Concentriq® Dx 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 these digital slide images of primary diagnosis. Concentriq® Dx 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 the validity of the interpretation of images using Concentriq Dx is intended for use with the Hamamatsu NanoZoomer S360MD Slide scanner and JVC JD-C240BN01A monitor.

Device Description

CONCENTRIQ DX IS OPERATED AS FOLLOWS:

1. The image acquisition is performed using the validated WSI scanner. A lab technician prepares, and scans slides and reviews the slide quality in accordance with the WSI scanner Instructional Manual and standard lab procedures. The Concentriq Dx workflow is initiated when the WSI from the local file system is ingested into Concentriq Dx.
1. The reading pathologist selects a case from a worklist external to the subject device or from within the subject device, whereby the subject device fetches the associated images from the image storage.
1. The reading pathologist uses the subject device to view and interpret the images:
- Zoom and pan the image ●
- Measure distances and areas in the image
- Annotate the image ●
- View multiple images side by side
1. Prior to using a whole slide image for diagnosis, a data and image quality assessment is performed.
1. The above steps are repeated as required.
1. After viewing all images for a case, the pathologist will make a diagnosis. The diagnosis will be documented in another system, e.g., a Laboratory Information System (LIS).
1. When finished using the system, the pathologist clicks "Sign Out" in the user menu.

Quality Control:

Prior to using a whole slide image for diagnosis, the pathologist should ensure that all scanned slide images have been imported for every case and the images are of acceptable quality for diagnostic purposes. The pathologist reviews scanned images from all the slides associated with a case before rendering a diagnosis.

AI/ML Overview

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

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Clinical Equivalence (Non-inferiority)	The major discordance rate between manual digital (MD) reads using Concentriq Dx and the ground truth (GT) should be non-inferior to the major discordance rate between manual optical (MO) reads using conventional light microscopy and the ground truth (GT). The prespecified non-inferiority threshold was 4%.	The difference in major discordance rates between MD and GT compared to MO and GT was -0.1% (95% CI, -1.0, 0.4) for all cases across the 3 reading pathologists. The upper limit of the CI for the difference was 0.4%, which is less than the 4% threshold.
Image Loading/Turnaround Time	Images load in less than 5 seconds when selected for viewing.	Images load in less than 5 seconds when selected for viewing.
	Images load in less than 2 seconds when spanning and zooming.	Images load in less than 2 seconds when spanning and zooming.
Measurement Accuracy (Area and Distance)	Measurements of markings made in the Concentriq viewer should accurately reflect the known distances and areas of markings on a calibrated cross scale slide.	Tests verified that the distance and area measurements made in the Concentriq Dx viewer accurately reflected the distance and area of the markings on an image of the calibrated slide.
Human Factors Validation	Concentriq Dx should be found safe and effective for the intended users, uses, and use environments.	Concentriq Dx has been found to be safe and effective for the intended users, uses and use environments.
Pixel-wise Image Reproduction (Bench Testing)	The 95th percentile of pixel-wise differences between Concentriq Dx and the NanoZoomer S360MD Slide scanner system should meet a certain threshold for identical image reproduction (though the text reports that it was not met, triggering the clinical study, rather than stating it as an acceptance criterion that was met). The text implies the initial expectation was closer to pixel-wise identity, but the outcome led to a clinical study instead.	The 95th percentile of pixel-wise differences between Concentriq Dx and NanoZoomer S360MD Slide scanner system was greater than 3 CIEDE2000, indicating their output images are not pixel-wise identical as Concentriq Dx applies image compression. This did not meet pixel-wise identicality, necessitating a clinical study.

Study Details

The provided text details a clinical study to establish the non-inferiority of Concentriq Dx for primary diagnosis compared to conventional light microscopy.

Sample Size Used for the Test Set and Data Provenance:
- Test Set Size: Not explicitly stated as a single number for cases or slides. The study involved "all cases across the 3 reading pathologists." Without additional context, the total number of cases/slides reviewed cannot be determined from this document alone.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved comparing reads against an "original sign-out pathologic diagnosis using MO [ground truth, (GT)] rendered at the institution." This suggests the data was retrospective from a clinical institution where standard diagnoses were already made.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts for Ground Truth: The ground truth (GT) was defined as the "original sign-out pathologic diagnosis using MO [ground truth, (GT)] rendered at the institution." This implies a single, qualified pathologist at the institution made the original diagnosis for each case, forming the initial ground truth.
- Qualifications of Experts for Study Reads: The study involved 3 reading pathologists. Their specific qualifications (e.g., years of experience) are not detailed in this document, but they are referred to as "qualified pathologist[s]" in the Indications for Use and Device Description sections who review and interpret digital slide images.
Adjudication Method for the Test Set:
- The document implies that the ground truth for the comparison was the "original sign-out pathologic diagnosis" from the institution. The study then measured major discordance rates between the digital reads (MD) and this established ground truth (GT), and between optical reads (MO) and GT. There is no mention of a separate adjudication process among multiple experts to establish the ground truth for the study itself; rather, they rely on pre-existing diagnoses.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- Yes, an MRMC comparative effectiveness study was done. The study specifically compared performance of "manual digital read (MD)" with "manual optical (MO)" against a "reference (main) diagnosis... [ground truth, (GT)]". It involved "3 reading pathologists."
- Effect Size: The study found that "The differences in major discordance rates between MD and GT compared to MO and GT were -0.1% (95% CI, -1.0, 0.4) for all cases across the 3 reading pathologists." The upper limit of the confidence interval (0.4%) was less than the prespecified noninferiority threshold of 4%, thereby demonstrating non-inferiority rather than a direct "improvement" effect size in the traditional sense of AI assistance. The study's goal was to show MD is not worse than MO. It does not quantify how much human readers improve with AI vs without AI assistance, as Concentriq Dx is a viewing/management software, not an AI-assisted diagnostic tool in this context, and the comparison is between digital vs. optical viewing.
If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- No. The device, Concentriq Dx, is a "software only device intended for viewing and management of digital images" and an "aid to the pathologist." The clinical study evaluated "manual digital read (MD)," which inherently involves a human pathologist-in-the-loop using the device. There is no mention of a standalone algorithm performance evaluation.
The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
- The ground truth (GT) was the "original sign-out pathologic diagnosis using MO [ground truth, (GT)] rendered at the institution." This is based on pathology diagnoses made by a qualified pathologist via conventional light microscopy.
The Sample Size for the Training Set:
- The document does not mention a specific training set size or methodology for Concentriq Dx. Given its description as a "software only device intended for viewing and management of digital images," not an AI diagnostic algorithm, it likely does not undergo a "training" process in the machine learning sense that would require a dedicated training set. The clinical study is for validation, not training.
How the Ground Truth for the Training Set Was Established:
- As no training set or AI algorithm training is described for Concentriq Dx in this document, this question is not applicable based on the provided information.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 8, 2024

Proscia, Inc. Kim Rendon Director of Regulatory Affairs 1700 Market St. 23rd Floor Philadelphia, Pennsylvania 19103

Re: K230839

Trade/Device Name: Concentriq Dx Regulation Number: 21 CFR 864.3700 Regulation Name: Whole slide imaging system Regulatory Class: Class II Product Code: QKQ Dated: March 27, 2023 Received: March 27, 2023

Dear Kim Rendon:

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 (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.

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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).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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

Shyam Kalavar -S

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

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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) K230839

Device Name

Concentriq Dx

Indications for Use (Describe)

For In Vitro Diagnostic Use

Concentria® Dx 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 these digital slide images of primary diagnosis. Concentria® Dx is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.

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

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510(k) Summary Concentriq® Dx

DATE PREPARED: February 7, 2024

SUBMITTER

Proscia, Inc. 1700 Market Street 23rd Floor Philadelphia, PA 19103 (215) 608-5411

PRIMARY CONTACT PERSON

Kim Rendon Director of Regulatory Affairs

DEVICE

Proprietary Name/Trade Name:	Concentriq® Dx
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

Proprietary Name:	NanoZoomer S360MD Slide scanner system
Submission Number:	K213883

INDICATIONS FOR USE

For In Vitro Diagnostic Use

Concentrig® Dx 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 these digital slide images for the purpose of primary diagnosis. Concentriq® Dx 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 the validity of the interpretation of images using Concentriq Dx. Concentriq Dx is intended for use with the Hamamatsu NanoZoomer S360MD Slide scanner and JVC JD-C240BN01A monitor.

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DEVICE DESCRIPTION

CONCENTRIQ DX IS OPERATED AS FOLLOWS:

1. The image acquisition is performed using the validated WSI scanner. A lab technician prepares, and scans slides and reviews the slide quality in accordance with the WSI scanner Instructional Manual and standard lab procedures. The Concentriq Dx workflow is initiated when the WSI from the local file system is ingested into Concentriq Dx.
1. The reading pathologist selects a case from a worklist external to the subject device or from within the subject device, whereby the subject device fetches the associated images from the image storage.
1. The reading pathologist uses the subject device to view and interpret the images:
- Zoom and pan the image ●
- Measure distances and areas in the image
- Annotate the image ●
- View multiple images side by side
1. Prior to using a whole slide image for diagnosis, a data and image quality assessment is performed.
1. The above steps are repeated as required.
1. After viewing all images for a case, the pathologist will make a diagnosis. The diagnosis will be documented in another system, e.g., a Laboratory Information System (LIS).
1. When finished using the system, the pathologist clicks "Sign Out" in the user menu.

Quality Control:

Table 1: WSI scanner

Manufacturer	Model
Hamamatsu	NanoZoomer S360MD Slide scanner

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Table 2: WSI display

Manufacturer	Model
JVC	JD-C240BN01A

Table 3: Computer environment/System Requirements:

WorkstationComponent	Specifications
Processor	2 GHz processor or higher with at least 4 cores
Memory	8 GB or higher
Monitor	JVC JD-C240BN01A for use with Hamamatsu NanoZoomerS360MD Slide scanner
Network connectivity	100 Mbps (1 Gbps LAN recommended) connection
Keyboard / Mouse /Trackpad	Windows 10 compatibleOptional: 3Dconnexion SpaceMouse Pro, 3Dconnexion SpaceMouseCompact
Operating system	Windows 10
Supported browsers	Google Chrome 119.0.6045.105, Microsoft Edge 118
Antivirus software	Norton Antivirus V22.22.6.10 and McAfee Antivirus 16.0

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES

The following table summarizes the similarities and differences between the Concentriq Dx and the predicate device, NanoZoomer System.

Specification	Predicate Device	Proposed Subject Device
Device TradeName	NanoZoomer System(NZViewMD)	Concentriq Dx
Product Code	PSY	QKQ
Regulation	21 C.F.R. § 864.3700	21 C.F.R. § 864.3700
Regulation Name	Whole Slide Imaging System	Whole Slide Imaging System
Specification	Predicate Device	Proposed Subject Device
Classification	II	II
Indications forUse	The NanoZoomer S360MD Slidescanner system ("NanoZoomerSystem") is an automated digitalslide creation, viewing, andmanagement system. TheNanoZoomer System is intendedfor in vitro diagnostic use as an aidto the pathologist to review andinterpret digital images of surgicalpathology slides prepared fromformalin-fixed paraffin embedded("FFPE") tissue. The NanoZoomerSystem is not intended for use withfrozen section, cytology, or non-FFPE hematopathology specimens.The NanoZoomer Systemcomprises the NanoZoomerS360MD Slide scanner, theNZViewMD Software and the JVCKenwood JD-C240BN01A display.The NanoZoomer System is forcreation and viewing of digitalimages of scanned glass slides thatwould otherwise be appropriate formanual visualization byconventional light microscopy. It isthe responsibility of a qualifiedpathologist to employ appropriateprocedures and safeguards toassure the validity of theinterpretation of images obtainedusing NanoZoomer System.	For In Vitro Diagnostic UseConcentriq® Dx is a software onlydevice intended for viewing andmanagement of digital images ofscanned surgical pathology slidesprepared from formalin-fixedparaffin embedded (FFPE) tissue. Itis an aid to the pathologist toreview, interpret and manage thesedigital slide images for the purposeof primary diagnosis. Concentriq®Dx is not intended for use withfrozen sections, cytology, or non-FFPE hematopathology specimens.It is the responsibility of a qualifiedpathologist to employ appropriateprocedures and safeguards toassure the quality of the imagesobtained and the validity of theinterpretation of images usingConcentriq Dx. Concentriq Dx isintended for use HamamatsuNanoZoomer S360MD Slidescanner and JVC JD-C240BN01Amonitor.
Scanner	NanoZoomer S360MD Slidescanner	NanoZoomer S360MD Slidescanner
CompatibleDisplay	JVC Kenwood JD-C24BN01A	JVC Kenwood JD-C24BN01A
Specimen Type	Same	Surgical pathology slides preparedfrom FFPE tissue
Specification	Predicate Device	Proposed Subject Device
Image FileFormats	Same	Hamamatsu's NZAcquireMD .ndpifile format
ImageManipulationFunctions	Same	Panning, zooming, imageadjustments, annotations, anddistance/area measurements
Type of SoftwareApplication	Windows based	Internet browser based
DeviceComponents	Scanner, Image ManagementSoftware and Display	Image Management Software
Principle ofOperation	After WSI are acquired by usingNanoZoomer S360MD Slidescanner, the WSI are automaticallysaved to the hard disk duringscanning and may be viewed laterby using the included viewingsoftware. During review, thepathologist opens WSI from theimage storage attached to localnetwork, performs further QC andreads WSI of the slides to make adiagnosis.	After the WSI are acquired byusing NanoZoomer S360MD Slidescanner, the WSI are stored incustomer provided image storage.During image review, thepathologist opens the WSI(displayed as .ndpi images) fromthe image storage using ConcentriqDx; performs further QC and thenreads the WSI to make a diagnosis.
User Interface	NZViewMD	Concentriq Dx

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SUBSTANTIAL EQUIVALENCE COMPARISON

The proposed subject device has the same Indications for Use and similar Functional and Technological Characteristics to the predicate device's Image Management System (IMS) application software and is therefore substantially equivalent to the predicate device.

PERFORMANCE DATA

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Performance data	Description
Pixel-wise comparison	A pixel-wise comparison test was performed to compare imageswhich were reproduced by Concentriq Dx and NZViewMD for thesame NDPI file to validate identical image reproduction. Test resultsshowed that the 95th percentile of pixelwise differences betweenConcentriq Dx and NanoZoomer S360MD Slide scanner system wasgreater than 3 CIEDE2000, indicating that their output images are notpixel-wise identical as Concentriq Dx applies image compression toits output. Based on the findings from bench testing, a clinical studywas performed to establish the safety and effectiveness of the device.
Clinical Study	A clinical study was conducted to demonstrate that viewing,reviewing, and diagnosing WSIs of H&E stained FFPE tissue slidesusing Concentriq Dx [manual digital read (MD)] is non-inferior toglass slide reads using optical (light) microscopy [manual optical(MO)]. The primary endpoint of the study was the difference in majordiscordance rates between MD and MO when compared to thereference (main) diagnosis, which was the original sign-out pathologicdiagnosis using MO [ground truth, (GT)] rendered at the institution.The differences in major discordance rates between MD and GTcompared to MO and GT were -0.1% (95% CI, -1.0, 0.4) for all casesacross the 3 reading pathologists. The upper limit of the CI for thedifference in the major discordance rate was 0.4%, which is less thanthe prespecified noninferiority threshold of 4%, therefore meeting theprimary objective of the study.
Turnaround	The system requirements have been fulfilled:● Images load in less than 5 seconds when selected for viewing● Images load in less than 2 seconds when spanning and zooming
Measurements of Areaand Distance	Measurement accuracy has been verified by comparing themeasurements of markings made in the Concentriq viewer to themeasurements of markings on a calibrated cross scale slide withknown sizes. The tests were used to validate the measurementaccuracy of the subject device. Tests verified that the distance andarea measurements made in the Concentriq Dx viewer accuratelyreflected the distance and area of the markings on an image of thecalibrated slide. These results show that Concentriq performedaccurate measurements with respect to its intended use.
Performance data	Description
Human FactorsValidation Study	Concentriq Dx has been found to be safe and effective for the intended users, uses and use environments.

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CONCLUSION

Based on the information provided in the 510(k), the subject device Concentriq Dx is substantially equivalent to the previously cleared predicate device, when used Hamamatsu NanoZoomer S360MD Slide scanner and JVC JD-C240BN01A monitor. A clinical study was conducted to establish the Substantial Equivalence of the device.

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.