Search Results

The Test of Variables of Attention (T.O.V.A.) provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

The Test of Variables of Attention (T.O.V.A.) is an accurate and objective continuous performance test (CPT) that measures the key components of attention and inhibitory control. The T.O.V.A. is used by qualified healthcare professionals in the assessment of attention deficits, including attention-deficit/hyperactivity disorder (ADHD), in children and adults. In addition, the visual T.O.V.A. is used to evaluate treatment for attention deficits, including ADHD.

The T.O.V.A. is a culture- and language-free, sufficiently long computerized test that requires no left/right discrimination or sequencing. Responses to visual or auditory stimuli are recorded with a specially designed, highly accurate (±1 ms) microswitch. The T.O.V.A. calculates response time variability (consistency), response time (speed), commissions (impulsivity), and omissions (focus and vigilance). These calculations are then compared to a large age- and gender-matched normative sample (over 1,700 individuals for the visual test, and over 2,500 individuals for the auditory test), as well as to a sample population of individuals independently diagnosed with ADHD. These comparison results are used to create an immediately available, easy-to-read report.

The T.O.V.A. system includes: a USB flash drive with software installer for Mac and Windows PCs, a T.O.V.A. USB device, a T.O.V.A. Microswitch, an Installation Guide, a User's Manual, a Clinical Manual, and accessory cables (USB, VGA, and audio cables).

This document is a 510(k) premarket notification for the Test of Variables of Attention (T.O.V.A.) version 9.0. It primarily focuses on demonstrating substantial equivalence to a predicate device (QbTest) rather than outlining specific clinical trials to prove device performance against acceptance criteria in the manner one might find for an AI/ML medical device.

Therefore, many of the requested details about acceptance criteria and a study proving those criteria are not explicitly present in the provided text, as the submission relies on demonstrating equivalence through technical specifications, safety, and functionality, rather than novel clinical performance endpoints.

However, I can extract and infer information relevant to the various sections of your request based on the provided document:

Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence Claim)

Since this is a 510(k) submission, the "acceptance criteria" are primarily established by demonstrating substantial equivalence to a predicate device, meaning the new device performs at least as safely and effectively as the predicate for its stated indications for use. There isn't a table of specific clinical performance metrics with numerical targets as would be seen for a new AI/AD.

The "device performance" is primarily assessed against regulatory standards (electrical safety, EMC) and functional verification, as well as the comparison to the predicate device's established performance (which is implicitly "accepted" by prior FDA clearance).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Test Set (for the K173915 submission specifically to demonstrate substantial equivalence): The document primarily refers to technical testing (IEC 60601-1, IEC 60601-1-2, T.O.V.A. Verification Testing) and a comparison with the predicate device's specifications. These are not "test sets" in the sense of a clinical performance study with patient data against a ground truth.
  • For the technical verification, there isn't a specified "sample size" of devices, but rather laboratory testing of the device system.
  • The "normative samples" used to establish the large age- and gender-matched comparison data for the T.O.V.A. itself are:
    • Visual Test: Over 1,700 individuals (stated as 1,714 in the comparison table)
    • Auditory Test: Over 2,500 individuals (stated as 2,680 in the comparison table)
  • Data Provenance: Not specified in terms of country of origin or retrospective/prospective. The description of normative samples and "sample population of individuals independently diagnosed with ADHD" suggests pre-existing or collected data, but the collection methodology (retrospective/prospective) is not detailed for this specific 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This is not applicable as there isn't a "test set" in the context of clinical images or patient cases requiring expert interpretation for ground truth. The device measures objective quantities (response time, omissions, commissions).
• For the normative data, the document mentions comparison to a "sample population of individuals independently diagnosed with ADHD." This implies that clinical diagnoses (established by qualified healthcare professionals) served as a form of "ground truth" for the ADHD sample, but the number or specific qualifications of these diagnosing professionals are not provided. The T.O.V.A. itself is intended to "aid in the assessment" and "results should only be interpreted by qualified professionals."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. There is no clinical imaging or interpretative "test set" here that would require an adjudication process.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is not an AI-assisted diagnostic tool that aids human readers in interpreting complex data like medical images. It's a continuous performance test that generates objective measurements.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• The T.O.V.A. is inherently a "standalone" device in terms of its measurement capabilities, as it directly calculates various performance metrics (response time, omissions, etc.). However, it is explicitly stated that "T.O.V.A. results should only be interpreted by qualified professionals." This means it's a tool for professionals, not a standalone diagnostic that provides a final diagnosis without human interpretation. So, while the measurement itself is algorithmic, the clinical utility is human-in-the-loop.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the "sample population of individuals independently diagnosed with ADHD," the ground truth was clinical diagnosis (presumably by qualified professionals).
• For the normative data, the "ground truth" is simply a large, healthy normative population against which patient results are compared.

8. The sample size for the training set:

• The term "training set" doesn't strictly apply in the sense of an AI/ML algorithm being trained on data to learn patterns.
• However, the normative samples which the device uses for comparison can be considered analogous to a "training set" for establishing statistical norms. These are:
  • Visual T.O.V.A.: Over 1,700 individuals (1,714)
  • Auditory T.O.V.A.: Over 2,500 individuals (2,680)

9. How the ground truth for the training set was established:

• For the normative samples, the "ground truth" was established by collecting data from a large population of individuals, presumably healthy or without a pre-existing ADHD diagnosis at the time of data collection for the normative comparison. The document states they are "age- and gender-matched normative sample."
• For the "sample population of individuals independently diagnosed with ADHD" (used for comparison to distinguish ADHD from normative data), the ground truth was established by independent clinical diagnoses of ADHD. The specifics of how these diagnoses were confirmed (e.g., DSM criteria, multiple clinicians, etc.) are not provided in this 510(k) summary.

Ask a specific question about this device

The Test of Variables of Attention (T.O.V.A.) provides healthcare professionals with objective measurements of attention and inhibitory control, which aid in the assessment of attention deficits, including attention-deficit/hyperactivity disorder (ADHD). T.O.V.A. results should only be interpreted by qualified healthcare professionals.

The Test of Variables of Attention (T.O.V.A.) is an accurate and objective continuous performance test (CPT) that measures the key components of attention and inhibitory control. The T.O.V.A. is used by qualified healthcare professionals in the assessment of attention deficits, including attention-deficit/hyperactivity disorder (ADHD), in children and adults.
The T.O.V.A. is a culture- and language-free, sufficiently long computerized test that requires no left/right discrimination or sequencing. Responses to visual or auditory stimuli are recorded with a specially designed, highly accurate (±1 ms) microswitch. The T.O.V.A. calculates response time variability (consistency), response time (speed), commissions (impulsivity), and omissions (focus and vigilance). These calculations are then compared to a large age- and gender-matched normative sample (over 1,700 individuals for the visual test, and over 2,500 individuals for the auditory test), as well as to a sample population of individuals independently diagnosed with ADHD. These comparison results are used to create an immediately available, easy-to-read report.
The T.O.V.A. system includes: a USB flash drive with software installer for Mac and Windows PCs, a T.O.V.A. USB device, a T.O.V.A. Microswitch, an Installation Guide, a User's Manual, a Clinical Manual, and accessory cables (USB, VGA, and audio cables).

Here's a breakdown of the acceptance criteria and study information for the Test of Variables of Attention (T.O.V.A.) version 9.0 device, based on the provided text:

Acceptance Criteria and Device Performance

The provided text focuses on the device's adherence to safety, essential performance, and electromagnetic compatibility (EMC) standards rather than clinical performance metrics for diagnosing ADHD. The acceptance criteria essentially stem from proving substantial equivalence to the predicate device, the Gordon Diagnostic System Model I (K854903), in these engineering and regulatory aspects.

Study Information Pertaining to Device Verification and Validation:

The document primarily describes a set of verification and validation activities rather than a clinical study evaluating diagnostic performance. The focus is on demonstrating that the T.O.V.A. 9.0 functions correctly and meets established engineering standards and design requirements.

1. Sample Size used for the test set and data provenance:

   • IEC 60601-1:2005 & IEC 60601-1-2:2014: These tests involve the physical device itself and do not typically use "patient samples." The "test set" here refers to the device prototypes subjected to standardized electrical and functional tests.
   • T.O.V.A. Verification Testing: This involved the T.O.V.A. system (software and hardware). The "test set" refers to the various functions and modules of the software and hardware that were tested according to a detailed matrix of requirements. No human participant data is mentioned for these verification tests.
   • Normative Data: While not a "test set" for performance evaluation against a gold standard in the context of device accuracy, the device's internal comparison data uses a large normative sample:
     • Visual test: over 1,700 individuals
     • Auditory test: over 2,600 individuals
     • These normative samples were described as "age- and gender-matched" and "non-ADHD individuals." The provenance (country of origin, retrospective/prospective) is not specified in the provided text.

2. Number of experts used to establish the ground truth for the test set and their qualifications:

   • For the engineering and software verification tests described (IEC standards, T.O.V.A. Verification Testing), the "ground truth" is defined by the technical specifications of the standards and the design requirements. The "experts" would be the certified test engineers at the third-party facilities (UL, Inc. and Element, Inc.) and The TOVA Company's internal design and quality assurance teams, who assess compliance with these objective standards. Specific qualifications beyond being "third-party test facilities" are not detailed.
   • Regarding the normative data used by the device (not to test the device's diagnostic accuracy directly), the text mentions "a sample population of individuals independently diagnosed with ADHD." However, it does not specify the number or qualifications of experts who established these independent ADHD diagnoses.

3. Adjudication method for the test set:

   • For the engineering and software verification tests, the adjudication method is typically direct assessment against the defined standard or requirement. There isn't an "adjudication method" in the sense of multiple experts reviewing cases to establish a clinical ground truth.
   • For the normative data and the "independently diagnosed with ADHD" population, the adjudication method for the ADHD diagnosis itself is not described.

4. 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 MRMC comparative effectiveness study is mentioned in the provided text. The T.O.V.A. device provides objective measurements to aid in assessment by healthcare professionals; it is not described as an AI-assisted diagnostic tool where human readers improve with its assistance in the typical sense of interpreting images or complex data with AI overlays. Its function is to generate objective metrics for a clinician's interpretation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The T.O.V.A. is described as providing "objective measurements" that "aid in the assessment of attention deficits." It explicitly states that "T.O.V.A. results should only be interpreted by qualified healthcare professionals." This indicates it's designed as a tool for a human-in-the-loop workflow, not as a standalone diagnostic device. Therefore, a standalone performance study in a diagnostic capacity would not be applicable or described for this device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the engineering tests, the ground truth is compliance with the IEC 60601-1 and IEC 60601-1-2 standards and the device's own design specifications (for verification testing).
   • For the context of the device's internal comparisons, it uses a "normative sample" of "non-ADHD individuals" and a "sample population of individuals independently diagnosed with ADHD." The ground truth for these populations is derived from clinical diagnosis (likely expert consensus or established diagnostic criteria for ADHD), though the specifics are not detailed.

7. The sample size for the training set:

   • The document does not describe a machine learning algorithm that requires a "training set" in the conventional sense. The T.O.V.A. functions by comparing an individual's performance to existing "normative data." This normative data could be considered analogous to a "training set" for establishing typical ranges.
     • Visual normative data: 1,714 individuals
     • Auditory normative data: 2,680 individuals

8. How the ground truth for the training set was established:

   • For the normative data (analogous to a training set), the ground truth for these individuals was established as "non-ADHD individuals." This implies that they were clinically confirmed not to have ADHD. The specific diagnostic process or criteria used to classify these "non-ADHD" individuals are not detailed in the provided text. It is reasonable to assume this was established through standard clinical diagnostic procedures, excluding individuals with an ADHD diagnosis.

Ask a specific question about this device