(146 days)
Not Found
Yes
The device description explicitly states that it uses a "deep learning artificial intelligence algorithm" to analyze images.
No
The device is described as a "notification-only, parallel workflow tool" that identifies and communicates images of suspected ICH patients. It is explicitly stated that it "does not alter or remove the original medical image and is not intended to be used as a diagnostic device" and "should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis." This indicates it's an informational tool, not one that directly treats or diagnoses a condition.
No
The document explicitly states: "The device does not alter or remove the original medical image and is not intended to be used as a diagnostic device." and "NeuroICH is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis."
Yes
The device description explicitly states "NeurolCH is a software-only parallel workflow tool". It also describes the components as an image analysis module hosted on cloud and a mobile application, both of which are software components.
Based on the provided information, NeuroICH is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. NeuroICH analyzes medical images (CT scans), not biological specimens.
- The intended use explicitly states it's a "notification-only, parallel workflow tool" and "is not intended to be used as a diagnostic device." It assists in identifying potential issues in images for a specialist to review, but it does not perform a diagnostic test on a biological sample.
- The device description reinforces its role as a "software-only parallel workflow tool" that analyzes images and sends notifications.
While NeuroICH uses AI to analyze medical data and provides information that can be relevant to patient care, its function is focused on image analysis and workflow prioritization, not on performing a diagnostic test on a biological sample.
No
The input explicitly states "Control Plan Authorized (PCCP): Not Found", indicating no PCCP for this device.
Intended Use / Indications for Use
NeuroICH is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of suspected ICH patients to a specialist, independent of standard of care workflow.
The device uses an artificial intelligence algorithm to analyze non-contrast CT images of the head acquired in the acute setting for findings suggestive of intracranial hemorrhage (ICH) in parallel to the ongoing standard of care image interpretation and notify an appropriate clinician of these findings. Notifications include non-diagnostic preview images that are meant for informational purposes only. The device does not alter or remove the original medical image and is not intended to be used as a diagnostic device. Images can be previewed through a mobile application.
Notified clinicians are responsible for viewing high quality images on a diagnostic viewer per the standard of care and engaging in appropriate patient evaluation in conjunction with other patient information before making care-related decisions. NeuroICH is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
QAS
Device Description
NeurolCH is a software-only parallel workflow tool designed for use by hospital networks and trained clinicians to identify and communicate prioritized images of specific patients to an appropriate specialist such as neurovascular or neurosurgical specialist independent of the standard of care workflow. NeuroICH mainly consists of an image analysis module hosted on cloud, and a mobile application for preview of notification and non-diagnostic images. The standalone software device automatically receives and analyzes non-contrast head CT (NCCT) studies of patients undergoing stroke protocol, for image features that indicate the presence of an intracranial hemorrhage (ICH) using deep learning artificial intelligence algorithm, and upon detection of a suspected ICH case, sends a notification along with non-diagnostic image on mobile application to alert a specialist clinician.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Non-contrast CT images of the head
Non contrast CT scan of the head
Anatomical Site
Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital networks and trained clinicians
Neurovascular or Neurosurgical Specialist
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
A retrospective, blinded study was conducted to evaluate the software's performance in identifying non-contrast (NCCT) head CT scans containing intracranial hemorrhage (ICH). Primarily 376 studies were used with recognizable representation of positive and negative ICH cases (35.90 % ICH positive studies and 64.09 % normal studies).
Ground truth established by three US board certified Neurologists.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A retrospective, blinded study was conducted to evaluate the software's performance in identifying non-contrast (NCCT) head CT scans containing intracranial hemorrhage (ICH). Primarily 376 studies were used with recognizable representation of positive and negative ICH cases (35.90 % ICH positive studies and 64.09 % normal studies).
AUC: 0.9367
Sensitivity and specificity on the primary dataset were observed to be 94.81% (89.68% - 97.43%) and 92.53% (88.50% - 95.21%), respectively.
Accuracy: 93.35% (90.37% - 95.45%)
The average time to alert a specialist by NeurolCH was 0.37 +/- 0.20 minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 94.81% (89.68% - 97.43%)
Specificity: 92.53% (88.50% - 95.21%)
Accuracy: 93.35% (90.37% - 95.45%)
Area Under the Curve (AUC): 0.9367
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2080 Radiological computer aided triage and notification software.
(a)
Identification. Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations.
(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage (
e.g., improved time to review of prioritized images for pre-specified clinicians).(iii) Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts (
e.g., subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment.(iv) Stand-alone performance testing protocols and results of the device.
(v) Appropriate software documentation (
e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results).(2) Labeling must include the following:
(i) A detailed description of the patient population for which the device is indicated for use;
(ii) A detailed description of the intended user and user training that addresses appropriate use protocols for the device;
(iii) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality for certain subpopulations), as applicable;(iv) A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images;
(v) Device operating instructions; and
(vi) A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness (
e.g., improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (e.g., confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.
0
November 7, 2024
Image /page/0/Picture/1 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Neurocareai Inc. Junaid Siddiq Kalia Chief Executive Officer 8992 Preston Rd Ste 110-255 Frisco. Texas 75034
Re: K241719
Trade/Device Name: NeuroICH Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological Computer Aided Triage And Notification Software Regulatory Class: Class II Product Code: QAS Dated: October 8, 2024 Received: October 8, 2024
Dear Junaid Siddiq Kalia:
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 (the 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.
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"
1
(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); 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-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 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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-regulatory
2
assistance/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,
Samul for
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
NeurolCH
Indications for Use (Describe)
NeuroICH is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of suspected ICH patients to a specialist, independent of standard of care workflow.
The device uses an artificial intelligence algorithm to analyze non-contrast CT images of the head acquired in the acute setting for findings suggestive of intracranial hemorrhage (ICH) in parallel to the ongoing standard of care image interpretation and notify an appropriate clinician of these findings. Notifications include non-diagnostic preview images that are meant for informational purposes only. The device does not alter or remove the original medical image and is not intended to be used as a diagnostic device. Images can be previewed through a mobile application.
Notified clinicians are responsible for viewing high quality images on a diagnostic viewer per the standard of care and engaging in appropriate patient evaluation in conjunction with other patient information before making care-related decisions. NeuroICH is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
K241719
Image /page/4/Picture/3 description: The image is a blue banner with the words "NeuroCare.AI" in white. To the left of the text is a white outline of a brain. The banner is rectangular with rounded corners.
510(k) Summary of NeuroICH bv NEUROCAREAI INC
- Applicant Name: NEUROCAREAI INC. 8992 PRESTON RD STE 110-255 FRISCO, TX 75034 Phone Number: +1 (214) 346-6083 Whatsapp: +1 (469) 954-0346
- Contact Person: Junaid Kalia Chief Executive Officer Email: junaidkalia@neurocare.ai
- Date Prepared: June 12, 2024
Device Name and Classification
Name of Device: NeuroICH
Classification Name: Radiological Computer Aided Triage and Notification Software
Common Name: Intracranial Hemorrhage Detection and Notification Software
- Classification Panel: Radiology
- Regulation Number: 21 C.F.R. § 892.2080
Regulatory Class: Class II
Product Code: QAS
Predicate Device:
| Manufacturer | Device Name | Application Number |
|---|---|---|
| Viz.ai, Inc. | Viz ICH | K210209 |
5
Device Description:
NeurolCH is a software-only parallel workflow tool designed for use by hospital networks and trained clinicians to identify and communicate prioritized images of specific patients to an appropriate specialist such as neurovascular or neurosurgical specialist independent of the standard of care workflow. NeuroICH mainly consists of an image analysis module hosted on cloud, and a mobile application for preview of notification and non-diagnostic images. The standalone software device automatically receives and analyzes non-contrast head CT (NCCT) studies of patients undergoing stroke protocol, for image features that indicate the presence of an intracranial hemorrhage (ICH) using deep learning artificial intelligence algorithm, and upon detection of a suspected ICH case, sends a notification along with non-diagnostic image on mobile application to alert a specialist clinician.
Intended Use:
The intended use of NeurolCH software is to detect and notify neurovascular specialists or trained clinicians regarding the presence of intracranial hemorrhage in non-contrast head CT scan images. Intracranial hemorrhage is identified if any one of the subtypes - extradural, subdural, subarachnoid, intraparenchymal and intraventricular hemorrhages is detected. The device uses an artificial intelligence algorithm to analyze images in parallel to the ongoing standard of care image interpretation and present users with notifications and preview images of suspected ICH patients on the mobile application, that are meant for informational purposes only and not intended for diagnostic use.
Indications for Use:
NeurolCH is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of suspected ICH patients to a specialist, independent of standard of care workflow.
The device uses an artificial intelligence algorithm to analyze non-contrast CT images of the head acquired in the acute setting for findings suggestive of intracranial hemorrhage (ICH) in parallel to the ongoing standard of care image interpretation and notify an appropriate clinician of these findings. Notifications include non-diagnostic preview images that are meant for informational purposes only. The device does not alter or remove the original medical image and is not intended to be used as a diagnostic device. Images can be previewed through a mobile application.
Notified clinicians are responsible for viewing high quality images on a diagnostic viewer per the standard of care and engaging in appropriate patient evaluation in coniunction with other patient information before making care-related decisions. NeurolCH is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.
Comparison of Technological Characteristics:
The subject device and predicate device have equivalent indications for use as both of them analyze non-contrast head CT scans of the patients for the features suggestive of the same abnormality i.e., intracranial hemorrhage and upon detection send the notification to designated neurovascular or neurosurgical specialist.
The technological characteristics of subject and predicate devices are similar as both of them use the similar process of automatic data identification and transfer to send images from the local hospital network to a remote location for image storage, processing and analysis.
6
Both the subject and predicate device uses a deep learning artificial intelligence algorithm to analyze non-contrast CT scan images of the head and classify cases with suspected ICH in parallel to the ongoing standard of care image interpretation. Like the predicate device, the NeuroICH algorithm does not externalize any internal segmentation, analysis, or intermediate outputs used in determining if an ICH is present in the NCCT, nor does either algorithm mark, highlight or draw attention to the specific regions of the analyzed NCCT image.
Both NeurolCH and Viz ICH software supports a mobile application interface that allows a user to receive push notifications, preview related non-diagnostic images, and view patient details associated with a series. The NeurolCH mobile application is subject to the same non-diagnostic viewing limitations as the predicate and has the same non-diagnostic warning on the image viewing screen as the predicate. Furthermore, the mobile application for both the devices can perform similar image viewing functions (window level change, image rotation, zoom, scroll through a cine, slice change).
Similar to the predicate device, the NeurolCH software does not affect the normal standard of care workflow of the hospital and moreover does not remove cases from a reading queue of the hospital PACs system. In conclusion, the NeurolCH device is substantially equivalent to the predicate device, Viz ICH in terms of both indications for use and technological characteristics.
| Parameter | Subject Device
NeuroICH | Predicate Device
Viz ICH |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications of
use | NeurolCH is a notification-only,
parallel workflow tool for use by
hospital networks and trained
clinicians to identify and
communicate images of
suspected ICH patients to a
specialist, independent of
standard of care workflow. | Viz ICH is a notification-only,
parallel workflow tool for use by
hospital networks and trained
clinicians to identify and
communicate images of specific
patients to a specialist, independent
of standard of care workflow. |
| | The device uses an artificial
intelligence algorithm to analyze
non-contrast CT images of the
head acquired in the acute setting
for findings suggestive of
intracranial hemorrhage (ICH) in
parallel to the ongoing standard of
care image interpretation and
notify an appropriate clinician of
these findings. Notifications
include non-diagnostic preview
images that are meant for
informational purposes only. The
device does not alter or remove
the original medical image and is
not intended to be used as a
diagnostic device. Images can be | Viz ICH uses an artificial
intelligence algorithm to analyze
images for findings suggestive of a
prespecified clinical condition and
to notify an appropriate medical
specialist of these findings in
parallel to standard of care for
image interpretation. Identification
of suspected findings is not for
diagnostic use beyond notification.
Specifically, the device analyzes
non-contrast CT images of the brain
acquired in the acute setting, and
sends notifications to a
neurovascular or neurosurgical
specialist that a suspected
intracranial hemorrhage has been
identified and recommends review |
| | previewed through a mobile
application. | of those images. Images can be
previewed through a mobile
application. |
| | Notified clinicians are responsible
for viewing high quality images on
a diagnostic viewer per the
standard of care and engaging in
appropriate patient evaluation in
conjunction with other patient
information before making
care-related decisions. NeurolCH
is limited to analysis of imaging
data and should not be used
in-lieu of full patient evaluation or
relied upon to make or confirm
diagnosis. | Images that are previewed through
the mobile application may be
compressed and are for
informational purposes only and not
intended for diagnostic use beyond
notification. Notified clinicians are
responsible for viewing
non-compressed images on a
diagnostic viewer and engaging in
appropriate patient evaluation and
relevant discussion with a treating
physician before making
care-related decisions or requests.
Viz ICH is limited to analysis of
imaging data and should not be
used in-lieu of full patient evaluation
or relied upon to make or confirm
diagnosis. |
| Device
components | 1. Image forwarding module
configured on site machine at
hospital end for transferring
DICOM studies.
2. Image analysis software
algorithm hosted on AWS cloud
managed by NEUROCAREAI.
3. Mobile application software
module for review of notification
and non-diagnostic images.
4. Admin panel as web application
for registration and management
of systems, sites and clinicians
accounts. | 1. Image analysis software
algorithm hosted on Viz.ai's
servers.
2. Mobile application software
module for review of notification
and non-diagnostic images. |
| Anatomical
region
of
interest | Head | Head |
| Diagnostic
application | Notification only | Notification only |
| Intended user | Neurovascular or Neurosurgical
Specialist | Neurovascular or Neurosurgical
Specialist |
| Data
acquisition | Acquires medical image data from
DICOM compliant imaging
devices and modalities. | Acquires medical image data from
DICOM compliant imaging devices
and modalities. |
| Data
acquisition | Non contrast CT scan of the head | Non contrast CT scan of the head |
| | | |
| DICOM
compatible | Yes | Yes |
| View DICOM
data | DICOM Information about the
patient, study, and current image | DICOM Information about the
patient, study and current image |
| Segmentation
of the region
of interest | No; the device does not mark,
highlight, or direct users' attention
to a specific location in the
original image. | No; the device does not mark,
highlight, or direct users' attention
to a specific location in the original
image. |
| Al used | Yes | Yes |
| Notification | Yes | Yes |
| Preview
images | Presentation of a preview of the
study for initial assessment not
meant for diagnostic purposes.
The device operates in parallel
with the standard of care, which
remains the default option for all
cases. | Presentation of a preview of the
study for initial assessment not
meant for diagnostic purposes.
The device operates in parallel with
the standard of care, which remains
the default option for all cases. |
| Alteration
of
original image | No | No |
| Removal of
cases from
worklist queue | No | No |
| Abnormalities
triaged | ICH | ICH |
| Preview
image
information | Preview images returned to the
Mobile application for view. | Preview images returned to the
Mobile application for view. |
A table comparing the key features of the subject and predicate device is provided below:
7
8
Performance Data:
A retrospective, blinded study was conducted to evaluate the software's performance in identifying non-contrast (NCCT) head CT scans containing intracranial hemorrhage (ICH). Primarily 376 studies were used with recognizable representation of positive and neqative ICH cases (35.90 % ICH positive studies and 64.09 % normal studies) to calculate Sensitivity (Se), Specificity (Sp), Accuracy, Area Under the Curve (AUC) and Time-to-Notification (TTN) regarding suspected ICH case.
Sensitivity, specificity, AUC and accuracy were calculated as primary endpoints with 95% clopper-pearson confidence interval, comparing the NeurolCH's output to the ground truth as established by three US board certified Neurologists. Sensitivity and specificity on the primary dataset were observed to be 94.81% (89.68% - 97.43%) and 92.53% (88.50% - 95.21%), respectively. Because the lower bound of each confidence interval exceeded 80%, the study met the pre-specified performance goals of 80% for sensitivity and was comparative to the values achieved by the predicate device Viz ICH. In addition, the accuracy and area under the receiver operating characteristic curve (AUC) were 93.35% (90.37% -95.45%) and 0.9367 respectively, demonstrating the clinical utility and potential benefits of the classifier based on the imaging study results.
9
Image /page/9/Figure/2 description: The image is a plot of the receiver operating characteristic (ROC) curve. The ROC curve plots the true positive rate against the false positive rate. The ROC curve is a measure of the performance of a binary classification model. The area under the ROC curve (AUC) is 0.94, which indicates that the model has good performance. A dashed line is also plotted, which represents a model that has no skill.
The performance metrics were calculated for individual data distributions as well to showcase the evaluation on important data cohorts. The stratification of device performance is demonstrated in tables below:
| Device Performance by Age | ||
|---|---|---|
| Age Range (Years) | Sensitivity [95% CI] | Specificity [95% CI] |
| 22 to 50 | 94.87% (83.08% - 98.43%) | 89.86% (80.48% - 94.93%) |
| 50 to 70 | 95.83% (86.02% - 98.72%) | 92.05% (84.46% - 96.04%) |
| 70 + | 93.75% (83.13% - 97.73%) | 95.24% (88.39% - 98.06%) |
| Device Performance by Gender | ||
|---|---|---|
| Gender | Sensitivity [95% CI] | Specificity [95% CI] |
| Male | 93.07% (86.37% - 96.55%) | 90.91% (84.74% - 94.30%) |
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| Female | 100% (90% - 99.93%) | 96.92% (89.48% - 99.05%) |
|---|
| Device Performance by Slice Thickness | ||
|---|---|---|
| Slice Thickness | Sensitivity [95% CI] | Specificity [95% CI] |
| 2 mm ≤ Slice Thickness |