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.

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.

Device Description

IMAGEnet6 Ophthalmic Data System is a Web application that allows management of patient information, exam information and image information. It is installed on a server PC and operated via a web browser of a client PC.

When combined with 3D OCT-1 (type: Maestro2), IMAGEnet6 provides GUI for remote operation function. This function is an optional function which enables users to use some of the image capture function by operating the PC or tablet PC connected to the external PC of 3D OCT-1 (Type:Maestro2) device 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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for the IMAGEnet6 Ophthalmic Data System. This device is a Medical Image Management and Processing System, classified as Class II, with product code NFJ.

Based on the document, the IMAGEnet6 Ophthalmic Data System, subject device (version 2.52.1), is considered substantially equivalent to the predicate device (IMAGEnet6, version 1.52, K171370). The submission is primarily for a software update with changes including a modified remote operation function and expanded compatibility with additional Topcon devices.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria in a typical clinical study format (e.g., target sensitivity, specificity). Instead, the acceptance criterion for the software modification (remote operation function) appears to be that its performance (image quality and diagnosability) is equivalent to or the same as the device without the remote operation function.

Acceptance Criterion (Implicit)	Reported Device Performance
Image quality with remote operation function is the same as without.	Confirmed that image quality is the same with or without the remote operation function.
Diagnosability with remote operation function is the same as without.	Confirmed that diagnosability is the same with or without the remote operation function.

2. Sample size used for the test set and data provenance:

Sample Size for Test Set: Not explicitly stated. The document mentions "comparison testing" was performed for the modified remote operation function, but the size of the test set (number of images or cases) is not provided.
Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

This information is not provided in the document. As "clinical performance data was not required for this 510(k) submission," there is no mention of expert-established ground truth for a clinical test set. The assessment of "image quality and diagnosability" was likely an internal validation, possibly by qualified personnel, but the specifics are not disclosed.

4. Adjudication method for the test set:

This information is not provided. Given that clinical performance data was not required, a formal adjudication process akin to clinical trials is unlikely to have been detailed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is an image management and processing system, not an AI-powered diagnostic tool intended to assist human readers in interpretation.
Effect Size: Not applicable, as no such study was performed or required.

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

The document implies that "comparison testing" was conducted to confirm image quality and diagnosability with and without the remote operation function. This would be a form of standalone performance assessment of the system's ability to maintain image integrity and diagnostic utility, but it does not involve the standalone diagnostic performance of an algorithm without human input for disease detection.

7. The type of ground truth used:

The document states that "clinical performance data was not required." Therefore, there is no mention of a ground truth established by expert consensus, pathology, or outcomes data for diagnostic accuracy. The ground truth for the "comparison testing" of the remote operation function would likely be the inherent quality and diagnostic features of the images generated by the original (non-remote) system. The testing aimed to confirm that the remote function did not degrade this baseline.

8. The sample size for the training set:

IMAGEnet6 is described as 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 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."

This suggests the device itself is not a deep learning AI model that requires a "training set" in the conventional sense of machine learning for diagnostic tasks. Rather, it integrates existing algorithms and reference databases. Therefore, the concept of a "training set" for the IMAGEnet6 software as a whole is not applicable in the context of this 510(k) submission.

9. How the ground truth for the training set was established:

As the concept of a training set for a machine learning model is not applicable to the functionality described for IMAGEnet6 in this submission, the method for establishing ground truth for a training set is not relevant or discussed. The reference databases it utilizes would have had their own data collection and establishment methods, but those pertain to the underlying instruments, not the IMAGEnet6 system itself regarding this submission.

Summary

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March 01, 2024

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

Re: K232828

IMAGEnet6 Ophthalmic Data System Trade/Device Name: Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: NFJ Dated: January 26, 2024 Received: January 26, 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 QS 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 (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/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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-reporting-mdr-how-reportmedical-device-problems.

For comprehensive re11gulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Alexander Beylin -S 2024.03.01 14:35:46

Alexander Beylin -S -05'00'

for Elvin Ng

Assistant Director THT1A3: Retinal and Diagnostics Devices Team 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) K232828

Device Name IMAGEnet6 Ophthalmic Data System

Indications for Use (Describe)

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

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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Image /page/3/Picture/1 description: The image shows the logo for Topcon. The logo features a stylized, abstract symbol in blue, resembling two overlapping shapes that could be interpreted as stylized letter 'T's. Below the symbol, the word 'TOPCON' is printed in a bold, sans-serif font, also in black.

510(k) SUMMARY TOPCON CORPORATION Traditional 510(k) for: IMAGEnet6 Ophthalmic Data System

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:

March 1, 2024

DEVICE INFORMATION

SUBJECT DEVICE:

IMAGEnet6 Ophthalmic Data System
Name of Device:	IMAGEnet6 Ophthalmic Data System
Device Class:	Class II
Classification Name:	21 C.F.R. § 892.2050Medical image management and processing system
Product Code:	NFJ

PREDICATE DEVICE:

IMAGEnet6 Ophthalmic Data System:

Company	Topcon Corporation
Device	IMAGEnet6 Ophthalmic Data System
510(k) No.	K171370

Classification Name: 21 C.F.R. § 892.2050

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Image /page/4/Picture/1 description: The image shows the logo for TOPCON. The logo consists of a stylized blue symbol above the word "TOPCON" in a sans-serif font, also in blue. The symbol resembles two overlapping letter "N" shapes, creating a unique and recognizable mark for the company.

Medical image management and processing system

Product Code:	NFJ
Subsequent ProductCodes	HKI, OBO

Brief Device Description

IMAGEnet6 Ophthalmic Data System

Intended Use / Indications for Use

IMAGEnet6 Ophthalmic Data System

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

Performance Data

It has been verified that the subject device functions as intended by tests or evaluations based on the following FDA-recognized, voluntary consensus standards, and the in-house test specification. The results of the testing support substantial equivalence by demonstrating that the device performs as intended and complies with the same standards as the predicate device.

IMAGEnet6 Ophthalmic Data System

FDA-recognized, voluntary consensus standards

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Image /page/5/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 overlapping shapes that resemble the letter "N" or two curved brackets facing each other.

IEC 62304:2015	Medical device software - Software life cycle processes
NEMA PS 3.1 - 3.202022d	Digital Imaging and Communications in Medicine(DICOM) Set

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 modified remote operation function, 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).

Clinical Performance Data

This section is not applicable because clinical data was not required for this 510(k) submission.

Substantial Equivalence

The subject device is substantially equivalent to the predicate device because the intended use/indications for use, operation principle and technological characteristics of the subject device is substantially equivalent to those of the predicate device as shown in Table 1 below.

ModelNumber	Subject DeviceIMAGEnet6 (ver2.52.1)	Predicate deviceIMAGEnet6 (ver1.52)	SubstantialEquivalenceDiscussion
Trade Name	Ophthalmic Data SystemIMAGEnet6	Ophthalmic Data SystemIMAGEnet6	N/A
510(k)submitter	TOPCON Corporation	TOPCON Corporation	Same
510(k)Number	K232828	K171370	N/A
Product code	NFJ	NFJ	Same
Regulation No.	21 CFR 892.2050	21 CFR 892.2050	Same
Product class	II	II	Same
Intendedpurpose	The IMAGEnet6 Ophthalmic DataSystem is a software program that isintended for use in the collection,storage and management of digitalimages, patient data, diagnostic data	The IMAGEnet6 Ophthalmic DataSystem is a software program that isintended for use in the collection,storage and management of digitalimages, patient data, diagnostic data	DifferentDeleted thefollowing sentencedue to addition ofremote operation
ModelNumber	Subject DeviceIMAGEnet6 (ver2.52.1)	Predicate deviceIMAGEnet6 (ver1.52)	SubstantialEquivalenceDiscussion
	and clinical information from Topcondevices.	and clinical information fromTOPCON devices withoutcontrolling or altering the functionsor parameters of any medicaldevices or through computerizednetworks.	function:without controllingor altering thefunctions orparameters of anymedical devices orthrough
	It is intended for processing anddisplaying ophthalmic images andoptical coherence tomography data.	It is intended for processing anddisplaying ophthalmic images andoptical coherence tomography data.	computerizednetworks.
	The IMAGEnet6 Ophthalmic DataSystem uses the same algorithms andreference databases from the originaldata capture device as a quantitativetool for the comparison of posteriorocular measurements to a database ofknown normal subjects.	The IMAGEnet6 Ophthalmic DataSystem uses the same algorithmsand reference databases from theoriginal data capture device as aquantitative tool for the comparisonof posterior ocular measurements to adatabase of known normalsubjects.	This difference doesnot affect the SEdiscussion becausecomparison testingconfirmed thatimage quality anddiagnosability is thesame with or withoutthe remote operationfunction.
Connectabledevices	TRC-50DX, TRC-NW300, TRC-NW7SF MARK IIITRC-NW8, TRC NW8F,TRC NW8F plus, TRC NW400,NW500	TRC-50DX, TRC-NW300, TRC-NW7SF MARK IIITRC-NW8, TRC NW8F,TRC NW8F plus, TRC NW400,	DifferentThe followingdevice connectionshave been added:3D OCT-1(Type:Maestro2), DRI
	DC-3, DC-43D OCT-1000, 3D OCT-2000,3D OCT-13D OCT-1(Type: Maestro2), DRIOCT Triton,CA-800, KR-800PA, Aladdin,	DC-3, DC-43D OCT-1000, 3D OCT-2000,3D OCT-1	OCT Triton, CA-800, KR-800PA,Aladdin, NW500This difference doesnot affect the SEdiscussion becausethe intended purposeto collection, storage
			and management ofdigital images,patient data,diagnostic data andclinical informationfrom Topcon devicesdoes not changefrom the predicatedevice evenconnectable device
ModelNumber	Subject DeviceIMAGEnet6 (ver2.52.1)	Predicate deviceIMAGEnet6 (ver1.52)	SubstantialEquivalenceDiscussion
Database	YES	YES	Same
Patientmanagement	YES	YES	Same
Acquisition	YES	YES	Same
ArchiveandBackup	YES	YES	Same
DVD / CD-Rfor archiving	YES	YES	Same
Imageprocessing	YES	YES	Same
Import/ExportimagesDICOM	YES	YES	Same
Interacts withOTSPCinstalledsoftwareofMaestro2	YES	NO	DifferentIMAGEnet6nowinteracts with theOTS PC installedsoftwareofMaestro2.This difference doesnot affect the SEdiscussionbecausethe intended purposeto collection, storageand management ofdigitalimages,patientdata,diagnostic data andclinical informationfrom Topcon devicesdoesnotchangefrom the predicatedeviceevenconnectabledeviceis added.For the modifiedremoteoperationfunction,comparisontestingconfirmedthatimage quality anddiagnosability is thesame with or without

TABLE 1: SUBSTANTIAL EQUIVALENCE: IMAGENET6

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Image /page/6/Picture/1 description: The image shows the logo for Topcon. The logo consists of the word "TOPCON" in black, block letters, with a stylized blue symbol above it. The symbol appears to be two overlapping, rounded shapes, possibly representing the letter "N" or a stylized eye.

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Image /page/7/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 resembles two overlapping, curved shapes with a horizontal white line running through the middle.

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Image /page/8/Picture/0 description: The image contains the logo for Topcon. The logo consists of a stylized blue symbol above the word "TOPCON" in a bold, sans-serif font. The symbol appears to be two overlapping shapes with a horizontal line through the middle.

ModelNumber	Subject DeviceIMAGEnet6 (ver2.52.1)	Predicate deviceIMAGEnet6 (ver1.52)	SubstantialEquivalenceDiscussion
			function.

Conclusions

Topcon's IMAGEnet 6 Ophthalmic Data System (version 2.52.1) is as safe and effective as the previously cleared IMAGEnet 6 (version 1.52), K171370.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).