(90 days)
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
| Acceptance Criterion (Inferred) | Reported Device Performance (T.O.V.A. v9.0) |
|---|---|
| Safety and Essential Performance (Electrical): Compliance with IEC 60601-1:2005 | Passed: "The T.O.V.A. passed the state of the art for electrical safety and functional testing." (Performed by UL, Inc.) |
| Safety and Essential Performance (Electromagnetic Compatibility): Compliance with IEC 60601-1-2:2014 | Passed: "The T.O.V.A. passed the state of the art for electromagnetic compatibility and electromagnetic immunity testing." (Performed by Element, Inc.) |
| Functional Verification: Device functions as intended. (Implicitly, without introducing new safety/effectiveness concerns compared to predicate). | Passed: "The T.O.V.A. functioned as intended, passing all major verification tests, and was FDA cleared under K170082." (Performed by The TOVA Company). |
| Timing Accuracy: Measurement of response times. (Compared to predicate, though predicate's accuracy is "Unknown"). | Accurate to ±1 milliseconds. (This is a specific performance claim for T.O.V.A.). |
| Normative Data Sample Size: Sufficiently large and representative normative sample for comparison. | Visual Test: Over 1,700 individuals (ages 4-80). Auditory Test: Over 2,500 individuals (ages 6-29). (This is larger than the predicate's 1,307 individuals for visual, ages 6-60). |
| Device Components and Functionality: Similar technological characteristics and principles of operation to predicate. | Similar: Both are Continuous Performance Tests (CPT) with Go/No Go tasks and visual stimuli (geometric shapes). Both use a microswitch for subject response. T.O.V.A. adds auditory stimuli, has larger normative data, and is compatible with Mac in addition to Windows. These are deemed "minor technological differences" that "raise no new issues of safety or effectiveness." |
| Intended Use/Indications for Use: Substantially equivalent clinical utility for assessing attention deficits and ADHD. | Substantially Equivalent: Both provide objective measurements for assessing and evaluating treatment for attention deficits/ADHD. T.O.V.A. adds specific mention of auditory test for assessment of attention deficits, including ADHD. The scope of use remains for qualified professionals. |
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.
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March 22, 2018
The TOVA Company Chris Holder, CEO 2828 SW Corbett Ave, Suite 128 Portland. Oregon 97201
Re: K173915
Trade/Device Name: Test of Variables of Attention (T.O.V.A.) version 9.0 Regulatory Class: Unclassified Product Code: LOD Dated: December 20, 2017 Received: December 22, 2017
Dear Chris Holder:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
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803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
MichaelJ. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173915
Device Name
Test of Variables of Attention (T.O.V.A.) version 9.0
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
| Date: | March 19th, 2018 |
|---|---|
| 510(k) Submitter: | The TOVA Company2828 SW Corbett Ave suite 128Portland, OR 97201 USAContact Person: Chris HolderTel 360-661-2899Email: chris@thetovacompany.com |
| Trade Name:Common name:Product Code:Classification name:Device class: | Test of Variables of Attention (T.O.V.A.) version 9.0Continuous Performance Test (CPT)LQDRecorder, attention task performanceUnclassified |
| Predicate Device: | QbTest from Qbtech AB (K133382) |
| Device Description: | The Test of Variables of Attention (T.O.V.A.) is an accurate and objective continuousperformance test (CPT) that measures the key components of attention and inhibitorycontrol. The T.O.V.A. is used by qualified healthcare professionals in the assessment ofattention deficits, including attention-deficit/hyperactivity disorder (ADHD), in childrenand adults. In addition, the visual T.O.V.A. is used to evaluate treatment for attentiondeficits, including ADHD. |
| The T.O.V.A. is a culture- and language-free, sufficiently long computerized test thatrequires no left/right discrimination or sequencing. Responses to visual or auditorystimuli are recorded with a specially designed, highly accurate (±1 ms) microswitch. TheT.O.V.A. calculates response time variability (consistency), response time (speed),commissions (impulsivity), and omissions (focus and vigilance). These calculations arethen compared to a large age- and gender-matched normative sample (over 1,700individuals for the visual test, and over 2,500 individuals for the auditory test), as well asto a sample population of individuals independently diagnosed with ADHD. Thesecomparison 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 andWindows PCs, a T.O.V.A. USB device, a T.O.V.A. Microswitch, an Installation Guide, aUser's Manual, a Clinical Manual, and accessory cables (USB, VGA, and audio cables). | |
| Indications for Use: | The Test of Variables of Attention (T.O.V.A.) provides healthcare professionals withobjective measurements of attention and inhibitory control. The visual T.O.V.A. aids inthe assessment of, and evaluation of treatment for, attention deficits, includingattention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in theassessment of attention deficits, including ADHD. T.O.V.A. results should only beinterpreted by qualified professionals. |
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Image /page/4/Picture/0 description: The image is a logo for "the TOVA company". The logo consists of a blue circle with a white square inside, and a smaller blue square inside the white square. To the right of the circle is the text "the TOVA company", with "the" in a smaller font above "TOVA", and "company" in a smaller font below "TOVA".
| Technological | |
|---|---|
| Characteristics: | The T.O.V.A. consists of the TO.V.A. USB Device, the T.O.V.A. Microswitch, and a USBflash drive with software for use on a Mac or Windows PC. The T.O.V.A. has beendesigned and tested to be safe and effective when used by qualified professionals. |
| Performance Data: | The T.O.V.A. has been verified and validated in accordance with design controls. TheT.O.V.A. has passed testing for safety and essential performance under IEC 60601-1:2005"Medical electrical equipment - Part 1: General requirements for basic safety andessential performance" and electromagnetic compatibility under IEC 60601-1-2:2014"Medical electrical equipment - Part 1-2: General requirements for basic safety andessential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests". In all instances, the T.O.V.A. functioned as intended and theperformance observed was as expected. Testing for safety and essential performancefor electrical and electromagnetic capability is identical to the T.O.V.A. cleared underK170082. |
| Test | Test Method Summary | Results |
|---|---|---|
| IEC 60601-1:2005 "Medicalelectrical equipment - Part 1:General requirements forbasic safety and essentialperformance" | A third-party test facility (UL,Inc.) tested the T.O.V.A. 9system to IEC 60601-1:2005. | The T.O.V.A. passed the state of the art forelectrical safety and functional testing.Although no such testing was done for theQbTest, it met the safety and functionaltesting required for 510(k) clearance in 2014.Thus, the T.O.V.A. has equivalent safety andfunctionality testing to the QbTest. |
| IEC 60601-1-2:2014 "Medicalelectrical equipment - Part 1-2: General requirements forbasic safety and essentialperformance - CollateralStandard: Electromagneticdisturbances - Requirementsand tests" | A third-party test facility(Element, Inc.) tested theT.O.V.A. 9 system to IEC60601-1-2:2014. | The T.O.V.A. passed the state of the art forelectromagnetic compatibility andelectromagnetic immunity testing. Althoughno such testing was done for the QbTest, itmet the safety and functional testingrequired for a traditional 510(k) premarketnotification in 1989. Thus, the T.O.V.A. hasequivalent electrical performance to theQbTest. |
| T.O.V.A. Verification Testing | The T.O.V.A. system was fullytested (verified) by the TOVACompany. | The T.O.V.A. functioned as intended, passingall major verification tests, and was FDAcleared under K170082. Since the QbTest wascleared under K133382, T.O.V.A. and QbTestmeet equivalent verification testingrequirements. |
Substantial
Equivalence:
The T.O.V.A. is substantially equivalent to the QbTest that was cleared under submission number K133382. The T.O.V.A. has similar intended use and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the T.O.V.A. and its predicate devices raise no new issues of safety or effectiveness. A detailed comparison is shown below.
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Image /page/5/Picture/1 description: The image contains the logo for "The TOVA Company". The logo consists of a blue circle with a white square inside, and a smaller blue square inside the white square. To the right of the circle is the text "the TOVA company", with "the" in a smaller font above "TOVA" and "company" in a smaller font below "TOVA".
| QbTest | Test of Variables of Attention (T.O.V.A.) | |
|---|---|---|
| 510(k) Number | K133382 | K170082 |
| FDA CODE | LQD | LQD |
| FDA Class | Unclassified | Unclassified |
| Intended Use | QbTest provides clinicians withobjective measurements ofhyperactivity, impulsivity, andinattention to aid in the clinicalassessment of ADHD and in theevaluation of treatmentinterventions in patients withADHD. QbTest results should beinterpreted only by qualifiedprofessionals. | The Test of Variables of Attention (T.O.V.A.)provides healthcare professionals with objectivemeasurements of attention and inhibitorycontrol. The visual T.O.V.A. aids in theassessment of, and evaluation of treatment for,attention deficits, including attention-deficit/hyperactivity disorder (ADHD). Theauditory T.O.V.A. aids in the assessment ofattention deficits, including ADHD. T.O.V.A.results should only be interpreted by qualifiedprofessionals. |
| Normative studyrange | Visual: Ages 6 to 60 | Visual: Ages 4 to 80.Auditory: Ages 6 to 29. |
| Norming Data | Normative data are based on 1,307individuals ages 6 to 60. | Normative data are based on 1,714 (visual) and2,680 (auditory) individuals ages 4 to 80. |
| Device Description(510k Summary) | QbTest is a non-invasive test thathas been developed to provide:precise quantitative assessment ofthe capacity of an individual to payattention to visual stimuli andinhibit impulses. There are threecardinal disturbances in Attention-Deficit Hyperactivity Disorder(ADHD); impaired attention,hyperactivity and impulsivity.QbTest provides an accurate andreproducible measure of anindividual's capacity in each ofthese three domains by utilizing aconsistent challenge paradigmcoupled with detailed real-timemeasurements of behavior andperformance. The fundamentalcore of QbTest is a computer-assisted attention and impulsecontrol task and simultaneousrecording of activity using aninfrared camera for motionmeasurements.The system consists of thefollowing components:• Client software | The Test of Variables of Attention (T.O.V.A.) is anaccurate and objective continuous performancetest (CPT) that measures the key components ofattention and inhibitory control. The T.O.V.A. isused by qualified healthcare professionals in theassessment of attention deficits, includingattention-deficit/hyperactivity disorder (ADHD),in children and adults. In addition, the visualT.O.V.A. is used to evaluate treatment forattention deficits, including ADHD.The T.O.V.A. is a culture- and language-free,sufficiently long computerized test that requiresno left/right discrimination or sequencing.Responses to visual or auditory stimuli arerecorded with a specially designed, highlyaccurate (±1 ms) microswitch. The T.O.V.A.calculates response time variability (consistency),response time (speed), commissions (impulsivity),and omissions (focus and vigilance). Thesecalculations are then compared to a large age-and gender-matched normative sample (over1,700 individuals for the visual test, and over2,600 individuals for the auditory test), as well asto a sample population of individualsindependently diagnosed with ADHD. Thesecomparison results are used to create animmediately available, easy-to-read report |
| QbTest | Test of Variables of Attention (T.O.V.A.) | |
| Responder button (also referred to as responder unit)Infrared cameraReflective motion markerUser manualTechnical manualStimulus cardCamera standMeasuring tapeQbTest Behavior Rating ScaleIn addition, the user must have access to a remote server that generates test reports | 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). | |
| Length of test | 15 to 20 minutes. | 10.8 to 21.6 minutes. |
| ContinuousPerformance Test(CPT) | Yes (Go/No Go task). | Yes (Go/No Go task). |
| Visual stimuli | Yes (geometric shapes). | Yes (geometric shapes). |
| Auditory stimuli | None | Yes (tones). |
| Technology | Software on a Windows PC with a"response unit" microswitch andinfra-red camera and reflectorheadband. | Real-time, microcontroller-based, portable stand-alone unit, with USB connection to a Mac orWindows PC. |
| Subject responsemechanism | "Response Unit" (microswitch). | T.O.V.A. Microswitch. |
| Timing accuracy | Unknown. | Accurate to $\pm$ 1 milliseconds. |
| Statistics gathered | Omissions (false negatives),Commissions (false positives),Response Times,Response Time Variability,Anticipatory Responses,Multiple Responses,Head motion. | Omissions (false negatives),Commissions (false positives),Response Times,Response Time Variability,Anticipatory Responses,Multiple Responses. |
| Report | 1-page graphical report | 6-page graphical report |
| Accessories | Client software, responder unit,Infrared camera, Reflective motionmarker, Stimulus card, Camerastand, Measuring tape, QbTestBehavior Rating Scale | T.O.V.A. USB Device, T.O.V.A. Microswitch, USBflash drive, and off-the-shelf USB, audio, andvideo cables. |
| Software | Software, updateability unknown. | Firmware and software, fully updateable. |
| Platforms | Windows PCs running Windows 7 – 10. | Windows PCs running Windows 7 – 10.Mac computers running Mac OS X 10.8 – 10.12 |
| Standards withwhich the DeviceComplies | IEC 60601-1: 2012 and IEC 60601-1-2:2014 | IEC 60601-1: 2012 and IEC 60601-1-2:2014 |
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Image /page/6/Picture/1 description: The image contains the logo for "The TOVA Company". The logo consists of a blue circle with a white square inside, and a smaller blue square inside the white square. To the right of the circle is the word "the" in a smaller font, and the word "TOVA" in a larger, bold, blue font. Below the word "TOVA" is the word "company" in a smaller font.
N/A