The imageSPECTRUM V6 is an ophthalmic software system indicated for acquiring, storing, managing, and display patient, diagnostic and image data from Canon digital retinal cameras. It is also indicated for review of patient, diagnostic and image data and measurement by trained healthcare professional.

Device Description

The imageSPECTRUM V6 is an ophthalmic imaging software for acquiring, storing, managing, processing and displaying patient, diagnostic and image data from Canon digital retinal cameras. The imageSPECTRUM V6 consists of three software; iS Capture. iS Review, and iS Server. The "iS Capture" has functions to communicate with Canon's retinal camera to take retinal images. The "iS Review" has functions for displaying, processing, and transferring retinal images. The "iS Server" has functions for storing and archiving retinal images.

The imageSPECTRUM V6 is an ophthalmic software system indicated for acquiring, storing, managing, processing, and display patient, diagnostic and image data from Canon digital retinal cameras. It is also indicated for review of patient, diagnostic and image data and measurement by trained healthcare professional.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for the ImageSPECTRUM V6 ophthalmic software system. It determines the device is substantially equivalent to a previously cleared predicate device.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

Important Note: The document focuses on demonstrating substantial equivalence to a predicate device, not on proving de novo clinical effectiveness or establishing performance thresholds against specific diagnostic accuracy metrics typically associated with AI/ML devices. Therefore, a table of "acceptance criteria" in the traditional sense of diagnostic performance (e.g., sensitivity, specificity) and reported performance metrics is not present in this type of 510(k) submission for a Picture Archiving and Communication System (PACS) software. The acceptance criteria here would primarily relate to functional requirements, safety, and equivalence to predecessor devices.

Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a PACS software system, the "acceptance criteria" are more about functional equivalence and safety rather than diagnostic accuracy. The document states:

"Canon concluded that the Canon imageSPECTRUM V6 is substantially equivalent to the predicate devices based on identical intended use and substantially equivalent technological characteristics and the similarities in functional design."

The "reported device performance" is implicitly that the device performs its intended functions (acquiring, storing, managing, processing, and displaying ophthalmic image data) safely and effectively, similar to the predicate device. The performance data section vaguely mentions "Software verification and validation was performed to ensure that the software device performed as intended."

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document's purpose):

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (Summary from Document)
Functional Equivalence	- Acquiring, storing, managing, processing, and displaying patient, diagnostic, and image data from Canon digital retinal cameras. - Review of patient, diagnostic, and image data and measurement by trained healthcare professionals. Specific Functional Similarities (from Table 1): - User Management: Supported - Patient Management (Backup/Restoration): Supported - Compatible Devices: Canon's retinal cameras (CR-2 Plus AF) - Image Types: Color, FA, FAF - Capture Function (Communication, Sequence, Auto Exposure, Auto Focus, Auto Shot Control): Supported - View Image (Single, Comparison, Both Eyes): Supported - Drawing Function: Supported - Image Processing (Brightness, Contrast, Zoom, RGB Filters, Redfree, Emboss, Mosaic, Overlay): Supported (Emboss, Mosaic, Overlay are new/different but deemed to raise no safety/efficacy questions) - Annotation (Drawing Function, Add text): Supported (New annotation tools like Macular Grid, PDT Marker, PDT Counter, AVR, Protractor added, deemed to raise no safety/efficacy questions) - Standalone Configuration: Supported - Server Client Configuration: Supported - DICOM Communication (Worklist, Storage, Commitment): Supported - STEREO Viewing: Supported - Printing Image: Supported - Viewing Reports by Multiple Users: Supported
Safety and Efficacy Equivalence	- The device is deemed safe and effective for its stated indications for use, equivalent to the predicate device. - No new safety or efficacy questions are raised by the differences in added annotation or image processing tools. - Software verification and validation was performed to ensure that the software device performed as intended.
Hardware/Software Compatibility	- Software requirements: Microsoft Windows 10 Pro (64-bit) - Hardware requirements: CPU: Core-i7 2GHz or Greater, RAM: 4GB or more, Display Screen resolution: 1920x1080 (These are higher than predicate but indicate functional capability and not a performance claim for the software itself)

Beyond this, the document provides limited details on the "study" as it would be understood for an AI/ML diagnostic device with performance metrics. This 510(k) is for a PACS system, which is typically a Class II device where the focus is on functional equivalence and risk management, rather than complex performance studies of an AI algorithm making diagnostic interpretations.

Here are the details from the document regarding the "study" closest to what was requested:

Sample size used for the test set and the data provenance:
- The document mentions "Software verification and validation was performed to ensure that the software device performed as intended." However, it does not specify any sample size for a test set of medical images or patient data.
- Data Provenance: Not specified. It's likely that internal corporate data (from Canon, Japan) was used for software validation, but no specifics are provided regarding country of origin or whether it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. This type of information is generally required for AI/ML diagnostic devices where expert consensus is needed to establish ground truth for a labeled dataset. For a PACS system, the "ground truth" is that the software correctly acquires, stores, manages, and displays the image data as designed, and that its tools function accurately (e.g., measurement tools calculate correctly). The document implies internal software testing and validation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not specified. Adjudication methods are typically used in clinical studies involving human readers and ground truth establishment for diagnostic tasks, which is not the primary focus of this PACS software.
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:
- No, an MRMC study was NOT done. This device is a PACS system, not an AI-based diagnostic tool designed to assist human readers. Its function is to manage and display images.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not explicitly stated for diagnostic performance. The "algorithm" here is the PACS software itself. Its performance is its ability to handle and display images, and its various tools. There isn't a complex diagnostic "algorithm" that would perform in a standalone mode. The functions listed (image processing, annotation, etc.) are features of the software for use by a "trained healthcare professional."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated in terms of medical ground truth. As a PACS system, the "ground truth" for its validation would be the verification that the software correctly implements its specified functions (e.g., images are stored correctly, retrieved accurately, measurements are mathematically precise, display quality is as expected). This would typically involve internal software testing against functional specifications.
The sample size for the training set:
- N/A. This device is a PACS software, not an AI/ML model that is 'trained' on a dataset in the conventional sense. The "training" for this software would be its development and programming based on established software engineering principles.
How the ground truth for the training set was established:
- N/A. See point 7.

Summary

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September 25, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' in blue, with 'ADMINISTRATION' written below in a smaller font.

Ryan Bouchard, Official Correspondent o/b/o Canon Inc. 9-1, Imaikami-cho Nakahara-ku, Kawasaki, Kanagawa 211-8501 Japan

Re: K201273

Trade/Device Name: ImageSPECTRUM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: NFJ Dated: July 31, 2020 Received: August 5, 2020

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.

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 803) for

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

Enclosure

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Indications for Use

510(k) Number (if known) K201273

Device Name imageSPECTRUM V6

Indications for Use (Describe)

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

Submitter Canon Inc. 9-1, Imaikami-cho, Nakahara-ku, Kawasaki Kanagawa 211-8501 Japan

Contact person Mr. Akira Hirai Canon Inc. Medical Components Group TEL: 81-3-3758-2111 FAX: 81-44-739-6695 Email: hirai.akira@mail.canon

Date prepared July 29, 2020

Submission type Traditional 510(k)

Name of Device Trade Name: imageSPECTRUM V6 Common Name: Picture archiving and communications systems. Classification Name: System, Image Management, Ophthalmic Classification Regulation: 892.2050 Product Code: NFJ

Predicate Device Ophthalmic Software Platform RX (K173689)

Reference Device CR-2 Plus AF (K123208)

Device Description

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Statement of Substantial Equivalence

Canon Inc.'s imageSPECTRUM V6 is substantially equivalent to Canon Inc.'s Ophthalmic Software Platform RX cleared in K173689 and the reference device, Canon Inc.'s CR-2 PLUSAF cleared in K123208. imageSPECTRUM V6 has the same intended use and similar indications for use, similar principles of operation, and similar technological characteristics as the previously cleared predicate device. See Table 1 for a substantial equivalence chart comparing the similarities and differences between imageSPECTRUM V6 and the predicate and reference. Thus, imageSPECTRUM V6 is substantially equivalent to its predicates.

		Proposed Device	Predicate Device	Reference Device
Model		imageSPECTRUM V6(iS Review V6.0,iS Capture V6.0,iS Server V6.0)	Ophthalmic SoftwarePlatform RX(RX Capture for RetinalCamera, RX Server, RXViewer)	CR-2 PLUSAF(Retinal imaging controlsoftware)
510(k) Submitter[Number]		Canon Inc.[K201273]	Canon Inc.[K173689]	Canon Inc.[K123208]
Product Code andClassification		NFJ21CFR 892.2050	NFJ21CFR 892.2050	HKI21CFR 886.1120
Indications for Use		imageSPECTRUM V6 is anophthalmic software systemindicated for acquiring,storing, managing,processing, and display ofpatient, diagnostic andimage data from Canondigital retinal cameras. It isalso indicated for review ofpatient, diagnostic andimage data andmeasurement by trainedhealthcare professional.	The OphthalmicSoftware Platform RXis an ophthalmicsoftware systemindicated for acquiring,storing, managing,processing, and displayof patient, diagnosticand image data fromCanon digital retinalcameras. It is alsoindicated for review ofpatient, diagnostic andimage data andmeasurement by trainedhealthcare professional.	The Digital Retinal CameraCR-2 Plus AF is intendedto be used for taking digitalimages of the retina of thehuman eye without amydriatic. The CR-2 PlusAF has the followingphotography modes: color,red free, cobalt digital andfundus autofluorescence(FAF).
User Management		Supported	Supported	Supported
Patient Management		SupportedBackup (Archive)Restoration	SupportedBackupRestoration	SupportedBackupRestoration
Devices that are compatible		Canon's retinal cameras(CR-2 Plus AF)	Canon's retinal cameras(CR-2 AF, CR-2 PlusAF, CX-1)	Canon's retinal cameras(CR-2 Plus AF)
Type of Retinal Cameraimage		Color, FA, FAF	Color, FA, FAF	Color, FA, FAF
CaptureFunction	Communicationwith retinalcamera'sfirmware	Supported	-	Supported
	CaptureSequence	Supported	-	Supported
		Proposed Device	Predicate Device	Reference Device
	Auto ExposureControl	Supported	-	Supported
	Auto FocusControl	Supported	-	Supported
	Auto ShotControl	Supported	-	Supported
View Image		Single View	Single View	Single View
		Comparison	Both Eyes	Both Eyes
		Comparison	Comparison	Comparison
Drawing Function		Supported	Supported	Supported
Image Processing		Brightness	Brightness	Brightness
		Contrast	Contrast	Contrast
		Zoom	Zoom	Zoom
		RGB Filters	RGB Filters	RGB Filters
		Redfree	Redfree	Redfree
		Emboss	Emboss	-
		Mosaic(optional)	Mosaic(optional)	Mosaic(optional)
		Overlay	Overlay	-
Annotation		Drawing Function	Drawing Function	-
		Add text on the image	Add text on the image	-
		Cup to Disc	Cup to Disc	Cup to Disc
		Macular Grid	-	-
		PDT Marker	-	-
		PDT Counter	-	-
		AVR	-	-
		Protractor	-	-
Standalone Configuration		Supported	Supported	Unsupported
Server Client Configuration		Supported	Supported	Unsupported
DICOM Communication		Modality Worklist	Modality Worklist	Modality Worklist
		DICOM Storage	DICOM Storage	DICOM Storage
		Commitment	Commitment	Commitment
		-	MPPS	MPPS
STEREO Viewing		Supported	Supported	Supported
Printing Image		Supported	Supported	Supported
Software requirements		Microsoft Windows 10Pro(64-bit)	Microsoft Windows 10Pro(64-bit)	Microsoft Windows 7Professional SP1(32-bit/64-bit)
Hardware requirements		CPU: Core-i7 2GHz orGreater,RAM: 4GB or more,Display Screen resolution:1920x1080	CPU: Core i3 2.4GHzor Greater,RAM: 4G or More,Display: 1920x1080pixels	CPU: Core 2 Duo 2.4 GHzor higher,RAM: 2GB or moreDisplay: Screenresolution(1280x800pixel)or higher,Hard disk: 7,200 rpm orhigher
Viewing Reports by MultipleUsers		Supported	Supported	Unsupported

Table 1 imageSPECTRUM V6 Substantial Equivalence Table

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Summary of Differences

The differences between the proposed device and the predicate and reference devices are summarized below along with the possible effects these differences may have on safety and efficacy. For all items where either the predicate device or the reference device has a matching

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function, no safety or efficacy questions are raised. The items which are unique to the proposed device are listed below:

Annotation: The Annotation tools can be used to label (i.e., with text), measure or bring attention to a specific area in an image. Annotation tools are present in the predicate and reference device however additional annotation tools have been added to the proposed device.

The annotation tools that have been added to the proposed device are Macular Grid, PDT Marker, PDT Counter, AVR, and Protractor.

Macular Grid: Overlays a grid over the macula. ●
PDT Marker: This tool allows the user to circumscribe a PDT lesion, recording inner and ● outer diameters, as well as square area.
PDT Counter: This tool is used to size and count various lesions.
A VR: Provides a tool to measure artery and vein diameters. Reports multiple artery to vein ratios.
Protractor: Creates a protractor graphic on the image for easy measurement purposes. ●

The tools provided are to aid in viewing and measuring features within the image. There are no safety or efficacy questions raised by any of these tools. Instructions for the use of the tools are provided in the User Manual.

Performance Data

Software verification and validation was performed to ensure that the software device performed as intended.

Conclusion

Canon concluded that the Canon imageSPECTRUM V6 is substantially equivalent to the predicate devices based on identical intended use and substantially equivalent technological characteristics and the similarities in functional design.

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).