The Visibly Digital Acuity Product (VDAP) is a web-based, self-quided software application intended for use by adults, ages 22 to 40, who have the capability to perform a self-test at home, to aid in the evaluation of visual acuity with or without correction. The software allows users to view and respond to displayed optotypes and uses the responses to categorize a patient's visual acuity into one of two categories, with an individual output for each eye:

. TRUE - visual acuity that is consistent with normal vision
FALSE visual acuity that is not consistent with normal vision .
The Visibly Digital Acuity Product recommendations are intended to be supportive recommendations that will be used by an eye care provider, along with the patient's medical history and profile, prior corrective evewear prescriptions, and subjective vision data. The Visibly Digital Acuity Product does not provide screening or diagnosis of eye health or other disease, nor is it intended to replace an in-person eye exam.

Device Description

The Visibly Digital Acuity Product is a web-based, software application intended for use by adults, at home, to aid in the evaluation of visual acuity with or without correction. The standalone software application allows the user to interface with the software via a web browser on two internet-enabled devices:

A computer screen (the Display) which displays optotypes. O
A touchscreen mobile device (the Remote) which operates as a remote control and o interface for the user to respond to prompts related to the optotypes appearing on the Display while standing 10 feet away.
The software allows users to view and respond to displayed optotypes and uses the responses to categorize a user's vision acuity into one of two buckets: (1) TRUE - visual acuity that is consistent with normal vision (2) FALSE - visual acuity that is not consistent with normal vision.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the Visibly Digital Acuity Product (VDAP) meets them, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the primary and secondary endpoints described in the "Performance Data" section. There aren't explicit numeric acceptance criteria stated for all metrics (e.g., sensitivity, specificity), but a performance goal is given for reproducibility.

Metric (Endpoint)	Acceptance Criteria/Performance Goal	Reported Device Performance (Pooled Study Eye and Non-Study Eye)
Primary Agreement Endpoints
Positive Predictive Value (PPV)	Not explicitly stated, implied to be high for substantial equivalence	95.8% (95% CI: 93.6% - 97.6%)
Negative Predictive Value (NPV)	Not explicitly stated, implied to be high for substantial equivalence	49.1% (95% CI: 40.0% - 58.1%)
Sensitivity	Not explicitly stated, implied to be high for substantial equivalence	85.5% (95% CI: 81.9% - 88.9%)
Specificity	Not explicitly stated, implied to be high for substantial equivalence	78.8% (95% CI: 69.1% - 87.6%)
Primary Reproducibility Endpoint
Reproducibility (Proportion of study eyes with matching VDAP VA classifications for two VDAP tests)	Performance goal of 75%	89.3% (95% CI: 85.9% - 92.6%) (p-value < 0.0001 vs 75%)
Secondary Agreement Endpoint
Subject Level Agreement (Proportion of subjects with matching VDAP and ETDRS classifications for both eyes)	Not explicitly stated, implied to be high for substantial equivalence	75.9% (95% CI: 71.3% - 80.5%)
Secondary Reproducibility Endpoint
Subject Level Reproducibility (Proportion of subjects with matching VDAP VA Classifications for the two VDAP tests for both eyes)	Not explicitly stated, implied to be high for substantial equivalence	82.8% (95% CI: 78.7% - 86.9%)

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

Sample Size: n=329 subjects participated in the prospective, multi-center clinical study.
Data Provenance: The study was "prospective, multi-center." The document doesn't specify the country of origin of the data. It's unclear if the "multi-center" refers to multiple locations within the US or internationally.

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

The ground truth for the test set was established using an "ETDRS Visual Acuity (VA) Lane Test." This is a standardized clinical method for assessing visual acuity, typically performed by trained eye care professionals (e.g., ophthalmologists, optometrists, or trained technicians). The document does not explicitly state the number of experts or their specific qualifications (e.g., 10 years of experience) who performed the ETDRS VA Lane Tests. However, given it's a clinical study comparing to a gold standard, it's implied that qualified personnel administered the ETDRS tests.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the ETDRS ground truth or resolving discrepancies in readings. The ETDRS VA Lane Test is a direct measurement, so typically, it doesn't require an adjudication process in the same way an AI-assisted diagnosis might.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described in the provided text. The study compared the VDAP's performance to an ETDRS VA Lane Test, which serves as a clinical reference standard, not a comparative effectiveness study of human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done

Yes, the primary clinical study evaluates the standalone performance of the VDAP. The VDAP is described as a "web-based, self-guided software application" that categorizes a user's vision. The study directly compares the VDAP's classification output ("TRUE - visual acuity that is consistent with normal vision" or "FALSE - visual acuity that is not consistent with normal vision") to the ETDRS VA Lane Test. The device itself (the software) performs the classification without human intervention based on user responses.

7. The Type of Ground Truth Used

The ground truth used was the ETDRS Visual Acuity (VA) Lane Test. This is a well-established and highly standardized clinical measurement of visual acuity, widely considered the gold standard in clinical research.

8. The Sample Size for the Training Set

The document does not provide any information about the sample size used for the training set of the Visibly Digital Acuity Product. The clinical study described (n=329) is explicitly referred to as a "Performance Data" study, which usually implies it's a validation or test set, not a training set.

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

Since the document does not mention the training set, it also does not provide information on how the ground truth for any training set was established.

Summary

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September 30, 2022

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Visibly, Inc. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, Pennsylvania 19103

Re: K220090

Trade/Device Name: Visibly Digital Acuity Product Regulation Number: 21 CFR 886.1150 Regulation Name: Visual Acuity Chart Regulatory Class: Class I Product Code: OTO

Dear Janice Hogan:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 12, 2022. Specifically, FDA is updating this SE Letter as an administrative correction because of a typo in the Indications for Use form.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Elvin Ng, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 240-402-4662, Elvin.Ng@fda.hhs.gov.

Sincerely,

Elvin Y. Ng -S

Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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August 12, 2022

Visibly, Inc. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, Pennsylvania 19103

Re: K220090

Trade/Device Name: Visibly Digital Acuity Product Regulation Number: 21 CFR 886.1150 Regulation Name: Visual Acuity Chart Regulatory Class: Class I Product Code: QTO Dated: January 11, 2022 Received: January 11, 2022

Dear Janice Hogan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/2/Picture/5 description: The image shows the name "Tieuvi H. Nguyen -S" in a large, clear font. The text is horizontally oriented and appears to be a title or heading. The background is plain, with a faint watermark-like design that is barely visible.

for Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K220090

Device Name

Visibly Digital Acuity Product

Indications for Use (Describe)

. TRUE - visual acuity that is consistent with normal vision
FALSE visual acuity that is not consistent with normal vision .

The Visibly Digital Acuity Product recommendations are intended to be supportive recommendations that will be used by an eye care provider, along with the patient's medical history and profile, prior corrective evewear prescriptions, and subjective vision data. The Visibly Digital Acuity Product does not provide screening or diagnosis of eye health or other disease, nor is it intended to replace an in-person eye exam.

Type of Use (Select one or both, as applicable)

□ Prescription Use (Part 21 CFR 801 Subpart D)

区 Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY Visibly, Inc.'s Visibly Digital Acuity Product K220090

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Visibly, Inc. 207 E Ohio Street, #233 Chicago, IL 60611 Phone: 217-971-4852 Contact Person: Paul Foley CFO/COO

Date Prepared: August 11, 2022

Name of Device

Visibly Digital Acuity Product

Classification Name

Visual Acuity Chart (21 CFR 886.1150, Class I, Product Code QTO)

Predicate Devices

Predicate Device:

Vimetrics, LLC Central Vision Analyzer (CVA-1000)

Reference Devices:

SoloHealth, Inc. SoloHealth Station (K113402)

Vital Art and Science, Inc. MyVisionTrack Model 005 (K143211)

Intended Use / Indications for Use

The Visibly Digital Acuity Product (VDAP) is a web-based, self-guided software application intended for use by adults, ages 22 to 40, who have the capability to perform a self-test at home, to aid in the evaluation of visual acuity with or without correction. The software allows users to view and respond to displayed optotypes and uses the responses to categorize a patient's visual acuity into one of two categories, with an individual output for each eye:

TRUE visual acuity that is consistent with normal vision ●
FALSE - visual acuity that is not consistent with normal vision

The Visibly Digital Acuity Product recommendations are intended to be supportive recommendations that will be used by an eye care provider, along with the patient's medical history and profile, prior corrective eyewear prescriptions, and subjective vision data. The Visibly Digital Acuity Product does not provide screening or diagnosis of eye health or other disease, nor is it intended to replace an in-person eye exam.

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Technological Characteristics

A computer screen (the Display) which displays optotypes. O
A touchscreen mobile device (the Remote) which operates as a remote control and o interface for the user to respond to prompts related to the optotypes appearing on the Display while standing 10 feet away.

The software allows users to view and respond to displayed optotypes and uses the responses to categorize a user's vision acuity into one of two buckets: (1) TRUE - visual acuity that is consistent with normal vision (2) FALSE - visual acuity that is not consistent with normal vision.

A table comparing the key features of the subject, predicate, and reference devices is provided below.

	Visibly DigitalAcuity Product(subject)	Vimetrics CentralVision Analyzer 1000(CVA-1000)(predicate)	SoloHealth Station(reference)	MyVisionTrackModel 0005(reference)
510(k)	K220090	K100095	K113402	K143211
Product Code	QTO	HOX, Chart, VisualAcuity	DXN, AutomatedBlood PressureMonitorHOX, Chart, VisualAcuity	HOQ, Amsler grid
Indications forUse	The Visibly DigitalAcuity Product(VDAP) is a web-based, self-guidedsoftware applicationintended for use byadults, ages 22 to40, who have thecapability to performa self-test at home,to aid in theevaluation of visualacuity with orwithout correction.The software allowsusers to view andrespond to	The CVA-1000 isintended for useunder the directsupervision of anophthalmologist oroptometrist in themeasurement ofvision at fixation inone or both eyes, withor without opticalcorrection.	The SoloHealthStation is intendedto be used by thegeneral public sothat a user canmeasure his/herown blood pressureand pulse rate andhis/her own weight.Additionally, theSoloHealth Stationis intended toscreen adults forclarity of centralvision. SoloHealthStation does notprovide a general	ThemyVisionTrack®Model 0005 isintended for thedetection andcharacterization ofcentral 3 degreesmetamorphopsia(visual distortion) inpatients withmaculopathy,including age-related maculardegeneration anddiabetic retinopathy,and as an aid inmonitoring
Visibly DigitalAcuity Product(subject)	Vimetrics CentralVision Analyzer 1000(CVA-1000)(predicate)	SoloHealth Station(reference)	MyVisionTrackModel 0005(reference)
displayed optotypesand uses theresponses tocategorize apatient's visualacuity into one oftwo categories, withan individual outputfor each eye:TRUE - visualacuity that isconsistent withnormal vision FALSE - visualacuity that is notconsistent withnormal vision The Visibly DigitalAcuity Productrecommendationsare intended to besupportiverecommendationsthat will be used byan eye careprovider, along withthe patient'smedical history andprofile, priorcorrective eyewearprescriptions, andsubjective visiondata. The VisiblyDigital AcuityProduct does notprovide screeningor diagnosis of eyehealth or otherdisease, nor is itintended to replacean in-person eyeexam.		screening of visualfunction and doesnot provide adiagnosis of eyehealth or otherdisease. TheSoloHealth Stationonly screens clarityof central vision.Users shouldconsult theirpersonal physiciansif they haveconcerns regardingtheir eyesight.	progression ofdisease factorscausingmetamorphopsia. Itis intended to beused by patientswho have thecapability toregularly perform asimple self-test athome. ThemyVisionTrack®Model 0005 is notintended todiagnose; diagnosisis the responsibilityof the prescribingeye-careprofessional.
	Visibly DigitalAcuity Product(subject)	Vimetrics CentralVision Analyzer 1000(CVA-1000)(predicate)	SoloHealth Station(reference)	MyVisionTrackModel 0005(reference)
IntendedPopulation	Adults, ages 22 to40	General Public	General Public	Patients at high riskor alreadydiagnosed withmaculopathy
Prescription orOTC	OTC	Prescription	OTC	Prescription homeuse by patients
Device Type	Web-basedsoftware application	Device with electronicdisplay	Device withelectronic display	Downloadableapplication to cellphone or tablet
HardwarePlatform	Display: Computer,laptop or tabletRemote:Touchscreensmartphone ormobile device	Display: Computer, 2LCD computermonitors, keyboard,mouse	Display: LCDcomputer monitor,Interactive CentralVision Panel	Display: Usersupplied cell phoneor tablet
SoftwareDesign	Interactive softwareplatform with audioand visual prompts	Interactive softwareplatform with audioand visual prompts. Ithas two panels:Interactive CentralVision Panel andChart Panel	Interactive softwareplatform with audioand visual prompts	Interactive softwareplatform with visualprompts
TargetPresentation	Landolt C optotypeswith crowding bars,facing 4 differentdirections (openingsat 180, 270, 0, and90 degrees)Optotypes arepresented singly	Multiple and Individualoptotypes (dependingon the panel selected)	Multiple optotypesas well assentences andparagraphs	Distorted andundistorted shapes
How/WhereUsed	At home	Clinical environments	Non-clinicalenvironments	At home
TestAdministration	Self-administration	Setup and TestingMethod is selected byHCP	Self-administration	Self-administration
	Visibly DigitalAcuity Product(subject)	Vimetrics CentralVision Analyzer 1000(CVA-1000)(predicate)	SoloHealth Station(reference)	MyVisionTrackModel 0005(reference)
		Testing process iscompleted via self-administration
TestProcedureSummary	Based on optotypespresented on theDisplay, the userwill select whatobject they see ontheir Remote. Thefollowing outputsare generated forEye Care Provider(ECP) review: (1)user-inputted dataconfirmed duringQualification; (2)Visual Acuity outputby eye classifyingthe individual eye'svision into one ofthe followingbuckets:TRUE - visualacuity that isconsistent withnormal vision FALSE - visualacuity that is notconsistent withnormal vision	Chart Panel: Amonitor, viewed bythe patient, presentstraditional symbolcharts withprogressive 0.1logMAR gradations ofsymbol size, each ofwhich may bepresented in thefollowing Michelsoncontrasts of blackletters presentedagainst a whitebackground in a rangeof progressivelyreduced contrasts.The examiner mayview on the physicianmonitor what ispresented to thepatient on the patientmonitor so he canmark the letters thatare correctlyidentified, allowingeither line-by-line orletter-by-letter scoring.The total letters readcorrectly are recordedas well as thesmallest line readcorrectly in which thetraditional method ofscoring is utilized.Interactive CentralVision Panel: Amonitor is viewed by	Near distancescreening issimulated at 17inches through aseries of promptson the computermonitor wherepatients are askedto view the clarity ofsentences andletters at differentsizes. Far distancescreening issimulated at 11 feetthrough a viewfinder on thedevice. Patientsare asked todetermine theclarity of a set ofletters.	ThemyVisionTrack®Model 0005implements a shapediscriminationhyperacuity (SDH)vision test. Thedistorted shape iscreated bymodulating theradius of the circlewith a sinusoid.The user is shownfour circles andasked to identify thedistorted circle.
Visibly DigitalAcuity Product(subject)	Vimetrics CentralVision Analyzer 1000(CVA-1000)(predicate)	SoloHealth Station(reference)	MyVisionTrackModel 0005(reference)
	the patient in whichautomatedmeasurements areconducted by aninteractive computerprogram at logMAR0.05 gradations ofsymbol size. Thepatient sits in a chairin the darkenedexamination roomwith or without opticalcorrection(spectacles, contactlenses, or trial lenses)and with one eye orboth eyes exposed,he/she views in amirror at the end ofthe room an LCDmonitor (patientmonitor) mounted onthe wall next to theexaminer's desk (totaldistance entered intothe computer programat the time ofinstallation). Theexaminer selects themethod of operationand contrasts to betested by keyboardand mouse interactionand with informationpresented on thephysician's workingmonitor.

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Performance Data

The following testing is provided to support the safety and performance of the VDAP:

. Luminance Testing was completed to demonstrate that the luminance of the Display hardware is above the minimum threshold for luminance (80 cd/m²) in accordance with: (1) ANSI Z80.21-2010(R2015). American National Standard for Ophthalmics -Instruments - General-Purpose Clinical Visual Acuity Charts; (2) ISO 8596:2017. Ophthalmic optics - Visual acuity testing - Standard and clinical optotypes and their presentation and (3) International Council of Ophthalmology (1984) Visual Acuity Measurement Standard.
Optotype Sizing Testing was conducted to validate each optotype size rendered during . the VDAP test. For each of the 22 optotypes presented by the visual acuity test, the arc length of optotype gap and the optotype diameter were measured using manufacturer-calibrated Mitutoyo Digital Calipers. All measurements of arc length and optotype diameter were ±5% of the pre-specified size equivalent for each LogMar Size.
Human Factors testing to confirm that the VDAP can be used safely and effectively by . the intended users in the intended use environment - i.e.. adults aged 22 to 40 years old in a home environment (n=18). This testing established that the overall residual risk of use errors with the VDAP have been mitigated to an acceptable level. Therefore, VDAP can be used without use errors or problems that could result in an inaccurate visual acuity assessment.
The controlling software for the VDAP presents a "moderate" level of concern as . defined in FDA's "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" (May 2005). The appropriate supportive software documentation was provided, including a hazard analysis. Verification and validation activities demonstrated that VDAP functioned as intended. In addition, since the VDAP is sent to a medical device data system (MDDS) that is necessary for viewing by clinicians. Visibly provided software documentation consistent with a minor level of concern for the MDDS per the FDA Guidance "Multiple Function Device Products: Policy and Considerations" (July 2020).
Potential cybersecurity risks were addressed by providing the documentation . requested in the FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (October 2014). The software mitigates or prevents the unauthorized access, modification, misuse and unauthorized use of information that is stored, accessed or transferred.

A prospective, multi-center clinical study was also completed (n=329) to evaluate the safety and effectiveness of the VDAP compared to an ETDRS Visual Acuity (VA) Lane Test. This study evaluated the agreement of the VDAP with the ETDRS VA Lane Test as well as the reproducibility of the VDAP. The primary agreement endpoints were the PPV, defined as the proportion of study eyes with VA of 20/25 or better for which ETDRS VA was also 20/25 or better, and the NPV, defined as the proportion of study eves with VDAP VA worse than 20/25 for which ETDRS VA was also worse than 20/25. Supportive analyses included a subgroup analysis for performance stratified by the actual, measured viewing distance from which the subjects took the VDAP test.

Selection of the study eye occurred after subjects exited the study following the completion of VDAP and ETDRS assessments of each eye. The study eye was selected based upon the

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subject's first VDAP VA assessment. If one of the subject's eyes had "20/25 of Better" VDAP VA and the other eye had "Worse than 20/25" VDAP VA, the eye with the "Worse than 20/25" was selected as the study eve. If both eves had the same VDAP VA, the study eve was selected randomly.

The observed PPV, NPV, sensitivity, and specificity for study eves were as follows: (97.3%, 95% Cl: 95.2% - 99.4%), (48.1%, 95% Cl: 38.6% - 57.6%), 79.7% (95% Cl: 74.9% - 84.5%) and 89.5% (95% CI: 81.5% - 97.4%). The observed PPV, NPV, sensitivity, and specificity for non-study eyes were as follows: (94.5%, 95% Cl: 91.9% - 97.2%), (50.9%, 95% Cl: 37.5% -64.4%), 90.9% (95% Cl: 87.6% - 94.2%) and 64.3% (95% Cl: 49.8% - 78.8%).

Observed agreement performance in sensitivity and specificity diverged between the Study Eye and Non-Study Eye cohorts due to the study eye selection methodology discussed above. As a result, a pooled analysis combining Study Eye and Non-Study Eyes was completed. The observed PPV, NPV, sensitivity, and specificity for the pooled Study Eye and Non-Study Eye cohort were as follows: (95.8%, 95% Cl: 93.6% - 97.6%), (49.1%, 95% Cl: 40.0% - 58.1%), 85.5% (95% Cl: 81.9% - 88.9%) and 78.8% (95% Cl: 69.1% - 87.6%).

PPV and NPV in the pooled cohort are similar to what was observed in Study Eve and Non-Study Eye Cohorts. Sensitivity and Specificity for the pooled cohort reflect true device performance for these metrics as they are not impacted by the study eye selection methodology in the way the Study Eve and Non-Study Eve Cohorts were.

The secondary agreement endpoint was subject level agreement, defined as the proportion of subjects with matching VDAP and ETDRS classifications (20/25 or Better vs. Worse than 20/25) for both eyes (study eye and non-study eye). The secondary reproducibility endpoint was subject level reproducibility, defined as the proportion of subjects with matching VDAP VA Classifications for the two VDAP tests for both eyes.

The subject level agreement was as follows: 75.9% (95% Cl: 71.3% - 80.5%). The subject level reproducibility was as follows: 82.8% (95% Cl: 78.7% - 86.9%).

The primary reproducibility endpoint was the proportion of study eves with matching VDAP VA classifications for the two VDAP tests. The observed reproducibility for Study Eves (89.3%, 95% Cl: 85.9% - 92.6%) was statistically significantly greater than the performance goal of 75% (p-value < 0.0001). There were no safety concerns found with VDAP assessments throughout the study. Furthermore, the reproducibility of the VDAP was confirmed in this study, and the PPV and NPV results of VDAP demonstrate that the selected cut off point of 20/25 Snellen is appropriate. Therefore, the device performance was adequate to support an indication for use as an aid in the assessment of visual acuity.

Conclusion

The VDAP is as safe and effective as the predicate device. The VDAP also shares similar technological characteristics as the reference devices. The VDAP has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the VDAP and its predicate devices raise no new issues of safety or effectiveness. Furthermore, performance data demonstrate that the VDAP is as safe and effective as the predicate device. Therefore, the VDAP is substantially equivalent.

Regulation Number and Section

§ 886.1150 Visual acuity chart.

(a)
Identification. A visual acuity chart is a device that is a chart, such as a Snellen chart with block letters or other symbols in graduated sizes, intended to test visual acuity.(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.