3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System by Topcon Corporation

The Topcon 3D Optical Coherence Tomography 3D OCT-1 (Type:Maestro2) is a non-contact, high resolution tomographic and biomicroscopic imaging device that incorporates a digital camera for photographing, displaying and storing the data of the retina and surrounding parts of the eye to be examined under mydriatic conditions.

It is indicated for in vivo viewing, axial cross sectional, and three-dimensional imaging and measurement of posterior ocular structures, including retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures.

It also includes a reference database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the human retina to a database of known normal subjects.

It is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.

All the above functionalities and indications are available in combination with IMAGEnet 6.

· Indications for Use of the combination of the Maestro2 in conjunction with IMAGEnet6

Maestro2 in combination with IMAGEnet 6 is indicated as an aid in the visualization of vascular structures of the posterior segment of the eye including the retina, optic disc and choroid.

· IMAGEnet6 Ophthalmic Data System
The IMAGEnetto Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices.

It is intended for processing and displaying ophthalmic images and optical coherence tomography data.

The IMAGEnet6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of posterior ocular measurements to a database of known normal subjects.

· Indications for Use of the combination of the Maestro2 in conjunction with IMAGEnet6

Maestro2 in combination with IMAGEnet 6 is indicated as an aid in the visualization of vascular structures of the posterior segment of the eye including the retina, optic disc and choroid.

Device Description

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2) with system linkage software (herein referred to as "Maestro2") is a non-contact ophthalmic device combining spectral-domain optical coherence tomography (SD-OCT) with digital color fundus photography. Maestro2 includes an optical system of OCT, fundus camera (color, IR and Red-free image), and anterior observation camera. Maestro2 is used together with IMAGEnet6 by connecting via System linkage software which is a PC software installed to off the shelf PC connected to Maestro2 is capable of OCT imaging and color fundus photography. For this 510(k) notification, Maestro2 has been modified to allow for OCT "angiographic" imaging (only in conjunction with IMAGEnet6).

IMAGEnet6 is a software program installed on a server computer and operated via web browser on a client computer. It is used in acquiring, storing, managing, processing, measuring, displaying of patient information, examination information and image information delivered from TOPCON devices.

When combined with Maestro2, IMAGEnet6 plays an essential role as the user interface of the external PC by working together with the linkage software of Maestro2. In this configuration, IMAGEnet6 performs general GUI functions such as providing of the log-in screen, display of the menu icons, display function, measurement, analysis function, image editing functions, storing and management of data of the captured OCT scans and provides the reference database for quantitative comparison. For this 510(k) notification, IMAGEnet6 has been modified to allow for OCT "angiographic" imaging on the Maestro2.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the Topcon Corporation's 3D OCT-1 (Maestro2) and IMAGEnet6 Ophthalmic Data System, primarily focusing on the new OCT Angiography functionality:

Acceptance Criteria and Device Performance

The study primarily focused on comparing the performance of the Maestro2 (with IMAGEnet6) against the predicate CIRRUS HD-OCT, particularly for its new OCT Angiography (OCTA) imaging capabilities. The acceptance criteria were implicitly defined through the evaluation of "response rates" and agreement metrics.

Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (Maestro2 vs. CIRRUS HD-OCT)
OCTA Image Quality Response Rate (Maestro2 scans same or better grade than CIRRUS HD-OCT)	High percentage indicating comparable or superior image quality.	Entire Cohort: - 3x3-mm macular scan: 75.0% - 6x6-mm macular scan: 71.0% - 4.5x4.5-mm disc scan: 71.0%Pathology Group: - 3x3-mm macular scan: 75.6% - 6x6-mm macular scan: 77.9% - 4.5x4.5-mm disc scan: 74.4%
Visibility of Key Anatomical Vascular Features Response Rate (FAZ, large, medium, small vessels/capillaries - Maestro2 scans same or better grade than CIRRUS HD-OCT)	High percentage indicating comparable or superior visibility of features.	Entire Cohort: - 3x3-mm Macular Scan: FAZ visibility 87.1%, medium vessels 87.9%, small vessels/capillaries 82.3% - 6x6-mm Macular Scan: FAZ visibility 81.5%, large vessels 87.1%, medium vessels 77.4%, small vessels/capillaries 79.8% - 4.5x4.5-mm Disc Scan: large vessels 83.9%, medium vessels 80.6%, small vessels/capillaries 80.6%
Positive Percent Agreement (PPA) for Pathological Vascular Features (Maestro2 vs. FA/ICGA)	High PPA indicating good sensitivity in identifying pathologies.	Microaneurysms (MAs): - 3x3-mm macular scans: 96.6% - 6x6-mm macular scans: 96.6% - 4.5x4.5-mm disc scans: 73.9%Retinal Ischemia/Capillary Dropout (RI/CD): - 3x3-mm scans: 93.1% - 6x6-mm scans: 100% - 4.5x4.5-mm disc scans: 75.0%Choroidal Neovascularization (CNV): - 3x3-mm macular scans: 88.9% - 6x6-mm macular scans: 84.2% - 4.5x4.5-mm disc scans: 66.7%
Negative Percent Agreement (NPA) for Pathological Vascular Features (Maestro2 vs. FA/ICGA)	High NPA indicating good specificity in ruling out pathologies.	Microaneurysms (MAs): - 3x3-mm macular scans: 92.7% - 6x6-mm macular scans: 92.7% - 4.5x4.5-mm disc scans: 100%Retinal Ischemia/Capillary Dropout (RI/CD): - 3x3-mm scans: 85.4% - 6x6-mm scans: 87.8% - 4.5x4.5-mm disc scans: 85.7%Choroidal Neovascularization (CNV): - 3x3-mm macular scans: 82.7% - 6x6-mm macular scans: 84.3% - 4.5x4.5-mm disc scans: 98.4%
Response Rate for Identification of Pathologies (Maestro2 scans same or better outcome than CIRRUS HD-OCT)	High percentage indicating comparable or superior ability to identify specific pathologies.	Microaneurysms (MAs) response rates: - 3x3-mm macular scans: 81.0% - 6x6-mm macular scans: 82.1% - 4.5x4.5-mm disc scan: 75.6%RI/CD response rates: - 3x3-mm macular scans: 76.2% - 6x6-mm macular scans: 79.8% - 4.5x4.5-mm disc scans: 71.8%CNV response rates: - 3x3-mm macular scans: 79.8% - 6x6-mm macular scans: 81.0% - 4.5x4.5-mm disc scan: 75.3%

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 124 eligible eyes from 122 subjects. This included 38 "normal" eyes and 86 "pathology" eyes.
- Data Provenance: Prospective, multi-center, observational study. The country of origin of the data is not explicitly stated in the provided text, but "multi-center" suggests data from various clinical sites.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated. The text mentions that images were sent to an "independent reading center (RC) for image grading," implying multiple experts, but the exact number is not provided.
- Qualifications of Experts: Not explicitly stated. The nature of the study (comparing OCTA images and identifying vascular pathologies) suggests that the graders at the independent reading center would be ophthalmologists or trained image graders with expertise in retinal imaging and pathology.
Adjudication method for the test set:
- The document implies that an "independent reading center (RC)" performed "image grading." The specific adjudication method (e.g., 2+1, 3+1, none) is not explicitly stated.
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 a comparative effectiveness study, but it primarily compared device performance (Maestro2 vs. CIRRUS HD-OCT) and visualization capabilities against a reference standard (dye-based angiography), rather than assessing improvement in human readers with AI assistance versus without. The OCTA function itself is part of the imaging device, providing images for human interpretation, not an AI assisting human reads. Therefore, an effect size of human readers improving with/without AI assistance is not applicable to this study design as described. The study aims to demonstrate that the new device's OCTA images are comparable or superior to the predicate device and aid in visualizing vascular structures.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document describes the device as providing visualization capabilities ("indicated as an aid in the visualization"). The PPA/NPA results compare the device's diagnostic capability for certain pathologies against dye-based angiography, suggesting a standalone assessment of the image data's ability to reveal these pathologies. However, the exact methodology for pathology identification (e.g., whether it relied purely on automated detection within the device or expert interpretation of the OCTA images generated by the device) is not fully detailed. Given the context of "image grading" by a reading center, it strongly suggests expert interpretation of the images produced by the Maestro2 (device-only output).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for identifying key pathological vascular features (Microaneurysms, Retinal Ischemia/Capillary Dropout, and Choroidal Neovascularization) was established by dye-based angiography (e.g., fluorescein angiography [FA] and indocyanine green angiography [ICGA]). This is referred to as the reference standard against which the OCTA images from Maestro2 and CIRRUS HD-OCT were compared. Additionally, "clinically significant pathology" as determined by clinical assessment was used to categorize the "Pathology Population."
The sample size for the training set:
- The document only describes a clinical performance test study. Information regarding a specific training set size is not provided within this document. The device uses algorithms and reference databases, suggesting prior training, but details on that process or data size are absent.
How the ground truth for the training set was established:
- As no information on a specific training set is provided, how its ground truth was established is also not detailed in this document. The document mentions "reference databases for posterior ocular measurements" (e.g., for normal subjects), implying ground truth for these databases would have been established through prior clinical studies or expert consensus on normal ocular anatomy.

Summary

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July 17, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".

Topcon Corporation % Lena Sattler President Orasi Consulting 226 1st Street Bonita Springs, Florida 34134

Re: K241081

Trade/Device Name: 3D OPTICAL COHERENCE TOMOGRAPHY (3D OCT-1(type: Maestro2)); IMAGEnet6 Ophthalmic Data System Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, HKI, NFJ Dated: April 18, 2024 Received: April 19, 2024

Dear Lena Sattler:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Elvin Y. Ng -S

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

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Enclosure

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Indications for Use

510(k) Number (if known) K241081

Device Name

· 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)

IMAGEnet6 Ophthalmic Data System

Indications for Use (Describe)

· 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)

It is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.

All the above functionalities and indications are available in combination with IMAGEnet 6.

· Indications for Use of the combination of the Maestro2 in conjunction with IMAGEnet6

Maestro2 in combination with IMAGEnet 6 is indicated as an aid in the visualization of vascular structures of the posterior segment of the eye including the retina, optic disc and choroid.

· IMAGEnet6 Ophthalmic Data System
The IMAGEnetto Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices.

It is intended for processing and displaying ophthalmic images and optical coherence tomography data.

· Indications for Use of the combination of the Maestro2 in conjunction with IMAGEnet6

Maestro2 in combination with IMAGEnet 6 is indicated as an aid in the visualization of vascular structures of the posterior segment of the eye including the retina, optic disc and choroid.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

I. General information

Submitter's information: TOPCON Corporation 75-1 Hasunuma-cho, Itabashi-ku Tokyo, 174-8580, Japan

Contact person:

Lena Sattler President, Orasi Consulting Phone: 440-554-3706 Email: lena@orasiconsulting.com

Date Prepared:

July 16, 2024

II. Subject device:

Name of Device:	1) 3D OPTICAL COHERENCE TOMOGRAPHY3D OCT-1(type: Maestro2)2) IMAGEnet6 Ophthalmic Data System
Device Class:	Class II
Classification Name:	21 C.F.R. § 886.1570, Ophthalmoscope
Product Code:	OBO
Associated Product Code:	HKI, NFJ

III. Predicate devices:

PRIMARY PREDICATE DEVICE:

Company	Carl Zeiss Meditec, Inc.
Device	CIRRUS HD-OCT with Software Version 10
510(k) No.	K181534
Classification Name:	21 CFR § 886.1570Ophthalmoscope
Product Code:	OBO

SECONDARY PREDICATE DEVICES:

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(1) 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2):
Company	Topcon Corporation
Device	3D OPTICAL COHERENCE TOMOGRAPHY3D OCT-1(type: Maestro2)
510(k) No.	K233561
Classification Name:	21CFR § 886.1570 Ophthalmoscope
Product Code:	OBO HKI

	(2) IMAGEnet6 Ophthalmic Data System:

Company	Topcon Corporation
Device	IMAGEnet6 Ophthalmic Data System
510(k) No.	K232828
Classification Name:	21 C.F.R. § 892.2050Medical image management and processing system
Product Code:	NFJ

IV. Brief Device Descriptions

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2)

The software version for this 510(k) are: Maestro2 Main software: Ver.3.00 PC Software for System Linkage: Ver.3.00

IMAGEnet6 Ophthalmic Data System

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Image /page/7/Picture/0 description: The image shows the logo for Topcon. The logo consists of a stylized blue symbol above the word "TOPCON" in black, block letters. The symbol is composed of two overlapping shapes that resemble stylized eyes or lenses, giving the logo a modern and technological feel.

IMAGEnet6 also provides the GUI for remote operation. This function is an optional function which enables end-users to use some of the image capture function by operating the PC or tablet PC connected to the external PC of Maestro2 via ethernet cable. The remote operation function is not intended to be used from any further distance (e.g., operation from different rooms or different buildings) other than social distancing recommendations.

The software version for this 510(k) is: IMAGEnet6 Ophthalmic Data System Ver. 4.01

V. Intended use

The Maestro2 has the same intended use as the primary predicate and IMAGEnet 6 has the same intended use as the secondary predicate K232828. The modified Maestro2 and IMAGEnet6 devices will have the following Indications for Use (IFU) statements, which are not substantially different from those of the primary and/or secondary predicates:

Indications for Use

● 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)

It is indicated for in vivo viewing, axial cross sectional, and threedimensional imaging and measurement of posterior ocular structures, including retina, retinal nerve fiber layer, macula and optic disc as well as imaging of anterior ocular structures.

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Image /page/8/Picture/1 description: The image shows the logo for Topcon. The logo consists of a stylized blue symbol above the word "TOPCON" in black, block letters. The symbol is composed of two curved shapes that resemble stylized wings or petals, with a horizontal line running through the center, creating a sense of connection or unity.

It also includes a reference database for posterior ocular measurements which provide for the quantitative comparison of retinal nerve fiber layer, optic nerve head, and the macula in the human retina to a database of known normal subjects.

It is indicated for use as a diagnostic device to aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.

All the above functionalities and indications are available in combination with IMAGEnet 6.

IMAGEnet6 Ophthalmic Data System ●

The IMAGEnet6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices.

It is intended for processing and displaying ophthalmic images and optical coherence tomography data.

. Indications for Use of the combination of the Maestro2 in conjunction with IMAGEnet6

Maestro2 in combination with IMAGEnet 6 is indicated as an aid in the visualization of vascular structures of the posterior segment of the eye including the retina, optic disc and choroid.

VI. Comparison of the technological characteristics between the subject and predicate devices

The subject and predicate devices do not share identical technological characteristics. However, these differences do not raise new or different questions of safety and effectiveness.

Comparison of the technological characteristics between the subject and predicate devices are summarized in Tables 1, 2 and 3 below.

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TABLE 1: PREDICATE COMPARISON–MAESTRO2 AND IMAGENET6 VERSUS PRIMARY PREDICATE ON OCT ANGIOGRAPHY

	(Under lines shows the differences.)
ModelNumber	Subject Device3D OCT-1 Maestro2Software versionMaestro2 Main software:Ver.3.00PC Software for SystemLinkage: Ver.3.00	Subject DeviceIMAGEnet6Software version Ver4.01	Primary predicate deviceCIRRUS HD-OCT	SubstantialEquivalenceDiscussion
Trade Name	3D OPTICALCOHERENCETOMOGRAPHY 3D OCT-1(type: Maestro2)	Ophthalmic Data SystemIMAGEnet6	CIRRUS HD-OCT	NA
510(k)submitter	TOPCON Corporation	TOPCON Corporation	Carl Zeiss Meditec, Inc.	NA
510(k)Number	K241081	K241081	K181534	NA
PrimaryProduct code	OBO	OBO	OBO	Same
Regulation No.	21 C.F.R. § 886.1570	21 C.F.R. § 886.1570**Due to bundling ofMaestro2 and IMAGEnet6under the same 510(k)submission	21 C.F.R. § 886.1570	Same
Product class	II	II	II	Same
Indications forUse	The Topcon 3D OpticalCoherence Tomography 3DOCT-1 (Type:Maestro2) isa non-contact, highresolution tomographic andbiomicroscopic imagingdevice that incorporates adigital camera forphotographing, displayingand storing the data of theretina and surroundingparts of the eye to beexamined under Mydriaticand non-Mydriaticconditions.It is indicated for in vivoviewing, axial crosssectional, and three-dimensional imaging andmeasurement of posteriorocular structures, includingretina, retinal nerve fiberlayer, macula and opticdisc as well as imaging ofanterior ocular structures.It also includes a ReferenceDatabase for posteriorocular measurementswhich provide for thequantitative comparison ofretinal nerve fiber layer,optic nerve head, and themacula in the human retina	The IMAGEnet6Ophthalmic Data System isa software program that isintended for use in thecollection, storage andmanagement of digitalimages, patient data,diagnostic data and clinicalinformation from Topcondevices.It is intended forprocessing and displayingophthalmic images andoptical coherencetomography data.The IMAGEnet6Ophthalmic Data Systemuses the same algorithmsand reference databasesfrom the original datacapture device as aquantitative tool for thecomparison of posteriorocular measurements to adatabase of known normalsubjects.	CIRRUS™ HD-OCT is anon-contact, highresolution tomographic andbiomicroscopic imagingdevice intended for in-vivoviewing, axial cross-sectional, and three-dimensional imaging ofanterior and posteriorocular structures. Thedevice is indicated forvisualizing and measuringanterior and posteriorocular structures, includingcornea, corneal epithelium,retina, retinal nerve fiberlayer, ganglion cell plusinner plexiform layer,macula, and optic nervehead.The CIRRUS normativedatabases are quantitativetools indicated for thecomparison of retinal nervefiber layer thickness,macular thickness,ganglion cell plus innerplexiform layer thickness,and optic nerve headmeasurements to adatabase of normalsubjects.	Similar.The combinationof Maestro2 andIMAGEnet6 issimilar to theCIRRUS HD-OCT.Both are OCTimaging systemswith a referencedatabase (RDB).OCTA and funduscamera features.Clinicalperformancetesting wasconducted on theOCTA function ofMaestro2 (andIMAGEnet6combination) andon the CIRRUSHD-OCT.
(Under lines shows the differences.)
ModelNumber	Subject Device3D OCT-1 Maestro2Software versionMaestro2 Main software:Ver.3.00PC Software for SystemLinkage: Ver.3.00	Subject DeviceIMAGEnet6Software version Ver4.01	Primary predicate deviceCIRRUS HD-OCT	SubstantialEquivalenceDiscussion
Indications forUseofthecombination ofthe Maestro2in conjunctionwithIMAGEnet6	to a database of knownnormal subjects.It is indicated for use as adiagnostic device to aid inthe diagnosis,documentation andmanagement of ocularhealth and diseases in theadult population.All the abovefunctionalities andindications are available incombination withIMAGEnet 6.	Maestro2 in combination with IMAGEnet 6 is indicated asan aid in the visualization of vascular structures of theposterior segment of the eye including the retina, optic discand choroid.	Angiography is indicatedas an aid in thevisualization of vascularstructures of the retina andchoroid. (Model 5000only.)CIRRUS HD-OCT isindicated as a diagnosticdevice to aid in thedetection and managementof ocular diseasesincluding, but not limitedto, macular holes, cystoidmacular edema, diabeticretinopathy, age-relatedmacular degeneration, andglaucoma.	NA
Light Source	Spectral domain OCT(SDOCT) using a superluminescent diode (SLD)with center wavelength 840nm.	NA	Spectral domain OCT(SDOCT) using a superluminescent diode (SLD)with center wavelength 840nm.	Same
Scan Speed	50,000 A-scans/sec	NA	27,000 A-scans/sec68,000 A-scans/sec forOCT Angiography	Different.There is adifference in scanspeed.Clinicalperformancetesting wasconducted on theOCTA function ofMaestro2 andIMAGEnet6combination andon the CIRRUSHD-OCT.
A-scan Depth	2.6 mm (in tissue)	NA	2.0 mm	Different.Clinicalperformancetesting wasconducted on theOCTA function ofMaestro2 andIMAGEnet6combination and
(Under lines shows the differences.)
ModelNumber	Subject Device3D OCT-1 Maestro2Software versionMaestro2 Main software:Ver.3.00PC Software for SystemLinkage: Ver.3.00	Subject DeviceIMAGEnet6Software version Ver4.01	Primary predicate deviceCIRRUS HD-OCT	SubstantialEquivalenceDiscussion
				on the CIRRUSHD-OCT.Different.
Resolution	Axial: 6 μm (in tissue)Transverse: 20 μm(intissue)	NA	Axial: 5 μm (in tissue)Transverse: ≤15 μm	Clinicalperformancetesting wasconducted on theOCTA function ofMaestro2 andIMAGEnet6combination andon the CIRRUSHD-OCT.
Scan Patterns	For posterior3D scan- 12x9 mm (512x128)- 6x6 mm (512x128)Line scan- 6 mm (1024)- 9 mm (1024)5LineCross scan- 6 mm (1024) x 5 x 2- 9 mm (1024) x 5 x 2For anteriorRadial scan- 6 mm x 12 (1024x12)Line scan- 3 mm (1024)- 6 mm (1024)	NA	Macular Cube- 6x6 mm (512x128)- 6x6 mm (200x200)Optic Disc Cube- 6x6 mm (200x200)5 Line RasterHD (high-definition)Raster- HD 1 Line 100x- HD 21 Line- HD Radial- HD Cross- HD 5-Line RasterAnterior Segment CubeScan512x128Anterior Segment 5-LineRasterHD AngleAnterior ChamberWide-to-AngleHD CorneaPachymetry	Similar
OCTA ScanPatterns	Macular- 3x3mm (256x256)- 6x6mm (360x360)Disc:- 4.5x4.5mm (320x320)	NA	AngioPlex- 3x3 mm- 6x6 mm- 8 x8 mm	Different. Clinicalperformancetesting wasconducted on theOCTA function ofMaestro2 andIMAGEnet6combination andon the CIRRUSHD-OCT.
OCTAalgorithm	OCTARA	NA	OMAG	DifferentClinicalperformance
	(Under lines shows the differences.)
ModelNumber	Subject Device3D OCT-1 Maestro2Software versionMaestro2 Main software:Ver.3.00PC Software for SystemLinkage: Ver.3.00	Subject DeviceIMAGEnet6Software version Ver4.01	Primary predicate deviceCIRRUS HD-OCT	SubstantialEquivalenceDiscussion
				testing wasconducted on theOCTA function ofMaestro2 andIMAGEnet6combination andon the CIRRUSHD-OCT.
Default OCTAen face slabs	NA	Macular scans default slabsSuperficial- ILM toIPL/INL + 15.6µmDeep- IPL/INL + 15.6µmto IPL/INL + 70.2µmOuter Retina- IPL/INL +70.2µm to BMChoriocapillaris- BM toBM + 20.8µmDisc scans default slabsVitreous- Top to ILMOptic Disc- ILM to BM -50µmRPC- ILM to RNFL/GCLChoriocapillaris- BM toBM + 20.8µm	Macular scans default slabsSuperficial- ILM to IPLDeep- IPL to OPLAvascular- OPL to RPE -70µmChoriocapillaris- RPE +29µm to RPE + 49µmDisc scans default slabsVitreous Retinal Interface-ILM - 300µm to ILMRetina- ILM to RPERPC- ILM to RNFL	DifferentClinicalperformancetesting wasconducted on theOCTA function ofMaestro2 andIMAGEnet6combination andon the CIRRUSHD-OCT.
LayerSegmentation	For posterior:1. ILM2. RNFL/GCL3. IPL/INL4. OS/RPE5. BMFor anterior:N/A	Manual adjustment ofsegmented layer.	Unknown	Similar.
QuantitativeAnalyses	For posterior:- Retinal layersegmentation- Optic disc analysisOCTA: None (qualitativevisualization only)For anterior:N/A	Thickness calculation	For posterior:- RNFL, Macula,AnteriorSegmentation- RNFL Thicknessanalysis- Optic Nerve Head(ONH) analysis- Guided ProgressionAnalysis (GPA) forRNFL- Guided ProgressionAnalysis (GPA) forGanglion Cell/IPL- Macular ThicknessAnalysis- Ganglion Cell OUAnalysis- Advanced RPEAnalysis- PanoMap AnalysisFor anterior:	Similar. There areno quantitativeanalyses associatedwith OCTAimaging fromeither the Maestro2or CIRRUS HD-OCT.
(Under lines shows the differences.)
ModelNumber	Subject Device3D OCT-1 Maestro2Software versionMaestro2 Main software:Ver.3.00PC Software for SystemLinkage: Ver.3.00	Subject DeviceIMAGEnet6Software version Ver4.01	Primary predicate deviceCIRRUS HD-OCT	SubstantialEquivalenceDiscussion
			• Anterior Segment-Analysis withquantitativemeasurement tools.
Display of En-face images	NA	YES	YES	Same
Fundusimagingavailable	Yes	NA	Yes	Same

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TABLE 2 SUBSTANTIAL EQUIVALENCE - MAESTRO2 VERSUS SECONDARY PREDICATE DEVICE

(Under lines shows the differences.)
ModelNumber	Subject Device3D OCT-1 Maestro2Software versionMaestro2 Main software: Ver.3.00PC Software for System Linkage: Ver.3.00	Secondary predicate device3D OCT-1 Maestro2Software versionMaestro2 Main software: Ver.2.11.1PC Software for System Linkage: Ver.2.11.1	SubstantialEquivalenceDiscussion
Trade Name	3D OPTICAL COHERENCETOMOGRAPHY 3D OCT-1(type:Maestro2)	3D OPTICAL COHERENCETOMOGRAPHY 3D OCT-1(type: Maestro2)	Same
510(k)submitter	TOPCON Corporation	TOPCON Corporation	Same
510(k)Number	K241081	K233561	NA
PrimaryProduct code	OBO	OBO	Same
RegulationNo.	21 C.F.R. § 886.1570	21 C.F.R. § 886.1570	Same
Product class	II	II	Same
Indicationsfor Use	The Topcon 3D Optical CoherenceTomography 3D OCT-1 (Type:Maestro2)is a non-contact, high resolutiontomographic and biomicroscopic imagingdevice that incorporates a digital camerafor photographing, displaying and storingthe data of the retina and surrounding partsof the eye to be examined under Mydriaticand non-Mydriatic conditions.It is indicated for in vivo viewing, axialcross sectional, and three-dimensionalimaging and measurement of posteriorocular structures, including retina, retinalnerve fiber layer, macula and optic disc as	The 3D Optical Coherence Tomography 3DOCT-1 (Type:Maestro2) is a noncontact, highresolution tomographic and biomicroscopicimaging device that incorporates a digitalcamera for photographing, displaying andstoring the data of the retina and surroundingparts of the eye to be examined underMydriatic and non-Mydriatic conditions.The 3D Optical Coherence Tomography 3DOCT-1 (Type:Maestro2) is indicated for invivo viewing, axial cross sectional, and three-dimensional imaging and measurement ofposterior ocular structures, including retina,retinal nerve fiber layer, macula and optic discas well as imaging of anterior ocular	Different.The modifiedMaestro2 canperform OCTAngiography incombinationwithIMAGEnet6.
(Under lines shows the differences.)
	well as imaging of anterior ocularstructures.It also includes a Reference Database forposterior ocular measurements whichprovide for the quantitative comparison ofretinal nerve fiber layer, optic nerve head,and the macula in the human retina to adatabase of known normal subjects.It is indicated for use as a diagnosticdevice to aid in the diagnosis,documentation and management of ocularhealth and diseases in the adult population.All the above functionalities andindications are available in combinationwith IMAGEnet 6.Indications for Use of the combination ofthe Maestro2 in conjunction withIMAGEnet6Maestro2 in combination with IMAGEnet6 is indicated as an aid in the visualizationof vascular structures of the posteriorsegment of the eye including the retina,optic disc and choroid.	It also includes a Reference Database forposterior ocular measurements which providefor the quantitative comparison of retinalnerve fiber layer, optic nerve head, and themacula in the human retina to a database ofknown normal subjects.The 3D Optical Coherence Tomography 3DOCT-1 (Type:Maestro2) is indicated for use asa diagnostic device to aid in the diagnosis,documentation and management of ocularhealth and diseases in the adult population.
Light Source	Spectral domain OCT (SDOCT) using asuper luminescent diode (SLD) with centerwavelength 840 nm.	Spectral domain OCT (SDOCT) using asuper luminescent diode (SLD) with centerwavelength 840 nm.	Same
Scan Speed	50,000 A-scans/sec	50,000 A-scans/sec	Same
A-scan Depth	2.6 mm (in tissue)	2.6 mm (in tissue)	Same
	Axial: 6 micron (in tissue)	Axial: 6 micron (in tissue)
Resolution	Transverse: 20 micron (in tissue)	Transverse: 20 micron (in tissue)	Same
Scan Patterns	For posterior:3D scan- 12x9 mm (512x128)- 6x6 mm (512x128)Line scan- 6mm (1024)- 9mm (1024)5LineCross scan- 6mm (1024) x 5 x 2- 9mm (1024) x 5 x 2For anterior:Radial scan- 6mm x 12 (1024x12)Line scan	For posterior:3D scan- 12x9 mm (512x128)- 6x6 mm (512x128)Line scan- 6mm (1024)- 9mm (1024)5LineCross scan- 6mm (1024) x 5 x 2- 9mm (1024) x 5 x 2For anterior:Radial scan- 6mm x 12 (1024x12)Line scan	Same
	- 3mm (1024)	- 3mm (1024)
	- 6mm (1024)	- 6mm (1024)
LayerSegmentation	For posterior:1. ILM2. RNFL/GCL3. IPL/INL4. OS/RPE5. Bruch's membrane (BM)	For posterior:1. ILM2. RNFL/GCL3. IPL/INL4. OS/RPE	Different.To support theaddition ofOCTA imaging,the Maestro2was modified tobe able to detect
(Under lines shows the differences.)
	For anterior:N/A	For anterior:N/A	BM.
ThicknessCalculation	No	No	Same
Analysis	Yes	Yes	Same
OCTA imagecapture	Macular- 3x3mm (256x256)- 6x6mm (360x360)Disc:- 4.5x4.5mm (320x320)	None	Different.Addition ofOCTA-specificscan patterns foracquisition ofOCTA images.
Image	Color/Digital red-free image	Color/Digital red-free image	Same
Angle of View	45 degree30 degree (digital zoom)	45 degree30 degree (digital zoom)	Same
OperatingDistance	34.8 mm (fundus photography)62.6 mm (anterior photography)	34.8 mm (fundus photography)62.6 mm (anterior photography)	Same
DioptricCompensation	-33D to +40D	-33D to +40D	Same
Power Source	Voltage/frequency: AC 100-240V/50-60HzPower input: 70-150VA	Voltage/frequency: AC 100-240V/50-60HzPower input: 70-150VA	Same
OverallDimensions	340-480mm (W) × 543-680mm (D) × 500-735mm(H)	340-480mm (W) × 543-680mm (D) × 500 -735mm(H)	Same
Linkage withIMAGEnet6via PCsoftware forSystemLinkage	Yes	Yes	Same
OptionalRemoteoperationfunction	Yes	Yes	Same

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TABLE 3 SUBSTANTIAL EQUIVALENCE – IMAGENET6 VERSUS SECONDARY PREDICATE DEVICE ON FUNCTION OTHER THAN OCT ANGIOGRAPHY

(Under lines shows the differences.)
Model Number	Subject DeviceIMAGEnet6Software version Ver4.01	Secondary predicate deviceIMAGEnet6 predicateSoftware version Ver2.52.1	SubstantialEquivalenceDiscussion
Trade Name	Ophthalmic Data System IMAGEnet6	Ophthalmic Data System IMAGEnet6	N/A
510(k) submitter	TOPCON Corporation	TOPCON Corporation	Same
510(k) Number	K241081	K232828	N/A
PrimaryProduct code	OBO	NFJ	Different.This difference isdue to the bundlingrule and does notaffect SE.
Regulation No.	21 C.F.R. § 886.1570	21 CFR 892.2050	Different.This difference isdue to the bundlingrule and does not
(Under lines shows the differences.)
Product class	II	II	affect SE.
Indications foruse	The IMAGEnet6 Ophthalmic DataSystem is a software program that isintended for use in the collection, storageand management of digital images,patient data, diagnostic data and clinicalinformation from Topcon devices.It is intended for processing anddisplaying ophthalmic images and opticalcoherence tomography data.The IMAGEnet6 Ophthalmic DataSystem uses the same algorithms andreference databases from the original datacapture device as a quantitative tool forthe comparison of posterior ocularmeasurements to a database of knownnormal subjects.Indications for Use of the combination ofthe Maestro2 in conjunction withIMAGEnet6Maestro2 in combination with IMAGEnet6 is indicated as an aid in the visualizationof vascular structures of the posteriorsegment of the eye including the retina,optic disc and choroid.	The IMAGEnet6 Ophthalmic DataSystem is a software program that isintended for use in the collection, storageand management of digital images,patient data, diagnostic data and clinicalinformation from Topcon devices.It is intended for processing anddisplaying ophthalmic images and opticalcoherence tomography data.The IMAGEnet6 Ophthalmic DataSystem uses the same algorithms andreference databases from the original datacapture device as a quantitative tool forthe comparison of posterior ocularmeasurements to a database of knownnormal subjects.	Different.The modifiedMaestro2 canperform OCTAngiography incombination withIMAGEnet6
Connectabledevices	TRC-50DXTRC-NW300TRC-NW7SF MARK IIITRC-NW8TRC-NW8FTRC-NW8F plusTRC-NW400DC-3DC-43D OCT-10003D OCT-20003D OCT-1 Maestro3D OCT-1(Type: Maestro2)DRI OCT TritonCA-800KR-800PAAladdinNW500	TRC-50DXTRC-NW300TRC-NW7SF MARK IIITRC-NW8TRC-NW8FTRC-NW8F plusTRC-NW400DC-3DC-43D OCT-10003D OCT-20003D OCT-1 Maestro3D OCT-1(Type: Maestro2)DRI OCT TritonCA-800KR-800PAAladdinNW500	Same
Database	YES	YES	Same
Patientmanagement	YES	YES	Same
Acquisition	YES	YES	Same
Archive andBackup	YES	YES	Same
DVD / CD-R forarchiving	YES	YES	Same
(Under lines shows the differences.)
Image processing	YES	YES	Same
Import/Exportimages DICOM	YES	YES	Same
Combination withMaestro2	YES	YES	Same
Display OCTAdata and creationof En-face image	YES	None	DifferentAddition of OCTAdata.This function isevaluated with theprimary predicatedevice.

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VII. Non-clinical performance testing

It has been verified that Maestro2 and IMAGEnet6 functions as intended by tests or evaluations based on the following FDA-recognized, voluntary consensus standards, and the in-house test specification. The result of the testing supports substantial equivalence by demonstrating that the device(s) perform as intended and comply with the same standards as the predicate device(s).

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)

FDA-recognized, voluntary consensus standards
IEC 60601-1-2:2014+AMD1:2020	Medical electrical equipment - Part 1-2:General requirements for basic safety and essentialperformance - Collateral standard: Electromagneticdisturbances - Requirements and tests
ANSI AAMI ES60601-1:2005/(R)2012 &A1:2012, C1:2009/(R)2012 &A2:2010/(R)2012 (Cons. Text) [Incl.AMD2:2021]	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance(IEC 60601-1:2005, MOD) [Including Amendment 2(2021)]
ISO 15004-1:2020	Ophthalmic instruments - Fundamental requirementsand test methods - Part 1: General requirementsapplicable to all ophthalmic instruments
ISO 10940:2009	Ophthalmic instruments – Fundus cameras
ANSI Z80.36-2021	American National Standard for Ophthalmics - LightHazard Protection for Ophthalmic Instruments
IEC 60601-1-6: 2020	Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance- Collateral standard: Usability
IEC62366-1:2015+AMD1:2020	Medical devices - Part 1: Application of usabilityengineering to medical devices
IEC 60825-1: 2007	Safety of laser products - Part 1: Equipmentclassification, and requirements
ISO 10993-1:2018	Biological evaluation of medical devices-Part 1:Evaluation and testing within a risk managementprocess

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FDA-recognized, voluntary consensus standards
ISO 10993-5:2009	Biological evaluation of medical devices-Part 5: Testsfor in vitro cytotoxicity
ISO 10993-10:2021	Biological evaluation of medical devices - Part 10:Tests for skin sensitization
ISO 10993-23:2021	Biological evaluation of medical devices - Part 23:Tests for irritation
IEC 62304:2015	Medical device software - Software life cycle processes
ISO 14155: 2020	Clinical investigation of medical devices for humansubjects - Good clinical practice

Software for Maestro2 was concluded to be a Basic Documentation Level. Software verification and validation testing such as software system testing was performed for Maestro2 as recommended by FDA's Guidance document Content of Premarket Submissions for Device Software Functions (issued on June 14, 2023).

For the remote operation function cleared in K233561, comparison testing confirmed that image quality and diagnosability is the same with or without the remote operation function.

Maestro2 is a cyber device per 524B(c) of the Food, Drug & Cosmetic Act. Maestro2 followed the recommendations in the FDA's Guidance document Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (issued on September 27, 2023).

IMAGEnet6 Ophthalmic Data System

FDA-recognized, voluntary consensus standards
IEC 62304:2015	Medical device software - Software life cycle processes
NEMA PS 3.1 - 3.20 2022d	Digital Imaging and Communications in Medicine (DICOM) Set
ISO 14155: 2020	Clinical investigation of medical devices for human subjects - Goodclinical practice

Software for IMAGEnet6 was concluded to be a Basic Documentation Level. Software verification and validation testing such as software system testing was performed for IMAGEnet6 as recommended by FDA's Guidance document Content of Premarket Submissions for Device Software Functions (issued on June 14, 2023).

For the remote operation function cleared in K232828, comparison testing confirmed that image quality and diagnosability is the same with or without the remote operation function.

IMAGEnet6 is a cyber device per 524B(c) of the Food, Drug & Cosmetic Act. IMAGEnet6 followed the recommendations in the FDA's Guidance document Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (issued on September 27, 2023).

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VIII. Clinical performance testing

A prospective, multi-center, observational study was conducted to compare the OCTA imaging performance (i.e., image quality and visualization of vascular features in the macula and optic disc) of the Maestro2 and the CIRRUS HD-OCT and to compare visualization of pathologic vascular features in the retina and choroid between the Maestro2 and CIRRUS HD-OCT versus dye-based angiography (e.g., fluorescein angiography). Maestro2 and CIRRUS HD-OCT images (OCTA macula 3x3-mm scan, macula 6x6-mm scan, and disc 4.5x4.5-mm scan) collected by the clinical sites were sent to an independent reading center (RC) for image grading. Participants age 22 years or older with or without relevant vascular pathology in at least one eye were enrolled and assigned to one of two groups: 1) "Normal Population" ("eyes without clinically significant pathology") and 2) "Pathology Population" ("eyes with vascular pathologies affecting different anatomical depths of the retina and choroid"). Best-corrected visual acuity (BCVA, in the study eye) in the "Pathology Population" was required to be 20/400 or better, in the "Normal Population 20/40 or better. The "Pathology Population" group was further stratified by vascular pathology primarily in the Outer Retina and/or Choriocapillaris slabs vs. vascular pathology in the Superficial and/or Deep slabs. The following endpoints were evaluated:

1. OCTA image "quality response rate" (percentage of eyes whose Maestro2 scans have the same or better grade than the corresponding CIRRUS HD-OCT scans).
1. Visibility of key anatomical vascular features (foveal avascular zone [FAZ] border, large blood vessels, medium blood vessels, and small blood vessels/capillaries) "response rate" (percentage of eyes whose Maestro2 scans have the same or better grade than the corresponding CIRRUS HD-OCT scans).
1. Positive percent agreement (PPA) and negative percent agreement (NPA) between Maestro2 and CIRRUS HD-OCT in the identification of key pathological vascular features (microaneurysms [MA], retinal ischemia/capillary dropout [RI/CD], and choroidal neovascularization [CNV]). In addition, a "response rate" was calculated based on the match outcome based on whether pathology identification was the same (i.e., a "match") between OCTA and FA/ICGA (percentage of eyes whose Maestro2 scans have the same or better outcome than the corresponding CIRRUS HD-OCT scans).

133 participants were enrolled. There were 41 eyes in the "normal" group, 93 eyes in the "pathology" group. 124 eyes of 122 subjects fulfilled eligibility criteria. Primary analyses were based on a cohort of these 124 eyes (eligible eyes with OCTA or FA/ICGA imaging; 38 "normal," 86 "pathology"). Participant age ranged from 22 to 87 years, with a mean age of 54.1±18.4 years (37.9 years in the "normal" group, 61 years in the "pathology" group). 45.9% (56/122) were men and 54.1% (66/122) were women. 71.3% (87/122) are White, 17.2% (21/122) Black/African American, 1.6% (2/122) American Indian/Alaskan Native, 7.4% (9/122) Asian. 0.8% (1/122) Native Hawaiian/Pacific Islander, and 2.5% (3/122)

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Other. 18.0% (22/122) are Hispanic or Latino and 82.0% (100/122) are not. In the "pathology" sub-group, 25.6% (22/86) had neovascular age-related macular degeneration, 22.1% (19/86) had non-proliferative diabetic retinopathy, 11.6% (10/86) had "other" retinal conditions (e.g., choroidal rupture), 10.5% (9/86) had proliferative diabetic retinopathy, 10.5% had branch retinal vein occlusion, 9.3% (8/86) had polypoidal choroidal vasculopathy, 8.1% had myopic CNV, 5.8% (5/86) had central retinal vein occlusion, 4.7% (4/86) had macular telangiectasia, 2.3% (2/86) had sickle cell retinopathy, 2.3% had central serous chorioretinopathy with CNV, and 2.3% had traumatic CNV. The distribution of vascular abnormalities is shown in the following table:

TABLE 4: ABNORMALITY OF STUDY EYES PER PRINCIPAL INVESTIGATOR (ANALYSIS POPULATION)

Retinal Abnormality1	NormalN = 38	PathologyN = 86	TotalN = 124
	n (%)	n (%)	n (%)
Abnormalities
None	38 (100%)	0 (0.0%)	38 (30.6%)
Retinal Ischemia (capillary dropout) (RI/CD)	0 (0.0%)	11 (12.8%)	11 (8.9%)
Microaneurysm (MA)	0 (0.0%)	29 (33.7%)	29 (23.4%)
Macroaneurysms	0 (0.0%)	0 (0.0%)	0 (0.0%)
Choroidal neovascularization (CNV)	0 (0.0%)	28 (32.6%)	28 (22.6%)
Retinal neovascularization (RNV)	0 (0.0%)	11 (12.8%)	11 (8.9%)
Macular Telangiectasia (MacTel)	0 (0.0%)	4 (4.7%)	4 (3.2%)
Sickle Cell Retinopathy	0 (0.0%)	2 (2.3%)	2 (1.6%)
Polypoidal choroidal vasculopathy (PCV)	0 (0.0%)	7 (8.1%)	7 (5.6%)
Intraretinal microvascular abnormalities (IRMA)	0 (0.0%)	4 (4.7%)	4 (3.2%)
Retinal Tortuosity	0 (0.0%)	9 (10.5%)	9 (7.3%)
Geographic Atrophy	0 (0.0%)	4 (4.7%)	4 (3.2%)
Branch Retinal Vein Occlusion (BRVO)	0 (0.0%)	7 (8.1%)	7 (5.6%)
Central Retinal Vein Occlusion (CRVO)	0 (0.0%)	5 (5.8%)	5 (4.0%)
Central Retinal Arterial Occlusion (CRAO)	0 (0.0%)	0 (0.0%)	0 (0.0%)
Other	0 (0.0%)	19 (22.1%)	19 (15.3%)
None	38 (100%)	--	38 (30.6%)
Retinal Ischemia (capillary dropout) (RI/CD)	--	6 (7.0%)	6 (4.8%)
Microaneurysm (MA)	--	15 (17.4%)	15 (12.1%)
Macroaneurysms	--	1 (1.2%)	1 (0.8%)
Choroidal neovascularization (CNV)	--	21 (24.4%)	21 (16.9%)
Retinal neovascularization (RNV)	--	6 (7.0%)	6 (4.8%)
Macular Telangiectasia (MacTel)	--	4 (4.7%)	4 (3.2%)
Sickle Cell Retinopathy	--	2 (2.3%)	2 (1.6%)
Polypoidal choroidal vasculopathy (PCV)	--	8 (9.3%)	8 (6.5%)
Intraretinal microvascular abnormalities (IRMA)	--	2 (2.3%)	2 (1.6%)
Retinal Tortuosity	--	5 (5.8%)	5 (4.0%)
Geographic Atrophy	--	1 (1.2%)	1 (0.8%)
Branch Retinal Vein Occlusion (BRVO)	--	4 (4.7%)	4 (3.2%)
Central Retinal Vein Occlusion (CRVO)	--	4 (4.7%)	4 (3.2%)

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Other	--	7 (8.1%)	7 (5.6%)
-------	----	----------	----------

An eye could have multiple retinal conditions.

The following results were obtained for the above endpoints:

1. Results for the image quality response rate for the entire cohort were as follows: for the 3x3-mm macular scan, 6x6-mm macular scan, and 4.5x4.5-mm disc scan were 75.0%, 71.0% and 71.0%, respectively. The overall response rates for the "pathology" group between the two devices for the 3x3-mm macular scan, 6x6-mm macular scan, and 4.5x4.5-mm disc scan were 75.6%, 77.9% and 74.4%, respectively.
1. Results for visibility of key anatomical features for the entire cohort were as follows: for the 3x3-mm macular scan, the response rates for FAZ visibility, medium vessels, and small vessels/capillaries were 87.1%, 87.9%, and 82.3%, respectively. For the 6x 6mm macular scan, the response rates for FAZ visibility, large vessels, medium vessels, and small vessels/capillaries were 81.5%, 87.1%, 77.4%, and 79.8%, respectively. For the 4.5x4.5-mm disc scan, the response rates for visibility of large vessels, medium vessels, and small vessels/capillaries were 83.9%, 80.6%, and 80.6%, respectively.
1. Results for key pathological vascular features for the "pathology" group were as follows:
- The Maestro2 PPA and NPA for microaneurysms (MAs) were 96.6% and 92.7% for a. 3×3-mm macular scans, respectively; 96.6% and 92.7% for 6×6-mm macular scans, respectively; 73.9% and 100% for 4.5×4.5-mm disc scans, respectively. The response rates for identification of MAs were 81.0% and 82.1% for the 3×3-mm and 6×6-mm macular scans, respectively. The MA response rate was 75.6% for the 4.5×4.5-mm disc scan.
- b. The Maestro2 PPA and NPA for RI/CD were 93.1% and 85.4% for 3×3-mm scans, respectively; 100% and 87.8% for 6×6-mm scans, respectively; 75.0% and 85.7% for 4.5×4.5-mm disc scans, respectively. The response rates were 76.2%, 79.8%, and 71.8% for the 3×3-mm macular, 6×6-mm macular, and 4.5×4.5-mm disc scans, respectively.
- The Maestro2 PPA and NPA for CNV were 88.9% and 82.7% for 3×3-mm macular c. scans, respectively; 84.2% and 84.3% for 6×6-mm macular scans, respectively; and 66.7% and 98.4% for 4.5×4.5-mm disc scans, respectively. The response rates were 79.8% and 81.0% for the 3×3-mm and 6×6-mm macular scans and 75.3% for the disc scan.

IX. Conclusions

The Maestro2 and the IMAGEnet6 have the same intended uses as the legally marketed

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predicate devices identified in this 510(k) notification. The Indications for Use (IFU) statements differ from those of the predicate devices, but these differences do not change the intended use of the devices. The technological characteristics of the Maestro2 and IMAGEnet6 differ from those of the predicate devices, however, the differences do not raise new or different questions of safety or effectiveness. Results of the non-clinical performance testing demonstrate that Maestro2 and IMAGEnet6 function as intended. Results of the clinical performance testing demonstrate a favorable clinical performance profile that supports a determination of substantial equivalence.

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.