FullFocus is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis. FullFocus is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.

It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. FullFocus is intended to be used with the interoperable components specified in the below Table.

Table: Interoperable components of FullFocus

Scanner Hardware	Scanner Output file format	Interoperable Displays
Leica Aperio GT 450 DX scanner	DICOM, SVS	Dell UP3017Dell U3023E
Hamamatsu NanoZoomer S360MD Slide Scanner	NDPI	Dell U3223QEJVC-Kenwood JD-C240BN01A

Device Description

FullFocus, version 2.29, is a web-based software-only device that facilitates the viewing and navigating of digitized pathology images of slides prepared from FFPE-tissue specimens acquired from FDA cleared digital pathology scanners on FDA cleared displays. FullFocus renders these digitized pathology images for review, management and navigation for pathology primary diagnosis.

Image acquisition is performed using the intended scanner (s), with the operator conducting quality control on the digital WSI images according to the scanner's instructions for use and lab specifications to determine if re-scans are needed. Please see the Intended Use section and below tables for specifics on scanners and respective displays for clinical use.

Once a whole slide image is acquired using the intended scanner and becomes available in the scanner's database file system, a separate medical image communications software (not part of the device), automatically uploads the image and corresponding metadata to persistent cloud storage. Integrity checks are performed during the upload to ensure data accuracy.

The subject device enables the reading pathologist to open a patient case, view the images, and perform actions such as zooming, panning, measuring distances and annotating images as needed. After reviewing all images for a case, the pathologist will render a diagnosis.

FullFocus operates with and is validated for use with the FDA cleared components specified in the tables below:

Scanner Hardware	Scanner Output file format	Interoperable Displays
Leica Aperio GT 450 DX scanner	DICOM, SVS	Dell UP3017Dell U3023E
Hamamatsu NanoZoomer S360MD Slide Scanner	NDPI	Dell U3223QEJVC-Kenwood JD-C240BN01A

Table 1: Interoperable Components Intended for Use with FullFocus

FullFocus version 2.29 was not validated for the use with images generated with Philips Ultra Fast Scanner.

Table 2: Computer Environment/System Requirements for during the use of FullFocus

Environment	Component	Minimum Requirements
Hardware	Processor	1 CPU, 2 cores, 1.6GHz
	Memory	4 GB RAM
	Network	Bandwidth of 10Mbps
Software	Operating System	• Windows• macOS
	Browser	• Google Chrome (129.0.6668.90 or higher)• Microsoft Edge (129.0.2792.79 or higher)

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Pixel-wise comparison: The 95th percentile of pixel-wise color differences in any image pair across all required screenshots must be less than 3.0 ΔE00 when compared to comparator (predicate device's Image Review Manipulation Software - IRMS) for identical image reproduction. This indicates visual adequacy for human readers.	The 95th percentile of pixel-wise differences between FullFocus and the comparators were less than 3 CIEDE2000, indicating that their output images can be considered to be pixel-wise identical. FullFocus has been found to visually adequately reproduce digital pathology images to human readers with respect to its intended use.
Turnaround time (Case selection): It should not take longer than 10 seconds until the image is fully loaded when selecting a case.	System requirements fulfilled: Not longer than 10 seconds until the image is fully loaded.
Turnaround time (Panning/Zooming): It shall not take longer than 7 seconds until the image is fully loaded when panning and zooming the image.	System requirements fulfilled: Not longer than 7 seconds until the image is fully loaded.
Measurement Accuracy (Straight Line): The 1mm measured line should match the reference value exactly 1mm ± 0mm.	All straight-line measurements compared to the reference were exactly 1mm, with no error.
Measurement Accuracy (Area): The measured area must match the reference area exactly 0.2 x 0.2 mm for a total of 0.04 mm² ± 0 mm².	All area measurements compared to the reference value were exactly 0.04mm², with no error.
Measurement Accuracy (Scalebar): 2mm scalebar is accurate.	All Tests Passed.
Human Factors Testing: (Implied from previous clearance) Safe and effective use by representative users for critical user tasks and use scenarios.	Human factors study designed around critical user tasks and use scenarios performed by representative users were conducted for previously cleared FullFocus, version 1.2.1, in K201005, per FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices (2016)". Human factors validation testing is not necessary as the user interface hasn't changed.

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

Sample Size for Pixel-wise Comparison: 30 formalin-fixed paraffin-embedded (FFPE) tissue glass slides, representing a range of human anatomical sites.
Sample Size for Turnaround Time & Measurements: Not explicitly stated as a number of distinct cases or images beyond the 30 slides used for pixel-wise comparison. For measurements, a "1 Calibration Slide" was used per test.
Data Provenance: The text does not explicitly state the country of origin. The slides are described as "representing a range of human anatomical sites," implying a diverse set of real-world pathology samples. It is a retrospective study as it states "30 formalin-fixed paraffin-embedded (FFPE) tissue glass slides... were scanned".

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

Pixel-wise Comparison: "For each WSI, three regions of interest (ROIs) were identified to highlight relevant pathological features, as verified by a pathologist."
- Number of Experts: At least one pathologist.
- Qualifications: "A pathologist" (specific qualifications like years of experience are not provided).
Measurements: No expert was explicitly mentioned for establishing ground truth for measurements; it relies on a "test image containing objects with known sizes" (calibration slide) and "reference value."

4. Adjudication Method for the Test Set

The text does not mention an explicit adjudication method (like 2+1 or 3+1 consensus) for the pixel-wise comparison or measurement accuracy. For the pixel-wise comparison, ROIs were "verified by a pathologist," suggesting a single-expert verification rather than a consensus process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done in this context. The study focused on demonstrating identical image reproduction (pixel-wise comparison) and technical performance (turnaround time, measurement accuracy) of the FullFocus viewer against predicate devices' viewing components. It did not directly assess the improvement in human reader performance (e.g., diagnostic accuracy or efficiency) with or without AI assistance. The device is a "viewer and management software," not an AI diagnostic aid in the sense of providing specific findings or interpretations.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone "algorithm only" performance was effectively done for the technical aspects. The pixel-wise comparison directly compares the image rendering of FullFocus with the predicate viewer's rendering without human intervention in the comparison process itself (though a pathologist verified ROIs). Similarly, turnaround times and measurement accuracy are intrinsic technical performances of the software.

7. The Type of Ground Truth Used

Pixel-wise Comparison: The ground truth for this test was the digital image data as rendered by the predicate device's IRMS. The goal was to show that FullFocus reproduces the same image data. The "relevant pathological features" within ROIs were "verified by a pathologist" which served as a reference for what areas to test, not necessarily a diagnostic ground truth for the device's output.
Measurements: The ground truth was based on known physical dimensions within a calibration slide and corresponding "reference values."

8. The Sample Size for the Training Set

The provided text does not mention a training set. This is expected because FullFocus is a viewer and management software for digital pathology images, not an AI or machine learning algorithm that is "trained" on data to make predictions or assist in diagnosis directly. Its core function is to display existing image data accurately and efficiently.

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

As no training set is mentioned (since it's a viewer software), this question is not applicable based on the provided text.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 9, 2025

Paige.AI, Inc Mufaddal Jafferji Director of Quality and Compliance 11 Times Sq, Floor 37 New York, NY 10036

Re: K241273

Trade/Device Name: FullFocus Regulation Number: 21 CFR 864.3700 Regulation Name: Whole Slide Imaging System Regulatory Class: Class II Product Code: QKQ Dated: May 6, 2024 Received: May 6, 2024

Dear Mufaddal Jafferji:

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 and Part 809); 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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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

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

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Sincerely,

Shyam Kalavar -S

Shyam Kalavar Deputy Branch Chief Division of Molecular Genetics and Pathology OHT7: Office of In Vitro Diagnostics 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) K241273

Device Name FullFocus

Indications for Use (Describe) For In Vitro Diagnostic Use

Table: Interoperable components of FullFocus

Scanner Hardware	Scanner Output file format	Interoperable Displays
Leica Aperio GT 450 DX scanner	DICOM, SVS	Dell UP3017Dell U3023E
Hamamatsu NanoZoomer S360MD Slide Scanner	NDPI	Dell U3223QEJVC-Kenwood JD-C240BN01A

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

☑ Prescription Use (Part 21 CER 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

FullFocus

Date Prepared: January 8, 2025

Submitter

Paige.AI, Inc. 11 Times Square, 37th Floor New York, NY 10036

Contact Person

Mufaddal Jafferji Director of Quality and Compliance 11 Times Square, 37th Floor New York, NY 10036 mufaddal.jafferji@paige.ai Phone: (774) 262-3461

Device

Proprietary Name of the Device:	FullFocus
Version:	2.29
Classification Name:	Whole Slide Imaging System
Regulation Number:	21 CFR 864.3700
Product Codes:	QKQ
Device Class:	Class II
Review Panel:	88 – Pathology
Common Name:	FullFocus
510(k) Number:	K241273

Predicate Devices

Trade name:

1. Aperio GT450X (K232202) Manufacturer: Leica Biosystems Imaging, Inc.
1. NanoZoomer S360MD Slide scanner system (K213883) Manufacturer: Hamamatsu Photonics K.K.

Device Class: Class II CFR section: 864.3700 Product code: PSY Classification name: Whole Slide Imaging System

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Device Description

FullFocus operates with and is validated for use with the FDA cleared components specified in the tables below:

Scanner Hardware	Scanner Output file format	Interoperable Displays
Leica Aperio GT 450 DX scanner	DICOM, SVS	Dell UP3017Dell U3023E
Hamamatsu NanoZoomer S360MD Slide Scanner	NDPI	Dell U3223QEJVC-Kenwood JD-C240BN01A

Table 1: Interoperable Components Intended for Use with FullFocus

FullFocus version 2.29 was not validated for the use with images generated with Philips Ultra Fast Scanner.

Table 2: Computer Environment/System Requirements for during the use of FullFocus

Environment	Component	Minimum Requirements
Hardware	Processor	1 CPU, 2 cores, 1.6GHz
	Memory	4 GB RAM
	Network	Bandwidth of 10Mbps
Software	Operating System	• Windows• macOS
	Browser	• Google Chrome (129.0.6668.90 or higher)• Microsoft Edge (129.0.2792.79 or higher)

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Intended Use/Indications for Use

Scanner Hardware	Scanner Output file format	Interoperable Displays
Leica Aperio GT 450 DXscanner	DICOM, SVS	Dell UP3017Dell U3023E
Hamamatsu NanoZoomerS360MD Slide Scanner	NDPI	Dell U3223QEJVC-Kenwood JD-C240BN01A

Table: Interoperable components of FullFocus

Summary of Technological Characteristics

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Comparison with Predicate (Aperio GT 450X):

Item	Subject Device (FullFocus)			Predicate Device (K232202)
Device TradeName	FullFocus			Aperio GT 450 DX
Intended Use/Indicationsfor Use	FullFocus is a software intended for viewing andmanagement of digital images of scanned surgicalpathology slides prepared from formalin-fixedparaffin embedded (FFPE) tissue. It is an aid to thepathologist to review, interpret and manage digitalimages of pathology slides for primary diagnosis.FullFocus is not intended for use with frozensections, cytology, or non-FFPE hematopathologyspecimens.It is the responsibility of a qualified pathologist toemploy appropriate procedures and safeguards toassure the quality of the images obtained and,where necessary, use conventional lightmicroscopy review when making a diagnosticdecision. FullFocus is intended to be used with theinteroperable components specified in the belowTable.			The Aperio GT 450 DX is an automated digital slide creation andviewing system. The Aperio GT 450 DX is intended for in vitrodiagnostic use as an aid to the pathologist to review and interpretdigital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The Aperio GT 450 DX isfor creation and viewing of digital images of scanned glass slidesthat would otherwise be appropriate for manual visualization byconventional light microscopy.Aperio GT 450 DX is comprised of the Aperio GT450 DX scanner,which generates images in the Digital Imaging and Communicationsin Medicine (DICOM) and in the ScanScope Virtual Slide (SVS) fileformats, the Aperio WebViewer DX viewer, and the displays. TheAperio GT 450 DX is intended to be used with the interoperablecomponents specified in Table 1.
	Table: Interoperable components of FullFocus			Table 1: Interoperable components of Aperio GT 450 DX
	ScannerHardware	ScannerOutputfileformat	InteroperableDisplays	ScannerHardware	ScannerOutputfileformat	InteroperableViewingSoftware	InteroperableDisplays
	Leica AperioGT 450 DXscanner	DICOM,SVS	Dell UP3017Dell U3023EDell U3223QE	Aperio GT450 DXscanner	SVS	AperioWebViewerDX	Barco MDPC-8127Dell UP3017Dell U3023EDell U3223QE
	HamamatsuNanoZoomerS360MD SlideScanner	NDPI	JVC-KenwoodJD-C240BN01A	Aperio GT450 DXscanner	SVS	Sectra DigitalPathologyModule (3.3)	Dell U3223QE
				Aperio GT450 DXscanner	DICOM	Sectra DigitalPathologyModule (3.3)	Dell U3223QE
SpecimenType	Digitized surgical pathology slides preparedfrom FFPE tissue			Same
Image fileformat	SVS & DICOM - Aperio GT450 DXNDPI - Hamamatsu NanoZoomer S360MDSlide scanner			SVS & DICOM
ImageManipulationFunctions	Panning, zooming, annotations, andmeasurements			Same
Type ofSoftwareApplication	Internet browser-based application			Same
DeviceComponents	FullFocus			Scanner, Webviewer DX, Display
End User'sInterface	FullFocus			WebViewer DX, Sectra Digital Pathology Module (3.3)
Principle ofOperation	After WSI images are successfully acquired byusing Aperio GT 450 DX scanner or HamamatsuNanoZoomer S360MD Slide scanner, the WSI			The Aperio GT 450 DX is a WSI system. The technician places theslides into the Aperio GT 450 DX scanner. The Aperio GT 450 DXscanner automatically loads the slides, takes the micro images, finds

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	pathologist opens WSI images from storage,perform further QC and reads WSI images of theslides render a diagnosis.	performs quality control (QC) and notifies the user of any imagequality issue during the image acquisition. The image data is sent toend-user-provided image storage attached to the local network. Duringthe review, the pathologist opens WSI images acquired with the WSIscanner from the image storage, performs further QC, and reads WSIimages of the slides to make a diagnosis.
ImageStorage	Images are stored in the cloud	Images are stored in the end-user provided image storage attached tothe local network

Comparison with Predicate (Hamamatsu NanoZoomer S360MD slide scanner system)

Item	Subject Device (FullFocus)	Predicate Device (K213883)
Device TradeName	FullFocus	NanoZoomer S360MD Slide scanner system
Intended Use/Indicationsfor Use	FullFocus is a software intended for viewing and managementof digital images of scanned surgical pathology slidesprepared from formalin-fixed paraffin embedded (FFPE)tissue. It is an aid to the pathologist to review, interpret andmanage digital images of pathology slides for primarydiagnosis. FullFocus is not intended for use with frozensections, cytology, or non-FFPE hematopathology specimens.It is the responsibility of a qualified pathologist to employappropriate procedures and safeguards to assure the quality ofthe images obtained and, where necessary, use conventionallight microscopy review when making a diagnostic decision.FullFocus is intended to be used with the interoperablecomponents specified in the below Table.	The NanoZoomer S360MD Slide scanner system("NanoZoomer System") is an automated digital slidecreation, viewing, and management system. TheNanoZoomer System is intended for in vitro diagnosticuse as an aid to the pathologist to review and interpretdigital images of surgical pathology slides prepared fromformalin-fixed paraffin embedded ("FFPE") tissue. TheNanoZoomer System is not intended for use with frozensection, cytology, or non-FFPE hematopathologyspecimens. The NanoZoomer System comprises theNanoZoomer S360MD Slide scanner, the NZViewMDSoftware and the JVC Kenwood JDC240BN01A display.The NanoZoomer System is for creation and viewing ofdigital images of scanned glass slides that wouldotherwise be appropriate for manual visualization byconventional light microscopy. It is the responsibility of aqualified pathologist to employ appropriate proceduresand safeguards to assure the validity of the interpretationof images obtained using NanoZoomer System.
Table: Interoperable components of FullFocus
Scanner Hardware	Scanner Output fileformat	InteroperableDisplays
Leica Aperio GT 450DX scannerHamamatsuNanoZoomer S360MDSlide Scanner	DICOM,SVSNDPI	Dell UP3017Dell U3023EDell U3223QEJVC-KenwoodJD-C240BN01A
SpecimenType	Digitized surgical pathology slides prepared from FFPEtissue	Same
Image fileformat	SVS & DICOM - Aperio GT450 DXNDPI - Hamamatsu NanoZoomer S360MD Slide scanner	NDPI
ImageManipulationFunctions	Panning, zooming, annotations, and measurements	The NZViewMD software provides the user with acontinuous view across the XY plane of the WSI with theability to: View images with continuous panning andzooming, Annotate and bookmark images, Track visitedareas and a software only subsystem with functionality thatincludes the ability to: View images and patient data,Organize workload, Annotate, bookmark, and/or tagimages, Manually score images, Invite and join others for ashared session annotations, Export images to a networkserver, Discrete Z-axis displacement
Type ofSoftware	Internet browser-based application	PC-based installed application

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Application
DeviceComponents	FullFocus	Scanner, NZViewMD, Display
End User'sInterface	FullFocus	NZViewMD
Principle ofOperation	After WSI images are successfully acquired by using LeicaAperio GT 450 DX scanner or Hamamatsu NanoZoomerS360MD Slide scanner, the WSI images are stored in thecloud. During review, the pathologist opens WSI imagesfrom storage, perform further QC and reads WSI images ofthe slides render a diagnosis.	The NanoZoomer S360MD Slide scanner system("NanoZoomer System") is an automated digital slidecreation, viewing, and management system. TheNanoZoomer System is intended for in vitro diagnostic useas an aid to the pathologist to review and interpret digitalimages of surgical pathology slides prepared fromformalinfixed paraffin embedded ("FFPE") tissue. TheNanoZoomer System is not intended for use with frozensection, cytology, or non-FFPE hematopathologyspecimens. The system's embedded image processingsoftware is responsible for image acquisition and theprocessing of individual tiles prior to image composition orstitching. Hamamatsu's NZAcquireMD software organizesall WSI tiles into a single NDPi file, which is a proprietaryfile format. During the review, the pathologist opens theWSI on the NZViewMD software to render a diagnosis.
ImageStorage	Images are stored in the cloud	Images are stored in the end-user provided image storageattached to the local network

Summary of Performance Testing Data

Test	Result
Pixel-wisecomparison	Pixel-wise comparison study was conducted to compare images reproduced by FullFocus, version 2.29, and the comparators (the predicate device's image review manipulation software (IRMS, as defined in FDA guidance document, "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices" dated April 20, 2016") as described below for the same image file format generated from the same intended use scanner to validate identical image reproduction on the same intended displays.
	Scanner	ImageFileFormat	Subject Device(Viewer/Browser)	Comparator (Predicatedevice IRMS)	Displays
	Leica AperioGT450DXscanner	DICOM	FullFocus/Chrome	Sectra UniView/Chrome	Dell UP3017
			FullFocus/Edge	Sectra UniView/Edge	Dell U3023E
		SVS	FullFocus/Chrome	Aperio WebViewerDX/Chrome	Dell U3223QE
			FullFocus/Edge	Aperio WebViewerDX/Edge	JVC-KenwoodJD-C240BN01A
	HamamatsuNanoZoomerS360MDSlide scanner	NDPI	FullFocus/Chrome	NZViewMD
			FullFocus/Edge	NZViewMD
A total of 30 formalin-fixed paraffin-embedded (FFPE) tissue glass slides, representing a

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range of human anatomical sites, were scanned at 40x magnification using both slide scanner systems. The slides scanned with the Leica Aperio GT450 DX scanner were saved in both DICOM and SVS formats, while the slides scanned with the Hamamatsu NanoZoomer S360MD Slide Scanner were saved in NDPI format. For each WSI, three regions of interest (ROIs) were identified to highlight relevant pathological features, as verified by a pathologist. Screenshots of these ROIs were captured at two magnification levels (10x and 40x) across multiple displays and browsers as specified in the above table. The testing process ensured comprehensive evaluation across display variations, with all image pairs registered and cropped for analysis. Every pixel of each screenshot was sampled to calculate the pixel-wise color difference using the CIEDE2000 ( $\Delta$ E00) metric. The acceptance criterion for this testing required that the 95th percentile of the pixel-wise color differences in any image pair across all required screenshots be less than 3.0 $\Delta$ E00. Test results showed that the 95th percentile of pixelwise differences between FullFocus and the comparators were less than 3 CIEDE2000, indicating that their output images can be considered to be pixel-wise identical. Therefore, FullFocus has been found to visually adequately reproduce digital pathology images to human readers with respect to its intended use.
Turnaroundtime	The system requirements have been fulfilled:• When selecting a case, it should not take longer than 10 seconds until the image is fully loaded.• When panning and zooming the image it shall not take longer than 7 seconds until the image is fully loaded.
Measurements	Measurement accuracy has been verified using a test image containing objects with known sizes. FullFocus has been found to perform accurate measurements with respect to its intended use. See the overview of the test results below.
	Description	Sample size	Acceptance Criteria	Results
	Straight LineMeasurement inChrome and Edgebrowsers	1 Calibration Slide	The 1 mm measured lineshould match the referencevalue exactly 1 mm ± 0mm	All measurements comparedto the reference were exactly1 mm, with no error.
	Area Measurementin Chrome andEdge browsers	1 Calibration Slide	The measured area mustmatch the reference areaexactly 0.2 x 0.2 mm for atotal of 0.04 mm2 ± 0 mm2	All area measurementscompared to the referencevalue were exactly 0.04mm2,with no error.
	ScalebarMeasurement inChrome and Edgebrowsers	1 Calibration Slide	2mm scalebar is accurate	All Tests Passed
HumanFactorsTesting	Human factors study designed around critical user tasks and use scenarios performed by representative users were conducted for previously cleared FullFocus, version 1.2.1, in K201005, per FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices (2016)". Human factors validation testing is not necessary as the user

Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision of FullFocus to the predicate devices.

Regulation Number and Section

§ 864.3700 Whole slide imaging system.

(a)
Identification. The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides. The system generates digital images that would otherwise be appropriate for manual visualization by conventional light microscopy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the following information:
(i) The indications for use must specify the tissue specimen that is intended to be used with the whole slide imaging system and the components of the system.
(ii) A detailed description of the device and bench testing results at the component level, including for the following, as appropriate:
(A) Slide feeder;
(B) Light source;
(C) Imaging optics;
(D) Mechanical scanner movement;
(E) Digital imaging sensor;
(F) Image processing software;
(G) Image composition techniques;
(H) Image file formats;
(I) Image review manipulation software;
(J) Computer environment; and
(K) Display system.
(iii) Detailed bench testing and results at the system level, including for the following, as appropriate:
(A) Color reproducibility;
(B) Spatial resolution;
(C) Focusing test;
(D) Whole slide tissue coverage;
(E) Stitching error; and
(F) Turnaround time.
(iv) Detailed information demonstrating the performance characteristics of the device, including, as appropriate:
(A) Precision to evaluate intra-system and inter-system precision using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(B) Reproducibility data to evaluate inter-site variability using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(C) Data from a clinical study to demonstrate that viewing, reviewing, and diagnosing digital images of surgical pathology slides prepared from tissue slides using the whole slide imaging system is non-inferior to using an optical microscope. The study should evaluate the difference in major discordance rates between manual digital (MD) and manual optical (MO) modalities when compared to the reference (
e.g., main sign-out diagnosis).(D) A detailed human factor engineering process must be used to evaluate the whole slide imaging system user interface(s).
(2) Labeling compliant with 21 CFR 809.10(b) must include the following:
(i) The intended use statement must include the information described in paragraph (b)(1)(i) of this section, as applicable, and a statement that reads, “It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using this device.”
(ii) A description of the technical studies and the summary of results, including those that relate to paragraphs (b)(1)(ii) and (iii) of this section, as appropriate.
(iii) A description of the performance studies and the summary of results, including those that relate to paragraph (b)(1)(iv) of this section, as appropriate.
(iv) A limiting statement that specifies that pathologists should exercise professional judgment in each clinical situation and examine the glass slides by conventional microscopy if there is doubt about the ability to accurately render an interpretation using this device alone.