Dynamyx Digital Pathology Software is 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 and interpret these digital images for the purposes of primary diagnosis.

Dynamyx Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.

It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Dynamyx Digital Pathology Software.

The Dynamyx Digital Pathology Software consists of the Installed Pathologist Client and the Pathologist Workstation Web Client. The Installed Pathologist Client is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor as well as Philips' Ultra Fast Scanner and Philips PP27QHD monitor. The Pathologist Workstation Web Client is intended for use with Philips' Ultra Fast Scanner and Philips PP27QHD monitor.

Device Description

Dynamyx Digital Pathology Software is a client-server software device used for importing, displaying, navigating, and annotating whole slide images obtained from the Leica Aperio AT2 DX scanner or the Philips Ultra Fast Scanner.

Whole slide images are created by scanning glass microscope slides using a digital slide scanner which are then imported into the Dynamyx Digital Archive server. Dynamyx uses the image decoding libraries licensed by Leica and Philips for the native images. Dynamyx then uses lossless compression to send the images to the Dynamyx viewer.

Note that Dynamyx has two different applications for two different inputs as specified below.

The Dynamyx Web Application running in the Chrome browser can only display WSI from the Philips Ultra Fast Scanner.
The Dynamyx Installed Client Application can display WSI from both the Leica AT2 DX Scanner and the Philips Ultra Fast Scanner.

Whole slide image files are viewed in the Dynamyx image viewer window by histologists and by pathologists who can also navigate (pan and zoom) and annotate the images.

Dynamyx incorporates typical histology/pathology workflow and is operated as follows:

1. Dynamyx receives whole slide images from the scanner as specified above and extracts a copy of the images' metadata. The unaltered images are then sent to the external image storage (Digital Archive). A copy of the image metadata (e.g. the pixel size) is stored in the subject device's database to increase the operational performance (e.g. response times) of Dynamyx.
1. Depending upon a laboratory's workflow, whole slide images may be reviewed first by histologists to confirm image quality and initiate any slide rescans as necessary prior to being viewed by pathologists. The digital slide review OC status determined by the histologist indicates which slides have been reviewed and approved. The OC status is available to the reading pathologist.
1. The reading pathologist selects a patient case from a selected worklist within Dynamyx whereby the case images are retrieved from the digital archive.
1. The reading pathologist uses Dynamyx to view, navigate, annotate, and interpret the digital images. The pathologist can perform the following actions to displayed image:
- a. Zoom and pan the image at will;
- b. Adjust the apparent image observed magnification level;
- c. Measure distances and areas;
- d. Annotate images and cases;
1. The above steps are repeated as required.

After viewing all images, the pathologist will make a diagnosis which is documented in a laboratory information system.

AI/ML Overview

There is no information regarding acceptance criteria and a study proving the device meets it for an AI/ML clinical decision support function in the provided text. The document refers to the Dynamyx Digital Pathology Software, which is a viewing and management software for digital images of pathology slides, not an AI/ML device.

The document discusses non-clinical performance testing for image reproduction, turnaround time, measurement accuracy, and usability, demonstrating substantial equivalence to predicate devices, but this is for the core functionality of a digital pathology viewer, not an AI feature.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI device meets them.

Summary

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March 01, 2022

Inspirata, Inc. Richard Morroney Director of Regulatory Compliance One North Dale Mabry Hwy Suite 600 Tampa, FL 33609

Re: K210811

Trade/Device Name: Dynamyx Digital Pathology Software Regulation Number: 21 CFR 864.3700 Regulation Name: Whole slide imaging system Regulatory Class: Class II Product Code: QKQ Dated: December 15, 2021 Received: December 16, 2021

Dear Richard Morroney:

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

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

Sincerely,

Soma Ghosh, Ph.D. Chief 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) K210811

Device Name

Dynamyx Digital Pathology Software

Indications for Use (Describe)

Dynamyx Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.

It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Dynamyx Digital Pathology Software.

Type of Use ( Select one or both, as applicable )
XPrescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)	XPrescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
XPrescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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6.0 510(k) Summary

Date Prepared:	February 28, 2022
Submitter:	Inspirata, Inc.One North Dale Mabry HwySuite 600Tampa, FL 33609
Contact Person:	Richard Morroney, RAC, CQADirector of Regulatory CompliancePhone: (813) 570-8900Fax: (813) 570-8901

Submission Date: March 15, 2021

Device Identification

Proprietary/Trade Name:	Dynamyx Digital Pathology Software
Classification Name:	Whole Slide Imaging System
Regulation Number:	21 CFR 864.3700
Product Code:	QKQ
Device Classification:	Class II
Review Panel:	88 – Pathology
Common Name:	Digital Pathology Image Viewing and Management Software

Predicate Device Identification

Proprietary/TradeName	Leica Aperio AT2 DXSystem	Philips IntelliSite PathologySolution (PIPS)
510(k) Number	K190332	DEN160056
Clearance Date	May 20, 2019	April 12, 2017
Classification Name	Whole Slide Imaging System
Regulation Number	21 CFR 864.3700
Product Code	PSY
Device Classification	Class II
Review Panel	88 – Pathology
Common Name	Digital Pathology Whole Slide Imaging System

Device Description

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Note that Dynamyx has two different applications for two different inputs as specified below.

The Dynamyx Web Application running in the Chrome browser can only display WSI from the Philips Ultra Fast Scanner.
The Dynamyx Installed Client Application can display WSI from both the Leica AT2 DX Scanner and the Philips Ultra Fast Scanner.

Whole slide image files are viewed in the Dynamyx image viewer window by histologists and by pathologists who can also navigate (pan and zoom) and annotate the images.

Dynamyx incorporates typical histology/pathology workflow and is operated as follows:

1. Dynamyx receives whole slide images from the scanner as specified above and extracts a copy of the images' metadata. The unaltered images are then sent to the external image storage (Digital Archive). A copy of the image metadata (e.g. the pixel size) is stored in the subject device's database to increase the operational performance (e.g. response times) of Dynamyx.
1. Depending upon a laboratory's workflow, whole slide images may be reviewed first by histologists to confirm image quality and initiate any slide rescans as necessary prior to being viewed by pathologists. The digital slide review OC status determined by the histologist indicates which slides have been reviewed and approved. The OC status is available to the reading pathologist.
1. The reading pathologist selects a patient case from a selected worklist within Dynamyx whereby the case images are retrieved from the digital archive.
1. The reading pathologist uses Dynamyx to view, navigate, annotate, and interpret the digital images. The pathologist can perform the following actions to displayed image:
- a. Zoom and pan the image at will;
- b. Adjust the apparent image observed magnification level;
- c. Measure distances and areas;
- d. Annotate images and cases;
1. The above steps are repeated as required.

After viewing all images, the pathologist will make a diagnosis which is documented in a laboratory information system.

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Intended Use Statement

Dynamyx Digital Pathology Software is intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed, paraffinembedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.

Dynamyx Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.

It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Dynamyx Digital Pathology Software.

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Summary of Technological Characteristics

Item	Subject DeviceDynamyx	Predicate DevicePhilips IntelliSite PathologySolution (PIPS)DEN160056	Predicate DeviceLeica Aperio AT2 DX SystemK190332
Similarities
Indicationsfor Use	Dynamyx Digital Pathology Software isintended for viewing and management ofdigital images of scanned surgicalpathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue.It is an aid to the pathologist to reviewand interpret these digital images for thepurposes of primary diagnosis.Dynamyx Digital Pathology Software isnot intended for use with frozen section,cytology, or non-FFPE hematopathologyspecimens.It is the responsibility of the pathologistto employ appropriate procedures andsafeguards to assure the validity of theinterpretation of images using DynamyxDigital Pathology Software.The Dynamyx Digital PathologySoftware consists of the InstalledPathologist Client and the PathologistWorkstation Web Client. The InstalledPathologist Client is intended for usewith Leica's Aperio AT2 DX scannerand Dell MR2416 monitor as well asPhilips' Ultra Fast Scanner and PhilipsPP27QHD monitor. The PathologistWorkstation Web Client is intended foruse with Philips' Ultra Fast Scanner andPhilips PP27QHD monitor.	The Philips IntelliSite PathologySolution (PIPS) is an automated digitalslide creation, viewing, and managementsystem. The PIPS is intended for invitro diagnostic use as an aid to thepathologist to review and interpretdigital images of surgical pathologyslides prepared from formalin-fixparaffin embedded (FFPE) tissue. ThePIPS is not intended for use with frozensection, cytology, or non-FFPEhematopathology 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 appropriate formanual visualization by conventionallight microscopy. It is the responsibilityof a qualified pathologist to employappropriate procedures and safeguardsto assure the validity of theinterpretation of images obtained usingPIPS.	The Leica Aperio AT2 DX System is anautomated digital slide creation andviewing system. The Leica Aperio AT2DX System is intended for in vitrodiagnostic use as an aid to thepathologist to review and interpretdigital images of surgical pathologyslides prepared from formalin-fixedparaffin embedded (FFPE) tissue. TheLeica Aperio AT2 DX System is notintended for use with frozen section,cytology, or non-FFPE hematopathologyspecimens.The Leica Aperio AT2 DX System iscomposed of the Leica Aperio AT2 DXscanner, the ImageScope DX reviewapplication and Display. The LeicaAperio AT2 DX System is for creationand viewing of digital images ofscanned glass slides that wouldotherwise be appropriate for manualvisualization by conventional lightmicroscopy. It is the responsibility of aqualified pathologist to employappropriate procedures and safeguardsto assure the validity of theinterpretation of images obtained usingthe Leica Aperio AT2 DX System.
Item	Subject DeviceDynamyx	Predicate DevicePhilips IntelliSite PathologySolution (PIPS)DEN160056	Predicate DeviceLeica Aperio AT2 DX SystemK190332
SpecimenType	Surgical pathology slides prepared fromFFPE tissue.	Same	Same
ImageStorage	Images are stored in end user providedimage storage attached to the localnetwork	Same	Same
ImageManipulationFunctions	Panning, zooming, image adjustments,annotations, and distance / areameasurements	Same	Same
ImageReview andDiagnosis	During review, the pathologist opensWSI images acquired with the WSIscanner from the image storage,performs further QC and interprets theWSI images to make a diagnosis.	Same	Same
DiagnosticStatus ofImages	Displays a visual indicator for thediagnostic status of an image.	Same	Same
User Interface	Full-featured image viewer withintegrated case list containing slidethumbnails.	Same	Same
DisplayMonitor	Dynamyx does not include a monitor butis indicated for use with the DellMR2416, and Philips PP27QHDmonitor with each system respectively.	Philips PP27QHD	Dell MR2416
Item	Subject DeviceDynamyx	Predicate DevicePhilips IntelliSite PathologySolution (PIPS)DEN160056	Predicate DeviceLeica Aperio AT2 DX SystemK190332
PerformanceTesting	• Color Reproducibility• Turnaround Time• Measurement Accuracy• Usability	Same	Same

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Item	Subject DeviceDynamyx	Predicate DevicePhilips IntelliSite PathologySolution (PIPS)DEN160056	Predicate DeviceLeica Aperio AT2 DX SystemK190332
Differences
Image QC	When used as part of the Philipssystem, image QC is embedded inworkflow. Scan techs view slide macroimages on the UFS interface toconfirm all tissue is contained in thescanned area. Users view the imagesto confirm scan quality using theDynamyx viewer. QC status availableto pathologist.When used as part of the Leica Aperiosystem, image QC is embedded inworkflow. Scan techs view slide macroimages on the AT2 DX interface toconfirm all tissue is contained in thescanned area. Users view the imagesto confirm scan quality using theDynamyx viewer. QC status availableto pathologist.	Image QC embedded in workflow.Scan techs view slide macro imageson the UFS interface to confirm alltissue is contained in the scanned area.Users view the images to confirm scanquality using the IMS Viewer.	Image QC embedded in workflow.Scan techs view slide macro imageson the AT2 DX interface to confirmtissue is contained in the scanned area.Users view the images to confirm scanquality using the ImageScope DXviewer.

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Item	Subject DeviceDynamyx	Predicate DevicePhilips IntelliSite PathologySolution (PIPS)DEN160056	Predicate DeviceLeica Aperio AT2 DX SystemK190332
Differences
UserInterface	Dynamyx is a stand-alone medicaldevice software.	The Image Management System (IMS)software is an integrated component ofthe PIPS.	Leica Aperio ImageScope DX viewersoftware is an integrated component ofthe AT2 DX system.
MicroscopeSlide Scanner	Dynamyx is a software only device anddoes not include any hardware orscanner. However, it is indicated for usewith the Leica Aperio AT2 DX Scannerand the Philips UFS.	Philips Ultra Fast Scanner (UFS)	Leica Aperio AT2 DX Slide Scanner
WSI DisplayInput	Dynamyx has two applications for twodifferent inputs.1. The Dynamyx Web Applicationrunning in the Chrome browser can onlydisplay WSI from the Philips Ultra FastScanner.2. The Dynamyx Installed ClientApplication can display WSI from boththe Leica AT2 DX Scanner and thePhilips Ultra Fast Scanner.	The IMS viewer is browser based andcan display only .iSyntax WSI files	ImageScope viewer is an installedapplication and can only display .svsWSI files

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Substantial Equivalence Comparison

The major difference between the predicate devices and Dynamyx is that the predicate devices are comprised of a system of hardware and software components, whereas Dynamyx is indicated for use with the same scanners and monitors. Therefore, the predicate device indications for use are slightly different to account for the creation of digital images whereas Dynamyx is intended as a replacement software component used for viewing and management of those images.

Dynamyx has two different applications for two different inputs as specified below.

The Dynamyx Web Application running in the Chrome browser can only display WSI from the Philips Ultra Fast Scanner.
The Dynamyx Installed Client Application can display WSI from both the Leica AT2 DX Scanner and the Philips Ultra Fast Scanner.

The IMS viewer is browser-based and can display only .iSyntax WSI files. The ImageScope viewer is an installed application and can only display .svs WSI files.

The AT2 DX scanner provides a color-coded status indication on the scanner control panel showing whether or not the scanner was able to focus on the tissue being scanned. The status colors are not an absolute indicator of image quality. They are used as a diagnostic tool alerting the user of possible problems with a scan. This scanner feature is independent of the viewer. The AT2 DX user manual states that regardless of the scan status color, all slides should be reviewed for acceptable image quality. Thus, digital slide image QC is performed using the image viewer.

The Ultra Fast Scanner provides a user interface where macro images of the scanned slide can be viewed to confirm that all the slide tissue was scanned. Digital slide image QC is performed using the Philips IMS viewer. The IMS user manual states that before a slide is used for diagnosis, the pathologist must check the image to ensure that it is suitable for diagnosis.

Using the Dynamyx viewer, a histotechnologist can review the quality of digital slide images and can assign the OC status of the images as rescan or reviewed/approved. The slide image review status (i.e., scan quality is approved or not approved ) is available to the pathologist. Ultimately, it is up to the pathologist to look at digital slide images to verify they are of sufficient quality to perform their task.

Both predicate devices have the ability to confirm scan quality, i.e., check for missing tissue and faint tissue at the scanner. Although Dynamyx does not include a scanner, that doesn't preclude these checks from being performed. Additionally, the check for missing or faint tissue can be performed using the Dynamvx viewer. Both the predicates and Dynamyx require an equivalent manual review of image quality. Therefore, these differences indicate that Dynamyx software does not introduce any new potential safety or efficacy issues.

The Dynamyx Digital Pathology Software when used with the Leica Aperio AT2 DX

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scanner / Dell MR2416 monitor and the Philips UFS scanner / PP27QHD monitor have similar indications for use, functional and technological characteristics as the ImageScope DX viewer and Philips IMS Viewer of the predicate devices and is therefore substantially equivalent to the Leica predicate device (K190332) and the Philips predicate device (DEN160056).

Summary of Non-Clinical Performance Testing:

Technical performance testing for Dynamyx Digital Pathology Software device was performed. The new device was compared to the Image Management Software (IMS) component of the Philips PIPS device and the ImageScope DX viewer software of Leica Aperio AT2 DX System. The following testing was performed:

Pixel-wise comparison with the predicate device including zooming and panning a. operations
The equivalence between the subject and predicate image review manipulation software (IRMS, as defined in the FDA guidance titled "Guidance for Industry "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices", dated April 20, 2016 [TPA guidance, IV(A)(9)] was supported by bench testing data based on pixel-level comparison. The subject IRMS was tested as operating with the intended components, including the scanner, image management system and display, Scanned images from 33 FFPE tissue glass slides from different anatomic locations were used as the test input. For each region of interest (ROI), the differences between the views generated by the subject and predicate IRMS were evaluated with the 1976 International Commission on Illumination (CIE) color difference metric ΔE for each corresponding pixel pair. The two views generated by the subject and predicate IRMS were adjusted and registered by using only the graphical user interface without image processing. The test cases of ROIs included relevant biological features at different magnification levels such as 40x, 20x and 10x. Horizontal/vertical stitching seams between the tiles were included in the ROIs when possible.

Sixty image pairs at 40x, 20x, and 10x were used to test Dynamyx Digital Pathology Software Installed Pathologist Client against the predicate Leica AT2 DX. Similarly, sixty image pairs at 40x and 20x were used to test Dynamyx Digital Pathology Software Installed Pathologist Client against the predicate Philips PIPS. In addition, sixty image pairs at 40x and 20x were used to test Dynamyx Digital Pathology Software Pathologist Workstation Web Client running in the Chrome browser against Philips PIPS.

The color differences of all pixels within each ROI were reported. The image data of all ROIs were also provided for verification. The test results demonstrated that all image pairs are identical with zero ΔE. The subject device has been found to adequately reproduce digital pathology images at the pixel level with respect to its intended use.

b. Turnaround Time

Turnaround time test was performed to verify the streaming indicator functionality and to measure the turnaround time for initial image load, panning via mouse drag and zooming with 10 concurrent users using Leica Aperio AT2 DX scanner images and Philips UFS images. Test results are acceptable.

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c. Measurement Accuracy

Measurement accuracy testing was performed to verify the calculated measurement for each annotation (e.g., length and area) is accurate to within 5% of the reference measurement using a certified micron scale image created using a Leica Aperio AT2 DX scanner and a Philips UFS. Test results showed that the subject device performed accurate measurements with respect to its intended use.

d. Human Factors (Usability) Testing

Formative and summative usability testing was conducted on the Dynamyx Pathology Workstation and the Histologist Workstation interfaces in accordance with FDA Guidance on Applying Human Factors and Usability Engineering to Medical Devices, Usability Engineering procedure and the Risk Management Process.

A systematic evaluation of task-based usability including critical tasks required for operation of the device were evaluated at multiple sites using multiple users. All tasks associated with reviewing and reporting results for cases including confirmation that all slides belonging to specific cases are reviewed before reporting results, were included in the study. Overall, the results of the human factors testing were acceptable.

Summary of Clinical Performance Data:

Clinical study results are not required for a substantial equivalence determination. Therefore, this submission contains no clinical study information.

Conclusion:

The Dynamyx Digital Pathology Software when used with the Leica Aperio AT2 DX scanner / Dell MR2416 monitor and the Philips Ultra Fast Scanner / Philips PP270HD monitor, has similar indications for use, functional, and technological characteristics as the ImageScope DX viewer application and the IMS Viewer software of the predicate devices. The results of non-clinical testing demonstrate that the subject device is safe and effective and substantially equivalent to the Leica Aperio AT2 DX (K190332) and Philips PIPS (DEN160056) 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.