FullFocus™ is a software only device 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 of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. FullFocus is intended for use with Philips Ultra Fast Scanner and monitor displays validated with verified test methods to meet required performance characteristics.

Device Description

FullFocus is a web-based software-only device for viewing and manipulating digital pathology images of glass slides obtained from the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS) on the monitor displays that are validated with verified test methods to meet required performance characteristics. FullFocus reproduces the whole slide images and is an aid to the pathologist to review. interpret and manage digital images of pathology slides for primary diagnosis.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the FullFocus device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Pixel-wise comparison	Visually adequately reproduces digital pathology images to human readers with respect to its intended use (compared to PIPS, including zooming and panning).
Turnaround time (Case selection)	Not longer than 10 seconds until the image is fully loaded.
Turnaround time (Panning)	Not longer than 7 seconds until the image is fully loaded (for panning one quarter of the monitor).
Measurements Accuracy	Performs accurate measurements (verified using a test image containing objects with known sizes).
Human factors testing	Found to be safe and effective for the intended users, uses, and use environments; user interface is intuitive, safe, and effective for the range of intended users.

Further Study Information

Sample size used for the test set and data provenance:
- Clinical Study: No clinical study involving diagnosis by human readers for diagnostic accuracy comparison is mentioned in this document. The "studies" described are non-clinical technical performance assessments and human factors testing.
- Pixel-wise comparison: The document doesn't specify a sample size for slides or images, only that it "was conducted to compare color images reproduced by FullFocus and PIPS IMS." Data provenance is not mentioned, but it's implied the images were generated by a Philips Ultra Fast Scanner, given the device's compatibility and comparison to the PIPS IMS.
- Measurements: "a test image containing objects with known sizes" was used. Specific sample size is not indicated.
- Human Factors Testing: "Task-based usability tests" were performed. The number of participants (intended users) is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the pixel-wise comparison, the "ground truth" was essentially the visual fidelity to images produced by the predicate device (PIPS IMS). The "human readers" mentioned in the performance description are not described as experts establishing ground truth, but rather as observers confirming visual adequacy. No specific number or qualifications of these readers are given.
- For measurements, the ground truth was the "known sizes" of objects within a test image. This would not require expert pathologists to establish.
- For human factors testing, the "ground truth" relates to usability and safety, which is assessed directly by intended users during task performance, rather than established by an "expert" in the diagnostic sense.
Adjudication method for the test set:
- Not applicable as there was no study described that involved diagnostic interpretations requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- No. The document explicitly states that FullFocus is a "software only device intended for viewing and management of digital images... It is an aid to the pathologist to review, interpret, and manage digital images...". It is a viewer, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed or described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. FullFocus is a viewing and management system for pathologists, not a standalone diagnostic algorithm. Its function is to facilitate human review.
The type of ground truth used:
- For Pixel-wise comparison, the ground truth was the visual representation and fidelity of images from the predicate device (PIPS IMS).
- For Measurements, the ground truth was "known sizes" of objects in a test image.
- For Turnaround time and Human factors testing, the ground truth was based on pre-defined system requirements and direct usability observations/feedback.
The sample size for the training set:
- Not applicable. FullFocus is described as a viewing and management software, not an AI or machine learning algorithm that requires a training set in the typical sense for diagnostic performance.
How the ground truth for the training set was established:
- Not applicable, as no training set for an AI/ML algorithm is described.

Summary

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July 15, 2020

Jillian Sue, MS Product Manager Paige.AI, Inc. 11 Times Square, 37th Floor New York, NY 10036

Re: K201005

Trade/Device Name: FullFocus Regulation Number: 21 CFR 864.3700 Regulation Name: Whole Slide Imaging System Regulatory Class: Class II Product Code: QKQ Dated: April 16, 2020 Received: April 16, 2020

Dear Jillian Sue:

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely,

Soma Ghosh, Ph.D. Chief Molecular Pathology and Cytology Branch Division of Molecular Genetics and Pathology OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K201005

Device Name

FullFocus™

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 FullFocus™

Date Prepared: July 15, 2020

Submitter

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

Contact Person

Jillian Sue Product Manager 11 Times Square, 37th Floor New York, NY 10036 jillian.sue@paige.ai Phone: (646) 849-5088

Device

Proprietary Name of the Device:	FullFocus
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:	The FullFocus Viewer
Predicate Device

Proprietary/Trade Name: Philips IntelliSite Pathology Solution (PIPS) Submission Number: DEN160056

Device Description

The subject device is typically operated as follows:

1. The image acquisition is performed using the predicate device, PIPS UFS. The operator performs quality control of the digital slides per the instructions of PIPS and lab specifications to determine if re-scans are necessary.

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1. Once slide image is acquired using PIPS UFS, according to its Instructions for Use, and becomes available in scanner database file systems, a separate medical image communications software (not part of the device) will automatically initiate uploading the slide image and corresponding metadata to persistent cloud storage. Integrity checks are being performed at upload time when data is copied to storage.
1. The reading pathologist uses the subject device to select a case (patient), view the images and is able to perform the following actions, as needed:
- a. Zoom and pan the image
- b. Measure distances and areas in the image
- Annotate images C.

After viewing all images belonging to a particular case (patient), the pathologist will make a diagnosis.

FullFocus is compatible with:

Monitor displays:
- Barco PP27QHD o
- o Philips PS27QHDCR
FDA-cleared scanners: ●
- o Philips Ultra Fast Scanner
Browsers:
- o Google Chrome
- O Microsoft Edge
- o Firefox

Additional monitor displays will be validated with verified test methods to meet required performance characteristics.

Intended Use

FullFocus is a software only device 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 for use with Philips Ultra Fast Scanner and monitor displays validated with verified test methods to meet required performance characteristics.

Item	Subject Device (K201005)	Predicate (DEN160056)
Device TradeName	FullFocus	Philips IntelliSite Pathology Solution
Indications for Use	FullFocus is a software onlydevice intended for viewing andmanagement of digital images ofscanned surgical pathology slidesprepared from formalin-fixedparaffin embedded (FFPE) tissue.It is an aid to the pathologist to	The Philips IntelliSite PathologySolution (PIPS) is an automateddigital slide creation, viewing, andmanagement system. The PIPS isintended for in vitro diagnostic use asan aid to the pathologist to reviewand interpret digital images of
	review, interpret, and managedigital images of pathology slidesfor primary diagnosis. FullFocusis not intended for use with frozensections, cytology, or non-FFPEhematopathology specimens.It is the responsibility of aqualified pathologist to employappropriate procedures andsafeguards to assure the quality ofthe images obtained and, wherenecessary, use conventional lightmicroscopy review when makinga diagnostic decision. FullFocusis intended for use with PhilipsUltra Fast Scanner and monitordisplays validated with verifiedtest methods to meet requiredperformance characteristics.	surgical pathology slides preparedfrom formalin-fixed paraffinembedded (FFPE) tissue.The PIPS is not intended for use withfrozen section, cytology, or non-FFPE hematopathology specimens.The PIPS comprises the ImageManagement System (IMS), the UltraFast Scanner (UFS) and Display. ThePIPS is for creation and viewing ofdigital images of scanned glass slidesthat would otherwise be appropriatefor manual visualization byconventional light microscopy. It isthe responsibility of a qualifiedpathologist to employ appropriateprocedures and safeguards to assurethe validity of the interpretation ofimages obtained using PIPS.
Specimen Type	Digitized surgical pathologyslides prepared from FFPE tissue	Surgical pathology slides preparedfrom FFPE tissue
Image file format	iSyntax	Same
ImageManipulationFunctions	Panning, zooming, colormanipulation function,annotations, and measurements(distance & area)	Same
Type ofSoftwareApplication	Internet browser-basedapplication	Same
DeviceComponents	FullFocus image viewingsoftware	Ultra Fast Scanner (UFS), ImageManagement System (IMS), Display
Principle ofOperation	After WSI images are successfullyacquired by using PIPS UFS, theWSI images are stored in thecloud. During review, thepathologist opens WSI imagesfrom storage, perform further QCand reads WSI images of theslides to make a diagnosis.	After WSI images are successfullyacquired by using PIPS UFS, the WSIimages are stored in IMS ApplicationServer & Storage software that is notprovided as part of the PIPS, but maybe located in a central server roomseparate from the workstation with theIMS viewing software and Display.During review, the pathologist opensWSI images from IMS Server &Storage, perform further QC and readsWSI images of the slides to make adiagnosis.
Image Storage	Images are stored in the cloud.	Images are stored in an end userprovided image storage (PIPS IMSApplication Server & Storage)attached to the local network

Summary of Technological Characteristics

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Performance data	Description
Pixel-wise comparison	Based on pixel-wise comparison to PIPS, including zooming andpanning operations across multiple tiles, FullFocus has been foundto visually adequately reproduce digital pathology images tohuman readers with respect to its intended use.
Turnaround time	The system requirements have been fulfilled:· When selecting a case, it should not take longer than 10 secondsuntil the image is fully loaded.· When panning the image (one quarter of the monitor) it shallnot take longer than 7 seconds until the image is fully loaded.
Measurements	Measurement accuracy has been verified using a test imagecontaining objects with known sizes.
Human factors testing	FullFocus has been found to be safe and effective for the intendedusers, uses, and use environments.

Substantial Equivalence Comparison

The major difference between the subject and predicate device is that the predicate device includes the Ultra Fast Scanner (UFS) and Philips PS27QHDCR monitor display, whereas the subject device is only the review software and indicated for use with the same scanner and monitor. The indications for use are slightly different since the PIPS Indication for Use includes the creation of digital images and FullFocus Indication for use solely describes viewing and managing those digital images.

When FullFocus is used with the PIPS UFS scanner and Philips PS27QHDCR monitor, the software has similar Indications for Use. Functional, and Technological Characteristics to the predicate Image Management System (IMS) application software and is therefore substantially equivalent to the predicate device (DEN160056).

Summary of Studies

Non-clinical test results

Conducted per FDA's Guidance on Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices:

Pixel-wise comparison study was conducted to compare color images reproduced by FullFocus and PIPS IMS. It was determined that color images reproduced by FullFocus were visually adequate with respect to its intended use.

Turnaround times for panning and zooming have been determined and found to be adequate for the intended use of the subject device.

The subject device has been found to perform accurate measurements with respect to its intended use.

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Conducted per FDA's Guidance on Applying Human Factors and Usability Engineering to Medical Devices:

Task-based usability tests verified the FullFocus user interface to be intuitive, safe, and effective for the range of intended users.

Conclusion:

When FullFocus is used with the PIPS UFS scanner and PS27QHDCR monitor display, it has similar Indications for Use, Functional, and Technological Characteristics as the predicate IMS viewer application software. The results of non-clinical testing demonstrate the device is substantially equivalent to the PIPS (DEN160056).

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.