(162 days)
Not Found
Yes
The intended use statement explicitly states that "Cina uses an artificial intelligence algorithm to analyze images".
No
The device is a radiological computer-aided triage and notification software. It does not treat or alleviate health conditions, but rather assists in workflow triage by flagging suspected findings for radiologists.
No
The "Intended Use / Indications for Use" section explicitly states, "The device does not alter the original medical image, and it is not intended to be used as a diagnostic device." Additionally, notifications and preview images are "not intended for diagnostic use beyond notification" and "not intended for primary diagnosis beyond notification." The device is intended for triage and workflow prioritization.
Yes
The device description explicitly states "Cina is a radiological computer-assisted triage and notification software device" and details its components as "algorithm-programmed components" and "standard off-the-shelf operating system and additional image processing applications," without mentioning any dedicated hardware components included with the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device's function: This device analyzes medical images (CT scans) of the head. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's a "radiological computer aided triage and notification software" and is intended to "assist hospital networks and trained radiologists in workflow triage." It explicitly states, "The device does not alter the original medical image, and it is not intended to be used as a diagnostic device."
- Nature of input: The input is medical imaging data (DICOM images), not biological samples.
Therefore, while it is a medical device used in a clinical setting, its function and intended use fall outside the scope of In Vitro Diagnostics. It is a software device that aids in the interpretation and prioritization of medical images.
No
The letter does not explicitly state that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
Intended Use / Indications for Use
Cina is a radiological computer aided triage and notification software indicated for use in the analysis of (1) non-enhanced head CT images and (2) CT angiography of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of (1) head CT images for Intracranial Hemorrhage (ICH) and (2) head CT angiography for large vessel occlusion (LVO) of the anterior circulation (distal ICA, MCA-M1 or proximal MCA-M2). Cina uses an artificial intelligence algorithm to analyze images and highlight cases with detected (1) ICH or (2) LVO on a standalone Web application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH or LVO findings. Notifications include compressed preview images that are meant for informational purposes only, and are not intended for diagnostic use bevond notification. The device does not alter the original medical image, and it is not intended to be used as a diagnostic device. The results of Cina are intended to be used in conjunction with other patient information and based on professional judgement to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.
Product codes (comma separated list FDA assigned to the subject device)
OAS
Device Description
Cina is a radiological computer-assisted triage and notification software device. The software system is based on algorithm-programmed components and is comprised of a standard off-the-shelf operating system and additional image processing applications. DICOM images are received, recorded and filtered before processing. The series are processed chronologically by running algorithms on each series to detect suspicious results of an intracranial hemorrhage (ICH) or a large vessel occlusion (LVO), then notifications on the flagged series are sent to the Worklist Application. The Worklist Application (on premise) displays the pop-up notifications of new studies with suspected findings when they come in, and provides both active and passive notifications. Active notifications are in the form of a small pop-up containing patient name, accession number and the type of suspected findings (ICH or LVO). All the non-enhanced head CT images and head CT angiography studies received by Cina device are displayed in the worklist and those on which the algorithms have detected a suspected finding (ICH or LVO) are marked with an icon (i.e., passive notification). In addition, a compressed, small black and white image that is marked "not for diagnostic use" is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification. Presenting the radiologist with notification facilitates earlier triage by allowing one to prioritize images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
(1) non-enhanced head CT images and (2) CT angiography of the head.
Anatomical Site
Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital networks and trained radiologists; The user is presented with notifications for cases with suspected ICH or LVO findings.
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
Avicenna.Al conducted a retrospective, blinded, multinational study with the Cina software with the primary endpoint to evaluate the software's performance in 1) non-contrast CT (NCCT) head images pertaining to patient with suspected intracranial hemorrhage (ICH) findings and 2) CT angiography (CTA) head series pertaining to patient with suspected large vessel occlusion (LVO) findings, in 814 and 476 clinical anonymized cases, respectively. The data was provided from 3 clinical sources (2 US and 1 OUS). There were 255 (31.3%) positive ICH (images with ICH) and 188 (39.5%) positive LVO (images with LVO) cases included in the analysis. Within the 188 LVO positive cases, 156 (83%) were US and 32 (17%) OUS. Both tested dataset (for ICH and LVO) contained a sufficient number of cases from important cohorts in terms of imaging acquisitions (e.g., scanner makers – GE, Siemens, Philips and Toshiba/Canon; number of detector rows, gantry tilt and slice thickness) and patients' groups (e.g., age, sex and US regions). Device sensitivities and specificities were compared to ground truth established by concurrence of three US-board-certified neuroradiologist readers.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Avicenna.Al conducted a retrospective, blinded, multinational study with the Cina software.
Sample size: 814 clinical anonymized cases for ICH; 476 clinical anonymized cases for LVO.
AUC: ICH: 0.94; LVO: 0.98.
Standalone performance: overall agreement (accuracy) of 95.6% for ICH and 97.7% for LVO.
Key results: Performance goals of 80% sensitivity and specificity were achieved for both ICH and LVO applications. The time-to-notification was 13.2 ± 2.9 seconds for ICH and 25.8 ± 7.0 seconds for LVO.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity and Specificity for the "ICH" prioritization and triage application are 91.4% (95% Cl: 87.2% – 94.5%) and 97.5% (95.8% – 98.6%), respectively.
Sensitivity and Specificity for the "LVO" prioritization and triage application are 97.9% (95% Cl: 94.6% - 99.4%) and 97.6% (95% Cl: 95.1% - 99%), respectively.
PPV and NPV are presented in Table 1 based on prevalence:
| Prevalence | Cina - ICH triage application | Cina - LVO triage application | ||
|---|---|---|---|---|
| PPV (%) | NPV (%) | PPV (%) | NPV (%) | |
| 10% | 80.2 | 99.0 | 81.7 | 99.8 |
| 15% | 86.6 | 98.5 | 87.7 | 99.6 |
| 20% | 90.1 | 97.8 | 91.0 | 99.5 |
| 25% | 92.4 | 97.1 | 93.1 | 99.3 |
| 30% | 94.0 | 96.3 | 94.5 | 99.1 |
| 35% | 95.2 | 95.5 | 95.6 | 98.8 |
| 40% | 96.1 | 94.4 | 96.4 | 98.6 |
| 45% | 96.8 | 93.2 | 97.1 | 98.2 |
| 50% | 97.3 | 91.9 | 97.6 | 97.9 |
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
Avicenna.ai % John Smith Partner Hogan Lovells US LLP 555 13th Street, NW WASHINGTON, DISTRICT OF COLUMBIA 20004
November 22, 2022
Re: K221716
Trade/Device Name: Cina Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological Computer Aided Triage And Notification Software Regulatory Class: Class II Product Code: OAS Dated: October 21, 2022 Received: October 25, 2022
Dear John Smith:
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
1
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 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 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,
Jessica Lamb
Jessica Lamb, 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement on last page
| 510(k) Number | K221716 |
|---|---|
| Device Name | Cina |
Indications for Use (Describe)
Cina is a radiological computer aided triage and notification software in the analysis of (1) not-enhanced head CT images and (2) CT angiography of the head.
The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of (1) head CT images for Intracranial Hemorthage (ICH) and (2) head CT angiography for large vessel occlusion (LVO) of the anterior circulation (distal ICA, MCA-M1 or proximal MCA-M2). Cina uses an artificial intelligence algorithm to analyze images and highlight cases with detected (1) ICH or (2) LVO on a standalone Web application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH or LVO findings.
Notifications include compressed preview images that are meant for informational purposes only, and are not intended for diagnostic use beyond notification. The device does not alter the original medical image, and it is not intended to be used as a diagnostic device.
The results of Cina are intended to be used in conjunction with other patient information and based on professional judgement to assist with triage/prioritization of medical images. Notified clinicians are ultimately reviewing full images per the standard of care.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. "
FORM FDA 3881 (6/20)
3
510(k) SUMMARY
AVICENNA.AI's Cina
l. Submitter
Applicant:
AVICENNA.AI Espace Mistral- Batiment A 297 Avenue du Mistral 13600 La Ciotat France
Contact Person:
Stephane Berger Regulatory Manager Phone: +33 612122813 E-mail: stephane.berger@avicenna.ai
John J. Smith, MD, JD Partner, Hogan Lovells US LLP Phone: +1 202 637 3638 E-mail: john.smith@hoganlovells.com
Date prepared: November, 22, 2022
II. Device Identification
| Name of Device: | Cina |
|---|---|
| Classification Name: | Radiological Computer-Assisted Triage And |
| Notification Software | |
| Regulation No: | 21 CFR § 892.2080 |
| Product Code: | QAS |
| Regulatory Class: | Class II |
| Classification Panel: | Radiology devices |
III. Predicate Device
The Cina is claimed to be substantially equivalent to Cina (K200855).
IV. Purpose of the Special 510(k) Notice
The modifications to Cina consist in minor software changes and labeling updates.
The main following modification that has been made is to the indications for use of the device within the labeling:
Indications for use have been modified with new information to include:
4
"large vessel occlusion (LVQ) of the anterior circulation (distal ICA, MCA-M1 or proximal MCA-M2)."
V. Intended Use / Indications for Use
Cina is a radiological computer aided triage and notification software indicated for use in the analysis of (1) non-enhanced head CT images and (2) CT angiography of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of (1) head CT images for Intracranial Hemorrhage (ICH) and (2) head CT angiography for large vessel occlusion (LVO) of the anterior circulation (distal ICA, MCA-M1 or proximal MCA-M2).
Cina uses an artificial intelligence algorithm to analyze images and highlight cases with detected (1) ICH or (2) LVO on a standalone Web application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH or LVO findings. Notifications include compressed preview images that are meant for informational purposes only, and are not intended for diagnostic use bevond notification. The device does not alter the original medical image, and it is not intended to be used as a diagnostic device.
The results of Cina are intended to be used in conjunction with other patient information and based on professional judgement to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.
VI. Device Description
Cina is a radiological computer-assisted triage and notification software device.
The software system is based on algorithm-programmed components and is comprised of a standard off-the-shelf operating system and additional image processing applications.
DICOM images are received, recorded and filtered before processing. The series are processed chronologically by running algorithms on each series to detect suspicious results of an intracranial hemorrhage (ICH) or a large vessel occlusion (LVO), then notifications on the flagged series are sent to the Worklist Application.
The Worklist Application (on premise) displays the pop-up notifications of new studies with suspected findings when they come in, and provides both active and passive notifications. Active notifications are in the form of a small pop-up containing patient name, accession number and the type of suspected findings (ICH or LVO). All the non-enhanced head CT images and head CT angiography studies received by Cina device are displayed in the worklist and those on which the algorithms have detected a suspected finding (ICH or LVO) are marked with an icon (i.e., passive notification). In addition, a compressed, small black and white image that is marked "not for diagnostic use" is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification. Presenting the radiologist with notification facilitates earlier triage by allowing one to prioritize images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.
VII. Summary of Technological Characteristics
The subject and predicate devices have the same technological characteristics.
5
Cina runs on a standard "off the shelf" server/workstation and is made of the following software components:
- . Cina Image Processing Applications including two applications: ICH and LVO;
- . Cina Platform server that includes the Worklist client application in which notifications from the Cina Image Processing applications (ICH and LVO) are received.
Cina receives scans identified by the Cina Platform or other compatible medical image communications device, processes them using algorithmic methods involving execution of multiple computational steps to identify suspected presence of ICH or LVO and generates results files to be transferred by Cina Platform or a similar medical image communications device for output to a PACS system or workstation for worklist prioritization. Each of these components is briefly described below.
VII.1. Cina Platform
The Cina platform is an example of medical image communications platform for integrating and deploying the Cina ICH and LVO image processing applications. It provides the necessary requirements for interoperability based on the standardized DICOM protocol and services to communicate with existing systems in the hospital radiology department such as CT modalities or other DICOM nodes (DICOM router or PACS for example). It is responsible for transferring, storing, converting formats, notifying of suspected findings and displaying medical device data such as radiological data. The Cina Platform server includes the Worklist client application in which notifications from the Cina Image Processing applications (ICH and LVO) are received.
VII.2. ICH Application
The ICH application includes the software algorithm responsible for identifying and quantifying image characteristics that are consistent with an ICH. This application reads provided DICOM files, checks the DICOM properties to verify the compatibility with the recommended acquisition protocol. launches the algorithm and provides notification results (when an ICH is detected) compatible with the Cina Platform and with DICOM format.
VII.3. LVO Application
The LVO application includes the software algorithm responsible for identifying and quantifying image characteristics that are consistent with an LVO. This application reads provided DICOM files, checks the DICOM properties to verify the compatibility with recommended acquisition protocol, launches the algorithm part and provides notification results (when a LVO is detected) compatible with the Cina Platform and with DICOM format.
VIII. Substantial Equivalence
The subject and predicate devices have a similar intended use, technological characteristics, and principles of operation. The only difference is that the intended use of the subject has been revised to include the vessels (arteries) for which the device was designed and tested to detect LVO (the anterior circulation: distal ICA, MCA-M1 or proximal MCA-M2). Both devices are intended to provide the users with notifications and unannotated preview images of suspect studies for the purpose of preemptive triage, and are therefore substantially equivalent. A table comparing the key features of the subject and predicate devices is provided below.
6
| Intended Use /
Indications for
Use | Subject device: Cina Software | Predicate device: Cina software
(K200855) |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Cina is a radiological computer
aided triage and notification
software indicated for use in the
analysis of (1) non-enhanced head
CT images and (2) CT angiography
of the head.
The device is intended to assist
hospital networks and trained
radiologists in workflow triage by
flagging and communicating
suspected positive findings of (1)
head CT images for Intracranial
Hemorrhage (ICH) and (2) CT
angiography of the head for large
vessel occlusion (LVO) of the
anterior circulation (distal ICA,
MCA-M1 or proximal MCA-M2). | Cina is a radiological computer aided
triage and notification software
indicated for use in the analysis of (1)
non-enhanced head CT images and
(2) CT angiographies of the head.
The device is intended to assist
hospital networks and trained
radiologists in workflow triage by
flagging and communicating
suspected positive findings of (1) head
CT images for Intracranial
Hemorrhage (ICH) and (2) CT
angiographies of the head for large
vessel occlusion (LVO). |
| | Cina uses an artificial intelligence
algorithm to analyze images and
highlight cases with detected (1)
ICH or (2) LVO on a standalone
Web application in parallel to the
ongoing standard of care image
interpretation. The user is
presented with notifications for
cases with suspected ICH or LVO
findings. | Cina uses an artificial intelligence
algorithm to analyze images and
highlight cases with detected (1) ICH
or (2) LVO on a standalone Web
application in parallel to the ongoing
standard of care image interpretation.
The user is presented with
notifications for cases with suspected
ICH or LVO findings. |
| | Notifications include compressed
preview images that are meant for
informational purposes only, and
are not intended for diagnostic use
beyond notification. The device
does not alter the original medical
image, and it is not intended to be
used as a diagnostic device. | Notifications include compressed
preview images that are meant for
informational purposes only, and are
not intended for diagnostic use beyond
notification. The device does not alter
the original medical image, and it is
not intended to be used as a
diagnostic device. |
| | The results of Cina are intended to
be used in conjunction with other
patient information and based on
professional judgment to assist with
triage/prioritization of medical
images. Notified clinicians are
ultimately responsible for reviewing
full images per the standard of care. | The results of Cina are intended to be
used in conjunction with other patient
information and based on professional
judgment to assist with
triage/prioritization of medical images.
Notified clinicians are ultimately
responsible for reviewing full images
per the standard of care. |
| | Subject device: Cina Software | Predicate device: Cina software (K200855) |
| User
population | Radiologist | Radiologist |
| Anatomical
region of
interest | Head | Head |
| Data
acquisition
protocol | Non contrast CT scan of the head
or neck and CT angiogram images
of the brain | Non contrast CT scan of the head or
neck and CT angiogram images of the
brain |
| View DICOM
data | DICOM information about the
patient, study and current image | DICOM information about the patient,
study and current image |
| Segmentation
of region of
interest | No; device does not mark, highlight,
or direct users' attention to a
specific location in the original
image | No; device does not mark, highlight, or
direct users' attention to a specific
location in the original image |
| Algorithm | Artificial intelligence algorithm with
database of images | Artificial intelligence algorithm with
database of images |
| Notification /
Prioritization | 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 |
| Structure | - LVO and ICH image processing
applications
- Cina Platform (worklist and Image
Viewer) | - LVO and ICH image processing
applications - Cina Platform (worklist and Image
Viewer) |
Table 1: Substantial Equivalence Chart
7
IX. Summary of Performance Data
The following performance data were provided in support of the substantial equivalence determination.
IX.1. Software Verification and Validation Testing
The Cina device has been evaluated and verified in accordance with software specifications and applicable performance standards through Software Development and Validation & Verification Process to ensure performance according to specifications, User Requirements and Federal Regulations and Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
IX. 2. Performance Testing
8
Avicenna.Al conducted a retrospective, blinded, multinational study with the Cina software with the primary endpoint to evaluate the software's performance in 1) non-contrast CT (NCCT) head images pertaining to patient with suspected intracranial hemorrhage (ICH) findings and 2) CT angiography (CTA) head series pertaining to patient with suspected large vessel occlusion (LVO) findings, in 814 and 476 clinical anonymized cases, respectively. The device's Sensitivity and Specificity were analyzed, in addition to time-to-notification.
The data was provided from 3 clinical sources (2 US and 1 OUS). There were 255 (31.3%) positive ICH (images with ICH) and 188 (39.5%) positive LVO (images with LVO) cases included in the analysis. Within the 188 LVO positive cases, 156 (83%) were US and 32 (17%) OUS. Both tested dataset (for ICH and LVO) contained a sufficient number of cases from important cohorts in terms of imaging acquisitions (e.g., scanner makers – GE, Siemens, Philips and Toshiba/Canon; number of detector rows, gantry tilt and slice thickness) and patients' groups (e.g., age, sex and US regions).
Device sensitivities and specificities were compared to ground truth established by concurrence of three US-board-certified neuroradiologist readers.
Sensitivity and Specificity for the "ICH" prioritization and triage application are 91.4% (95% Cl: 87.2% – 94.5%) and 97.5% (95.8% – 98.6%), respectively. These findings achieved the 80% performance goal and are the same as those reported for Cina - ICH (K200855, the predicate device.
The ROC curve shows an AUC of 0.94, which is also the same as for the predicate device.
Regarding the "LVO" prioritization and triage application, Sensitivity and Specificity of 97.9% (95% Cl: 94.6% - 99.4%) and 97.6% (95% Cl: 95.1% - 99%), respectively are observed. These results achieved the 80% performance goal and are the same as the ones reported for Cina - LVO (K200855), the predicate device.
The ROC curve shows an AUC of 0.98, which is also the same as for the predicate device.
The results of the standalone assessment study demonstrated an overall agreement (accuracy) of 95.6% and 97.7% for the "ICH" and "LVO" tested cases, respectively, when compared to the ground truth (operators' visual assessments).
Positive predictive value (PPV) and negative predictive value (NPV) with varying prevalence, for both applications, are presented in Table 1 below:
| Prevalence | Cina - ICH triage application | Cina - LVO triage application | ||
|---|---|---|---|---|
| PPV (%) | NPV (%) | PPV (%) | NPV (%) | |
| 10% | 80.2 | 99.0 | 81.7 | 99.8 |
| 15% | 86.6 | 98.5 | 87.7 | 99.6 |
| 20% | 90.1 | 97.8 | 91.0 | 99.5 |
| 25% | 92.4 | 97.1 | 93.1 | 99.3 |
| 30% | 94.0 | 96.3 | 94.5 | 99.1 |
| 35% | 95.2 | 95.5 | 95.6 | 98.8 |
Table 1: PPV and NVP values for ICH and LVO image processing applications
9
| 40% | 96.1 | 94.4 | 96.4 | 98.6 |
|---|---|---|---|---|
| 45% | 96.8 | 93.2 | 97.1 | 98.2 |
| 50% | 97.3 | 91.9 | 97.6 | 97.9 |
Additionally, both "ICH" and "LVO" prioritization and triage effectiveness were evaluated by the standalone per-case processing time of the device (time-to-notification), the results are presented in Table 2 below:
Table 2: Time-to-notification for ICH and LVO image processing applications
| Time-to-
Notification | MEAN ± SD
(seconds) | MEDIAN
(seconds) | Lower
95% CI
(seconds) | Upper
95% CI
(seconds) | MIN
(seconds) | MAX
(seconds) |
|--------------------------|------------------------|---------------------|------------------------------|------------------------------|------------------|------------------|
| Cina-ICH
(N = 814) | $13.2 \pm 2.9$ | 13.2 | 13.0 | 13.4 | 8.6 | 39.1 |
| Cina-LVO
(N = 476) | $25.8 \pm 7.0$ | 24.7 | 25.1 | 26.4 | 13.0 | 55.3 |
The standalone effectiveness assessment demonstrated a substantial equivalence of the Cina -ICH triage application when compared to the predicate device (Cina-ICH - K200855). Specifically, the Cina's "ICH" triage mean ± SD "time-to-notification" is estimated to 13.2 ± 2.9 seconds. This is similar to the one reported for the predicate device (Cina-ICH - K200855: 21.6 ± 4.4 seconds).
Regarding Cina - LVO triage application, the mean ± SD "time-to-notification" is estimated to 25.8 ± 7.0 seconds. This demonstrated a substantial equivalence with the predicate device (Cina-LVO - K200855: 34.7 ± 10.7 seconds).
The performance testing of the Cina device establishes that the subject device is as safe and effective as the predicate device. This established that the Cina device meets its intended use statement and is substantially equivalent to the predicate device.
X. Conclusions
The subject Cina device is as safe and effective as the predicate Cina, with the similar intended use, technological characteristics, and principles of operation. Including in the intended use the vessels (arteries) for which the device was designed and tested to detect LVO does not raise new or different questions of safety or effectiveness.