(213 days)
No
The summary describes a software application that uses user responses to displayed optotypes to categorize visual acuity. There is no mention of AI, ML, or complex algorithms beyond basic response processing and categorization. The performance studies focus on standard statistical metrics like PPV, NPV, sensitivity, and specificity, which are typical for non-AI/ML medical devices.
No.
The device is intended to aid in the evaluation of visual acuity, categorize it, and provide recommendations for an eye care provider. It explicitly states it "does not provide screening or diagnosis of eye health or other disease, nor is it intended to replace an in-person eye exam." This indicates it is for assessment and information, not direct treatment or therapy.
No.
The "Intended Use / Indications for Use" section explicitly states: "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." It categorizes visual acuity, but does not provide a diagnosis.
Yes
The device is described as a "web-based, software application" that runs on existing internet-enabled devices (computer screen and touchscreen mobile device) and does not include any proprietary hardware components.
Based on the provided information, the Visibly Digital Acuity Product (VDAP) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- VDAP's Function: The VDAP is a software application that evaluates visual acuity by presenting optotypes and recording user responses. It does not involve the collection or analysis of any biological specimens from the human body.
- Intended Use: The intended use clearly states it's "to aid in the evaluation of visual acuity" and "does not provide screening or diagnosis of eye health or other disease." This aligns with a functional assessment rather than a diagnostic test based on biological samples.
Therefore, the VDAP falls outside the scope of an In Vitro Diagnostic device. It is a medical device used for a functional assessment of vision.
N/A
Intended Use / Indications for Use
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.
Product codes
QTO
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.
- A touchscreen mobile device (the Remote) which operates as a remote control and 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults, ages 22 to 40
Intended User / Care Setting
Intended for use by adults, ages 22 to 40, who have the capability to perform a self-test at home. 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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
- PPV for study eyes: 97.3% (95% Cl: 95.2% - 99.4%)
- NPV for study eyes: 48.1% (95% Cl: 38.6% - 57.6%)
- Sensitivity for study eyes: 79.7% (95% Cl: 74.9% - 84.5%)
- Specificity for study eyes: 89.5% (95% CI: 81.5% - 97.4%)
- PPV for non-study eyes: 94.5% (95% Cl: 91.9% - 97.2%)
- NPV for non-study eyes: 50.9% (95% Cl: 37.5% -64.4%)
- Sensitivity for non-study eyes: 90.9% (95% Cl: 87.6% - 94.2%)
- Specificity for non-study eyes: 64.3% (95% Cl: 49.8% - 78.8%)
- PPV for pooled Study Eye and Non-Study Eye cohort: 95.8% (95% Cl: 93.6% - 97.6%)
- NPV for pooled Study Eye and Non-Study Eye cohort: 49.1% (95% Cl: 40.0% - 58.1%)
- Sensitivity for pooled Study Eye and Non-Study Eye cohort: 85.5% (95% Cl: 81.9% - 88.9%)
- Specificity for pooled Study Eye and Non-Study Eye cohort: 78.8% (95% Cl: 69.1% - 87.6%)
- Subject level agreement: 75.9% (95% Cl: 71.3% - 80.5%)
- Subject level reproducibility: 82.8% (95% Cl: 78.7% - 86.9%)
- Reproducibility for Study Eves: 89.3% (95% Cl: 85.9% - 92.6%)
Predicate Device(s)
Vimetrics, LLC Central Vision Analyzer (CVA-1000) K100095
Reference Device(s)
SoloHealth, Inc. SoloHealth Station (K113402), Vital Art and Science, Inc. MyVisionTrack Model 005 (K143211)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
September 30, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA seal. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
Image /page/1/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
2
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
3
510(k) Number (if known)
K220090
Device Name
Visibly Digital Acuity Product
Indications for Use (Describe)
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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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.
5
Technological Characteristics
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.
A table comparing the key features of the subject, predicate, and reference devices is provided below.
| | Visibly Digital
Acuity Product
(subject) | Vimetrics Central
Vision Analyzer 1000
(CVA-1000)
(predicate) | SoloHealth Station
(reference) | MyVisionTrack
Model 0005
(reference) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K220090 | K100095 | K113402 | K143211 |
| Product Code | QTO | HOX, Chart, Visual
Acuity | DXN, Automated
Blood Pressure
Monitor
HOX, Chart, Visual
Acuity | HOQ, Amsler grid |
| 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 | The CVA-1000 is
intended for use
under the direct
supervision of an
ophthalmologist or
optometrist in the
measurement of
vision at fixation in
one or both eyes, with
or without optical
correction. | The SoloHealth
Station is intended
to be used by the
general public so
that a user can
measure his/her
own blood pressure
and pulse rate and
his/her own weight.
Additionally, the
SoloHealth Station
is intended to
screen adults for
clarity of central
vision. SoloHealth
Station does not
provide a general | The
myVisionTrack®
Model 0005 is
intended for the
detection and
characterization of
central 3 degrees
metamorphopsia
(visual distortion) in
patients with
maculopathy,
including age-
related macular
degeneration and
diabetic retinopathy,
and as an aid in
monitoring |
| Visibly Digital
Acuity Product
(subject) | Vimetrics Central
Vision Analyzer 1000
(CVA-1000)
(predicate) | SoloHealth Station
(reference) | MyVisionTrack
Model 0005
(reference) | |
| 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. | | screening of visual
function and does
not provide a
diagnosis of eye
health or other
disease. The
SoloHealth Station
only screens clarity
of central vision.
Users should
consult their
personal physicians
if they have
concerns regarding
their eyesight. | 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
myVisionTrack®
Model 0005 is not
intended to
diagnose; diagnosis
is the responsibility
of the prescribing
eye-care
professional. | |
| | Visibly Digital
Acuity Product
(subject) | Vimetrics Central
Vision Analyzer 1000
(CVA-1000)
(predicate) | SoloHealth Station
(reference) | MyVisionTrack
Model 0005
(reference) |
| Intended
Population | Adults, ages 22 to
40 | General Public | General Public | Patients at high risk
or already
diagnosed with
maculopathy |
| Prescription or
OTC | OTC | Prescription | OTC | Prescription home
use by patients |
| Device Type | Web-based
software application | Device with electronic
display | Device with
electronic display | Downloadable
application to cell
phone or tablet |
| Hardware
Platform | Display: Computer,
laptop or tablet
Remote:
Touchscreen
smartphone or
mobile device | Display: Computer, 2
LCD computer
monitors, keyboard,
mouse | Display: LCD
computer monitor,
Interactive Central
Vision Panel | Display: User
supplied cell phone
or tablet |
| Software
Design | Interactive software
platform with audio
and visual prompts | Interactive software
platform with audio
and visual prompts. It
has two panels:
Interactive Central
Vision Panel and
Chart Panel | Interactive software
platform with audio
and visual prompts | Interactive software
platform with visual
prompts |
| Target
Presentation | Landolt C optotypes
with crowding bars,
facing 4 different
directions (openings
at 180, 270, 0, and
90 degrees)
Optotypes are
presented singly | Multiple and Individual
optotypes (depending
on the panel selected) | Multiple optotypes
as well as
sentences and
paragraphs | Distorted and
undistorted shapes |
| How/Where
Used | At home | Clinical environments | Non-clinical
environments | At home |
| Test
Administration | Self-administration | Setup and Testing
Method is selected by
HCP | Self-administration | Self-administration |
| | Visibly Digital
Acuity Product
(subject) | Vimetrics Central
Vision Analyzer 1000
(CVA-1000)
(predicate) | SoloHealth Station
(reference) | MyVisionTrack
Model 0005
(reference) |
| | | Testing process is
completed via self-
administration | | |
| Test
Procedure
Summary | Based on optotypes
presented on the
Display, the user
will select what
object they see on
their Remote. The
following outputs
are generated for
Eye Care Provider
(ECP) review: (1)
user-inputted data
confirmed during
Qualification; (2)
Visual Acuity output
by eye classifying
the individual eye's
vision into one of
the following
buckets:
TRUE - visual
acuity that is
consistent with
normal vision FALSE - visual
acuity that is not
consistent with
normal vision | Chart Panel: A
monitor, viewed by
the patient, presents
traditional symbol
charts with
progressive 0.1
logMAR gradations of
symbol size, each of
which may be
presented in the
following Michelson
contrasts of black
letters presented
against a white
background in a range
of progressively
reduced contrasts.
The examiner may
view on the physician
monitor what is
presented to the
patient on the patient
monitor so he can
mark the letters that
are correctly
identified, allowing
either line-by-line or
letter-by-letter scoring.
The total letters read
correctly are recorded
as well as the
smallest line read
correctly in which the
traditional method of
scoring is utilized.
Interactive Central
Vision Panel: A
monitor is viewed by | Near distance
screening is
simulated at 17
inches through a
series of prompts
on the computer
monitor where
patients are asked
to view the clarity of
sentences and
letters at different
sizes. Far distance
screening is
simulated at 11 feet
through a view
finder on the
device. Patients
are asked to
determine the
clarity of a set of
letters. | The
myVisionTrack®
Model 0005
implements a shape
discrimination
hyperacuity (SDH)
vision test. The
distorted shape is
created by
modulating the
radius of the circle
with a sinusoid.
The user is shown
four circles and
asked to identify the
distorted circle. |
| Visibly Digital
Acuity Product
(subject) | Vimetrics Central
Vision Analyzer 1000
(CVA-1000)
(predicate) | SoloHealth Station
(reference) | MyVisionTrack
Model 0005
(reference) | |
| | the patient in which
automated
measurements are
conducted by an
interactive computer
program at logMAR
0.05 gradations of
symbol size. The
patient sits in a chair
in the darkened
examination room
with or without optical
correction
(spectacles, contact
lenses, or trial lenses)
and with one eye or
both eyes exposed,
he/she views in a
mirror at the end of
the room an LCD
monitor (patient
monitor) mounted on
the wall next to the
examiner's desk (total
distance entered into
the computer program
at the time of
installation). The
examiner selects the
method of operation
and contrasts to be
tested by keyboard
and mouse interaction
and with information
presented on the
physician's working
monitor. | | | |
6
7
8
9
10
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
11
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