(318 days)
Not Found
No
The description focuses on image viewing, management, and basic measurement/annotation tools for pathologists. There is no mention of automated analysis, pattern recognition, or any features that would typically involve AI/ML. The performance studies focus on image reproduction, clinical non-inferiority to glass slides, and basic system performance metrics.
No
The device is a software-only device intended for viewing and managing digital images of surgical pathology slides, acting as an aid to pathologists for diagnosis. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Concentriq® Dx is a software only device intended for viewing and management of digital images of scanned surgical pathology slides... It is an aid to the pathologist to review, interpret and manage these digital slide images of primary diagnosis." The clinical study further demonstrates its use in facilitating diagnosis by comparing WSI reads to optical microscopy.
Yes
The device description explicitly states "Concentriq® Dx is a software only device". While it is intended for use with specific hardware (scanner and monitor), the device itself is described as solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states "For In Vitro Diagnostic Use".
- Intended Use: The device is intended for "viewing and management of digital images of scanned surgical pathology slides... as an aid to the pathologist to review, interpret and manage these digital slide images of primary diagnosis." This directly relates to the examination of biological specimens (tissue slides) outside of the body to aid in diagnosis, which is the core definition of an in vitro diagnostic device.
- Clinical Study: The inclusion of a clinical study comparing the device's performance to traditional microscopy for diagnostic purposes further supports its classification as an IVD.
- Predicate Device: The predicate device listed (NanoZoomer S360MD Slide scanner system) is also an IVD, indicating that devices in this workflow are typically classified as such.
While the software itself doesn't perform the diagnostic interpretation, it is an essential tool used by a qualified pathologist to perform the in vitro diagnostic process.
N/A
Intended Use / Indications for Use
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.
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.
Product codes
QKQ
Device Description
CONCENTRIQ DX IS OPERATED AS FOLLOWS:
-
- 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.
-
- 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.
-
- 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
-
- Prior to using a whole slide image for diagnosis, a data and image quality assessment is performed.
-
- The above steps are repeated as required.
-
- 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).
-
- When finished using the system, the pathologist clicks "Sign Out" in the user menu.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found. Input is digital images of scanned surgical pathology slides.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Pathologist / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pixel-wise comparison: A pixel-wise comparison test was performed to compare images which were reproduced by Concentriq Dx and NZViewMD for the same NDPI file to validate identical image reproduction. Test results showed that the 95th percentile of pixelwise differences between Concentriq Dx and NanoZoomer S360MD Slide scanner system was greater than 3 CIEDE2000, indicating that their output images are not pixel-wise identical as Concentriq Dx applies image compression to its output. Based on the findings from bench testing, a clinical study was 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 slides using Concentriq Dx [manual digital read (MD)] is non-inferior to glass slide reads using optical (light) microscopy [manual optical (MO)]. The primary endpoint of the study was the difference in major discordance rates between MD and MO when compared to the reference (main) diagnosis, which was the original sign-out pathologic diagnosis using MO [ground truth, (GT)] rendered at the institution. 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 CI for the difference in the major discordance rate was 0.4%, which is less than the prespecified noninferiority threshold of 4%, therefore meeting the primary objective of the study.
Turnaround: The system requirements have been fulfilled: Images load in less than 5 seconds when selected for viewing and Images load in less than 2 seconds when spanning and zooming.
Measurements of Area and Distance: Measurement accuracy has been verified by comparing the measurements of markings made in the Concentriq viewer to the measurements of markings on a calibrated cross scale slide with known sizes. The tests were used to validate the measurement accuracy of the subject device. 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. These results show that Concentriq performed accurate measurements with respect to its intended use.
Human Factors Validation Study: Concentriq Dx has been found to be safe and effective for the intended users, uses and use environments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Study: 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 CI for the difference in the major discordance rate was 0.4%, which is less than the prespecified noninferiority threshold of 4%, therefore meeting the primary objective of the study.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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.
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.
| 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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4
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.
5
DEVICE DESCRIPTION
CONCENTRIQ DX IS OPERATED AS FOLLOWS:
-
- 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.
-
- 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.
-
- 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
-
- Prior to using a whole slide image for diagnosis, a data and image quality assessment is performed.
-
- The above steps are repeated as required.
-
- 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).
-
- 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.
Table 1: WSI scanner
| Manufacturer | Model |
|---|---|
| Hamamatsu | NanoZoomer S360MD Slide scanner |
6
Table 2: WSI display
| Manufacturer | Model |
|---|---|
| JVC | JD-C240BN01A |
Table 3: Computer environment/System Requirements:
| Workstation
| Component | 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 NanoZoomer |
| S360MD Slide scanner | |
| Network connectivity | 100 Mbps (1 Gbps LAN recommended) connection |
| Keyboard / Mouse / | |
| Trackpad | Windows 10 compatible |
| Optional: 3Dconnexion SpaceMouse Pro, 3Dconnexion SpaceMouse | |
| Compact | |
| 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 Trade | ||
| Name | 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 for | ||
| Use | The NanoZoomer S360MD Slide | |
| scanner system ("NanoZoomer | ||
| System") is an automated digital | ||
| slide creation, viewing, and | ||
| management system. The | ||
| NanoZoomer System is intended | ||
| for in vitro diagnostic use as an aid | ||
| to the pathologist to review and | ||
| interpret digital images of surgical | ||
| pathology slides prepared from | ||
| formalin-fixed paraffin embedded | ||
| ("FFPE") tissue. The NanoZoomer | ||
| System is not intended for use with | ||
| frozen section, cytology, or non- | ||
| FFPE hematopathology specimens. | ||
| The NanoZoomer System | ||
| comprises the NanoZoomer | ||
| S360MD Slide scanner, the | ||
| NZViewMD Software and the JVC | ||
| Kenwood JD-C240BN01A display. | ||
| The NanoZoomer System is for | ||
| creation and viewing of digital | ||
| images of scanned glass slides that | ||
| would otherwise be appropriate for | ||
| manual visualization by | ||
| conventional light microscopy. 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 NanoZoomer System. | For In Vitro Diagnostic Use | |
| 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 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 Hamamatsu | ||
| NanoZoomer S360MD Slide | ||
| scanner and JVC JD-C240BN01A | ||
| monitor. | ||
| Scanner | NanoZoomer S360MD Slide | |
| scanner | NanoZoomer S360MD Slide | |
| scanner | ||
| Compatible | ||
| Display | JVC Kenwood JD-C24BN01A | JVC Kenwood JD-C24BN01A |
| Specimen Type | Same | Surgical pathology slides prepared |
| from FFPE tissue | ||
| Specification | Predicate Device | Proposed Subject Device |
| Image File | ||
| Formats | Same | Hamamatsu's NZAcquireMD .ndpi |
| file format | ||
| Image | ||
| Manipulation | ||
| Functions | Same | Panning, zooming, image |
| adjustments, annotations, and | ||
| distance/area measurements | ||
| Type of Software | ||
| Application | Windows based | Internet browser based |
| Device | ||
| Components | Scanner, Image Management | |
| Software and Display | Image Management Software | |
| Principle of | ||
| Operation | After WSI are acquired by using | |
| NanoZoomer S360MD Slide | ||
| scanner, the WSI are automatically | ||
| saved to the hard disk during | ||
| scanning and may be viewed later | ||
| by using the included viewing | ||
| software. During review, the | ||
| pathologist opens WSI from the | ||
| image storage attached to local | ||
| network, performs further QC and | ||
| reads WSI of the slides to make a | ||
| diagnosis. | After the WSI are acquired by | |
| using NanoZoomer S360MD Slide | ||
| scanner, the WSI are stored in | ||
| customer provided image storage. | ||
| During image review, the | ||
| pathologist opens the WSI | ||
| (displayed as .ndpi images) from | ||
| the image storage using Concentriq | ||
| Dx; performs further QC and then | ||
| reads the WSI to make a diagnosis. | ||
| User Interface | NZViewMD | Concentriq Dx |
7
8
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
9
| Performance data | Description |
|---|---|
| Pixel-wise comparison | A pixel-wise comparison test was performed to compare images |
| which were reproduced by Concentriq Dx and NZViewMD for the | |
| same NDPI file to validate identical image reproduction. Test results | |
| showed that the 95th percentile of pixelwise differences between | |
| Concentriq Dx and NanoZoomer S360MD Slide scanner system was | |
| greater than 3 CIEDE2000, indicating that their output images are not | |
| pixel-wise identical as Concentriq Dx applies image compression to | |
| its output. Based on the findings from bench testing, a clinical study | |
| was 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 slides | |
| using Concentriq Dx [manual digital read (MD)] is non-inferior to | |
| glass slide reads using optical (light) microscopy [manual optical | |
| (MO)]. The primary endpoint of the study was the difference in major | |
| discordance rates between MD and MO when compared to the | |
| reference (main) diagnosis, which was the original sign-out pathologic | |
| diagnosis using MO [ground truth, (GT)] rendered at the institution. | |
| 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 CI for the | |
| difference in the major discordance rate was 0.4%, which is less than | |
| the prespecified noninferiority threshold of 4%, therefore meeting the | |
| primary 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 Area | |
| and Distance | Measurement accuracy has been verified by comparing the |
| measurements of markings made in the Concentriq viewer to the | |
| measurements of markings on a calibrated cross scale slide with | |
| known sizes. The tests were used to validate the measurement | |
| accuracy of the subject device. 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. These results show that Concentriq performed | |
| accurate measurements with respect to its intended use. | |
| Performance data | Description |
| Human Factors | |
| Validation Study | Concentriq Dx has been found to be safe and effective for the intended users, uses and use environments. |
10
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.