(377 days)
Not Found
No
The summary describes a software device for viewing and managing digital pathology images, focusing on image reproduction and clinical non-inferiority to traditional microscopy. There is no mention of AI, ML, or any algorithms that would suggest automated analysis or interpretation beyond basic image display and management.
No
Explanation: The device is intended for viewing and managing digital images of pathology slides to aid pathologists in diagnosis, not for treating any condition or directly providing therapy.
Yes
Novo is described as an aid to the pathologist to "review, interpret, and manage digital images of these slides for primary diagnosis," and an "aid pathology professionals in the viewing, interpretation, and management of digital whole slide images (WSIs)". Further, under "Intended Use", it states that "It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision." These statements explicitly connect the device to the process of making a diagnosis.
Yes
The device description explicitly states "The PathAI Novo device is a web-based software-only device". While it interacts with hardware (scanner, display), the device itself, as described and regulated, is solely the software component.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that Novo is "an aid to the pathologist to review, interpret, and manage digital images of these slides for primary diagnosis." Primary diagnosis is a key function within the in vitro diagnostic process, where a pathologist examines biological specimens (in this case, tissue slides) to determine the presence or absence of disease.
- Specimen Type: The device is intended for use with "digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue." This is a type of biological specimen commonly used in diagnostic pathology.
- Role in Diagnosis: While it's a software-only device and an "aid," its role is directly tied to the interpretation of diagnostic images for the purpose of making a primary diagnosis.
- Clinical Study: The inclusion of a clinical study comparing digital reads to glass slide reads for diagnostic purposes further supports its classification as an IVD. The study's primary endpoint is related to diagnostic accuracy (major discordance rates).
- Predicate Device: The predicate device listed, Philips IntelliSite Pathology Solution (PIPS), is also an IVD system for digital pathology.
The fact that it's software-only and doesn't perform the initial scanning or staining doesn't preclude it from being an IVD. Its function in the interpretation and management of diagnostic images for primary diagnosis places it within the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
Novo is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret, and manage digital images of these slides for primary diagnosis. Novo is not intended for use with frozen sections, cytology, or non- FFPE hematopathology specimens.
It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. Novo is intended for use with the Philips Ultra Fast Scanner and the Barco PP27QHD or Philips PS27QHDCR display.
Product codes
QKQ
Device Description
The PathAI Novo device is a web-based software-only device that is intended to aid pathology professionals in the viewing, interpretation, and management of digital whole slide images (WSIs) of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue using the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS).
The proposed device is typically operated as follows:
-
- A user prepares and scans slides and reviews the slide quality in accordance with the PIPS UFS IFU and standard lab procedures. The Novo device workflow is initiated when a user uploads WSIs from the local file system to the cloud storage using Novo.
-
- After uploading WSIs to cloud storage using Novo, a user builds a patient accession using the patient's medical record number (MRN), date of birth (DOB) and accession ID to support linkage of one or more slides from a single procedure using patient identifiers in Novo.
-
- A pathologist uses the slide viewer to perform their primary diagnosis workflow including zooming and panning images.
After viewing all images belonging to a particular accession, the pathologist will make a diagnosis.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital whole slide images (WSIs) of scanned surgical pathology slides
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Pathologist / Not Found (implied clinical setting)
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 Novo and the Philips IntelliSite Pathology Solution Image Management System (PIPS/IMS) for the same iSyntax file to demonstrate identical image reproduction. Test results show that the color differences (ΔE00) between Novo and PIPS/IMS are not zero. Further, testing was conducted to compare Novo-generated images with JPEG-compressed PIPS/IMS-generated images. Test results show that the Novo-generated images are similar to PIPS/IMS-generated images that had been JPEG-compressed at quality 95. Based on the findings from bench testing, an additional 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 Novo [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, -2.05, 1.78) for all organs. The upper limit of the CI for the major discordance rate was 1.78%, which is less than the prespecified noninferiority threshold of 4%, therefore meeting the primary objective of the study.
Turnaround time: The system requirements have been fulfilled: Images load in less than 7 seconds when selected for viewing Images load in less than 10 seconds when panning or zooming
Human factors testing: Novo has been found to be safe and effective for the intended users, uses, and use environments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Major discordance rates between MD and GT compared to MO and GT were -0.1% (95% CI, -2.05, 1.78) for all organs. The upper limit of the CI for the major discordance rate was 1.78%.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left 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.
PathAI, Inc Katy Wack VP, Clinical Development & Regulatory Affairs PathAI, Inc. 1325 Boylston Street Suite 10000. Boston, MA 02215
September 1, 2022
Re: K212361
Trade/Device Name: Novo Regulation Number: 21 CFR 864.3700 Regulation Name: Whole slide imaging system Regulatory Class: Class II Product Code: QKQ
Dear Katy Wack:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 11, 2022. Specifically, FDA is updating this SE letter for errors in the correspondent name as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Shyam Kalavar, OHT7: Office of In Vitro Diagnostics, Phone: 301-796-6807, Email: shyam.kalavar@fda.hhs.gov.
Sincerely,
Shyam Kalavar -S
Shyam Kalavar Branch Chief Division of Molecular Genetics and Pathology 2 OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
August 11, 2022
Image /page/1/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
PathAI, LLC Katy Wack, Ph.D. VP, Clinical Development & Regulatory Affairs 120 Brookline Avenue Boston, Massachusetts 02215
Re: K212361
Trade/Device Name: Novo Regulation Number: 21 CFR 864.3700 Regulation Name: Whole Slide Imaging System Regulatory Class: Class II Product Code: QKO Dated: July 28, 2021 Received: July 30, 2021
Dear Katy Wack:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
2
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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shyam Kalavar -S 2022.08.11 16:53:55 -04'00'
Shyam Kalavar Deputy Branch Chief Division of Molecular Genetics and Pathology 2 OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K212361
Device Name Novo
Indications for Use (Describe)
Novo is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret, and manage digital images of these slides for primary diagnosis. Novo is not intended for use with frozen sections, cytology, or non- FFPE hematopathology specimens.
It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. Novo is intended for use with the Philips Ultra Fast Scanner and the Barco PP27QHD or Philips PS27QHDCR display.
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 Novo
Date Prepared: August 11, 2022
Submitter
PathAI, Inc. 1325 Boylston Street Suite 10000 Boston, MA 02215
Contact Person
Katy Wack Phone: (617) 500-8457
DEVICE
| Proprietary Name: | |
|---|---|
| Common Name: | |
| Classification Name: | |
| Regulation Section: | |
| Regulatory Classification: | |
| Product Code: | |
| Review Panel: |
PREDICATE DEVICE
Proprietary Name: Philips IntelliSite Pathology Solution (PIPS) Submission Number: DEN160056
Novo
Class II OKO
The PathAI Novo Viewer Whole Slide Imaging System
21 CFR 864.3700
88 - Pathology
DEVICE DESCRIPTION
The PathAI Novo device is a web-based software-only device that is intended to aid pathology professionals in the viewing, interpretation, and management of digital whole slide images (WSIs) of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue using the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS).
The proposed device is typically operated as follows:
-
- A user prepares and scans slides and reviews the slide quality in accordance with the PIPS UFS IFU and standard lab procedures. The Novo device workflow is initiated when a user uploads WSIs from the local file system to the cloud storage using Novo.
5
-
- After uploading WSIs to cloud storage using Novo, a user builds a patient accession using the patient's medical record number (MRN), date of birth (DOB) and accession ID to support linkage of one or more slides from a single procedure using patient identifiers in Novo.
-
- A pathologist uses the slide viewer to perform their primary diagnosis workflow including zooming and panning images.
After viewing all images belonging to a particular accession, the pathologist will make a diagnosis.
Novo operates with the following components:
Table 1: WSI scanner
| Manufacturer | Model |
|---|---|
| Philips Medical Systems Nederland B.V. | Ultra Fast Scanner (UFS) |
Table 2: WSI displays
| Manufacturer | Model |
|---|---|
| Barco N.V. | PP27QHD |
| Philips | PS27QHDCR |
Table 3: Computer environment/ System Requirements
| System | Details |
|---|---|
| Computer System | RAM: 4.0 GB |
| Display Calibration tool: MediCal QAWeb Agent for Philips and Barco | |
| Displays | |
| Display | Barco (PP27QHD) or Philips (PS27QHDCR) |
| Pixel resolution: 2560w x 1440h | |
| Panel type: Color LCD | |
| Technology: IPS technology with a-Si Thin Film Transistor | |
| Physical size: 648.5 mm x 423 mm x 91.3 mm (with backlight disc) | |
| Web Browser | Google Chrome 81.0 or later |
| Network | Internet access |
| Outbound traffic enabled to port 443 | |
| 25 Mbps download and upload speed |
6
INDICATIONS FOR USE/INTENDED USE
Novo is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret, and manage digital images of pathology slides for primary diagnosis. Novo is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. Novo is intended for use with the Philips Ultra Fast Scanner and the Barco PP27QHD or Philips PS27QHDCR display.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE
The following table summarizes the similarities and differences between the PathAI device and the predicate device, Philips IntelliSite Pathology Solution (PIPS).
| Attribute | Predicate Device | Proposed PathAI Device |
|---|---|---|
| Device Trade | ||
| Name | Philips IntelliSite Pathology Solution | |
| (PIPS) (DEN160056) | Novo | |
| Intended | ||
| Use/Indications | ||
| for Use | The Philips IntelliSite Pathology | |
| Solution (PIPS) is an automated digital | ||
| slide creation, viewing, and management | ||
| system. The PIPS 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 | ||
| PIPS is not intended for use with frozen | ||
| section, cytology, or non-FFPE | ||
| hematopathology specimens. |
The PIPS comprises the Image
Management System (IMS), the Ultra
Fast Scanner (UFS) and Display. The
PIPS 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 PIPS. | Novo is a software only device intended
for viewing and management of digital
images of scanned surgical pathology
slides prepared from formalin-fixed
paraffin embedded (FFPE) tissue. It is an
aid to the pathologist to review,
interpret, and manage digital images of
pathology slides for primary diagnosis.
Novo is not intended for use with frozen
sections, cytology, or non-FFPE
hematopathology specimens.
It is the responsibility of a qualified
pathologist to employ appropriate
procedures and safeguards to assure the
quality of the images obtained and,
where necessary, use conventional light
microscopy review when making a
diagnostic decision. Novo is intended for
use with the Philips Ultra Fast Scanner and
the Barco PP27QHD or Philips
PS27QHDCR display. |
| Product Code | PSY | OKO |
7
| Specimen Type | Surgical pathology H&E slides prepared
from FFPE tissue | Same |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image File
Format | Philips UFS iSyntax File | Philips UFS iSyntax File converted to
device specific image format |
| Image
Manipulation
Functions | Panning, zooming, color manipulation
function, annotations, and measurements
(distance & area) | Panning, zooming, notes |
| Type of
Software
Application | Internet Browser Based | Same |
| Device
Components | Ultra Fast Scanner (UFS), Image
Management System (IMS), Display | Image viewing Software (Novo) |
| Principle of
Operation | After WSI images are successfully
acquired by using PIPS UFS, the WSI
images are stored in IMS Application
Server & Storage software that is not
provided as part of the PIPS, but may be
located in a central server room separate
from the workstation with the IMS
viewing software and Display. During
review, the pathologist opens WSI images
from IMS Server & Storage, perform
further QC and reads WSI
images of the slides to make a diagnosis. | After WSI images are successfully
acquired by using PIPS UFS, the WSI
images are stored in the cloud. During
review, the pathologist opens WSI image
from storage (displayed as DZI images),
performs further QC and reads WSI
images of the slides to make a diagnosis. |
| Image Storage | Images are stored in an end user
provided image storage (PIPS IMS
Application Server & Storage) attached
to the local network | Images are stored in the cloud |
| End User's
Interface | PIPS Image Management System (IMS) | Novo |
Substantial Equivalence Comparison
The proposed device has the same Indications for Use and similar Functional and Technological Characteristics to the predicate Image Management System (IMS) application software and is therefore substantially equivalent to the predicate device.
PERFORMANCE DATA
| Performance data | Description |
|---|---|
| Pixel-wise comparison | A pixel-wise comparison test was performed to |
| compare images which were reproduced by Novo and | |
| the Philips IntelliSite Pathology Solution Image | |
| Management System (PIPS/IMS) for the same iSyntax | |
| file to demonstrate identical image reproduction. Test | |
| results show that the color differences ( $(\Delta)E00$ ) between | |
| Novo and PIPS/IMS are not zero. Further, testing was | |
| conducted to compare Novo-generated images with | |
| JPEG-compressed PIPS/IMS-generated images. Test |
8
| results show that the Novo-generated images are
similar to PIPS/IMS-generated images that had been
JPEG-compressed at quality 95. Based on the findings
from bench testing, an additional 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 Novo [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, -2.05, 1.78) for all organs. The upper limit of | |
| the CI for the major discordance rate was 1.78%, | |
| which is less than the prespecified noninferiority | |
| threshold of 4%, therefore meeting the primary | |
| objective of the study. | |
| Turnaround time | The system requirements have been fulfilled: |
| Images load in less than 7 seconds when selected for viewing Images load in less than 10 seconds when panning or zooming | |
| Human factors testing | Novo has been found to be safe and effective for the |
| intended users, uses, and use environments. |
CONCLUSION
Based on the information provided in this 510(k), the proposed PathAI device is substantially equivalent to the previously cleared predicate, when used with the PIPS UFS and Barco PP27QHD or Philips PS27QHDCR display. Please note that a clinical study was conducted to establish the Substantial Equivalence of the device.