Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model]: The Mirante SLO/OCT with scanning laser ophthalmoscope and optical coherence tomography function and with Image Filing Software NAVIS-EX is a non-contact system for imaging the fundus and for axial cross sectional imaging of ocular structures. It is indicated for in vivo imaging and measurement of:
· the retina, retinal nerve fiber layer, optic disc, and
· the anterior chamber and cornea (when used with the optional anterior segment OCT adapter)
and for color, angiography, autofluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.

Scanning Laser Ophthalmoscope Mirante [SLO Model]: The Mirante SLO with scanning laser ophthalmoscope function and with Image Filing Software NAVIS-EX is a noncontact system for imaging the fundus. It is indicated for color, angiography, auto-fluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments. It is intended to work with compatible NIDEK ophthalmic devices.

Device Description

The Nidek Mirante is an Optical Coherence Tomography (OCT) system intended for use as a non-invasive imaging device for viewing and measuring ocular tissue structures with micrometer range resolution. The Nidek Mirante is a computer controlled ophthalmic imaging system. The device scans the patient's eye using a low coherence interferometer to measure the reflectivity of retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices. The Nidek Mirante uses Fourier Domain OCT, a method that involves spectral analysis of the returned light rather than mechanic moving parts in the depth scan. Fourier Domain OCT allows scan speeds about 65 times faster than the mechanical limited Time Domain scan speeds. The Mirante utilizes Fourier spectroscopic imaging a Michelson interferometer. The interfering light of the reference light and the reflected light from the test eye obtained by the Michelson interferometer are spectrally divided by a diffraction grating and the signal is acquired by a line scan camera. The signal is inverse Fourier transformed to obtain the reflection intensity distribution in the depth direction of the patient's eve. The galvano mirror scans the imaging light in the XY direction to obtain a tomographic image. The Mirante includes scanning laser ophthalmoscope (SLO) functions as well as the OCT functions. The SLO component uses a confocal scanning system for image capture. The imaging light emitted from the laser oscillator passes through the hole mirror and enters the patient's eye. The reflected by the hole mirror and the signal is obtained by the detector. A resonant mirror and a galvanometer mirror placed in the imaging optical path scan the imaging light in the XY direction to obtain a flat surface image. The device includes Image Filing Software NAVIS-EX which is a software system intended for use to store, manage, process, measure, and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.

AI/ML Overview

The provided documentation describes the acceptance criteria and the study results for the Nidek Mirante Scanning Laser Ophthalmoscope and the Image Filing Software NAVIS-EX.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating "substantial equivalence" to previously cleared predicate devices through agreement and precision analyses, and superior or equivalent image quality. The performance is reported in terms of comparisons against these predicate devices.

Nidek Mirante (OCT Component) vs. Optovue Avanti (Predicate)

Metric	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Nidek Mirante)
Agreement Analysis (Mean Difference)	Demonstrate agreement with predicate device deemed clinically acceptable.	[ILM-RPE/BM] Thickness: Higher than Avanti (10-20 µm thicker). All parameters and populations met agreement performance goals. Disc Map RNFL Thickness: Higher than Avanti (around 10 µm thicker), with the exception of TSNIT Temporal. All parameters and populations met agreement performance goals. Disc Map Optic Disc: Lower Horizontal C/D Ratio and Vertical C/D Ratio, higher Disc Area and Cup Area (All Subjects). Similar differences for Normal, lower values for Glaucoma. All parameters and populations met agreement performance goals. Cornea Radial CCT: Higher than Avanti (around 15 µm thicker). Agreement performance goals met for All Subjects, but not met for Normal and Corneal Disease populations.
Precision Analysis (Repeatability)	Demonstrate acceptable variation (coefficient of variation, %CV) for measurements.	[ILM-RPE/BM] Thickness: Met precision goals for all parameters and groups. Disc Map RNFL Thickness: Met most precision goals for Normal population; most met for Glaucoma except for one TSNIT Nasal and one TSNIT Temporal parameter (slightly missed). Disc Map Optic Disc: Met most precision goals for Normal and Glaucoma populations, except for Cup Area in both populations (slightly missed). Cornea Radial CCT: Met precision goals for all parameters and populations.
Image Quality (ACA)	Clinically useful and overall quality comparable to predicate.	Not statistically significant difference in clinical utility and overall quality compared to Avanti.

Nidek Mirante (SLO Component) vs. OPTOS P200DTx (Predicate)

Metric	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Nidek Mirante)
Image Quality (Color Fundus)	Clinically useful and overall quality comparable to predicate.	Provided better clinical utility and overall quality compared to P200DTx (p<0.0001) for all subjects and individual populations (Normal, Glaucoma, Retinal Disease).
Image Quality (B-FAF)	Clinically useful and overall quality comparable to predicate.	Provided better clinical utility and overall quality compared to P200DTx (p<0.0001) for all subjects and individual populations (Normal, Glaucoma, Retinal Disease).
Image Quality (G-FAF)	Clinically useful and overall quality comparable to predicate.	Provided better clinical utility and overall quality compared to P200DTx (p<0.0001) for all subjects and individual populations (Normal, Glaucoma, Retinal Disease).

General Acceptance (Safety)

Metric	Acceptance Criteria	Reported Device Performance
Safety-related issues	No safety issues related to the study devices.	One adverse event (pinguecula), determined not related to the study device.

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

Test Set Sample Size: A total of 170 subjects were enrolled in the study.
- 45 subjects in the Normal group
- 46 subjects in the Glaucoma group
- 47 subjects in the Retinal Disease group
- 32 subjects in the Corneal Disease group
- 167 subjects completed the study.
Data Provenance: Prospective, comparative clinical study conducted at one clinical site in the United States.

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

The document mentions "Masked graders reviewing Anterior Chamber Angle (ACA) and SLO images were masked to the subject, device type, subject population, configuration order, device order and results from other graders."
However, the number of experts/graders and their qualifications are not explicitly stated in the provided text.

4. Adjudication Method for the Test Set

The document states: "Scan acceptability was by a 2-step process where the device operator identified acceptable scans and then an Investigator image reviews the scans making the final determination of which scans were acceptable or unacceptable." This implies a form of sequential review, with the "Investigator" making the final determination. It does not specify an adjudication method like 2+1 or 3+1 for resolving discrepancies between multiple graders for image quality assessment, as the number of graders is not mentioned. However, for "image quality" assessments (ACA and SLO), it states "The results from the 3 masked graders were documented," and uses "grader average." This suggests that if multiple graders were used, their averages were taken, rather than a formal adjudication process to resolve disagreements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This was not a multi-reader, multi-case (MRMC) comparative effectiveness study comparing human readers with AI vs. without AI assistance. The study compared the Nidek Mirante device's performance (including image quality) to predicate devices, and involved masked graders assessing image quality, but not in the context of improving human reader performance with AI assistance.

6. If a Standalone (algorithm only without human-in-the-loop performance) was Done

The primary purpose of the study was to assess the agreement and precision of the Nidek Mirante OCT measurements in comparison with a predicate device and to assess its image quality in comparison to predicate devices for both OCT and SLO. While precision analyses evaluate the device's inherent measurement consistency, and image quality assessment involves human graders, these do not represent a standalone "algorithm only without human-in-the-loop performance" in the general sense of an AI diagnostic algorithm operating independently. The device itself is an imaging system used by humans, not an AI for diagnosis.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The study does not establish an independent ground truth (e.g., pathology, clinical outcomes) for the disease states. Instead, it uses comparative effectiveness against predicate devices and agreement/precision analysis for quantitative measurements and human-graded qualitative image quality. The study categorized subjects into Normal, Glaucoma, Retinal Disease, and Corneal Disease groups. This implies that the diagnosis of these disease states served as a basis for evaluating the device's performance within those groups, but the precise method of establishing these diagnoses (e.g., expert consensus, other gold-standard tests) is not detailed for the "ground truth" of the disease classification itself. The "ground truth" for the device's performance metrics appears to be the measurements and image quality of the predicate devices, or the consistency of the Mirante itself.

8. The Sample Size for the Training Set

The document describes a clinical study to demonstrate substantial equivalence, but it does not mention a training set sample size or the development of an AI/ML algorithm that would typically involve a separate training set. The device itself is a scanning laser ophthalmoscope and optical coherence tomography system, not inherently an AI diagnostic tool. However, the NAVIS-EX software later references a "B-scan Denoising software" which is a new function. The document mentions this function "denoises a single B-scan image to an averaged image of 120 images added," suggesting it uses a computational approach, but does not provide details of a training set for this denoising algorithm if it were an AI-based method.

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

As no training set is explicitly mentioned for an AI/ML algorithm in the context of the Nidek Mirante device itself, the method for establishing ground truth for a training set is not applicable or described in the provided text. For the B-scan Denoising software, the mechanism is described as "averaging 120 images," which is an algorithmic process rather than a machine learning model requiring a ground-truth labeled training set in the typical sense.

Summary

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March 30, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. 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.

Nidek Co., LTD. % Ryan Bouchard Official Correspondent Ora. Inc. 300 Brickstone Square Andover, Massachusetts 01810

Re: K221320

Trade/Device Name: Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, MYC, NFJ Dated: February 22, 2023 Received: February 24, 2023

Dear Ryan Bouchard:

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 (QS) 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 medical devices and radiation-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).

Sincerely.

Elvin Y. I

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

510(k) Number (if known) K221320

Device Name

Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX

Indications for Use (Describe)

Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model]

The Mirante SLO/OCT with scanning laser ophthalmoscope and optical coherence tomography function and with Image Filing Software NAVIS-EX is a non-contact system for imaging the fundus and for axial cross sectional imaging of ocular structures. It is indicated for in vivo imaging and measurement of:

· the retina, retinal nerve fiber layer, optic disc, and

· the anterior chamber and cornea (when used with the optional anterior segment OCT adapter)

and for color, angiography, autofluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.

Scanning Laser Ophthalmoscope Mirante [SLO Model]

The Mirante SLO with scanning laser ophthalmoscope function and with Image Filing Software NAVIS-EX is a noncontact system for imaging the fundicated for color, angiography, auto-fluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments. It is intended to work with compatible NIDEK ophthalmic devices.

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

K221320

This summary of the 510(k) premarket notification for the Nidek Mirante with NAVIS-EX Software is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Owner Company name, address

NIDEK CO., LTD. 34-14 Meahama, Hiroishi-cho, Gamagori, Aichi, 443-0038 Japan Contact person: Tsutomu Sunada E-mail: Tsutomu Sunada(@nidek.co.jp

Contact/Application Correspondent

Ryan Bouchard Ora, Inc. 300 Brickstone Square Andover, MA 01810 Telephone: (978) 332-9574 Facsimile: (978) 689-0020 E-mail: rbouchard(@oraclinical.com

Date Prepared

March 30, 2023

Name of Device - Mirante

Trade Name:

Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX

Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX

Common Name:	Optical Coherence Tomography
Classification Name:	Ophthalmoscope
Classification Regulation:	21 CFR 886.1570
Product Code:	OBO, MYC, NFJ
Predicate Devices
Primary predicate:	Avanti (K180660)
Secondary predicate:	P200DTx: (K142897)
	Image Filing Software NAVIS-EX: (K181345)

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OCT/SLO Device Description

The Nidek Mirante uses Fourier Domain OCT, a method that involves spectral analysis of the returned light rather than mechanic moving parts in the depth scan. Fourier Domain OCT allows scan speeds about 65 times faster than the mechanical limited Time Domain scan speeds.

The Mirante utilizes Fourier spectroscopic imaging a Michelson interferometer. The interfering light of the reference light and the reflected light from the test eye obtained by the Michelson interferometer are spectrally divided by a diffraction grating and the signal is acquired by a line scan camera. The signal is inverse Fourier transformed to obtain the reflection intensity distribution in the depth direction of the patient's eve. The galvano mirror scans the imaging light in the XY direction to obtain a tomographic image.

The OCT scan patterns include the following:

Retinal Scan Patterns

Macula Line
Macula Cross
Macula Map
Macula Multi ●
Macula Radial ●
Disc Map
Disc Radial .

Anterior Scan Patterns

Cornea line
Cornea cross ●
Cornea radial
ACA line ●

The Mirante includes scanning laser ophthalmoscope (SLO) functions as well as the OCT functions. The SLO component uses a confocal scanning system for image capture. The imaging light emitted from the laser oscillator passes through the hole mirror and enters the patient's eye. The reflected by the hole mirror and the signal is obtained by the detector.

A resonant mirror and a galvanometer mirror placed in the imaging optical path scan the imaging light in the XY direction to obtain a flat surface image.

Indications for Use

Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model]

The Mirante SLO/OCT with scanning laser ophthalmoscope and optical coherence tomography function and with Image Filing Software NA VIS-EX is a non-contact system for imaging the fundus and for axial cross sectional imaging of ocular structures. It is indicated for in vivo imaging and measurement of:

· the retina, retinal nerve fiber layer, optic disc, and

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· the anterior chamber and cornea (when used with the optional anterior segment OCT adapter)

Scanning Laser Ophthalmoscope Mirante [SLO Model]

The Mirante SLO with scanning laser ophthalmoscope function and with Image Filing Software NAVIS-EX is a non-contact system for imaging the fundus. It is indicated for color, angiography, auto-fluorescence, and retro mode imaging of the retina as an aid in the diagnosis and management. The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.

Statement of Substantial Equivalence

Nidek believes that the Nidek Mirante described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to legally marketed predicate devices. These are Class II medical devices and include the Avanti OCT cleared in K180660 and the OPTOS P200DTx cleared in K142897.

Optical coherence tomography (OCT)

The Mirante is substantially equivalent to the Avanti for the intended use for imaging and measurements of anterior and posterior ocular structures. The Mirante has virtually the same intended use as Avanti (K180660) with the exception that the Mirante does not include a normative database.

The principle of operation is identical in that both devices employ a non-invasive, non-contact low-coherence interferometry technique [spectral domain optical coherence tomography (SD-OCT)] to generate high-resolution cross-sectional images of internal ocular tissue microstructures by measuring optical reflections from tissue. Both provide cross sectional images of the anterior structures of the eye (i.e., cornea and retina, including the ganglion and retinal nerve fiber layers).

Scanning Laser Ophthalmoscope (SLO)

The Mirante is substantially equivalent to the OPTOS P200DTx for the intended use as a widefield and retinal fluorescence and autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina. The Mirante has the same intended use as OPTOS P200DTx (K142897).

The principle of operation is identical in that both devices employ a confocal scanning system for image capture. The imaging light emitted from the laser oscillator passes through the hole mirror and enters the patient's eye. The reflected light is reflected by the hole mirror and the signal is obtained by the detector.

There are minor differences in technological characteristics between the Mirante and the predicate devices that do not raise questions of safety or effectiveness.

Discussion

Bench testing has been performed to demonstrate that the Mirante device performs as intended and is substantially equivalent to the predicate devices, Avanti (K180660) and OPTOS P200DTx

(K142897), with respect to imaging and measurement of ocular structures. Both devices comply with recognized consensus standards regarding electrical safety, optical safety and biocompatibility. The system level testing with software version 1.22 was conducted with passing results.

Performance testing included OCT and SLO system testing, optical safety testing, and Usability testing. The performance testing demonstrated that the device satisfies the performance requirements specified for its intended use and is equivalent to the relevant performance characteristics of the comparative predicate device.

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Therefore, based on the same intended use and similar technological characteristics with substantial equivalence to the predicate devices confirmed with performance testing, the Mirante is technologically and functionally equivalent to the predicate devices, Avanti (K180660) and OPTOS P200DTx (K142897). The differences between the proposed device, Mirante, and the predicate devices are insignificant and do not raise new issues of safety or effectiveness of the device.

The Comparison Table of Technological Characteristics follows.

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	Test Device	Primary Predicate Device	Secondary Predicate Device	Discussion
Device Name	Mirante SLO/OCT model withNAVIS-EX	Avanti	P200DTx
510(k) Number		(K180660)	(K142897)
Classification, Product Code	Class II, HLI, OBO, MYC	Class II, HLI, OBO	Class II, MYC	Same
Regulation number	21CFR 886.1570	21 CFR 886.1570	21 CFR 886.1570	Same
	(Ophthalmoscope, AC-Powered)	(Ophthalmoscope, AC-Powered)	(Ophthalmoscope, AC-Powered)	Same
Applicant	Nidek Co., Ltd.	Optovue, Inc.	Optos, Plc
Indications for use	The Mirante SLO/OCT withscanning laser ophthalmoscopeand optical coherencetomography function and withImage Filing Software NAVIS-EX is a non-contact system forimaging the fundus and foraxial cross sectional imaging ofocular structures. It is indicatedfor in vivo imaging andmeasurement of:• the retina, retinal nerve fiberlayer, optic disc, and• the anterior chamber andcornea (when used with theoptional anterior segment OCTadapter)and for color, angiography,autofluorescence, and retromode imaging of the retina asan aid in the diagnosis andmanagement.	The Avanti is an opticalcoherence tomography systemintended for the in vivoimaging, cross-sectional, andthree-dimensional imaging andmeasurement of anterior andposterior ocular structures,including retina, retinal nervefiber layer, ganglion cellcomplex (GCC), optic disc,cornea, corneal epithelia,corneal stroma, pachymetry,corneal power, and anteriorchamber of the eye. With theintegrated normative database,Avanti is also a quantitativetool for the comparison ofretina, retinal nerve fiber layer,and optic disc measurements inthe human eye to a database ofa known normal subjects. It isindicated for use as adiagnostic device to aid in thedetection and management ofocular diseases.	The P200DTx scanning laserophthalmoscope is indicatedfor use as a widefield andretinal fluorescence andautofluorescence imagingophthalmoscope to aid in thediagnosis and monitoring ofdiseases and disorders thatmanifest in the retina. It is alsoindicated for use as a widefieldscanning laser ophthalmoscopefor viewing choroidalcirculation patterns that areilluminated using IndocyanineGreen dye and for aiding inboth the assessment ofchoroidal circulation and in thediagnosis of choroiditis orchoroidal diseases.	Similar - All devices support imaging ofthe posterior and anterior segment of theeye. The Mirante does not include anintegrated normative database.The indications for use of the NAVIS-EXhave remained unchanged from theindications for use of the previouslycleared NAVIS-EX.
		Test Device	Primary Predicate Device	Secondary Predicate Device	Discussion
		The Image Filing SoftwareNAVIS-EX is a softwaresystem intended for use tostore, manage, process,measure, analyze and displaypatient data and clinicalinformation from computerizeddiagnostic instruments throughnetworks. It is intended to workwith compatible NIDEKophthalmic devices.	The Avanti with the AngioVuesoftware feature is indicated asan aid in the visualization ofvascular structures of the retinaand choroid in normal subjects,and in subjects with glaucomaand retinal diseases. TheAngioAnalytics softwarefeature of AngioVue isindicated for the measurementof vascular density, the fovealavascular zone, the thickness ofretinal layers, and nerve fiberlayer, and measurement ofoptic disc parameters in normalsubjects, and in subjects withglaucoma and retinal diseases.	-	-
OCT Function		-	-	-	-
Principle	Retina cross-sectionalobservation andimage capture	Spectral domain OCT	Spectral domain OCT	-	Same for the predicate device.
	Anterior segmentcross-sectionalobservation andimage capture	Spectral domain OCT	Spectral domain OCT	-	Same for the predicate device.
Light source wavelength		880 nm	840 nm	-	Similar valueThe difference does not result in anydifference in OCT image quality that canaffect diagnosis. Thus, the light sourcewavelength is considered to besubstantially equivalent between theMirante and the predicate device.
	Scan rate (temporal resolution)	85,000 A-Scan/sec	70,000 A-Scan/sec	-	SimilarThe higher scan rate for the Test devicedoes not affect the safety and efficacy ascompared to the predicate
		Test Device	Primary Predicate Device	Secondary Predicate Device	Discussion
Resolution(Opticalresolution)	Retina cross-sectional imagecapture	Retina cross-sectionalobservationHorizontal (X-Y) directions:$20 \mu m$Depth (Z) direction: $7 \mu m$	Horizontal: $15 \mu m$ ( accordingto brochure )Depth: $5 \mu m$		SimilarThe differences are not expected to affectthe safety or effectiveness of the device.
	Anterior segmentcross-sectionalobservation andimage capture	Anterior segment cross-sectional observation(Optional)Horizontal (X-Y) directions:$30 \mu m$Depth (Z) direction: $7 \mu m$	Horizontal (X-Y) direction:UnknownDepth: $5 \mu m$		Similar depthThe horizontal resolution of the predicatedevice is unknown., however, resolutionin the horizontal (X-Y) direction does notsubstantially affect the deviceeffectiveness.The differences are not expected to affectthe safety or effectiveness of the device
Angle ofview	Retina cross-sectional imagecapture	Scan width: 3 mm to 16.5 mm,Scan depth: 2.1 mm	Scan width: 2 mm to 12 mm,Scan depth: 2 mm to 3 mm		Similar valuesThe scan width and scan depth areconsidered to be substantially equivalentbetween the Mirante and the predicatedevice.
	Anterior segmentcross-sectionalimage capture	Scan width: 2 to 8 mm,Scan depth: 2.1 mm	12 mm × 8 mm (Field of view)Maximum of 2.3mm(according to Operator'sManual)		Similar valuesThe scan width and scan depth areconsidered to be substantially equivalentbetween the Mirante and the predicatedevice.
Displayresolution	Retina cross-sectional imagecapture	Horizontal (X-Y) directions: 3$\mu$ m/pixelDepth (Z) direction 4 $\mu$ m/pixel	unknown		predicate information unknown
	Anterior segmentcross-sectionalimage capture	Horizontal (X-Y) directions 2$\mu$ m/pixelDepth (Z) direction 4 $\mu$ m/pixel	unknown		Because the length per pixel of theMirante is smaller than the opticalresolution, this only contributes to thefineness of the depicted structures and theamount of information obtained fordiagnosis remains unchanged. Therefore,this is not considered to be an issue forsafety or effectiveness for the Mirante.
		Test Device	Primary Predicate Device	Secondary Predicate Device	Discussion
Required pupil diameter		2.5 mm in diameter (3 mm in diameter or larger is recommended.)	2.3 mm		Similar valuesThe required pupil diameter is consideredto be substantially equivalent between theMirante and the predicate OCT device.
Sensitivity		Regular, Fine, Ultrafine	unknown		The predicate information is unknownThe [Fine] or [Ultra Fine] setting mayallow capturing of proper cross sectional(OCT) images even though only OCTimages with lower quality were capturedfor the eye with the [Regular] setting".The provision of the [Fine] or [UltraFine] setting does not improve theeffectiveness. The increase in the statusof target eyes that Mirante can deliver thebasic performance (or capture the OCTimages) will act to reduce the risk ofmisdiagnosis due to insufficientinformation, and will raise no new safetyconcerns.
OCT ScanPattern	Retinal scanpattern	Macula Line	Line		Similar functionsAlthough the scan patterns are slightlydifferent in terms of names andvariations, both the Mirante and thepredicate device have similar scanpatterns.
		Macula Cross	Cross Line
		Macula Map	Grid
		Macula Multi	Raster
		Macula Radial	Retina Map
		Disc Map	3D Retina
		Disc Radial	3D Widefield
			3D Widefield With MCT
			Radial Lines
			Enhances HD Line
			GCC
			ONH
			3D Disc
			3D Clinical
	Anterior scanpattern	Cornea line	Pachymetry
		Cornea cross	Pachymetry Wide
		Test Device	Primary Predicate Device	Secondary Predicate Device	Discussion
		Cornea radial	Pachymetry + Corneal Power
		ACA line	Cornea Line
			Cornea Cross Line
			Angle
			3D Cornea
Choroidal mode (EDI)		Yes	Yes		Same
Position of		ILM	ILM		Same
retinal layer		NFL/GCL	NFL
borderline as		IPL/INL	IPL
segmentationalgorithms		RPE/BM	RPE
Position of		Anterior	Anterior		Same
corneal layer		Posterior	Posterior
borderline as
segmentationalgorithms
	Anterior segment imaging function
Principal		SLO: Confocal laser scanningmethod	Monochrome CCD Camera		The devices use different methods toperform the function. These differencesare not expected to have an impact on thedevice safety or efficacy.
Light source wavelength		IR (Infrared): 790 nm	NIR (Near Infrared): 735 nmLED
Field of View		22.6 mm ±5% in diameter	12 mm×8 mm
SLO Function
Principle		SLO: Confocal laser scanningmethod		SLO: Confocal laser scanningmethod	Same
Light source wavelength		Blue: 488 nm		Blue: 488 nm	The test device has similar light sourcewavelengths compared to the predicatedevice.
		Green: 532 nm		Green: 532 nm
		Red: 670 nm		Red: 635 nm	The difference in wavelengths isconsidered not to cause substantialdifferences between the Mirante and thepredicate device.
		IR (Infrared): 790 nm		IR (Infrared): 802 nm
Resolving power		Regular angle		Unknown

	Test Device	Primary Predicate Device	Secondary Predicate Device	Discussion
	Center:-- Horizontal direction: 32 lp/mm- Vertical direction: 50 lp/mm50% Image height : 25 lp/mm		Unknown	Mirante is considered to have the minimum resolving power required for fundus cameras. Thus, Mirante is considered to have substantially equivalent resolving power compared to fundus imaging devices on the market.
	95% Image height: 16 lp/mmWide angle (Optional)Center:- Horizontal direction: 17.5 lp/mm- Vertical direction: 28 lp/mm50% Image height: 11 lp/mm95% Image height: 5.4 lp/mm
HD on/off	Available		None	The HD on/off function for reducing noises contributes to the convenience, not to the effectiveness. The presence of this function does not substantially affect the safety and effectiveness of the Mirante.
Angle of view	Regular angle: 60°Wide angle (Optional): 110°		148° x 115° (external to eye)	The predicate devices have different references for the angel of view. This does not indicate a safety or efficacy issue with the test deviceBoth the Mirante and the predicate device obtain equivalent information that is essentially necessary for diagnosis. Thus, the angle of view is considered to be substantially equivalent between the Mirante and the predicate device.
Required pupil diameter	Regular angle: 3.3 mm in diameterWide angle (Optional): 3.3 mm in diameter		2 mm	Similar requirements. No safety or efficacy impact.
(Fundus surface imaging function)
Mode	IR (refraction of Infrared light)FA (fluorescein angiography using blue light)		Red FreeFA	Similar modes.The test device has an I/R mode that is not present in the predicate.
		Test Device	Primary Predicate Device	Secondary Predicate Device	Discussion
		ICG (indocyanine greenangiography using infraredlight)	-	ICG	These differences are not expected tohave an impact on the device safety orefficacy. The differences in SLO modes
		FAF(fundus autofluorescenceusing blue or green light)	-	FAF	are considered not to affect the safetyand effectiveness.
		Color (using blue, green, andred light)	-	Color
		Retro (This mode is to capturethe image of retina that isilluminated from behind byinfrared light scattered bychoroid. This is a kind ofRetro illumination method.)	-	-
Image size	-	4096 × 4096, 2048 × 2048,1536×1536, 1024×1024, 768× 768, 512× 512	-	Optomap plus: 3900 pixels (W)x 3072 pixels (H)Optomap: 2600 pixels (W) x2048 pixels (H)	SimilarMirante has both lower and higher pixelpatterns than the predicate device.
					Thus, the resolution is considered to besubstantially equivalent between theMirante and the predicate device.
Panorama	-	Yes	unknown	-	predicate information unknown
					The function allows Mirante to capturesimages for panorama image compositionfor viewing so that NAVIS-EX overlapsand composes multiple fundus imagescaptured at different angles. This functionincreases the convenience, but does notincrease the amount of information. Thisfunction is considered not to affect thesafety and effectiveness.
Others	-
Focus range/Focus compensation		- 15D to +15D ( V.D.=12 )	- 15D to +12D	-12D to +7D	SimilarThe differences do not affect the safetyand effectiveness in clinical use.
Workingdistance	Fundus surface /Anterior segment	19.0 mm ±1mm (betweenobjective lens and cornea)	Fundus Imager: 22 mm	Unknown	Similar
		Test Device	Primary Predicate Device	Secondary Predicate Device	Discussion
	front imagingfunction	Wide Angle (Optional): 9.0mm ±1mm or more	Corneal Imager: 13 mm		These specifications are related toconvenience in image capture but do notaffect the safety and effectiveness.
	OCT	19.0 mm ±1mm (betweenobjective lens and cornea)	22 mm
		15.4 mm ±1 mm (Anteriorsegment cross-sectional imagecapture)
Movementrange	Main body(verticalmovement)	30 mm	25 mm	Unknown
	Main body(horizontal	Forward and backward: 165mm	X: 100 mm	Unknown
	movement)	Left and right: 110 mm	Y: 85 mm
	Chinrest (verticalmovement)	80 mm	65 mm	Unknown
Dimensionsand weight	Main Body	[SLO/OCT model]	380 (W) × 524 (D) × 499 to531(H) mm	550(W) x 550(D) x 608 to632(H) mm
		345 (W) × 548 (D) × 527 to557 (H) mm (Image capturingunit)23 kg (Image capturing unit)	34kg	34 kg
		203 (W) × 424 (D) × 438 (H)mm (Control box)
		20 kg (Control box)
		[SLO model]
		345 (W) × 548 (D) × 527 to557 (H) mm (Image capturingunit)
		22 kg (Image capturing unit)
		203 (W) × 424 (D) × 438 (H)mm (Control box)
		16 kg (Control box)
	IsolationTransformer	130 (W) × 220 (D) × 125 (H)mm	142(W) × 564(D) × 239(H)mm
		7.0 kg	15kg
	Computer	177 (W) × 480 (D) × 426 (H)mm	210(W) × 477(D) × 430(H)mm
		19 kg (Computer)	18kg
		508 (W) × 56 (D) × 325 (H)mm	(without monitor)
		Test Device	Primary Predicate Device	Secondary Predicate Device	Discussion
Power supplyspecifications	Main Body	4.0 kg (Computer monitor)	AC110VAC and 230VAC,1.8A, 50/60Hz	100-240Vac, 50/60Hz
	IsolationTransformer	AC100V-240V150VA,50/60Hz	AC110-240 VAC,1.8A, 50/60Hz
	Computer	AC100V1000VA, 50/60Hz	unknown
		400 W (Computer)
		27 W (Computer monitor)
Others	Auto shot	Yes (OCT)	None	Yes	Similar
	Eye Tracer	Yes	Yes	Unknown	Same
	Color Fundusimage capturemode	Pseudo Color	None	Pseudo Color	Similar
	External fixationlamp	Yes	Yes	None	Same
Appearance		Image: Optical device	Image: Optical device	Image: Optical device

Table 1: Comparison Table of Technological Characteristics – Mirante

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With regards to the technical differences between the Mirante, the RTVue XR Avanti and the P200DTx in the Comparison Table above the clinical and non-clinical testing demonstrates that the differences do not raise any new questions about safety and effectiveness. Summaries of the non-clinical testing are provided in the following sections.

The following are the differences in measurement and analysis between the devices:

Substantial Equivalence Discussion for the Nidek Mirante per the 510(k) Decision-Making Flowchart

Are the predicate device(s) legally marketed? Q1.
Yes, the predicate device Avanti OCT was cleared in K180660 and the OPTOS P200DTx SLO was cleared in K142897.
1. Do the devices have the same intended use?
  Yes, the Mirante OCT/SLO has the same intended use as the predicate devices except that the Mirante does not include a normative database. Both Mirante and Avanti are ophthalmic imaging devices for viewing the fundus and anterior segment structures using optical coherence tomography. Avanti is provided with a normative database, while Mirante is not. Absence of the normative database that is a useful tool in diagnosis after fundus image capture does not impair the functions as an ophthalmic imaging device.
Q3. Do the devices have the same technological characteristics?
No, based on the information available the Mirante has different technological characteristics when compared to the Avanti OCT.

No, based on the information available the Mirante has different technological characteristics when compared to the OPTOS P200DTx SLO.

The differences in OCT that are found are include:

Light source wavelength:
The difference in interference signal emission that is ascribed to the difference in wavelength (40 nm) does not result in any difference in OCT image quality that can affect the diagnosis, considering that resolution of OCT in the Z (depth) direction is on the order of micrometer. Thus, the light source wavelength is considered to be substantially equivalent between the Mirante and the predicate device.
Scan rate (temporal resolution):
The Mirante has a higher scan rate 85,000 A-scan/second versus 70,000 A-scan/second. The higher scan rate results in the time for scanning of 1.54 seconds at 85000 A-scan/sec versus 1.87 seconds at 70,000 A-scan/sec resulting in a difference of less than 0.4 seconds when A-Scan is set to 1024 and B-Scan is set to 128. The slightly decreased imaging time with the Mirante is considered to be substantially equivalent to the predicate device.
Resolution (Optical resolution):
(a) Retina cross-sectional image capture. The Mirante has a lower optical resolution in the horizontal (X-Y ) direction, but the reduced resolution of 20 um does not decrease the essential information for diagnosis.

Resolution in the depth (Z) direction was verified to be less than or equal to 7 um. The actual measured values ranged from 6.62 to 6.94 um in air and from 4.78 to 5.01 um when converted to

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the values in the eye. This means that the resolution in the Z direction is approximately 5 um in the eye, which is equivalent to the resolution in the depth (Z) direction of the predicate device.

Thus, the resolution in the depth direction is considered to be substantially equivalent between the Mirante and the predicate device.

(b) Anterior segment cross-sectional observation and image capture. The horizontal resolution of the predicate device is unknown, however, resolution in the horizontal (X-Y) direction does not substantially affect the device effectiveness.

Resolution for the Mirante in the depth (Z) direction was verified to be less than or equal to 7 um. The actual measured values ranged from 6.89 to 6.98 um in air and from 4.98 to 5.04 um when converted to the values in the eye. This means that the resolution in the Z direction is approximately 5 µm in the eye, which is equivalent to the resolution in the depth (Z) direction of the predicate device. Thus, the resolution in the depth direction is considered to be substantially equivalent between the Mirante and the predicate device.

. Angle of View:
(a) Retina cross-sectional image capture. The Mirante has a wider scan width than the predicate device, but the wider scan width does not substantially increase the effectiveness. The Mirante has a shorter scan depth than the predicate device by 0.9 mm. The depth of 2.1 mm corresponds to more than 5 times the thickness of the retina, which is a sufficient scan depth for diagnosis and the difference does not decrease the substantial effectiveness. Thus, the scan width and scan depth are considered to be substantially equivalent between the Mirante and the predicate device.

(b) Anterior segment cross-sectional image capture. Mirante has a shorter scan width but the width is sufficient for capturing in one image a range from a cornea center to a corneal peripheral part or from the corneal limbus to the proximity of pupillary edge at the iris that is an important part for diagnosis, and the difference between Mirante and the predicate device does not decrease the substantial effectiveness.

The Mirante has a shorter scan depth than Avanti by 0.2 mm. The depth of 0.2 mm is about 4 times as thick as the cornea and is sufficient for measuring the anterior chamber angle, and the difference does not decrease the substantial effectiveness. Thus, the scan width and scan depth are considered to be substantially equivalent between the Mirante and the predicate device.

Display resolution:
The predicate information for this point is unknown. Because the length per pixel of the Mirante is smaller than the optical resolution, this only contributes to the fineness of the depicted structures and the amount of information obtained for diagnosis remains unchanged. Therefore, this is not considered to be an issue for safety or effectiveness for the Mirante.
. Required pupil diameter:
Although the required pupil diameter of Mirante is larger than that of Avanti, it is assumed that the pupils of most of the patients would be larger than the required pupil diameter under the intended environment. An OCT is intended to be used in a darkened room or half-darkened room and pupils open to an average of 3.24 mm under illumination of 4.00 lux and 4.05 mm under illumination of 0.40 lux. Thus, the required pupil diameter is considered to be substantially equivalent between the Mirante and the predicate OCT device.
. Sensitivity: predicate information for this function is unknown.
[Regular] "OCT Sensitivity" performs high-speed image capture with standard OCT sensitivity, while [Fine] or [Ultra Fine] setting allows a Signal Strength Index (SSI) value higher than that

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obtained respectively with [Regular] or [Fine] by increasing the OCT sensitivity. The [Fine] or [Ultra Fine] setting may allow capturing of proper cross sectional (OCT) images even though only OCT images with lower quality were captured for the eye with the [Regular] setting.

There are cases where the device does not fully exert its basic performance to capture proper OCT images. Using the [Fine] or [Ultra Fine] setting covers those cases to some extent. In other words, using those settings expands the range where the device fully exerts its effectiveness.

Thus, the provision of the [Fine] or [Ultra Fine] setting does not improve the effectiveness. The increase in the status of target eyes that Mirante can deliver the basic performance (or capture the OCT images) will act to reduce the risk of misdiagnosis due to insufficient information, and will raise no new safety concerns.

OCT Scan Patterns: ●
Although scan patterns are slightly different in terms of names and variations, both the Mirante and the predicate device have similar scan patterns.
Anterior Segment Imaging Function: .
The anterior segment imaging function acquires images used to show the position to which the anterior segment OCT image corresponds, and any essential difference lies in the presence or absence of this function itself; detailed specifications do not affect the essence of this function. Thus, the difference in principle is considered not to cause substantial differences between the Mirante and the predicate device.

The differences in SLO that are found are minor and include:

. Light source wavelength:
Red and infrared wavelengths are different between Mirante and the predicate device. Theoretically, different wavelengths reach different depths in structure but do not cause differences in observation for images related to diagnosis. Although chromatic aberration is also different between the Mirante and the predicate device, this is corrected respectively during color composition and alignment, and also does not cause differences in observation for images related to diagnosis. Thus, the difference in wavelengths is considered not to cause substantial differences between the Mirante and the predicate device.
Resolving Power:
The predicate device resolving power is unknown. The Mirante is considered to have the minimum resolving power required for fundus cameras such as previously cleared AFC-330 (K113451), taking into account the reduction associated with the increased angle of view:

There are no international standards, guidelines, or other official criteria applicable to the optical performance of fundus SLOs. For this reason, NIDEK referred to the requirements for resolving power in ISO 10940:2009 for fundus cameras that are also fundus imaging devices to verify the specifications for resolving power in SLO bench testing provided in Appendix 8 1 34.

ISO 10940:2009, Section 4.2 requires the following resolving power:

Angle of view >30

Center ≧ 60 lp/mm

Center ≥ 40 lp/mm

Periphery ≥ 25 lp/mm

In addition, in general, it is clear that optical performance deteriorates as the angle of view

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increases.

NIDEK assumed that the above criteria in ISO 10940:2009 to be the minimum requirement for the angle of view of 30°.

In consideration that optical performance decreases as the angle of view increases and based on assumption that the resolving power is inversely proportional to the angle of view for the above criteria in the standard, and the value obtained by multiplying the inverse of the angle of view is assumed to be the criteria of resolving power that corresponds to the angle of view for fundus SLOs.

Based on this assumption, the criteria of resolving power with a normal angle of view of 60° for Mirante are calculated as follows:

Center: 60 lp/mm x 30/60 = 30 lp/mm

Middle: 40 lp/mm x 30/60 = 20 lp/mm

Periphery: 25 lp/mm×30/60 = 12.5 lp/mm

The resolving powers of Mirante with the normal angle of view of Mirante meet the criteria as described on the left:

The criteria of resolving power with a wider angle of 110° for Mirante are calculated as follows:

Center: 60 lp/mm×30/110=16.4 lp/mm

Middle: 40 lp/mm×30/110=10.9 lp/mm

Periphery: 25 lp/mm×30/110=6.8 lp/mm

The resolving powers of the Mirante with a wider angle of view meet the criteria for the center and middle areas meet the criteria as described on the left, while it does not slightly meet the criterion for the periphery.

The eyeball is spherical, and the wider the angle of view, the greater the distortion in the periphery.

With an angle of view of 110°, the periphery is close to the equatorial plane and distortion is close to the maximum. Although the resolution in the periphery may not meet the criterion, this is considered to have no significant impact.

Thus, Mirante is considered to have substantially equivalent resolving power compared to fundus imaging devices on the market.

HD on/off:
This is available for the Mirante but not available for the predicate. The HD on/off function for reducing noises contributes to the convenience, not to the effectiveness. This function is not necessarily essential if a high-quality image is obtained at a time. The presence of this function does not substantially affect the safety and effectiveness of the Mirante.
Angle of View:
Mirante has a smaller angle of view than the predicate device both in normal image capture and wide-field image capture. However, both the Mirante and the predicate device have a 110 to 220degree ultra-wide angle field of view that is defined as an image of the far periphery of the retina, including the anterior edge of the vortex vein ampulla and beyond. Both the Mirante and the predicate device obtain equivalent information that is essentially necessary for diagnosis. Thus, the angle of view is considered to be substantially equivalent between the Mirante and the

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predicate device.

Required pupil diameter:
Although the required pupil diameter of Mirante is larger than that of the predicate device, it is assumed that the pupils of most of the patients would be larger than the required pupil diameter under the intended environment. An SLO is intended to be used in a darkened room or halfdarkened room and pupils open to an average of 3.24 mm under illumination of 4.00 lux and 4.05 mm under illumination of 0.40 lux. Thus, the required pupil diameter is considered to be substantially equivalent between the Mirante and the predicate OCT device.
. Mode:
Both Mirante and the predicate device have color imaging and fluorescence imaging functions. Although Mirante has infrared light (IR) imaging and retro mode imaging functions, but from a diagnostic standpoint, the information provided by IR images does not essentially exceed that of color SLO images. However, it is essentially a high-contrast monochromatic imaging mode. The retro mode imaging differs from the other imaging modes in its principle; the mode specializes in contrast enhancement and is essentially a high-contrast monochromatic imaging mode.

The differences in SLO modes are considered not to affect the safety and effectiveness.

. Image Size:
Mirante has both lower and higher pixel patterns than the predicate device.

With the setting of 4096 × 4096 pixels for the Mirante, which is a higher pixel number than Optomap plus of the predicate device, the length per pixel is approximately 3.25 um, which is a smaller scale than the resolution. For this reason, smooth and "easy-to-see" images are obtained whose contribution is limited to the convenience because the fineness of the structures that can be depicted remains unchanged and the amount of obtained information for diagnosis remains unchanged. Thus, the resolution is considered to be substantially equivalent between the Mirante and the predicate device.

Panorama:
Whether the predicate device is provided with this function is unknown. The function allows Mirante to capture images for panorama image composition for viewing so that NAVIS-EX overlaps and composes multiple fundus images captured at different angles. The function is equivalent to displaying multiple images captured at different angles at a time. This function increases the convenience but does not increase the amount of information. The presence or absence of this function is considered not to affect the safety and effectiveness.
Focus range/Focus compensation:
Diopter correction compensates for the refractive errors of the patient's eye. Mirante has a wider range of focus for patients, and can target the patients with wider range of refractive errors but this does not affect the safety and effectiveness in clinical use.
Working distance: .
These specifications are related to convenience in image capture but do not affect the safety and effectiveness of the device.

Therefore, the minor differences between the subject device and the predicate devices do not raise new questions of safety or effectiveness. The Nidek Mirante is as safe and effective as its predicate devices, and thus, may be considered substantially equivalent.

Conclusion

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The Nidek Mirante SLO/OCT has the same intended use and similar indications for use, technological characteristics, and principles of operation as the previously cleared predicates. A substantial equivalence chart comparing the similarities and differences between the subject device and its predicate device demonstrates substantial equivalence.

Mirante SLO only

Scanning Laser Ophthalmoscope (SLO)

There are minor differences in technological characteristics between the Mirante and the predicate devices that do not raise questions of safety or effectiveness.

Discussion

Bench testing has been performed to demonstrate that the Mirante device performs as intended and is substantially equivalent to the predicate device OPTOS P200DTx (K142897) with respect to imaging and measurement of ocular structures comply with recognized consensus standards regarding electrical safety, optical safety and biocompatibility. The system level testing with software version 1.22 was conducted with passing results.

Performance testing included SLO system testing, optical safety testing, and Usability testing. The performance testing demonstrated that the device satisfies the performance requirements specified for its intended use and is equivalent to the relevant performance characteristics of the comparative predicate device.

Therefore, based on the same intended use and similar technological characteristics and with substantial equivalence to the predicate devices confirmed with performance testing, the Mirante is technologically and functionally equivalent to the predicate device, OPTOS P200DTx (K142897). The differences between the proposed device, Mirante, and the predicate device are insignificant and do not raise new issues of safety or effectiveness of the device.

The Comparison Table of Technological Characteristics follows.

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	Test Device	Predicate Device	Discussion
Device Name	Mirante SLO with NAVIS-EX	P200DTx
510(k) Number		(K142897)
Classification, Product Code	ClassII, HLI, OBO, MYC	ClassII, MYC	Same
Regulation number	21CFR 886.1570	21 CFR 886.1570	Same
	(Ophthalmoscope, AC-Powered)	(Ophthalmoscope, AC-Powered)	Same
Applicant	Nidek Co., Ltd.	Optos, Plc
Intended Use	The Mirante SLO with scanning laserophthalmoscope function and withImage Filing Software NAVIS-EX isa non-contact system for imaging thefundus. It is indicated for color,angiography, auto-fluorescence, andretro mode imaging of the retina as anaid in the diagnosis and management.The Image Filing Software NAVIS-EX is a software system intended foruse to store, manage, process,measure, analyze and display patientdata and clinical information fromcomputerized diagnostic instrumentsthrough networks. It is intended towork with compatible NIDEKophthalmic devices.	The P200DTx scanning laserophthalmoscope is indicated for use asa widefield and retinal fluorescenceand autofluorescence imagingophthalmoscope to aid in thediagnosis and monitoring of diseasesand disorders that manifest in theretina. It is also indicated for use as awidefield scanning laserophthalmoscope for viewing choroidalcirculation patterns that areilluminated using Indocyanine Greendye and for aiding in both theassessment of choroidal circulationand in the diagnosis of choroiditis orchoroidal diseases.	Similar
SLO Function
Principle	SLO: Confocal laser scanning method	SLO: Confocal laser scanning method	Same
Light source wavelength	Blue: 488 nm	Blue: 488 nm	The test device has similar light source wavelengths comparedto the predicate device.
	Green: 532 nm	Green: 532 nm
	Red: 670 nm	Red: 635 nm	The difference in wavelengths is considered not to causesubstantial differences between the Mirante and the predicate
	IR (Infrared): 790 nm	IR (Infrared): 802 nm	device.
Resolving power	Regular angle	Unknown	Mirante is considered to have the minimum resolving power
	Center:- Horizontal direction: 32 lp/mm- Vertical direction: 50 lp/mm	Resolving power	required for fundus cameras. Thus, Mirante is considered tohave substantially equivalent resolving power compared tofundus imaging devices on the market.
	50% Image height: 25 lp/mm
	95% Image height: 16 lp/mm
	Wide angle (Optional)
	Test Device	Predicate Device	Discussion
	Center:- Horizontal direction: 17.5 lp/mm- Vertical direction: 28 lp/mm
	50% Image height: 11 lp/mm
	95% Image height: 5.4 lp/mm
HD on/off	Available	None	The HD on/off function for reducing noises contributes to theconvenience, not to the effectiveness. The presence of thisfunction does not substantially affect the safety andeffectiveness of the Mirante.
Angle of view	Regular angle: 60°	148° x 115° (external to eye)	The predicate devices have different references for the angelof view. This does not indicate a safety or efficacy issue withthe test device
	Wide angle (Optional): 110°		Both the Mirante and the predicate device obtain equivalentinformation that is essentially necessary for diagnosis. Thus,the angle of view is considered to be substantially equivalentbetween the Mirante and the predicate device.
Required pupil diameter	Regular angle: 3.3 mm in diameter	2mm	Similar requirements. No safety or efficacy impact.
(Fundus surface imaging function)	Wide angle (Optional): 3.3 mm indiameter
Mode		Red Free	Similar modes.
	IR (refraction of Infrared light)		The test device has an I/R mode that is not present in thepredicate. These differences are not expected to have an
	FA(fluorescein angiography usingblue light)	FA	impact on the device safety or efficacy. The differences inSLO modes are considered not to affect the safety and
	ICG (indocyanine green angiographyusing infrared light)	ICG	effectiveness.
	FAF(fundus autofluorescence usingblue or green light)	FAF
	Color (using blue, green, and redlight)	Color
	Retro (This mode is to capture theimage of retina that is illuminatedfrom behind by infrared light scatteredby choroid. This is a kind ofretroillumination method.)
		Test Device	Predicate Device	Discussion
Image size		4096 × 4096, 2048 × 2048, 1536 ×1536, 1024 × 1024, 768 × 768, 512 ×512	Optomap plus: 3900 pixels (W) x3072 pixels (H)Optomap: 2600 pixels (W) x 2048pixels (H)	SimilarMirante has both lower and higher pixel patterns than thepredicate device.Thus, the resolution is considered to be substantiallyequivalent between the Mirante and the predicate device.
Panorama		Yes		predicate information unknownThe function allows Mirante to captures images for panoramaimage composition for viewing so that NAVIS-EX overlapsand composes multiple fundus images captured at differentangles. This function increases the convenience, but does notincrease the amount of information. This function isconsidered not to affect the safety and effectiveness.
Others
Focus range/Focus compensation		- 15D to +15D ( V.D.=12 )	-12D to +7D	SimilarThe differences do not affect the safety and effectiveness inclinical use.
Workingdistance	Fundus surface / Anteriorsegment front imagingfunction	19.0 mm ±1mm (between objectivelens and cornea)Wide Angle (Optional): 9.0 mm±1mm or more	Unknown	predicate information unknownThese specifications are related to convenience in imagecapture but does not affect the safety and effectiveness.
Movementrange	Main body (verticalmovement)	30 mm	Unknown
Main body (horizontalmovement)		Forward and backward: 165 mmLeft and right: 110 mm	Unknown
	Chinrest (verticalmovement)	80 mm	Unknown
Dimensions and Main Bodyweight		[SLO/OCT model]345 (W) × 548 (D) × 527 to 557 (H)mm (Image capturing unit)23 kg (Image capturing unit)203 (W) × 424 (D) × 438 (H) mm(Control box)20 kg (Control box)[SLO model]	550(W) × 550(D) × 608 to 632(H)mm34 kg
		Test Device	Predicate Device	Discussion
		345 (W) × 548 (D) × 527 to 557 (H) mm (Image capturing unit)
		22 kg (Image capturing unit)
		203 (W) × 424 (D) × 438 (H) mm(Control box)
		16 kg (Control box)
	Isolation Transformer	130 (W) × 220 (D) × 125 (H) mm
		7.0 kg
	Computer	177 (W) × 480 (D) × 426 (H) mm
		19 kg (Computer)
		508 (W) × 56 (D) × 325 (H) mm
		4.0 kg (Computer monitor)
Power supply	Main Body	AC100V-240V150VA, 50/60Hz	100-240Vac, 50/60Hz
specifications	Isolation Transformer	AC100V1000VA, 50/60Hz
	Computer	400 W (Computer)
		27 W (Computer monitor)
Others	Auto shot	Yes (OCT)	Yes	Similar
	Eye Tracer	Yes	Unknown	predicate information unknown
	Color Fundus imagecapture mode	Pseudo Color	Pseudo Color	Similar
	External fixation lamp	Yes	None	Same
Appearance		Image: Optical device	Image: Optical device

Table 2: Comparison Table of Technological Characteristics – Mirante SLO

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With regards to the technical differences between the Mirante, the Avanti and the P200DTx in the Comparison Table above the clinical and non-clinical testing demonstrates that the differences do not raise any new questions about safety and effectiveness.

Substantial Equivalence Discussion for the Nidek Mirante per the 510(k) Decision-Making Flowchart

Q1. Are the predicate device(s) legally marketed?
Yes, the predicate device Avanti OCT was cleared in K180660 and the OPTOS P200DTx SLO was cleared in K142897.
Q2. Do the devices have the same intended use?
Yes, the Mirante OCT/SLO has the same intended use as the predicate devices except that the Mirante does not include a normative database.
Q3. Do the devices have the same technological characteristics?
No. based on the information available the Mirante has different technological characteristics when compared to the OPTOS P200DTx SLO. The differences found are minor and are summarized in Section 9.1.3 above.

However, the minor differences between the subject device and the predicate device do not raise new questions of safety or effectiveness. The Nidek Mirante is as safe and effective as its predicate device, and thus, may be considered substantially equivalent.

1.1.1.1. Conclusion

The Nidek Mirante has the same intended use and similar indications for use, technological characteristics, and principles of operation as the previously cleared predicates. A substantial equivalence chart comparing the similarities and differences between the subject device and its predicate device demonstrates substantial equivalence.

Scanning Laser Ophthalmoscope (SLO)

There are minor differences in technological characteristics between the Mirante and the predicate devices that do not raise questions of safety or effectiveness.

Performance testing, including both bench testing and clinical testing, demonstrate substantial equivalence.

Therefore, based on the same intended use and similar technological characteristics with substantial equivalence to the predicate devices confirmed with performance testing, the Mirante is technologically and functionally equivalent to the predicate devices, RTVue XR Avanti (K180660) and OPTOS P200DTx (K142897). The differences between the proposed device, Mirante, and the predicate device are insignificant and do not raise new issues of safety or effectiveness of the Nidek Mirante is as safe and effective as its predicate devices, and thus, may be considered substantially equivalent.

Performance Testing

The Mirante has been verified for performance and functionality to assure conformance to the requirements for its

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basic intended use.

The Mirante's compliance to electrical safety, light safety and biocompatibility has been established. The software development lifecycle and the associated verification activities have no unresolved major or critical bugs. A list of testing conducted included:

Medical electrical equipment Part 1: General requirements for basic safety and essential . performance: AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012
. Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests: IEC 60601-1-2:2014
. Medical device software - Software life cycle processes: IEC 62304: Edition 1.1 2015-06
Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]: IEC 62366-1: Edition 1.0 2015-02
American National Standard for Ophthalmics Light Hazard Protection for Ophthalmic ● Instruments: ANSI Z80.36-2016
. Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]: IEC 60825-1: Edition 2.0 2007-03
. Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments: ISO 15004-1: First edition 2006-06-01
Health software - Part 1: General requirements for product safety: IEC 82304-1 Edition 1.0 2016-10

The biocompatibility of the skin contacting materials was previously established for the SL-2000 (K163564) and the materials are identical to those previously approved.

Software documentation has been prepared and submitted for a "moderate" Level of Concern device in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The device software was verified and validated to support the proposed indications for use according to IEC 62304:2015 Medical device software life cycle processes and FDA's General Principles of Software Validation; Final Guidance for Industry and FDA Staff.

Risk Analvsis

The device and the device software have been assessed to make sure all the risks were sufficiently mitigated according to the intended use. Identification of the associated hazards has been performed in order to evaluate, estimate and control the associated risks in accordance with EN ISO 14971 Application of risk analysis to medical devices.

Clinical Performance

Clinical performance testing was conducted to demonstrate substantial equivalence. A prospective, comparative clinical study was conducted in compliance with 21 CFR parts 50, 56, and 812 at one clinical site in the United States. The clinical testing was not subject to the regulations under 21 CFR 56.104 or 56.105. The primary purpose of the clinical study was to assess agreement and precision of the Nidek Mirante OCT in comparison with Avantı OCT and to assess image quality of Nidek Mirante OCT Anterior Chamber Angle image compared to Avanti. Additionally, the Nidek Mirante SLO image quality was compared to the OPTOS P200DTx. The secondary purpose was to evaluate any adverse event found during the clinical study.

Subject Disposition:

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A total of 170 subjects were enrolled in the study and included in the Safety Analysis Set and Full Analysis Set. This included:

45 subjects in the Normal group,
46 subjects in the Glaucoma group, ●
47 subjects in the Retinal Disease group, and ●
32 subjects in the Corneal Disease group. .

Of those, three subjects in the Glaucoma group discontinued due to a major protocol deviation of inclusion/exclusion and randomization category. A total of 167 subjects completed the study.

Demography and Baseline Characteristics:

The mean (standard deviation [SD]) age in the Full Analysis Set was:

44.9 (15.36) years for the normal eye subjects, ●
65.1 (9.20) years for the Glaucoma subjects,
69.7 (11.23) years for the Retinal Disease subjects, and ●
55.4 (15.09) years for the Corneal Disease subjects.

The overall mean age for all subjects was 59.2 (16.05) years, with the majority of subjects aged <65 years old (n = 96, 56.5%).

A total of 71 males and 99 females participated (41.8% and 58.2%, respectively) in this study, and the majority of subjects were white (n = 158, 92.9%) and not Hispanic or Latino (n = 159, 93.5%).

Iris color for all subjects included:

blue (n = 51, 30.0%),
brown (n = 73, 42.9%), ●
hazel (n = 37, 21.8%),
green (n = 8. 4.7%) and ●
gray (n = 1, 0.6%). ●

Scan Acceptability:

A total of 169 subjects had acceptable scans, and 115 subjects had unacceptable scans (105 subjects for Mirante scans, 55 subjects for Avanti scans, and 9 subjects for Optos scans).

Scan acceptability was by a 2-step process where the device operator identified acceptable scans and then an Investigator image reviews the scans making the final determination of which scans were acceptable or unacceptable.

Effectiveness Results:

Agreement Analyses: Mirante / Avanti Analyses:

For the agreement analyses between Mirante and Avanti, agreement performance goals were met for [ILM-RPE/BM] and Disc Map RNFL Thickness for all parameters and each individual population.

Mean differences between Mirante and Avanti scans (Mirante – Avanti) were higher for the Mirante device for all populations for [ILM-RPE/BM] Thickness analysis, and were higher for most parameters, with the exception of Temporal, Superior, Nasal, Inferior, Temporal (TSNIT) Temporal in the All Subjects and Normal populations, for Disc Map RNFL Thickness.

For [ILM-RPE/BM] Thickness, Mirante is likely thicker by around 10-20 µm than Avanti due to the definition of lower line, where Mirante measures between RPE and BM while Avanti measure on RPE. Additionally, for the upper line, Mirante measure the upper line (vitrous side) of ILM whereas Avanti measure on ILM. For Disc Map - RFNL Thickness, Mirante is likely thicker (around 10 um), with the exception of TSNIT Temporal, due to the difference of segmentation algorism of blood vessels area, especially large blood vessels, with Mirante measuring

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line underside of blood vessels and Avanti crossing blood vessels. The exception of TSNIT Temporal being similar for both devices is because large blood vessels do not run in the Temporal area anatomically.

For Disc Map Optic Disc analysis, the Mirante scans had lower values compared to Avanti scans for Horizontal C/D Ratio and Vertical Cup-to-Disc (C/D) Ratio and higher values for Disc Area and Cup Area for the All Subjects population. Mirante had slightly similar mean differences for the Normal population and lower values for the Glaucoma population, compared to the Avanti scans. Agreement performance goals were met for all parameters and each individual population.

For Cornea Radial Central Corneal Thickness (CCT) analysis, the Mirante scans had higher mean differences than those of the Avanti device for the All Subjects. Normal Disease populations, but agreement performance goals were not met for the Normal and Corneal Disease populations for the CCT parameter.

Mirante is thicker by around 15 um than Avanti due to the definition of upper and lower line, with Mirante measuring inside and outside of the cornea surface and Avanti measuring on the cornea surface. There is a 1 to 2pixel difference for each on both sides, with one pixel at approximately 4 um for Mirante and approximately 3 um for Avanti.

Table 3: Summary of Limits of Agreement for All Configurations - [ILM-RPE/BM] Thickness - Nidek (Test) Mirante Macula Map (9 x 9 mm Tracing HD OFF) and Optovue (Predicate) Avanti Retina Map -|ILM- RPE/BM] Thickness Analysis Set

Subject PopulationComparableParameter	N	NidekMirante(Test)	OptovueAvanti(Predicate)Mean (SD)	MeanDifference(SD)	95% LOA	95% CILower LOA	95% CIUpper LOA
All Subjects
Center (µm)	134	276.097(35.3863)	265.068(34.8798)	11.029(5.5101)	(0.131, 21.928)	(-1.500,1.761)	(20.297,23.559)
Inner Temporal (µm)	134	320.440(23.3739)	302.664(22.2852)	17.776(5.7303)	(6.442, 29.110)	(4.746, 8.138)	(27.415,30.806)
Inner Superior (µm)	134	335.239(23.7142)	314.455(23.2685)	20.784(5.5608)	(9.784, 31.783)	(8.139,11.430)	(30.137,33.428)
Inner Nasal (µm)	134	338.187(21.0988)	317.963(20.9016)	20.224(5.7356)	(8.879, 31.569)	(7.182,10.577)	(29.871,33.266)
Inner Inferior (µm)	134	330.164(21.5906)	309.761(20.7669)	20.403(6.0364)	(8.463, 32.343)	(6.677,10.250)	(30.556,34.129)
Outer Temporal (µm)	134	278.836(18.6641)	269.007(18.5478)	9.828(5.7210)	(-1.488,21.144)	(-3.181,0.206)	(19.451,22.837)
Outer Superior (µm)	134	291.582(20.5746)	280.769(21.3256)	10.813(5.8876)	(-0.832,22.459)	(-2.575,0.910)	(20.716,24.201)
Outer Nasal (µm)	134	304.515(19.7799)	293.090(20.2820)	11.425(6.1551)	(-0.749,23.600)	(-2.571,1.072)	(21.778,25.422)
Outer Inferior (µm)	134	281.381(18.9728)	268.590(19.1473)	12.791(6.5328)	(-0.131,25.713)	(-2.064,1.803)	(23.779,27.646)
Normal
Center (µm)	45	272.467(17.1538)	261.808(17.2769)	10.658(4.3789)	(1.833, 19.483)	(-0.445,4.112)	(17.205,21.762)
Inner Temporal (µm)	45	327.800(12.4419)	308.600(12.7304)	19.200(6.4194)	(6.262, 32.138)	(2.922, 9.603)	(28.797,35.478)
Inner Superior (µm)	45	343.489(13.5824)	320.600(13.3355)	22.889(6.0386)	(10.719,35.059)	(7.577,13.861)	(31.917,38.201)
Inner Nasal (µm)	45	344.200(14.7980)	322.289(14.6778)	21.911(6.0521)	(9.714, 34.108)	(6.565,12.863)	(30.959,37.258)
Inner Inferior (um)	45	337.711(13.6509)	315.444(12.9554)	22.267(4.7645)	(12.665,31.869)	(10.185,15.144)	(29.390,34.348)

Outer Temporal (µm)	45	286.622(13.3387)	276.356(12.7888)	10.267(6.5796)	(-2.994,23.527)	(-6.417,0.430)	(20.103,26.951)
	Outer Superior (µm)	45	300.889(14.7882)	289.578(14.8989)	11.311(5.4306)	(0.366, 22.256)	(-2.460,3.192)
Outer Nasal (µm)		45	313.156(18.5079)	300.422(16.7434)	12.733(6.0317)	(0.577, 24.889)	(-2.562,3.716)
	Outer Inferior (µm)	45	289.622(15.3790)	275.778(14.7030)	13.844(5.5757)	(2.607, 25.082)	(-0.294,5.509)
Glaucoma
Center (µm)	43	269.977(17.4881)	258.562(17.5655)	11.415(4.8615)	(1.604, 21.226)	(-0.988,4.195)	(18.634,23.817)
	Inner Temporal (µm)	43	311.907(15.1104)	294.860(14.4149)	17.047(6.2104)	(4.513, 29.580)	(1.203, 7.824)
Inner Superior (µm)		43	327.628(15.5395)	307.000(14.2812)	20.628(5.8879)	(8.746, 32.510)	(5.607,11.884)
	Inner Nasal (µm)	43	331.977(14.4214)	312.256(13.6784)	19.721(6.1965)	(7.216, 32.226)	(3.913,10.519)
Inner Inferior (µm)		43	319.721(17.5232)	300.558(17.6302)	19.163(7.3870)	(4.255, 34.070)	(0.318, 8.193)
	Outer Temporal (µm)	43	269.930(15.4325)	260.302(15.4805)	9.628(5.3275)	(-1.123,20.379)	(-3.963,1.716)
Outer Superior (µm)		43	282.140(17.5819)	271.372(16.5946)	10.767(6.2786)	(-1.903,23.438)	(-5.250,1.444)
	Outer Nasal (µm)	43	296.837(16.4403)	285.814(16.0182)	11.023(5.8614)	(-0.806,22.852)	(-3.930,2.319)
Outer Inferior (µm)		43	270.349(19.8265)	257.767(17.6444)	12.581(6.3555)	(-0.244,25.407)	(-3.632,3.143)
	Retinal Disease
Center (µm)	46	285.370(54.6892)	274.337(53.6377)	11.032(6.9749)	(-3.016,25.080)	(-6.603,0.572)	(21.493,28.668)
	Inner Temporal (µm)	46	321.217(33.5545)	304.152(31.9332)	17.065(4.2079)	(8.590, 25.540)	(6.426,10.754)
Inner Superior (µm)		46	334.283(33.6450)	315.413(33.8254)	18.870(3.8965)	(11.022,26.717)	(9.017,13.026)
	Inner Nasal (µm)	46	338.109(28.8869)	319.065(29.2380)	19.043(4.5896)	(9.799, 28.287)	(7.439,12.160)
Inner Inferior (µm)		46	332.543(27.2394)	312.804(26.4143)	19.739(5.4014)	(8.860, 30.618)	(6.082,11.638)
	Outer Temporal (µm)	46	279.543(22.2797)	269.957(22.4914)	9.587(5.2560)	(-0.999,20.173)	(-3.703,1.704)
Outer Superior (µm)		46	291.304(24.0184)	280.935(26.6094)	10.370(6.0309)	(-1.777,22.516)	(-4.879,1.325)
	Outer Nasal (µm)	46	303.239(20.8925)	292.717(24.4483)	10.522(6.4524)	(-2.474,23.517)	(-5.793,0.845)
Outer Inferior (µm)		46	283.630(16.6244)	271.674(20.2068)	11.957(7.4951)	(-3.139,27.052)	(-6.994,0.716)
	Subject PopulationComparableParameter	N	NidekMirante (Test)Mean (SD)	OptovueAvanti(Predicate)Mean (SD)	MeanDifference(SD)	95% LOA	95% CILower LOA
All Subjects
Whole Chart (um)	88	97.000(16.3412)	88.596(15.3816)	8.404 (4.6438)	(-0.826,17.634)	(-2.531, 0.878)	(15.929,19.338)
S/I Inferior (um)	88	95.420(17.5255)	86.719(16.3613)	8.702 (6.3040)	(-3.828,21.232)	(-6.142, -1.515)	(18.918,23.545)
S/I Superior (um)	88	98.511(17.3411)	90.509(15.4476)	8.003 (6.3740)	(-4.666,20.672)	(-7.005, -2.327)	(18.333,23.011)
TSNIT Temporal (um)	88	67.102(10.4980)	68.451(11.3161)	-1.349 (9.6563)	(-20.542,17.844)	(-24.086, -16.998)	(14.300,21.388)
TSNIT Superior (um)	88	115.000(25.1935)	106.088(19.4355)	8.912 (9.8988)	(-10.763,28.587)	(-14.396, -7.131)	(24.954,32.219)
TSNIT Nasal (μm)	88	84.102(14.5563)	71.781(12.9573)	12.321(8.2437)	(-4.064,28.706)	(-7.090, -1.039)	(25.681,31.732)
TSNIT Inferior (um)	88	121.682(30.4025)	108.065(24.8988)	13.616(9.2922)	(-4.853,32.086)	(-8.263, -1.443)	(28.676,35.496)
Normal
Whole Chart (um)	45	107.200(10.6571)	97.967(9.7912)	9.233 (4.3936)	(0.378,18.088)	(-1.908, 2.664)	(15.801,20.374)
S/I Inferior (um)	45	106.022(12.1271)	96.297(10.9840)	9.725 (5.3925)	(-1.143,20.593)	(-3.949, 1.663)	(17.787,23.399)
S/I Superior (um)	45	108.267(10.8007)	99.712(9.4247)	8.554 (5.5885)	(-2.709,19.817)	(-5.617, 0.200)	(16.909,22.725)
TSNIT Temporal (um)	45	68.356(8.4803)	72.871(8.0139)	-4.515 (8.1383)	(-20.917,11.887)	(-25.152, -16.682)	(7.652, 16.121)
TSNIT Superior (um)	45	129.178(16.0981)	117.415(11.5151)	11.762(8.8701)	(-6.114,29.639)	(-10.730, -1.498)	(25.023,34.255)
TSNIT Nasal (um)	45	90.844(13.7807)	78.594(11.3470)	12.250(8.7671)	(-5.418,29.919)	(-9.981, -0.856)	(25.357,34.481)
TSNIT Inferior (um)	45	140.200(20.1433)	122.989(15.5779)	17.211(8.6067)	(-0.134,34.557)	(-4.613, 4.344)	(30.078,39.036)
Glaucoma
Whole Chart (um)	43	86.326(14.3539)	78.790(14.0397)	7.536 (4.7895)	(-2.130,17.201)	(-4.683, 0.423)	(14.648,19.754)
S/I Inferior (um)	43	84.326(15.3526)	76.695(15.0647)	7.631 (7.0398)	(-6.576,21.838)	(-10.329, -2.824)	(18.085,25.590)
S/I Superior (um)	43	88.302(17.0888)	80.877(14.6801)	7.426 (7.1255)	(-6.954,21.806)	(-10.752, -3.156)	(18.007,25.604)
TSNIT Temporal (um)	43	65.791(12.2271)	63.826(12.4558)	1.965(10.0886)	(-18.395,22.324)	(-23.773, -13.017)	(16.947,27.702)
TSNIT Superior (um)	43	100.163(24.5463)	94.235(19.0323)	5.928(10.1354)	(-14.526,26.382)	(-19.929, -9.123)	(20.980,31.785)
TSNIT Nasal (um)	43	77.047(11.8441)	64.652(10.5414)	12.395(7.7614)	(-3.268,28.058)	(-7.405, 0.869)	(23.921,32.195)
TSNIT Inferior (um)	43	102.302(27.1596)	92.448(23.2730)	9.854 (8.5394)	(-7.379,27.088)	(-11.931, -2.827)	(22.536,31.639)
Subject PopulationComparableParameter	N	NidekMirante(Test)	OptovueAvanti(Predicate)Mean (SD)	MeanDifference(SD)	95% LOA	95% CI LowerLOA	95% CIUpper LOA
All Subjects
Horizontal C/D Ratio	88	0.599 (0.1805)	0.620 (0.2637)	-0.020 (0.1740)	(-0.366, 0.325)	(-0.430, -0.302)	(0.262, 0.389)
Vertical C/D Ratio	88	0.563 (0.1787)	0.575 (0.2650)	-0.012 (0.1745)	(-0.359, 0.335)	(-0.423, -0.295)	(0.271, 0.399)
Disc Area (mm²)	88	2.130 (0.4577)	1.888 (0.3793)	0.241 (0.2494)	(-0.254, 0.737)	(-0.346, -0.163)	(0.646, 0.829)
Cup Area (mm²)	88	0.799 (0.5287)	0.776 (0.5350)	0.023 (0.2373)	(-0.448, 0.495)	(-0.535, -0.361)	(0.408, 0.582)
Normal
Horizontal C/D Ratio	45	0.511 (0.1189)	0.492 (0.2364)	0.018 (0.1977)	(-0.380, 0.417)	(-0.483, -0.277)	(0.314, 0.520)
Vertical C/D Ratio	45	0.467 (0.1252)	0.437 (0.2163)	0.030 (0.1944)	(-0.362, 0.422)	(-0.463, -0.261)	(0.321, 0.523)
Disc Area (mm²)	45	2.135 (0.3282)	1.864 (0.3021)	0.271 (0.1995)	(-0.131, 0.673)	(-0.235, -0.027)	(0.569, 0.777)
Cup Area (mm²)	45	0.541 (0.2754)	0.485 (0.3345)	0.055 (0.2236)	(-0.395, 0.506)	(-0.512, -0.279)	(0.390, 0.622)
Glaucoma
Horizontal C/D Ratio	43	0.692 (0.1887)	0.753 (0.2237)	-0.061 (0.1358)	(-0.335, 0.213)	(-0.407, -0.263)	(0.141, 0.285)
Vertical C/D Ratio	43	0.663 (0.1721)	0.719 (0.2339)	-0.056 (0.1401)	(-0.339, 0.226)	(-0.414, -0.264)	(0.152, 0.301)
Disc Area (mm²)	43	2.124 (0.5667)	1.914 (0.4484)	0.210 (0.2919)	(-0.379, 0.800)	(-0.534, -0.223)	(0.644, 0.955)
Cup Area (mm²)	43	1.070 (0.5939)	1.080 (0.5388)	-0.010 (0.2491)	(-0.513, 0.492)	(-0.646, -0.380)	(0.360, 0.625)

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Abbreviations: Cl = Confidence Interval; ILM-RPE/BM = Inner Limiting Membrane-Retinal Pigment Epithelium/Bruch's Membrane;
LOA = Limits of Agreement; SD = Standard Deviation;

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Table 4: Summary of Limits of Agreement for All Configurations - Retinal Nerve Fiber Layer (RNFL) Thickness- Nidek (Test) Mirante Disc Map (Tracing HD OFF) and Optovue (Predicate) Avanti ONH with 3D Disc Disc Map - RNFL Thickness Analysis

Abbreviations: CI = Confidence Interval; LOA = Limits of Agreement; SD = Standard Deviation; SQRT = Square Root; TSNIT = Temporal, Superior, Nasal, Inferior, Temporal.

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Table 5: Summary of Limits of Agreement for All Configurations - Optic Disc Nidek (Test) Mirante Disc Map (Tracing HD OFF) and Optovue (Predicate) Avanti ONH with 3D Disc - Disc Map Optic Disc Analysis

Abbreviations: C/D = Cup-to-Disc; C/ = Confidence Interval; LOA = Limits of Agreement; ONH = Optic Nerve Head; SD = Standard Deviation; SQRT = Square Root

Table 6: Summary of Limits of Agreement for All Configurations - Central Corneal Thickness (CCT) Nidek (Test) Mirante Cornea Radial and Optovue (Predicate) Avanti Pachymetry - Cornea Radial CCT Analysis

SubjectPopulationComparableParameter	N	Nidek Mirante(Test)Mean (SD)	Optovue Avanti(Predicate) Mean(SD)	MeanDifference (SD)	95% LOA	95% CILower LOA	95% CI UpperLOA
All SubjectsCCT (µm)	64	541.844 (36.7200)	525.828 (38.9650)	16.016 (5.5677)	(4.889, 27.142)	(2.480, 7.298)	(24.733, 29.551)
NormalCCT (µm)	45	543.867 (26.5515)	527.356 (26.1466)	16.511 (3.9117)	(8.628, 24.395)	(6.592, 10.663)	(22.359, 26.430)
Corneal DiseaseCCT (µm)	19	537.053 (54.4196)	522.211 (60.1928)	14.842 (8.3084)	(-2.613, 32.297)	(-9.549, 4.323)	(25.361, 39.233)

Abbreviations: CCT=Central Corneal Thickness; C1 = Confidence Interval; LOA = Limits of Agreement; SD = Standard Deviation.

Precision Analyses: Mirante / Avanti Analyses:

For the precision analyses between Mirante and Avanti, the Mirante device met precision performance goals, with acceptable variation among all parameters and each group (Normal, Glaucoma, and Retinal Disease) for JLM-RPE/BM] Thickness for repeatability.

For Disc Map RNFL Thickness, overall the Mirante device met most precision performance goals, with acceptable variation among all parameters in the Normal population, and among all but one TSNIT Nasal and one TSNIT Temporal parameter in the Glaucoma population for repeatability, which did not meet performance goals only slightly.

For Disc Map Optic Disc, overall the Mirante device met most precision performance goals, with acceptable variation among all parameters for repeatability in the Normal and Glaucoma populations, with the exception of cup area in both populations, which did not meet performance goals only slightly.

For Cornea Radial CCT, the Mirante device met precision performance goals, with acceptable variation among all

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parameters and all populations for repeatability.

Table 7: Summary of Repeatability and Reproducibility for [ILM-RPE/BM] Thickness Nidek (Test) Mirante Macula Map (9 x 9 mm Tracing HD OFF) and Optovue (Predicate) Avanti Retina Map - [ILM-RPE/BM] Thickness Analysis Set

Device ComparableParameter	N	OverallMean	Repeatability			Reproducibility
			%CV	%CV Lower95% CI	%CVUpper95% CI	%CV	%CVLower95% CI	%CVUpper95% CI
All Subjects
Nidek Mirante
Center (µm)	128	276.093	1.083%	1.031%	1.140%	1.263%	1.211%	1.320%
Inner Temporal (µm)	128	320.837	0.615%	0.586%	0.647%	0.805%	0.772%	0.842%
Inner Superior (µm)	128	335.394	0.620%	0.590%	0.653%	0.831%	0.797%	0.869%
Inner Nasal (µm)	128	337.909	0.513%	0.488%	0.539%	0.718%	0.689%	0.751%
Inner Inferior (µm)	128	330.687	0.672%	0.640%	0.708%	0.882%	0.845%	0.922%
Outer Temporal (µm)	128	278.721	0.847%	0.807%	0.892%	1.047%	1.004%	1.095%
Outer Superior (µm)	128	292.070	0.745%	0.710%	0.785%	0.920%	0.882%	0.961%
Outer Nasal (µm)	128	304.707	0.515%	0.490%	0.542%	0.702%	0.673%	0.734%
Outer Inferior (µm)	128	280.759	0.985%	0.938%	1.037%	1.374%	1.317%	1.436%
Optovue Avanti
Center (µm)	128	265.248	0.807%	0.768%	0.849%	0.967%	0.927%	1.011%
Inner Temporal (µm)	128	303.230	0.959%	0.913%	1.009%	1.190%	1.141%	1.244%
Inner Superior (µm)	128	315.142	0.900%	0.857%	0.947%	1.122%	1.076%	1.173%
Inner Nasal (µm)	128	318.527	0.955%	0.910%	1.005%	1.127%	1.080%	1.178%
Inner Inferior (µm)	128	310.091	0.893%	0.850%	0.940%	1.124%	1.077%	1.175%

Device ComparableParameter	N	OverallMean	%CV	%CV Lower95% CI	%CVUpper95% CI	%CV	%CVLower95% CI	%CVUpper95% CI
Outer Temporal (µm)	128	269.219	0.881%	0.839%	0.928%	1.106%	1.060%	1.156%
Outer Superior (µm)	128	281.515	0.833%	0.793%	0.877%	1.115%	1.068%	1.165%
Outer Nasal (µm)	128	293.518	0.729%	0.694%	0.767%	0.880%	0.844%	0.920%
Outer Inferior (µm)	128	268.654	0.838%	0.798%	0.882%	1.046%	1.003%	1.094%
Normal
Nidek Mirante
Center (µm)	44	271.242	1.034%	0.953%	1.130%	1.284%	1.196%	1.386%
Inner Temporal (µm)	44	327.341	0.425%	0.392%	0.465%	0.620%	0.577%	0.670%
Inner Superior (µm)	44	342.879	0.606%	0.558%	0.662%	0.797%	0.742%	0.860%
Inner Nasal (µm)	44	343.891	0.465%	0.428%	0.508%	0.664%	0.619%	0.717%
Inner Inferior (µm)	44	337.672	0.502%	0.463%	0.549%	0.733%	0.682%	0.791%
Outer Temporal (µm)	44	286.492	0.764%	0.704%	0.835%	0.969%	0.902%	1.046%
Outer Superior (µm)	44	301.556	0.682%	0.628%	0.745%	0.834%	0.777%	0.901%

{34}------------------------------------------------

Outer Nasal (µm)	44	313.465	0.415%	0.382%	0.454%	0.628%	0.585%	0.678%
Outer Inferior (µm)	44	288.927	0.865%	0.797%	0.945%	1.350%	1.257%	1.457%
Optovue Avanti
Center (µm)	44	260.974	0.669%	0.617%	0.731%	0.951%	0.885%	1.027%
Inner Temporal (µm)	44	308.816	1.023%	0.943%	1.119%	1.420%	1.322%	1.533%
Inner Superior (µm)	44	321.197	0.999%	0.921%	1.092%	1.294%	1.205%	1.398%
Inner Nasal (µm)	44	322.412	1.008%	0.929%	1.102%	1.270%	1.183%	1.371%
Inner Inferior (µm)	44	315.159	0.906%	0.835%	0.991%	1.321%	1.230%	1.426%
Outer Temporal (µm)	44	276.361	0.883%	0.814%	0.966%	1.196%	1.114%	1.291%
Outer Superior (µm)	44	290.141	0.778%	0.717%	0.851%	1.035%	0.964%	1.118%
Outer Nasal (µm)	44	300.821	0.761%	0.701%	0.832%	0.959%	0.893%	1.035%
Outer Inferior (µm)	44	275.573	0.763%	0.704%	0.835%	1.080%	1.006%	1.166%
Glaucoma
Nidek Mirante
Center (µm)	40	269.642	1.031%	0.946%	1.132%	1.178%	1.093%	1.277%
Inner Temporal (µm)	40	312.589	0.433%	0.397%	0.475%	0.706%	0.655%	0.765%
Inner Superior (µm)	40	327.497	0.531%	0.487%	0.583%	0.815%	0.757%	0.884%
Inner Nasal (µm)	40	331.311	0.441%	0.405%	0.485%	0.680%	0.632%	0.738%
Inner Inferior (µm)	40	320.528	0.678%	0.623%	0.745%	0.899%	0.834%	0.974%
Outer Temporal (µm)	40	269.889	0.786%	0.722%	0.863%	1.014%	0.941%	1.099%
Outer Superior (µm)	40	282.653	0.784%	0.720%	0.861%	1.042%	0.967%	1.129%
Outer Nasal (µm)	40	296.861	0.528%	0.484%	0.579%	0.672%	0.624%	0.729%
Outer Inferior (µm)	40	269.669	1.012%	0.929%	1.111%	1.366%	1.268%	1.481%
Optovue Avanti

			Repeatability			Reproducibility
Device ComparableParameter	N	OverallMean	%CV	%CV Lower95% CI	%CVUpper95% CI	%CV	%CVLower95% CI	%CVUpper95% CI
Center (µm)	40	258.359	0.707%	0.649%	0.776%	0.829%	0.769%	0.898%
Inner Temporal (µm)	40	295.250	0.899%	0.826%	0.988%	1.073%	0.996%	1.163%
Inner Superior (µm)	40	307.531	0.839%	0.770%	0.921%	1.008%	0.935%	1.092%
Inner Nasal (µm)	40	312.192	0.809%	0.743%	0.889%	0.962%	0.893%	1.043%
Inner Inferior (µm)	40	300.550	0.858%	0.788%	0.942%	0.987%	0.916%	1.070%
Outer Temporal (µm)	40	260.625	0.776%	0.712%	0.852%	0.932%	0.865%	1.010%
Outer Superior (µm)	40	272.317	0.773%	0.710%	0.849%	0.921%	0.855%	0.998%
Outer Nasal (µm)	40	285.511	0.631%	0.580%	0.693%	0.789%	0.732%	0.855%
Outer Inferior (µm)	40	257.772	0.689%	0.633%	0.757%	0.832%	0.772%	0.902%
Retinal Disease
Nidek Mirante
Center (µm)	44	286.808	1.163%	1.072%	1.271%	1.309%	1.219%	1.413%

{35}------------------------------------------------

Inner Temporal (µm)	44	321.831	0.863%	0.796%	0.944%	1.025%	0.954%	1.107%
Inner Superior (µm)	44	335.088	0.701%	0.646%	0.766%	0.879%	0.818%	0.949%
Inner Nasal (µm)	44	337.924	0.608%	0.561%	0.665%	0.800%	0.745%	0.864%
Inner Inferior (µm)	44	332.937	0.806%	0.743%	0.881%	0.999%	0.931%	1.079%
Outer Temporal (µm)	44	278.980	0.971%	0.895%	1.062%	1.149%	1.070%	1.241%
Outer Superior (µm)	44	291.146	0.776%	0.715%	0.848%	0.895%	0.834%	0.966%
Outer Nasal (µm)	44	303.081	0.593%	0.546%	0.648%	0.795%	0.740%	0.858%
Outer Inferior (µm)	44	282.672	1.075%	0.990%	1.175%	1.402%	1.306%	1.514%
Optovue Avanti
Center (µm)	44	275.784	0.976%	0.899%	1.067%	1.077%	1.003%	1.163%
Inner Temporal (µm)	44	304.899	0.939%	0.865%	1.027%	1.013%	0.944%	1.094%
Inner Superior (µm)	44	316.008	0.839%	0.773%	0.918%	1.019%	0.949%	1.100%
Inner Nasal (µm)	44	320.402	1.014%	0.934%	1.108%	1.104%	1.028%	1.192%
Inner Inferior (µm)	44	313.697	0.907%	0.836%	0.991%	1.009%	0.939%	1.089%
Outer Temporal (µm)	44	269.889	0.959%	0.884%	1.048%	1.141%	1.063%	1.232%
Outer Superior (µm)	44	281.250	0.932%	0.858%	1.018%	1.326%	1.235%	1.432%
Outer Nasal (µm)	44	293.495	0.772%	0.711%	0.844%	0.868%	0.808%	0.937%
Outer Inferior (µm)	44	271.626	1.005%	0.926%	1.099%	1.160%	1.081%	1.253%

Abbreviations: Cl = Confidence Interval; CV = Coefficient of Variation; ILM-RPE/BM = Imm-Limiting Membrane-Retinal Pigment
Epithelium/Bruch's Membrane; REML = Restricted Maxi

{36}------------------------------------------------

Table 8: Summary of Repeatability and Reproducibility for Retinal Nerve Fiber Layer (RNFL) Thickness Nidek (Test) Mirante Disc Map (Tracing HD OFF) and Optovue (Predicate) Avanti ONH with 3D Disc -----------------------------------------------------------------------------

				Repeatability			Reproducibility
Device ComparableParameter	N	OverallMean	%CV	%CVLower 95%CI	%CVUpper 95%CI	%CV	%CVLower95% CI	%CVUpper 95%CI
All Subjects
Nidek Mirante
TSNIT Inferior (µm)	74	124.710	4.715%	4.424%	5.048%	4.934%	4.668%	5.233%
TSNIT Nasal (µm)	74	84.308	7.198%	6.753%	7.707%	7.422%	7.021%	7.873%
TSNIT Superior (µm)	74	117.785	4.891%	4.589%	5.236%	5.869%	5.552%	6.225%
TSNIT Temporal (µm)	74	66.875	6.084%	5.708%	6.513%	6.340%	5.998%	6.725%
Whole Chart (µm)	74	98.416	2.812%	2.638%	3.010%	3.097%	2.930%	3.285%
S/I Inferior (µm)	74	96.655	4.629%	4.343%	4.956%	4.854%	4.593%	5.148%
S/I Superior (µm)	74	100.164	4.577%	4.294%	4.899%	5.165%	4.886%	5.478%
Optovue Avanti
TSNIT Inferior (µm)	74	110.853	2.835%	2.660%	3.035%	3.042%	2.878%	3.226%
TSNIT Nasal (µm)	74	72.811	3.270%	3.068%	3.500%	3.566%	3.374%	3.782%
TSNIT Superior (µm)	74	107.791	2.582%	2.423%	2.764%	2.933%	2.775%	3.110%
TSNIT Temporal (µm)	74	68.668	3.926%	3.683%	4.203%	4.152%	3.928%	4.403%
Whole Chart (µm)	74	90.031	1.485%	1.394%	1.590%	1.736%	1.642%	1.841%
S/I Inferior (µm)	74	88.114	2.179%	2.045%	2.332%	2.318%	2.193%	2.458%
S/I Superior (µm)	74	91.942	1.819%	1.707%	1.947%	2.255%	2.134%	2.391%
Normal
Nidek Mirante
TSNIT Inferior (µm)	40	139.464	3.813%	3.500%	4.188%	4.143%	3.845%	4.491%
TSNIT Nasal (µm)	40	88.853	6.730%	6.177%	7.394%	6.870%	6.374%	7.449%
TSNIT Superior (µm)	40	130.361	3.708%	3.404%	4.073%	5.070%	4.705%	5.497%
TSNIT Temporal (µm)	40	68.953	4.514%	4.143%	4.958%	4.927%	4.572%	5.341%
Whole Chart (µm)	40	106.894	2.268%	2.081%	2.490%	2.676%	2.484%	2.901%
S/I Inferior (µm)	40	104.989	3.950%	3.625%	4.338%	4.221%	3.917%	4.576%
S/I Superior (µm)	40	108.806	3.550%	3.258%	3.899%	4.170%	3.870%	4.520%
Optovue Avanti
TSNIT Inferior (µm)	40	123.259	2.047%	1.879%	2.248%	2.459%	2.282%	2.666%
TSNIT Nasal (µm)	40	78.506	2.937%	2.696%	3.226%	3.221%	2.990%	3.492%
TSNIT Superior (µm)	40	118.005	2.422%	2.223%	2.660%	2.674%	2.482%	2.899%
TSNIT Temporal (µm)	40	73.065	3.531%	3.241%	3.878%	3.788%	3.516%	4.107%
Whole Chart (µm)	40	98.209	1.271%	1.167%	1.396%	1.580%	1.467%	1.713%
S/I Inferior (µm)	40	96.199	1.657%	1.521%	1.820%	1.918%	1.780%	2.079%
S/I Superior (µm)	40	100.213	1.617%	1.484%	1.776%	1.993%	1.850%	2.161%
				Repeatability			Reproducibility
Device ComparableParameter	N	OverallMean	%CV	%CVLower 95%CI	%CVUpper 95%CI	%CV	%CVLower95% CI	%CVUpper 95%CI
Nidek Mirante
TSNIT Inferior (µm)	34	107.353	6.015%	5.482%	6.663%	6.125%	5.649%	6.689%
TSNIT Nasal (µm)	34	78.961	7.814%	7.121%	8.657%	8.149%	7.514%	8.901%
TSNIT Superior (µm)	34	102.990	6.495%	5.920%	7.195%	7.043%	6.496%	7.692%
TSNIT Temporal (µm)	34	64.431	7.703%	7.020%	8.534%	7.846%	7.235%	8.570%
Whole Chart (µm)	34	88.441	3.531%	3.219%	3.911%	3.680%	3.395%	4.018%
S/I Inferior (µm)	34	86.850	5.563%	5.071%	6.162%	5.735%	5.290%	6.263%
S/I Superior (µm)	34	89.997	5.900%	5.377%	6.535%	6.482%	5.978%	7.079%
Optovue Avanti
TSNIT Inferior (µm)	34	96.258	3.881%	3.537%	4.298%	3.881%	3.580%	4.237%
TSNIT Nasal (µm)	34	66.111	3.731%	3.401%	4.132%	4.046%	3.732%	4.417%
TSNIT Superior (µm)	34	95.774	2.812%	2.564%	3.114%	3.307%	3.051%	3.611%
TSNIT Temporal (µm)	34	63.494	4.451%	4.057%	4.930%	4.640%	4.280%	5.067%
Whole Chart (µm)	34	80.409	1.785%	1.627%	1.976%	1.959%	1.807%	2.139%
S/I Inferior (µm)	34	78.602	2.855%	2.602%	3.161%	2.865%	2.643%	3.128%
S/I Superior (µm)	34	82.211	2.106%	1.920%	2.332%	2.626%	2.423%	2.868%

{37}------------------------------------------------

Glaucoma

Abbreviations: CI = Confidence Interval; CV = Coefficient of Variation; REML = Restricted Maximum Likelihood Method; RNFL = Retinal Nerve Fiber Layer; SD = Standard Deviation; SI = Superior/Inferior; TSNT = Temporal, Superior, Nasal, Inferior, Temporal.

Table 9: Summary of Repeatability and Reproducibility for Optic Disc Nidek (Test) Mirante Disc Map (Tracing HD OFF) and Optovue (Predicate) Avanti ONH with 3D Disc - Disc Map Optic Disc Analysis Set

Device ComparableParameter	N	OverallMean	Repeatability			Reproducibility
			%CV	%CVLower 95%CI	%CVUpper 95%CI	%CV	%CVLower 95%CI	%CVUpper 95%CI
All Subjects
Nidek Mirante
Horizontal C/D Ratio	73	0.598	8.021%	7.521%	8.592%	8.772%	8.294%	9.310%
Vertical C/D Ratio	73	0.557	6.619%	6.207%	7.090%	7.574%	7.161%	8.037%
Disc Area (mm2)	73	2.132	6.710%	6.292%	7.187%	6.806%	6.435%	7.222%
Cup Area (mm2)	73	0.763	11.799%	11.061%	12.645%	13.686%	12.932%	14.533%
Optovue Avanti
Horizontal C/D Ratio	73	0.605	6.310%	5.917%	6.758%	6.522%	6.168%	6.921%
Vertical C/D Ratio	73	0.562	7.300%	6.845%	7.820%	7.903%	7.472%	8.387%
Disc Area (mm2)	73	1.890	4.559%	4.275%	4.882%	4.916%	4.649%	5.216%
Cup Area (mm2)	73	0.734	6.984%	6.550%	7.481%	7.328%	6.929%	7.777%
Normal
Nidek Mirante
Horizontal C/D Ratio	40	0.529	9.380%	8.606%	10.307%	10.055%	9.326%	10.907%
Vertical C/D Ratio	40	0.482	7.394%	6.785%	8.123%	8.564%	7.945%	9.288%

{38}------------------------------------------------

Device ComparableParameter	N	OverallMean	%CV	Repeatability		Reproducibility
				%CVLower 95%CI	%CVUpper 95%CI	%CV	%CVLower 95%CI	%CVUpper 95%CI
Disc Area (mm²)	40	2.144	5.892%	5.408%	6.472%	6.156%	5.713%	6.675%
Cup Area (mm²)	40	0.574	14.148%	12.974%	15.559%	16.255%	15.063%	17.655%
Optovue Avanti
Horizontal C/D Ratio	40	0.501	8.768%	8.046%	9.635%	9.032%	8.379%	9.796%
Vertical C/D Ratio	40	0.442	9.868%	9.054%	10.845%	10.541%	9.777%	11.436%
Disc Area (mm²)	40	1.880	4.329%	3.974%	4.755%	4.787%	4.443%	5.190%
Cup Area (mm²)	40	0.503	8.177%	7.504%	8.984%	8.578%	7.958%	9.304%
Glaucoma
Nidek Mirante
Horizontal C/D Ratio	33	0.680	6.725%	6.121%	7.462%	7.560%	6.963%	8.268%
Vertical C/D Ratio	33	0.647	5.912%	5.382%	6.560%	6.676%	6.150%	7.301%
Disc Area (mm²)	33	2.117	7.553%	6.874%	8.381%	7.553%	6.957%	8.261%
Cup Area (mm²)	33	0.992	10.047%	9.142%	11.152%	11.741%	10.809%	12.850%
Optovue Avanti
Horizontal C/D Ratio	33	0.732	4.074%	3.709%	4.520%	4.251%	3.916%	4.648%
Vertical C/D Ratio	33	0.707	5.319%	4.842%	5.901%	5.881%	5.418%	6.432%
Disc Area (mm²)	33	1.902	4.816%	4.384%	5.343%	5.064%	4.666%	5.537%
Cup Area (mm²)	33	1.014	6.050%	5.507%	6.712%	6.348%	5.848%	6.943%

Abbreviations: CI = Confidence Interval; CV = Coefficient of Variation; REML = Restricted Maximum Likelihood Method; RNFL = Retinal Nerve Fiber Layer; SD = Standard Deviation; S/I = Superior/Inferior; TSNT = Temporal, Superior, Nasal, Inferior, Temporal.

Table 10: Summary of Repeatability and Reproducibility for Central Corneal Thickness (CCT) Nidek (Test) Mirante Cornea Radial and Optovue (Predicate) Avanti Pachymetry - Cornea Radial CCT Analysis Set

Device Comparable Parameter	N	OverallMean	%CV	Repeatability%CVLower95% CI	%CVUpper95% CI	%CV	Reproducibility%CVLower95% CI	%CVUpper 95%CI
All Subjects
Nidek MiranteCentral Corneal Thickness (µm)	60	542.628	0.656%	0.612%	0.708%	0.799%	0.752%	0.853%
Optovue AvantiCentral Corneal Thickness (µm)	60	526.661	0.534%	0.498%	0.576%	0.769%	0.723%	0.821%

Normal
Nidek MiranteCentral Corneal Thickness (µm)	42	543.217	0.535%	0.492%	0.586%	0.709%	0.659%	0.767%
Optovue AvantiCentral Corneal Thickness (µm)	42	526.571	0.327%	0.301%	0.359%	0.470%	0.437%	0.509%

Corneal Disease
Nidek MiranteCentral Corneal Thickness (µm)	18	541.253	0.878%	0.775%	1.013%	0.980%	0.879%	1.108%
Optovue Avanti
Central Corneal Thickness (µm)	18	526.870	0.837%	0.739%	0.965%	1.206%	1.081%	1.363%

{39}------------------------------------------------

Abbreviations: CCT=Central Corneal Thickness; CJ=Conficient of Variation; REML=Restricted Maximum Likelihood Method; SD = Standard Deviation.

Precision Analyses: Mirante Only Analyses:

For the Mirante only precision analyses, both Mirante settings met precision performance goals, with acceptable variation among all parameters and each population for repeatability for Macula Trace. For Disc Trace RNFL Thickness and Disc Trace Optic Disc, both Mirante settings did not meet performance goals for some parameters in the Normal and Glaucoma populations. For Mirante-only Cornea Radial CCT, both devices met the precision performance goals, with acceptable variation among all parameters and each population for repeatability.

Image Quality

Masked graders reviewing Anterior Chamber Angle (ACA) and SLO images were masked to the subject, device type, subject population, configuration order, device order and results from other graders. Graders viewed the images using a secure file sharing platform. The graders only viewed and graded a single image at a time.

Image quality was assessed based on clinical utility and overall quality for both Mirante and Avanti or P200DTx devices on different paired scan types. Agreement of SLO Image Quality of Nidek Mirante and OPTOS P200DTx

The first acceptable SLO image captured by the Mirante and corresponding OPTOS P200DTx were compared to assess image quality. The results from the 3 masked graders were documented.

Mirante	P200DTx
Color	Color
B-FAF	FAF
G-FAF	FAF

Table 11: SLO Images Compared by Device

For SLO Color Fundus analysis, Mirante provided better clinical utility and overall quality in comparison to P200DTx (1-Sided Wilcoxon Signed-Rank Test; p<0.0001) for the grader average in the All Subjects population as well as in the individual Normal (p<0.0001), Glaucoma (p<0.0001), and Retinal Disease (Clinical Utility p<0.0001; Overall quality p = 0.0009) group.

For SLO B-Fundus Autofluorescence (FAF) analysis, Mirante provided better clinical utility and overall quality in comparison to P200DTx (1-Sided Wilcoxon Signed-Rank Test; p<0.0001) for the grader average in the All Subjects population as well as in the individual Normal (p<0.0001), Glaucoma (p<0.0001), and Retinal Disease (p = 0.0006) group.

For SLO G-FAF analysis, Mirante provided better clinical utility and overall quality in comparison to P200DTx (1-Sided Wilcoxon Signed-Rank Test; p<0.0001) for the grader average in the All Subjects population as well as in the individual Normal (p<0.0001), Glaucoma (p<0.0001), and Retinal Disease (p< 0.0001) group.

Agreement of OCT ACA Image Quality of Nidek Mirante and Avanti

The first acceptable OCT ACA image captured by the Mirante and corresponding Angle line image captured by the Avanti were compared to assess image quality.

For ACA analysis, clinical utility and overall quality in comparison to Avanti were not statistically significant for any of the populations.

Safety Results:

No safety-related issues related to the study devices were identified. There was a total of one adverse event of

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pinguecula in both eyes reported by one subject in the Normal population in this study, which was determined to be not related to the study device. The affected subject completed the study.

OCT/SLO Clinical Conclusion

In conclusion, agreement performance goals were met between Mirante and Avanti for [ILM-RPE/BM] Disc Map RNFL Thickness, and Optic Disc analysis for all parameters and each individual population. Mean differences between Mirante and Avanti scans (Mirante - Avanti) were higher for all populations for [ILM-RPE/BM] Thickness analysis and were higher for most parameters for Disc Map RNFL Thickness. For IILM- RPE/BM1 Thickness, Mirante is likely thicker by around 10-20 um than Avanti due to the definition of lower line, where Mirante measures between RPE and BM while Avanti measure on RPE. Additionally, for the upper line, Mirante measure the upper line (vitreous side) of ILM whereas Avanti measure on ILM. For Disc Map - RFNL Thickness, Mirante is likely thicker (around 10 um), with the exception of TSNT Temporal, due to the difference of segmentation algorism of blood vessels area, especially large blood vessels, with Mirante measuring line underside of blood vessels and Avanti crossing blood vessels. The exception of TSNIT Temporal being similar for both devices is because large blood vessels do not run in the Temporal area anatomically.

For the precision analyses, the Mirante device met precision performance goals for all parameters and each individual population for [ILM-RPE/BM] Thickness and Cornea Radial CCT for repeatability. Overall, the Mirante device met most precision performance goals for all parameters in the Normal population, and most parameters in the Glaucoma population for repeatability for Disc Map RNFL Thickness. For Optic Disc, the Mirante device met performance goals for all but one parameter for both Normal and Glaucoma populations. For Mirante only precision analyses, the precision performance goals were met for all parameters and all populations for repeatability for macula size, macula trace, and Cornea Radial CCT.

Image quality analyses demonstrated that Mirante provided better clinical utility and overall quality in comparison to P200DTx for SLO Color Fundus, SLO B-FAF, and SLO G-FAF analyses respectively, for the grader average in the All Subjects and each individual population.

Additionally, no safety-related issues related to the study devices were identified.

Thus, the several agreement and precision qualities and the clinical utility and overall quality of image with the Mirante device demonstrate its benefit in a clinical practice setting.

Image Filing Software NAVIS-EX

NAVIS-EX Device Description

The device includes Image Filing Software NAVIS-EX which is a software system intended for use to store, manage, process, measure, and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.

NAVIS-EX is equipped with functions for image acquisition, image drawing, image processing, image measurement, panorama image creation, stereo image observation, AF composite image creation, color composite image creation, viewer display of OCT image Follow-Up. (Depending on the image type, available functions are limited.) In addition, image data can be transferred by network or e-mail.

A network can be configured with multiple NAVIS-EX-installed computers, allowing access from the client computers for reference and editing.

The basic common functions that are provided by the NAVIS-EX software are listed in the table below.

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Function	Function Description
Network function	Adds and refers to data from multiple terminals configuring a network.
Image display function	Displays the images per patient.
Search function	Searches the captured data by patient information, date, and time period.
Zoom function	Enlarges and reduces the saved images.
Printing function	Prints the images or lists in a selected format. Exports and imports a printtemplate.
E-mail sending function	Sends the saved images by e-mail.
Report function	Outputs a report of data containing the saved images and patient informationto the specified destination.
External application activationfunction	Displays the saved images with an external application that can open JPEGand BMP files.
External system communicationfunction	Acquires patient information from an external system, and outputs data to anexternal system.
Patient specification function	Registers patient information using the command line or file linkage from anexternal system. It also allows specification of the patient to be displayed.
DICOM communication	Communicates data and saves the images in accordance with the DICOMstandard.
Ophthalmic photography devicecommunication function	Imports the images and XML files from the connected device.
Import and export functions	Acquires and outputs specified NAVIS-EX data for data exchange.
Data encryption/decryptionfunction	Encrypts patient information, exported data, and backup data, and decryptsthe encrypted imported data and restored data.
New Function: B-scanDenoising software	Processes the B-scan OCT images acquired from NIDEK devices to createclear OCT images with noise removed.

There are additional functions available based on the type of image that are detailed in the Operators Manual. These are summarized in the following table.

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Table 13: NAVIS-EX Functions based on type of image

OFunctions depending on type of image

Availability of function differ depending on the type of image (capturing device). Availability of function differ depending on the type of image (capturing device).

		AFC-330/DS-10/20	Mirante	RS-3000Advance
Acquiring images	"3.5 Acquiring Images (AFC-330)" (page 67)	○	×	×
	"3.6 Acquiring Images (RS-3000 Advance)" (page 68)	×	×	○
	"3.8 Acquiring Images (Import)" (page 70)	×	○	×
	"3.8 Acquiring Images (Import)" (page 70)	○	○	○
Image reference	"4.1 Image List Screen" (page 137)	○	○	×
	"12 VIEWER DISPLAY OF OCT IMAGE" (page 337)	×	O*1	O
Printing image data	"4.4 Printing Image Data" (page 168)	○	○	○
	"4.5 Export" (page 178)	○	○	×
Exporting image data	"12.15 Exporting OCT Images" (page 425)	×	O*1	O
Sending image data by e-mail	"4.6 E-mail Sending Function" (page 182)	○	○	×
	"12.16 Sending OCT Images by E-mail" (page 428)	×	O*1	O
Drawing to image	"7 DRAWING FUNCTION" (page 239)	○	O*2	×
Processing images	"8 IMAGE PROCESSING" (page 269)	○	O*2	×
Measuring image distanceand dimension	"9 IMAGE MEASUREMENT" (page 281)	○	O*2	×
Creating panoramacomposite images	"10 PANORAMA IMAGE FUNCTION" (page 295)	○	O*2	×
Stereo image creation andobservation	"11 STEREO VIEWING" (page 331)	○	O*2	×
Follow-Up	"3.12 Fundus Image Follow-Up" (page 116)	○	×	×
	"13 OCT IMAGE Follow-Up" (page 433)	×	×	O

△: Only still images can be captured

*1: Mirante OCT image

*2: Mirante "Fundus SLO" image

Note

· SLO image capture data of the Mirante can be displayed while Mirante Viewer is active. To play that data on the NAVIS-EX viewer, the data needs to be registered to NAVIS-EX as a "Fundus SLO" image using Mirante Viewer

Indications for Use

The Image Filing Software NAVIS-EX is a software system intended for use to store, manage, process, measure, analyze and display patient data and clinical information from computerized diagnostic instruments through networks. It is intended to work with compatible NIDEK ophthalmic devices.

Statement of Substantial Equivalence

Nidek believes that the Image Filing Software NAVIS -EX described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to the legally marketed predicate device. This is Class II medical device Image Filing Software NAVIS -EX cleared in K181345.

Therefore, based on the same intended use and technological characteristics with substantial equivalence to the predicate devices confirmed with performance testing, the NAVIS-EX is technologically and functionally equivalent to the predicate device. The difference between the proposed device and the predicate device is not significant and do not raise new issues of safety or effectiveness of the device.

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The Comparison Table of Technological Characteristics follows.

	Subject Device	Predicate Device	Discussion
Device Name	Image Filing SoftwareNAVIS-EX	Image Filing SoftwareNAVIS-EX	Same
Version	V1.11.0	V1.5.4
510(k) Number		K181345
Classification, Product Code	Class II NFJ	Class II NFJ

Applicant	Nidek Co., Ltd.	Nidek Co., Ltd.
Filing
	Network function	Yes	Yes	Same
	Image display function	Yes	Yes	Same
	Search function (patientinformation, date, period)	Yes	Yes	Same
	Zoom function	Yes	Yes	Same
	3D display function (OCTimage)	Yes	Yes	Same
	Printing function (single printing,multiple random layout printing,template)	Yes	Yes	Same
External I/F			Same
	E-mail function (sending imageby e-mail)	Yes	Yes	Same
	Report function (report dataoutput)	Yes	Yes	Same
	External application activationfunction (view the selectedimages from an externalapplication)	Yes	Yes	Same
	Link function (patientinformation acquisition and dataoutput)	Yes	Yes	Same
	Patient specification function(specify the patient from anexternal system)	Yes	Yes	Same
	DICOM	Yes	Yes	Same
Image acquisition			Same
	Link function	RS-3000 AdvanceCapture, Mirante Capture	RS-3000 AdvanceCapture	Added Mirante
	Import function	Yes	Yes	Same
	DCIM import function	Yes	Yes	Same
	Patient import/export function	Yes	Yes	Same
	Multiple patient import/exportfunction	Yes	Yes	Same
	Patient export functionspecifying examination data	Yes	Yes	Same
Image processing			Same
	Effect function	Yes	Yes	Same
	Color correction function	Yes	Yes	Same
	Rotate/Mirror function	Yes	Yes	Same
	Resize function	Yes	Yes	Same
	Subject Device	Predicate Device	Discussion
Device Name	Image Filing SoftwareNAVIS-EX	Image Filing SoftwareNAVIS-EX	Same
Measurement function	Yes	Yes	Same
Filter processing	Yes	Yes	Same
Simple image processing	Yes	Yes	Same
Stereo function	Yes	Yes	Same
Panorama function	Yes	Yes	Same
Composite function	Yes	Yes	Same
Drawing function	Yes	Yes	Same
3D display (OCT image)	Yes	Yes	Same
Retina layer border referenceposition display (OCT image)	Yes	Yes	Same
Retina layer border editingfunction (OCT image)	Yes	Yes	Same
Anterior segment layer borderreference position display (OCTimage)	Yes	Yes	Same
Optic disc shape edit function(OCT image)	Yes	Yes	Same
3D display video image savingfunction (OCT image)	Yes	Yes	Same
Follow-up function	Yes	Yes	Same
Video image acquisition			Same
Video image recording, saving	Yes	Yes	Same
Video image viewing	Yes	Yes	Same
Others			Same
Unit per package	1 unit	1 unit	Same
Standard accessories	Installation Disc, licensekey, Operator's Manual,Installation Manual	Installation CD, licensekey, Operator's Manual,Installation Manual	Same
Optional accessories	B-scan DenoisingSoftware	N/A	New functionThis function denoises a single B-scanimage to an averaged image of 120images added. 120 images can be addedwith Tracing HD of the OCT unit turnedon to obtain a substantially equivalentimage.The images denoised by this function areonly displayed; the denoised images arenot saved nor used for analysis.As described, this function only reducesimaging time, or increases conveniencewhen only B-scan images are read, anddoes not affect the substantialeffectiveness of the function.
	Viewer software plug-infor NAVIS-EX- AL-Scan Viewer	Viewer software plug-infor NAVIS-EX- AL-Scan Viewer	Same
	- CEM Viewer	- CEM Viewer	Same
	- MD Viewer	- MD Viewer	Same

Table 14: Comparison Table of Technological Characteristics – NAVIS-EX

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The technical differences between the NAVIS-EX V1.11.0 and the NAVIS-EX V1.5.4 in the Comparison Table above have been assessed through non-clinical testing which demonstrates that the differences do not raise any new questions about safety and effectiveness.

Substantial Equivalence Discussion for the Nidek Mirante per the 510(k) Decision-Making Flowchart

Are the predicate device(s) legally marketed? Q1.
Yes, the predicate device V1.5.4 was cleared in K181345.
Do the devices have the same intended use? Q2.
Yes, both the original software and the new version of the software have the same intended use.
1. Do the devices have the same technological characteristics?
  Yes, the NAVIS-EX version V1.5.4 includes all functions except for the newly added denoise function.

The differences between the subject device and the predicate device do not raise new questions of safety or effectiveness. The NAVIS-EX is as safe and effective as its predicate device, and thus, may be considered substantially equivalent.

Performance Testing

The NAVIS-EX has been verified for performance and functionality to assure conformance to the requirements for its basic intended use.

The NAVIS-EX compliance the software development lifecycle and the associated verification and validation activities have no unresolved major or critical bugs. A list of testing conducted included:

Medical device software Software life cycle processes: IEC 62304: Edition 1.1 2015-06 ●
Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]: IEC 62366-1: Edition 1.0 2015-02
. Health software - Part 1: General requirements for product safety: IEC 82304-1 Edition 1.0 2016-10

Risk Analvsis

The software device has been assessed to make sure all the risks were sufficiently mitigated according to the intended use. Identification of the associated hazards has been performed in order to evaluate, estimate and control the associated risks in accordance with EN ISO 14971 Application of risk analysis to medical devices.

Conclusion

The Nidek Mirante and the NAVIS-EX have the same intended use and similar indications for use, technological characteristics, and principles of operation as the previously cleared predicates.

The Nidek Mirante is technologically and functionally equivalent to the predicate device, Avanti (K180660) for OCT posterior and anterior segment imaging and measurement and to the OPTOS P200DTx (K142897) for posterior segment imaging. The differences between the proposed device, Mirante, and the predicate devices are

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not significant and do not raise new issues of safety or effectiveness of the Nidek Mirante is as safe and effective as the predicate devices, and thus, may be considered substantially equivalent.

The Image Filing Software NA VIS -EX has added one function to the previous list of functions available. The Bscan denoise software has been tested and has does not rase new issues of safety or effectiveness of the device. The NAVIS-EX is as safe and effective as the predicate device, and thus, may be considered substantially equivalent.

Regulation Number and Section

§ 886.1570 Ophthalmoscope.

(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.