The my Vision TrackTM is intended for the detection of central 3 degrees metamorphopsia (visual distortion) in patients with maculopathy, including agerelated macular degeneration and diabetic retinopathy, and as an aid in monitoring progression of disease factors causing metamorphopsia. It is intended to be used by patients who have the capability to regularly perform a simple self-test at home. The myVisionTrackTM is not intended to diagnose; diagnosis is the responsibility of the prescribing eye-care professional.

Device Description

The myVisionTrack™ is a vision function test provided on a commercially available cell phone. The myVisionTrack™ implements a shape discrimination hyperacuity (SDH) vision test which allows patients to perform their own vision test at home. This enables regular monitoring of disease progression, and for timely detection of significant changes in vision function. If a significant worsening of vision function is detected the physician will be notified and provided access to the vision self-test results so that they can decide whether the patient needs to be seen sooner than their next already scheduled appointment.

AI/ML Overview

The provided document describes the myVisionTrack™ Model 0003, a device intended for the detection and characterization of central 3 degrees metamorphopsia in patients with maculopathy, including age-related macular degeneration and diabetic retinopathy, and as an aid in monitoring progression of disease factors causing metamorphopsia.

However, the document does not explicitly state specific acceptance criteria (e.g., sensitivity, specificity thresholds) for the device's performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices and verifying that patients can effectively use the device for self-monitoring.

Here's an analysis based on the information provided, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, no explicit acceptance criteria thresholds (like specific sensitivity or specificity values) are provided in the document. The study's conclusion is that the device is "as safe, as effective and performs at least as safely and effectively as the predicate devices."

The document mentions that the study "did show a significant difference between those patients with mild-to-moderate non-proliferative DR (NPDR) and those with very severe NPDR or proliferative DR (PDR), whereas traditional clinic-based visual acuity and contrast sensitivity tests were not able to detect a significant difference." This implies a performance benefit in detecting disease severity, but no specific metrics or acceptance criteria are given for this.

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

Sample Size for Test Set: 36 individuals.
Data Provenance: The study was a "6-month Clinical Study" and "6-month longitudinal study" performed by VAS (Vital Art and Science Incorporated). The document does not explicitly state the country of origin but implies it was conducted by the submitter (Vital Art and Science Incorporated, Richardson, TX, USA). It was a prospective longitudinal study.

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

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated. The ground truth was based on "clinical judgment" and "traditional clinic-based visual acuity and contrast sensitivity tests" for assessing disease condition (NPDR vs. PDR). It is reasonable to assume these judgments were made by qualified ophthalmologists or eye care professionals, but specific numbers and qualifications are not detailed.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. The document mentions "clinical judgment" for assessing the disease condition, but how multiple experts (if any) arrived at a consensus is not described.

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

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described or conducted in the context of human readers improving with or without AI assistance. The study focused on the device's ability to monitor changes and patient compliance.

6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance)

Standalone Performance: Yes, the described study appears to be a standalone performance study. The myVisionTrack™ device "implements a shape discrimination hyperacuity (SDH) vision test which allows patients to perform their own vision test at home." The results are then analyzed by the device's algorithm, and "If a significant worsening of vision function is detected the physician will be notified." The study tested "effective self-monitoring... using myVisionTrack™" and demonstrated its ability to detect differences in disease states and generate notifications based on a "0.2 logMAR notification rule." This rule is an algorithmic threshold applied to the device's output.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for defining "significant change of disease condition" was based on clinical judgment by medical professionals and comparisons to traditional clinic-based visual acuity and contrast sensitivity tests.

8. Sample Size for the Training Set

Sample Size for Training Set: The document does not specify a separate training set or its sample size. The description of the clinical study appears to relate to the validation of the device's performance, not necessarily the training of its algorithm (which is a "shape discrimination hyperacuity test"). The algorithms are described as using an "adaptive staircase algorithm," which is a testing methodology, not typically a machine learning training process that requires a training set in the conventional sense.

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

Establishment of Ground Truth for Training Set: Not applicable, as a distinct training set for a machine learning algorithm is not described. The "shape discrimination hyperacuity test" is a known psychophysical testing method. The "adaptive staircase algorithm" is a method for efficiently finding thresholds. The document states "Numerous published studies have shown that patients with AMD and other forms of maculopathy have significantly poorer results as compared to normal subjects on the shape discrimination test," indicating that the underlying principle is well-established in scientific literature.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 7, 2017

Vital Art and Science Incorporated Mike Bartlett President 2725 N. Spring Drive Richardson, TX 75082

Re: K121738

Trade/Device Name: myVisionTrack™ Model 0003 Regulation Number: 21 CFR 886.1330 Regulation Name: Amsler grid Regulatory Class: Class I Product Code: HOQ Dated: January 15, 2013 Received: January 17, 2013

Dear Mike Bartlett:

This letter corrects our substantially equivalent letter of February 22, 2013

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.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR 801); medical device reporting (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"

(21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation

(21 CFR Part 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Denise L. Hampton -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Change Control Table, Change History

Change Control Table

Version	Document Author	Document Approver	Date Approved
1.00	Alexander Beylin, BiomedicalEngineer, ODE	Name, Title, Office	MM/DD/YYYY

Complete Change Control Table (all versions) retained in SWIFT Docs.

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Indications for Use

510(k) Number (if known) K121738

Device Name myVisionTrackTM Model 0003

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FEB 2 2 2013

510(k) Summary (Revised from Original) 5.

Date prepared: May 24, 2012

K Number K121738

Submitter:

Vital Art and Science Incorporated 2725 N. Spring Drive Richardson, TX 75082-4233

Contact Person:	Mike Bartlett
	President, Vital Art and Science Incorporated
	Phone: 214-929-2931
	Fax: 972-238-0420
	E-Mail: mike.bartlett@myvisiontrack.com

Name of the Device and Classification

Type of 510(k) Submission: Traditional Trade Name: myVisionTrack™ Model 0003 Common Name: Home vision function monitor Reason for Premarket Notification: New Device Regulation Number: 21 CFR 886 1605 Regulation Name: Perimeter, Automatic, AC-Powered Regulatory Class: Class I Product Code: HPT

Predicate Devices:

The Vital Art and Science Incorporated my VisionTrack™ Model 0003 (mVT™) is substantially equivalent to the following combination of predicate medical devices:

ForeseeHome supplied by Notal Vision; Perimeter, Automatic, AC-Powered, 21 . CFR 886.1605; K091579; Product Code: HPT
PreView PHPTM supplied by Notal Vision; Perimeter, Automatic, AC-Powered, . 21 CFR Part 886.1605; K05350; Product Code: HPT
Amsler Grid, a Class I Exempt Preamendments Medical Device (21 CFR . 886.1330); Product Code: HOQ

510(k) Summary

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Brief Device Description:

Indications for Use:

The my VisionTrack™ is intended for the detection and characterization of central 3 degrees metamorphopsia (visual distortion) in patients with maculopathy, including agerelated macular degeneration and diabetic retinopathy, and as an aid in monitoring progression of disease factors causing metamorphopsia. It is intended to be used by patients who have the capability to regularly perform a simple self-test at home. The my Vision Track™ is not intended to diagnose; diagnosis is the responsibility of the prescribing eye-care professional.

Indications for Use as compared to the Predicate Device:

myVisionTrackTM and the three predicate devices provide a method for a user to self-test their own vision function. All are used to detect significant changes in vision, which indicate disease progression.

The Amsler Grid, in various paper chart forms, is the most commonly prescribed method for home vision monitoring today. Studies have shown that most patients cannot use it effectively for a number of reasons, including the requirement for the user to remember previous results and to determine for themselves if a significant change has occurred.

myVisionTrack™ and the two devices from Notal Vision are automated devices which present visual test stimuli, collect user responses and compare current results to previous test results to determine if a significant change in vision function has occurred.

All three devices use a "hyperacuity" algorithm that tests the user's ability to detect differences in multiple stimuli. my Vision Track™ uses a test algorithm that does not require the user to fixate on a single point during the test. Therefore, it is not limited to users who have a stable fixation, which is a requirement of the Notal Vision devices.

510(k) Summarv

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The ForeseeHome and PreView PHP™ test the central and paracentral area of the retina whereas my VisionTrack™ tests only the central 3 degrees of the retina which is a smaller area. The predicate devices are intended for users diagnosed with age-related macular degeneration (AMD) whereas my VisionTrack™ is intended for users diagnosed with maculopathy, of which AMD and diabetic retinopathy (DR) are the primary diseases.

Principles of Operation:

The test images used by my VisionTrack™ are shown in Figure 5.1 where (a) is an undistorted image and (b) is a distorted image. The distorted version is created by modulating the radius of the circle with a sinusoid.

Image /page/6/Picture/3 description: The image shows two different shapes. The shape on the left is a circle. The shape on the right is a wavy circle with 8 points. The text "cyc/360" is at the bottom of the image.

(a) unmodulated (b) modulated Fig. 5.1. Patterns in the shape discrimination

In the test the user is shown three circles and asked to identify the distorted circle, as shown in Figure 5.2. The test begins with a large amplitude of distortion and moves quickly through a series of test images where the distortion amplitude is reduced in order to determine the lowest detectable level of distortion.

Image /page/6/Picture/6 description: The image shows a smartphone with a gray screen displaying three shapes. There is a circle on the left, a star in the middle, and another circle on the right. The shapes are outlined in a lighter gray color, contrasting with the darker gray background of the screen.

Figure 5.2

510(k) Summary

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K121738

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Clinical Testing Summary

Numerous published studies have shown that patients with AMD and other forms of maculopathy have significantly poorer results as compared to normal subjects on the shape discrimination test. VAS has performed our own 6-month Clinical Study on the specific shape discrimination hyperacuity test used in myVisionTrack™. This study of diabetic retinopathy (DR) patients did show a significant difference between those patients with mild-to-moderate non-proliferative DR (NPDR) and those with very severe NPDR or proliferative DR (PDR), whereas traditional clinic-based visual acuity and contrast sensitivity tests were not able to detect a significant difference. In this study, where patients were asked to test at least once per week for 6 months, there was an average weekly compliance rate of 84%, and the average number of times the patients performed the test was 1.7. This study verified that patients could and would effectively self-monitor their own vision function at home using myVisionTrackTM.

In this 6-month longitudinal study, we collected data on 36 individuals taking weekly measurements for a total of 2338 measurements. Individuals in this study had no significant change of disease condition over the 6-month period based on clinical judgment. Using the 6-month longitudinal study, we found 36 examples where a physician would have been notified according to the 0.2 logMAR notification rule.

Substantial Equivalence Comparison

The substantial equivalence of the my VisionTrack™ to the predicate devices is summarized in Table 5.1 below. Each of these devices provide a vision self-test for the patient.

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FunctionSpecification	Product Code	Amsler GridClass I ExemptPreamendments Device	HOQ	Notal Vision, Inc.PreView PHP™K050350	HPT	Notal Vision, Inc.ForeseeHomeK091579	HPT	VASmyVision Track™ Model0003 (Proposed)	HPT
RegulationNumber	21 CFR 886.1330	21 CFR 886.1605	21 CFR 886.1605	21 CFR 886.1605
Indicationsfor Use	Intended to rapidlydetect central andparacentral irregularitiesin the visual field.	The PreView PHP™ isintended for use in thedetection and monitoringthe progression of Age-related MacularDegeneration (AMD)including, but not limitedto, the detection ofchoroidalneovascularization (CNV).	The ForeseeHome isintended for use in thedetection andcharacterization of centraland paracentralmetamorphopsia (visualdistortion) in patients withage-related maculardegeneration as an aid inmonitoring progression ofdisease factors causingmetamorphopsia including,but not limited to choroidalneovascularization (CNV). Itis intended to be used athome for patients withstable fixation. TheForeseeHome is notintended to diagnose;diagnosis is theresponsibility of theprescribing eye-careprofessional.	The myVision Track™ isintended for the detectionand characterization ofcentral 3 degreesmetamorphopsia (visualdistortion) in patients withmaculopathy, including age-related maculardegeneration and diabeticretinopathy, and as an aid inmonitoring progression ofdisease factors causingmetamorphopsia. It isintended to be used bypatients who have thecapability to regularlyperform a simple self-test athome. The myVision Track™is not intended to diagnose;diagnosis is theresponsibility of theprescribing eye-careprofessional.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

KIZI738

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Item	FunctionSpecification	Amsler GridClass ExemptPreamendments Device	Notal Vision, Inc.PreView PHP™K050350	Notal Vision, Inc.ForeseeHomeK091579	VASmyVisionTrack™ Model0003 (Proposed)
4	TargetPopulation	Patients at high risk oralready diagnosed withMaculopathy	Patients already diagnosedwith age-related maculardegeneration	Patients already diagnosedwith age-related maculardegeneration	Patients already diagnosedwith Maculopathy, includingage-related maculardegeneration and diabeticretinopathy
5	Prescriptionor OTC	OTC	Prescribed by healthcareprofessional.	Prescribed by healthcareprofessional.	Prescribed by healthcareprofessional.
6	How/Whereused	Home use for self-testing by the patient.	Healthcare Clinic	Home use for self-testing bythe patient.	Home use for self-testing bythe patient.
7	HardwarePlatform	Paper chart.	Software Application to berun on a customer suppliedoff-the-shelf PC.	Dedicated unit withprocessor, display, mouseand software.	Software Applicationdelivered by the supplier onan off-the-shelf cell phone.
8	Vision Testalgorithmused	Patient is instructed toidentify and record blur,distorted or missingareas on the chart.	Preferential HyperacuityTest	Preferential HyperacuityTest	Shape DiscriminationHyperacuity Test with anadaptive staircase algorithm
9	FixationPoint for thepatientduringtesting?	Yes	Yes	Yes	No. The test employs avisual task involving globalvisual integration. Nofixation is required toperform the test.
10	Data uploadcapability?	No	Not specified	Yes, through a home phoneline.	Yes, through the cell phoneconnection.

the same of the same of the same of

K121738

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K121738

Standards to which Vital Art and Science Incorporated claims conformance for the myVisionTrack™ Model 0003

ISO 13485:2003 / EN ISO 13485:2003 / AC:2009 "Medical devices - Quality management systems - Requirements for regulatory purposes"
AAMI / ANSI / ISO 14971:2007/(R)2010, "Medical devices - Application of risk management to medical devices"
IEC 60234:2006 Ed. 1.0, "Medical device software - Software life cycle processes"
IEC 60601-1:2005 + A1:2012, 'Medical electrical equipment Part 1: General requirements for basic safety and essential performance"
IEC 60601-1-2:2007, "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard Electromagnetic compatibility - Requirements and tests"
IEC 60601-1-11:2010, "Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment"

Conclusion

In conclusion, the proposed my VisionTrack™ as compared to the already cleared predicate devices has:

. Similar indications for use:
Similar physical composition, in that all use visual testing software delivered on a ● validated hardware platform and operating system;
� Similar, but with a vision test algorithm that does not require a patient to focus on a single point constantly during testing;
A similar method of operation for the patient to perform self-testing at home; and .
Similar central monitoring of patient self-test results, but with a mobile device . upload method that does not require the patient to have a home phone or to perform any setup.

Based on our non-clinical and clinical testing of the my VisionTrack™ Model 0003 we have concluded that the my VisionTrack™ Model 0003 is as safe, as effective and performs at least as safely and effectively as the predicate devices.

Regulation Number and Section

§ 886.1330 Amsler grid.

(a)
Identification. An Amsler grid is a device that is a series of charts with grids of different sizes that are held at 30 centimeters distance from the patient and intended to rapidly detect central and paracentral irregularities in the visual field.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.