is listed.
- Sample Size used for the test set and data provenance: The document mentions "Clinical testing has also been performed," but does not specify the sample size used, the characteristics of the test set, or its provenance (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and qualifications: This information is not provided.
- Adjudication method for the test set: Not mentioned.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: The document does not describe such a study. Since the device is a diagnostic aid providing objective measurements rather than an AI-assisted reader, the concept of "human readers improve with AI vs without AI assistance" does not directly apply in the way it would for image interpretation AI.
- Standalone performance (algorithm only without human-in-the-loop performance): While the OPTAx system provides "objective measurements," the document implies these are intended to aid clinical assessment by qualified professionals, suggesting a human-in-the-loop scenario for interpretation. However, specific standalone performance metrics for the algorithm itself are not detailed.
- Type of ground truth used: Not specified. Given the intended use to "aid in the clinical assessment of ADHD," the ground truth would likely involve clinical diagnosis of ADHD, but the method for establishing this (e.g., expert clinical diagnosis, diagnostic interviews, outcome data over time) is not discussed.
- Sample size for the training set: Not mentioned. The document primarily discusses the device and its intended use, not the development or training of its underlying algorithms.
- How the ground truth for the training set was established: Not mentioned.
Conclusion:
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on intended use and technological characteristics. It lacks the detailed information regarding specific performance acceptance criteria and the results of clinical studies against those criteria that you are requesting. The statement "Clinical testing has also been performed" is a high-level acknowledgment without further substantiation in this particular document.
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