(85 days)
Yes
The "Intended Use / Indications for Use" section explicitly states that "CINA uses an artificial intelligence algorithm to analyze images".
No
Explanation: A therapeutic device is used to treat or prevent a disease or condition. This device is a diagnostic aid for assisting in the workflow triage of imaging, not for treatment.
No
The document explicitly states, "The device does not alter the original medical image, and it is not intended to be used as a diagnostic device." It also clarifies that notifications and preview images are "not intended for diagnostic use beyond notification" and are "meant for informational purposes only." The device's primary function is for workflow triage and prioritization.
Yes
The device is explicitly described as a "radiological computer-assisted triage and notification software device" and its components are listed as "algorithm-programmed components" and "standard off-the-shelf operating system and additional image processing applications." There is no mention of proprietary hardware being part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological specimens: In Vitro Diagnostics are designed to examine samples taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: CINA analyzes radiological images (CT scans) of the head. It does not interact with or analyze any biological specimens.
- The intended use is workflow triage and notification: The primary purpose of CINA is to assist in prioritizing medical images for review by trained radiologists, not to perform diagnostic tests on biological samples.
Therefore, CINA falls under the category of a medical device, specifically a radiological computer-assisted triage and notification software, but it is not an IVD.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The "Control Plan Authorized (PCCP) and relevant text" section explicitly states "Not Found".
Intended Use / Indications for Use
CINA is a radiological computer aided triage and notification software indicated for use in the analysis of (1) nonenhanced 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. 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.
Product codes
QAS
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 angiographies 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
non-enhanced head CT images, CT angiographies of the head
Anatomical Site
Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital networks and trained radiologists
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, multicenter, 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 (LVQ) 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. 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, multicenter, 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 (LVQ) findings, in 814 and 476 clinical anonymized cases, respectively.
Sensitivity and specificity for the "ICH" prioritization and triage application were observed to be 91.4% (95% Cl: 87.2% – 94.5%) and 97.5% (95% Cl: 95.8% – 98.6%), respectively. ROC curve showed an AUC of 0.94.
Regarding the "LVO" prioritization and triage application, Sensitivity of 97.9% (95% CI: 94.6% - 99.4%) and 97.6% (95% Cl: 95.1% - 99%), respectively were observed. ROC curve showed an AUC of 0.98.
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).
The standalone effectiveness assessment demonstrated a substantial equivalence of the CINA -ICH triage application when compared to the predicate device (BriefCase). Specifically, the CINA's "ICH" triage mean "time-to-notification" was estimated to be 21.6 seconds. This is similar to the one reported by the predicate BriefCase device (mean: 4.46 minutes).
Regarding CINA - "LVO" triage application, the mean "time-to-notification" was estimated to be 34.7 seconds. This demonstrated a substantial equivalence of the CINA - LVO triage application effectiveness when compared to the reference ContaCT device (mean: 7.32 minutes).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity (ICH): 91.4% (95% Cl: 87.2% – 94.5%)
Specificity (ICH): 97.5% (95% Cl: 95.8% – 98.6%)
AUC (ICH): 0.94
Sensitivity (LVO): 97.9% (95% CI: 94.6% - 99.4%)
Specificity (LVO): 97.6% (95% Cl: 95.1% - 99%)
AUC (LVO): 0.98
Accuracy (ICH): 95.6%
Accuracy (LVO): 97.7%
Time-to-Notification (ICH) MEAN ± SD: 21.6 ± 4.4 seconds
Time-to-Notification (ICH) MEDIAN: 20.4 seconds
Time-to-Notification (ICH) MIN: 14.4 seconds
Time-to-Notification (ICH) MAX: 53.3 seconds
Time-to-Notification (LVO) MEAN ± SD: 34.7 ± 10.7 seconds
Time-to-Notification (LVO) MEDIAN: 33.4 seconds
Time-to-Notification (LVO) MIN: 14.3 seconds
Time-to-Notification (LVO) MAX: 63.3 seconds
PPV and NPV are presented in Table 1:
| Prevalence | PPV (%) (ICH) | NPV (%) (ICH) | PPV (%) (LVO) | NPV (%) (LVO) |
|---|---|---|---|---|
| 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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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June 24, 2020
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AVICENNA.AI % John J. Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 Thirteenth Street, NW WASHINGTON DC 20004
Re: K200855
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: QAS Dated: March 31, 2020 Received: March 31, 2020
Dear Dr. 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 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
1
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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
Device Name
CINA
Indications for Use (Describe)
CINA is a radiological computer aided triage and notification software indicated for use in the analysis of (1) nonenhanced 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. 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.
| 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
AVICENNA.AI's CINA
I. Submitter
Applicant:
AVICENNA.AI 93 avenue des Sorbiers, Zone Athelia IV 13600 La Ciotat France
Contact Person:
Cyril Di Grandi CEO of Avicenna.Al Phone: +33 6 60 06 80 92 E-mail: cyril.di-grandi@avicenna.ai
Date prepared: March 31, 2020
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 device is substantially equivalent to the following FDA cleared predicate device with regard to indications for use, performance, and technological characteristics:
| 510(k): | K180647 |
|---|---|
| Trade Name: | BriefCase |
| Manufacturer: | AiDoc Medical, Ltd |
| Classification Name: | Radiological Computer-Assisted Triage And |
| Notification Software | |
| Regulation No: | 21 CFR § 892.2080 |
| Product Code: | QAS |
| Regulatory Class: | Class II |
4
A reference device is Viz.ai's ContaCT (DEN170073), which is a Class II device under the same requlation and product code as above.
IV. 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 angiographies 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.
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 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. 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.
5
VI. Summary of Technological Characteristics
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.
Each of these components is briefly described below.
VI.1. CINA Platform
The CINA platform is the technical platform for integrating and deploying CINA image processing applications. It provides the necessary requirements for interoperability 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, converting formats, notifying of suspected findings and display medical device data such as radiological data.
VI.2. ICH Application
The ICH application includes the software algorithm responsible for identifying 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.
VI.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.
VII. Summary of Performance Data
The following performance data were provided in support of the substantial equivalence determination.
VII.1. Software Verification and Validation Testing
6
The CINA device has been evaluated and verified in accordance with software specifications and applicable performance standards through Software Development and Validation Process to ensure performance according to specifications, User Requirements and Federal Requlations and Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
VII.2. Performance Testing
Avicenna.Al conducted a retrospective, blinded, multicenter, 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 (LVQ) 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.
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 were observed to be 91.4% (95% Cl: 87.2% – 94.5%) and 97.5% (95% Cl: 95.8% – 98.6%), respectively. These findings achieved the 80% performance goal and are similar to the results reported for the predicate device BriefCase (Aidoc Medical): Sensitivity and specificity of 93.6% (95% Cl: 86.6% - 97.6%) and 92.3% (95% CI: 85.4% - 96.6%), respectively. ROC curve showed an AUC of 0.94.
Regarding the "LVO" prioritization and triage application, Sensitivity of 97.9% (95% CI: 94.6% - 99.4%) and 97.6% (95% Cl: 95.1% - 99%), respectively were observed. These results achieved the 80% performance goal and are similar to the ones reported by the reference device ContaCT (Viz.Al): Sensitivity was 87.8% (95% Cl: 81.2% – 92.5%) and specificity was 89.6% (95% CI: 83.7% – 93.9%). ROC curve showed an AUC of 0.98.
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:
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| CINA - ICH triage application | CINA - LVO triage application | |||
|---|---|---|---|---|
| Prevalence | 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 |
Table 1: PPV and NVP values for ICH and LVO image processing applications
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:
| Time-to-Notification | MEAN ± SD | MEDIAN | MIN | MAX |
|---|---|---|---|---|
| (seconds) | (seconds) | (seconds) | (seconds) | |
| CINA - ICH | 21.6 ± 4.4 | 20.4 | 14.4 | 53.3 |
| CINA - LVO | 34.7 ± 10.7 | 33.4 | 14.3 | 63.3 |
The standalone effectiveness assessment demonstrated a substantial equivalence of the CINA -ICH triage application when compared to the predicate device (BriefCase). Specifically, the CINA's "ICH" triage mean "time-to-notification" was estimated to be 21.6 seconds. This is similar to the one reported by the predicate BriefCase device (mean: 4.46 minutes).
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Regarding CINA - "LVO" triage application, the mean "time-to-notification" was estimated to be 34.7 seconds. This demonstrated a substantial equivalence of the CINA - LVO triage application effectiveness when compared to the reference ContaCT device (mean: 7.32 minutes).
The performance testing of the CINA device establishes that the subject device is as safe and effective as the predicate and reference devices. This established that the CINA device meets its intended use statement and is substantially equivalent to the predicate and reference devices.
VIII. Substantial Equivalence
The subject CINA for ICH and LVO prioritization and triage, the predicate device BriefCase device for ICH triage and the reference Viz.Al for LVO triage are all intended to aid in prioritization and triage of radiological images for ICH and/or LVO. The labeling of the subject and the predicate devices clearly states that the devices are not for diagnostic use. All devices are software packages with similar technological characteristics and principles of operation, and incorporate deep learning Al algorithms that process images, and software to send notifications and to display unannotated preview images. In all three devices, the labeling instructs the user to further evaluate and diagnose based only on the original images in the local PACS.
All three devices operate in parallel to the standard of care workflow in the sense that they do not change the original image, do not provide any marking on the output preview, and do not remove images from the standard of care FIFO queue, thus not disturbing standard interpretation of the images by the attending radiologists. The subject, predicate and reference devices achieve performance of the time-to-notification metric in similar ranges of time, and thus contribute similarly to effective triage and early involvement of the radiologist in evaluating suspected images of ICH and/or LVO.
The standalone performance and effectiveness assessment studies demonstrated that the CINA device performs as intended is therefore substantially equivalent to the BriefCase and Viz.Al reference devices.
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Table 3 compares the key features of the subject and the predicate and reference devices.
| Table 3: Comparison of key features between CNA and predicate device (Aidoc BriefCase) and reference device (Viz.Al ContaCT) | |||||
|---|---|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------ | -- | -- | -- | -- | -- |
| | Subject device: CINA Software | Predicate device: Aidoc BriefCase
Software (K180647) | Reference device: Viz.AI ContaCT
software (DEN170073) |
|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
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 | BriefCase is a radiological computer
aided triage and notification software
indicated for use in the analysis of
non-enhanced head CT images.
The device is intended to assist
hospital networks and trained
radiologists in workflow triage by
flagging and communication of
suspected positive findings of
pathologies in head CT images,
namely Intracranial Hemorrhage
(ICH).
BriefCase uses an artificial
intelligence algorithm to analyze
images and highlight cases with
detected ICH on a standalone
desktop application in parallel to the
ongoing standard of care image
interpretation. The user is presented
with notifications for cases with
suspected ICH findings.
Notifications include compressed | ContaCT 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.
ContaCT uses an artificial intelligence
algorithm to analyze images for
findings suggestive of a pre-specified
clinical condition and to notify an
appropriate medical specialist of
these findings in parallel to standard
of care image interpretation.
Identification of suspected findings is
not for diagnostic use beyond
notification. Specifically, the device
analyzes CT angiogram images of
the brain acquired in the acute setting
and sends notifications to a
neurovascular specialist that a
suspected large vessel occlusion has
been identified and recommends
review of those images. Images can |
| | Subject device: CINA Software | Predicate device: Aidoc BriefCase
Software (K180647) | Reference device: Viz.Al ContaCT
software (DEN170073) |
| | 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 judgment to assist with
triage/prioritization of medical
images. Notified clinicians are
ultimately responsible for reviewing
full images per the standard of care. | preview images that are meant for
informational purposes only and not
intended for diagnostic use beyond
notification. The device does not alter
the original medical image and is not
intended to be used as a diagnostic
device.
The results of BriefCase 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
responsible for viewing full images
per the standard of care. | be previewed through a mobile
application.
Images that are previewed through
the mobile application are
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. ContaCT 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. |
| User population | Radiologist | Radiologist | Clinician (e.g., neurovascular
specialist) |
| Anatomical region
of interest | Head | Head | Head |
| Data acquisition
protocol | Non contrast CT scan of the head or
neck and CT angiogram images of | Non contrast CT scan of the head or
neck | CT angiogram images of the brain |
| | Subject device: CINA Software | Predicate device: Aidoc BriefCase Software (K180647) | Reference device: Viz.Al ContaCT software (DEN170073) |
| | the brain | | |
| View DICOM data | DICOM information about the patient, study and current image | 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 | 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 | Artificial intelligence algorithm |
| Notification / Prioritization | Yes | 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. | Presentation of a small, compressed, black and white preview image that is labeled "Not for diagnostic use". |
| Alteration of original image | No | No | No |
| Removal of cases from worklist queue | No | No | No |
| Structure | - LVO and ICH image processing | - AHS module (image acquisition), | - Image Forwarding Software |
| Subject device: CINA Software | Predicate device: Aidoc BriefCase
Software (K180647) | Reference device: Viz.Al ContaCT
software (DEN170073) | |
| applications
- CINA Platform (worklist and Image
Viewer) | - ACS module (image processing), - Aidoc Worklist application for
workflow integration (worklist and
Image Viewer). | - Image Processing and Analysis
Software - Non-diagnostic DICOM viewing
mobile application | |
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