(109 days)
Not Found
No
The description focuses on standard digital imaging and eye-tracking technology, with no mention of AI or ML for image analysis, diagnosis, or other functions.
No
The device is described as an imaging device for diagnosis and evaluation, not for providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the images captured by the device "are intended for use as an aid to clinicians in the evaluation, diagnosis, and documentation of ocular health." This clearly indicates its role in the diagnostic process.
No
The device description explicitly states it is a "tabletop fundus camera" and describes physical components like optics, a microdisplay, a knob on an external peripheral device, LEDs, and a color CMOS sensor, indicating it is a hardware device with integrated software.
Based on the provided information, the Verily Numetric Retinal Camera is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Verily Numetric Retinal Camera is a device that takes images of the retina in vivo (within the living body). It does not analyze samples taken from the body.
- Intended Use: The intended use is for "in-vivo viewing of the posterior segment of the eye" and the images are used as an "aid to clinicians in the evaluation, diagnosis, and documentation of ocular health." This involves direct imaging of the eye, not laboratory analysis of biological samples.
Therefore, the Verily Numetric Retinal Camera falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Verily Numetric Retinal Camera is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina segment of the eye to be evaluated under non-mydriatic conditions.
Verily Numetric Retinal Camera is indicated for in-vivo viewing of the posterior segment of the eye. The images are intended for use as an aid to clinicians in the evaluation, diagnosis, and documentation of ocular health.
Product codes (comma separated list FDA assigned to the subject device)
HKI
Device Description
The Verily Numetric Retinal Camera (VNRC), the subject device, is a tabletop fundus camera that provides non-mydriatic, color, posterior segment images of the eye as an aid to clinicians in the evaluation and diagnosis of eye disease. It is a non-contact, high-resolution digital imaging device that is suitable for photographing, displaying, and storing images of the retina to be evaluated under non-mydriatic conditions.
The Verily Numetric Retinal Camera takes images of the fundus in the following manner:
Focusing: The patient interactively focuses an image shown on a microdisplay to the best qualitative focus by turning a knob on an external peripheral device which modulates the camera optics.
Alignment: The patient is shown a fixation target on the microdisplay and through an interactive session with position feedback, the patient aligns their pupil to the camera. The pupil location is determined using eye-tracking.
Image Capture: White light from LEDs illuminates the fundus. The light reflection from the fundus is captured by a color CMOS sensor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Color CMOS sensor captures light reflection from the fundus.
Anatomical Site
retina segment of the eye, posterior segment of the eye, fundus.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional healthcare environment
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: Non-clinical performance testing for the Verily Numetric Retinal Camera includes analysis using raw data collected via a retrospective clinical study. Bench testing includes verification and validation of specifications. All tests confirmed that the subject device met the predetermined acceptance criteria and that the features driving performance are substantially equivalent to those present in the specified predicate device.
Bench Testing Summary: The VNRC has undergone performance testing before release to ensure that the device hardware and its software meet the functional requirements and to demonstrate equivalence to the predicate device.
Summary of results:
Field of view: 45 degrees, Pass
Pixel pitch tolerance:
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
December 9, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Verily Life Sciences, LLC % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K242508
Trade/Device Name: Verily Numetric Retinal Camera Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: November 13, 2024 Received: November 13, 2024
Dear Prithul Bom:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Elvin Y. Ng -S 2024.12.09
17:29:55 -05'00'
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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Indications for Use
Submission Number (if known)
Device Name
Verily Numetric Retinal Camera
Indications for Use (Describe)
Verily Numetric Retinal Camera is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina segment of the eye to be evaluated under non-mydriatic conditions.
Verily Numetric Retinal Camera is indicated for in-vivo viewing of the posterior segment of the eye. The images are intended for use as an aid to clinicians in the evaluation, diagnosis, and documentation of ocular health.
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 K242508
This summary of Traditional 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CPR 807.92.
| Date Prepared | December 9, 2024 |
|---|---|
| Submitter | Verily Life Sciences, LLC |
| Official Contact | Pooja Shah, Regulatory Affairs Specialist |
| 269 E Grand Avenue, South San Francisco, California, 94080 | |
| Email: shahpoo@verily.com | |
| Proprietary Name | Verily Numetric Retinal Camera |
| Common Name | Ophthalmic Camera |
| Classification | Class II Medical Device |
| Regulation Number: 21 CPR 886.1120 | |
| Product Code: HKI | |
| Predicate Device | K182199, |
| NFC-700 Non-Mydriatic Auto Fundus Camera | |
| Regulation Number: 21 CPR 886.1120 |
Indications for Use
Verily Numetric Retinal Camera is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina segment of the eye to be evaluated under non-mydriatic conditions.
Verily Numetric Retinal Camera is indicated for in-vivo viewing of the posterior segment of the eye. The images are intended for use as an aid to clinicians in the evaluation, diagnosis, and documentation of ocular health.
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Device Description
The Verily Numetric Retinal Camera (VNRC), the subject device, is a tabletop fundus camera that provides non-mydriatic, color, posterior segment images of the eye as an aid to clinicians in the evaluation and diagnosis of eye disease. It is a non-contact, high-resolution digital imaging device that is suitable for photographing, displaying, and storing images of the retina to be evaluated under non-mydriatic conditions.
The Verily Numetric Retinal Camera takes images of the fundus in the following manner:
Focusing: The patient interactively focuses an image shown on a microdisplay to the best qualitative focus by turning a knob on an external peripheral device which modulates the camera optics.
Alignment: The patient is shown a fixation target on the microdisplay and through an interactive session with position feedback, the patient aligns their pupil to the camera. The pupil location is determined using eye-tracking.
Image Capture: White light from LEDs illuminates the fundus. The light reflection from the fundus is captured by a color CMOS sensor.
Safety
All safety-related parameters of Verily Numetric Retinal Camera, such as light hazard protection, material biocompatibility, and IEC-60601 compliance, have been tested and conform to industry standards. The Verily Numetric Retinal Camera has the same analysis features as the predicate device; and all related test reports of safety show the Verily Numetric Retinal Camera is compliant with the same safety standards declared by the predicate device, NFC-700.
Biocompatibility Testing
The biocompatibility evaluation for Verily Numetric Retinal Camera has been conducted in accordance with ISO 10993-1.
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Effectiveness
The validation of effectiveness for the Verily Numetric Retinal Camera has been analyzed in detail and the image quality is similar to the predicate device. The results demonstrate that the Verily Numetric Retinal Camera is as effective as the predicate device, NFC-700.
Substantial Equivalence Discussion
Verily Numetric Retinal Camera is substantially equivalent to the predicate device, Crystalvue's NFC-700 Non-Mydriatic Auto Fundus Camera (a.k.a NFC-700) (K182199), as both the subject and predicate devices are intended as an aid to clinicians in the evaluation and diagnosis of eye disease. Both devices are indicated for photographing, displaying and storing images of the retina to be evaluated under non-mydriatic conditions. Similar to the predicate device, the subject device is classified as "Ophthalmic Camera" in accordance with 21 CPR 886.1120, Product Code HKI.
It is important to note that the method of alignment of the predicate device, NFC-700 camera is automatic, and that of the Verily Numetric Retinal Camera is interactive. The focusing on the Verily Numetric Retinal Camera is performed by the patient viewing a screen which is collocated in the same plane as the image sensor. It ensures that the fundus image is in sharp focus on the image sensor. These differences do not limit the camera's ability to be safe and effective.
The table below is a comparative summary of the similarities and differences between the Verily Numetric Retinal Camera (subject device) and the NFC-700 camera (predicate device) (K182199).
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| Product Item | Verily Numetric
Retinal Camera | Crystalvue, NFC-700
Non-Mydriatic Auto
Fundus Camera | Comparison
Comments |
|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K242508 | K182199 | |
| Intended Use | Verily Numetric
Retinal Camera
provides
non-mydriatic, color
posterior segment
images of the eye as an
aid to clinicians in the
evaluation and
diagnosis of eye
disease. | NFC-700 provides
non-mydriatic, color
posterior chamber and
external images of the
eye as an aid to
clinicians in the
evaluation and
diagnosis of eye
disease. | Verily Numetric Retinal Camera
does not acquire external
images of the eye for sharing
with the end users. The camera
acquires and shares retinal
images only. All else is
identical. |
| Indication for Use | Verily Numetric
Retinal Camera is a
non-contact, high
resolution digital
imaging device which
is suitable for
photographing,
displaying and storing
images of the retina
segment of the eye to
be evaluated under
non-mydriatic
conditions.
Verily Numetric
Retinal Camera is
indicated for in-vivo
viewing of the
posterior segment of
the eye. The images
are intended for use as
an aid to clinicians in
the evaluation,
diagnosis, and
documentation of
ocular health. | NFC-700 is a
non-contact, high
resolution digital
imaging device which
is suitable for
photographing,
displaying and storing
images of the retina
and external areas of
the eye to be evaluated
under non-mydriatic
conditions. NFC-700 is
indicated for in-vivo
viewing of the
posterior and external
area of the eye and the
images are intended for
use as an aid to
clinicians in the
evaluation, diagnosis
and documentation of
ocular health. | Verily Numetric Retinal Camera
does not acquire external
images of the eye. All else is
identical. |
| Where Used | Professional healthcare
environment | Hospital | The camera has been
demonstrated to be safe and
effective in healthcare
environments. |
| | | Design | |
| Shape | Verily Numetric
Retinal Camera and
Chromebook | All in one | No significant differences.
Minor hardware differences of
the operator display do not raise
different questions of safety and
effectiveness. |
| Dimensions
(WxDxH) | 257 x 420 x 360 (mm) | 282 x 485 x 492 (mm) | No significant differences.
Minor hardware differences do
not raise different questions of
safety and effectiveness |
| Weight | 6 kg | 17 kg | Physical weight of the device
do not raise different questions
of safety and effectiveness. |
| Eye Fixation | One (1) fixation point | 10 fixation points | Verily Numetric Retinal Camera
is designed to be used with a
single automated visual fixation
point. Both VNRC and
predicate are able to provide
gradable images to aid
clinicians in the evaluation and
diagnosis of eye disease. The
difference in number of
automated fixation points does
not limit the safety and
effectiveness of the device. |
| Power Supply | AC 100V to 240V,
50/60Hz (Auto
selected) | AC 100V to 240V,
50/60Hz (Auto
selected) | Same |
| Environment | Temp.: 15-30 °C /
Humidity: 20-75%RH | Temp.: 10-35 °C /
Humidity:
30-90%RH | No significant difference.
Professional healthcare
environments are within the
environmental ranges of both
cameras. |
| Light source
I.Observation:
2. Flash: | 1. Infrared LED
2. White LED | 1. Infrared LED
2. White LED | Same |
| Type of
Photography | Color posterior eye
image | Color / Digital red-free
/ Anterior eye image | The Verily Numetric Retinal
Camera only acquires color
images of the posterior
segment. |
| Operation Principle | The Verily Numetric
Retinal Camera takes
images of the fundus
in the following
manner:
I.Focusing: The
patient interactively
focuses an image
shown on a
microdisplay (located
at the same optical
plane as the image
sensor) into best
qualitative focus by
turning a knob on an
external peripheral
device which
modulates the camera
optics.
2. Image Capture:
The patient is shown
a fixation target and
through an interactive
session with position
feedback, the patient
aligns their pupil to
the camera. The pupil
location is
determined using
eye-tracking. White
light from LEDs
illuminate the fundus.
The light reflection
from the fundus is
captured by a color
CMOS sensor. | The optical design of
fundus camera is
based on the
principle of
monocular indirect
ophthalmoscopy.
- Fundus
observation:
A built in light ray
from the infrared
light LED source to
illuminate the
fundus. Alignment
of the device is
performed by a
built- in eye tracking
indicator and
working distance
indicator to adjust
the system to the
best XYZ position
automatically. - Image capture:
System uses
split-image technique
to do image focus
adjustment
automatically to
capture the best
quality of image.
White light from
LEDs Flash module
irradiates the fundus.
The light reflected
from eye portions
forms an image, and | The method of alignment of the
NFC-700 is automatic, and that
of the Verily Numetric Retinal
Camera is interactive.
The focusing is performed by
the user viewing a screen which
is collocated in the same plane
as the image sensor, it ensures
that the fundus image is in
focus on the image sensor.
These differences do not limit
the camera's ability to be safe
and effective. |
| | | | |
| | | the image is captured
by built-in color
CMOS camera
module for fundus
image capture. | |
| Material of Chinrest | No Chinrest | ABS | There is no chin rest for the
Verily Numetric Retinal Camera
device. |
| Material of Forehead
Rest | Silicone | TPE | The Verily Numetric Retinal
Camera device contains a
facerest that contacts the
forehead and cheek area.
The biocompatibility
has been tested by a
recognized lab, thus there is no
impact to safety. |
| Safety | Compliance with
• IEC 60601-1 | Compliance with
• IEC 60601-1 | Same |
| EMC | Compliance with
IEC 60601-1-2 | Compliance with
• IEC 60601-1-2 | Same |
| Performance | | | |
| Image (resolution) | 2.1 MP | 12MP | The difference in image
resolution does not affect the
safety and effectiveness of the
device. The VNRC camera
meets all optical performance
specifications recommended by
ISO 10940 standard. |
| Alignment | Interactive Guided
Alignment | Fully automatic 3D
tracking | The captured image is brought
into focus and alignment
interactively by the patient for
the Verily Numetric Retinal
Camera instead of
automatically by the instrument
for the NFC-700. The
differences in the method of |
| | | | alignment does not affect the
safety and effectiveness of the
device. |
| Field-of-View | 45° | 45° | Same |
| Minimum Pupil Size | 3.0 mm | 4.0 mm | The Verily Numetric Retinal
Camera is able to image
patients with smaller pupils than
the predicate. This difference
does not limit the camera's
ability to be safe and effective. |
| Operation Range
(Focus
Adjustment
Range): - Without
compensation
lens: - With
compensation
lens: | -20 to +20D | -15 to +10D
-30D to -10D or +5D
to +30D | Verily Numetric Retinal Camera
passes the ISO 10940
specification of+/- 15D without
the need of a compensation
lens. The difference does not
affect safety and effectiveness. |
| Interface | USB2.0 / Wi-Fi | USB2.0 / Ethernet /
HDMI | Differences in data modality
transfer do not impact the
safety and effectiveness of the
device. |
| Performance
Item | Verily Numetric Retinal Camera Acceptance
Criteria | Test Result | |
| Resolving power | ≥ 60 line pairs/mm at the center of the field
≥ 40 line pairs/mm at the mid field (r/2)
≥25 line pairs/mm at the periphery of the field (r) | Pass | |
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The differences in technological characteristics associated with the subject device and the predicate device, NFC-700 (K182199) have been evaluated through performance testing for the target population and there are no new questions of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate device.
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Non-Clinical Performance Data
Non-clinical performance testing for the Verily Numetric Retinal Camera includes analysis using raw data collected via a retrospective clinical study. Bench testing includes verification and validation of specifications. All tests confirmed that the subject device met the predetermined acceptance criteria and that the features driving performance are substantially equivalent to those present in the specified predicate device.
The Verily Numetric Retinal Camera has been tested and found to be in full compliance with the following FDA-recognized consensus standards:
- 트 ANSI Z80.36-2021 (Group 1 Instrument)
- ISO 10940 Second edition 2009
- IEEE ANSI C63.27-2017 l
- I AAMI TIR69:2017/(R2020)
Software Validation
The software verification and validation testing were conducted and documentation was provided as recommended by IEC-62304:2015, "Medical Device Software- Software Life Cycle Processes." The software for Verily Numetric Retinal Camera is classified as Class A according to the classification of IEC 62340:2015, and has been evaluated to be Basic Documentation Level as per FDA Guidance document - "Content of Premarket Submissions for Device Software Functions (June 2023)." Software used in the Verily Numetric Retinal Camera conforms to the safety principles and is demonstrated through the risk management process for medical devices.
Bench Testing Summary:
The VNRC has undergone performance testing before release to ensure that the device hardware and its software meet the functional requirements and to demonstrate equivalence to the predicate device.
A summary of the results of performance testing and the device requirements follows:
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| Field of view | 45 degrees | Pass |
|---|---|---|
| Pixel pitch tolerance |