(111 days)
Yes
The "Intended Use / Indications for Use" section explicitly states that "CINA CHEST uses an artificial intelligence algorithm to analyze images".
No
Explanation: The device is a software for workflow triage and notification of suspected findings, not for direct treatment or therapy. It assists in prioritizing images for radiologist review and does not provide therapeutic intervention.
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."
Yes
The device is explicitly described as a "radiological computer-assisted triage and notification software device" and its components are listed as a 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, CINA CHEST is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to obtain information for diagnostic or monitoring purposes.
- CINA CHEST's Function: CINA CHEST analyzes medical images (CT angiography) that are already acquired from the patient. It does not interact with or analyze biological specimens.
- 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 it is "not intended to be used as a diagnostic device."
- Device Description: The description reinforces that it processes DICOM images and provides notifications based on image analysis.
Therefore, CINA CHEST falls under the category of medical image analysis software, not In Vitro Diagnostics.
No
The letter explicitly states "Not Found" under the "Control Plan Authorized (PCCP) and relevant text" section, indicating no PCCP was approved or cleared.
Intended Use / Indications for Use
CINA CHEST is a radiological computer aided triage and notification software indicated for use in the analysis of Chest and Thoraco-abdominal CT angiography. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of (1) Chest CT angiography for Pulmonary Embolism (PE) and (2) Chest or Thoraco-abdominal CT angiography for Aortic Dissection (AD).
CINA CHEST uses an artificial intelligence algorithm to analyze images and highlight cases with detected PE and AD 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 PE or AD 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 CHEST 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 CHEST 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 suspected positive findings of a pulmonary embolism (PE) or an aortic dissection (AD), 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 (PE or AD). All the chest and thoraco-abdominal CT angiography studies received by CINA CHEST device are displayed in the worklist and those on which the algorithms have detected a suspected finding (PE or AD) 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
CT Angiography
Anatomical Site
Chest and Thoraco-abdominal
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, multicenter and blinded study with the CINA CHEST software with the primary endpoint to evaluate the software's performance in 1) Chest CT angiography (CTA) images pertaining to patient with suspected Pulmonary Embolism (PE) findings and 2) Chest or Thoraco-abdominal CT angiography (CTA) images series pertaining to patient with suspected Aortic Dissection (AD) findings, in 396 and 298 clinical anonymized cases, respectively.
The data was provided from multiple US clinical sites: 230 and 200 US cities, for PE and AD, respectively. There were 190 (48%) positive PE (images with PE) cases and 137 (46%) positive AD (images with AD) cases included in the analyses.
Device sensitivities and specificities were compared to ground truth established by concurrence of several US-board-certified radiologist readers.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Retrospective, multicenter and blinded study.
Sample size: 396 clinical anonymized cases for PE, and 298 clinical anonymized cases for AD.
Standalone performance:
Sensitivity and Specificity for the "PE" prioritization and triage application were found to be 91.1% [95% CI: 86.1% - 94.7 %] and 91.8% [95% Cl: 87.1% - 95.1%], respectively.
Regarding the "AD" prioritization and triage application, Sensitivity and Specificity of 96.4% (95% Cl: 91.7% - 98.8%] and 97.5% [95% Cl: 93.8% - 99.3%], respectively, were obtained.
The results of the standalone assessment study demonstrated an overall agreement (Accuracy) of 91.4% and 97% for the "PE" and "AD" tested cases, respectively, when compared to the ground truth (operators' visual assessments).
Regarding Matthews correlation coefficient (MCC), the found values were 0.83 and 0.94, which represent very good predictions.
Additionally, both "PE" and "AD" prioritization and triage effectiveness were evaluated by the standalone per-case processing time of the device (time-to-notification):
CINA CHEST - PE (N = 396): MEAN ± SD (seconds) 63 ± 16.1, MEDIAN (seconds) 60.8, Lower Confidence Limit (seconds) 61.5, Upper Confidence Limit (seconds) 64.6, MIN (seconds) 36.6, MAX (seconds) 122.7
CINA CHEST - AD (N = 298): MEAN ± SD (seconds) 36.5 ± 9.1, MEDIAN (seconds) 34.1, Lower Confidence Limit (seconds) 35.4, Upper Confidence Limit (seconds) 37.5, MIN (seconds) 17.8, MAX (seconds) 90.5
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity and Specificity for the "PE": 91.1% [95% CI: 86.1% - 94.7 %] and 91.8% [95% Cl: 87.1% - 95.1%], respectively.
Sensitivity and Specificity for the "AD": 96.4% (95% Cl: 91.7% - 98.8%] and 97.5% [95% Cl: 93.8% - 99.3%], respectively.
Overall agreement (Accuracy) for "PE": 91.4%
Overall agreement (Accuracy) for "AD": 97%
Matthews correlation coefficient (MCC) for "PE": 0.83
Matthews correlation coefficient (MCC) for "AD": 0.94
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.
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
May 19, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Avicenna.AI % John J. Smith, M.D., Ph.D. Partner Hogan Lovells US LLP 555 13th St. NW WASHINGTON DC 20004
Re: K210237
Trade/Device Name: CINA CHEST Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological Computer aided triage and notification software Regulatory Class: Class II Product Code: QAS Dated: April 23, 2021 Received: April 23, 2021
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- 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.
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
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 below
510(k) Number (if known)
K210237
Device Name
CINA CHEST
Indications for Use (Describe)
CINA CHEST is a radiological computer aided triage and notification software indicated for use in the analysis of Chest and Thoraco-abdominal CT angiography. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of (1) Chest CT angiography for Pulmonary Embolism (PE) and (2) Chest or Thoraco-abdominal CT angiography for Aortic Dissection (AD).
CINA CHEST uses an artificial intelligence algorithm to analyze images and highlight cases with detected PE and AD 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 PE or AD 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 CHEST are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notfiled 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)
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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3
510(k) SUMMARY
AVICENNA.AI's CINA CHEST
l. Submitter
Applicant:
AVICENNA.AI 93 avenue du Sorbiers, Zone Athelia IV 13600 La Ciotat France
Contact Person:
Stephane Berger Regulatory Manager Phone: +33 6 12 12 28 13 E-mail: stephane.berger@avicenna.ai
Date prepared: January 28, 2021
II. Device Identification
| Name of Device: | CINA CHEST |
|---|---|
| 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 CHEST device is substantially equivalent to the following predicate device with regard to indications for use, performance, and technological characteristics:
| 510(k): | K190072 |
|---|---|
| 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 Avicenna.Ai's CINA (K200855), which is a Class II device under the same regulation and product code as above.
IV. Device Description
CINA CHEST 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 suspected positive findings of a pulmonary embolism (PE) or an aortic dissection (AD), 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 (PE or AD). All the chest and thoraco-abdominal CT angiography studies received by CINA CHEST device are displayed in the worklist and those on which the algorithms have detected a suspected finding (PE or AD) 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 CHEST is a radiological computer aided triage and notification software indicated for use in the analysis of Chest and Thoraco-abdominal CT angiography. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of (1) Chest CT angiography for Pulmonary Embolism (PE) and (2) Chest or Thoracoabdominal CT angiography for Aortic Dissection (AD).
CINA CHEST uses an artificial intelligence algorithm to analyze images and highlight cases with detected PE and AD 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 PE or AD 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 CHEST 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 CHEST runs on a standard "off the shelt" server/workstation and is comprised of PE and AD Image Processing Applications, which can be integrated, deployed and used with the reference device (K200855) or other compatible medical image communications devices. CINA CHEST receives CTA 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 PE or AD 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.
VI.1. CINA Platform
The CINA platform is an example of medical image communications platform for integrating and deploying the CINA CHEST PE and AD 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 CHEST Image Processing applications (PE and AD) are received. The CINA Platform and base functions were cleared in the reference device (K200855).
VI.2. PE Application
The PE application includes the software algorithm responsible for identifying image characteristics that are consistent with a Pulmonary Embolism (PE). 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 a PE is detected) compatible with the CINA Platform and with DICOM format.
VI.3. AD Application
The AD application includes the software algorithm responsible for identifying and quantifying image characteristics that are consistent with an Aortic Dissection (AD). This application reads provided DICOM files, checks the DICOM properties to verify the compatibility with the recommended acquisition protocol, launches the algorithm part and provides notification results (when an AD is detected) compatible with the CINA Platform and with DICOM format.
6
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
The CINA CHEST device has been evaluated and verified in accordance with software specifications and applicable performance standards through a 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".
The mutual compatibility with the CINA Platform has been verified through the V&V activities that have been conducted at the system level to ensure the safe and proper use of the system. Special attention has been paid to:
- . DICOM analysis,
- Processing pipeline, ●
- Front-end interface, and .
- Notifications for suspected findings performances. ●
VII.2. Performance Testing
Avicenna.Al conducted a retrospective, multicenter and blinded study with the CINA CHEST software with the primary endpoint to evaluate the software's performance in 1) Chest CT angiography (CTA) images pertaining to patient with suspected Pulmonary Embolism (PE) findings and 2) Chest or Thoraco-abdominal CT angiography (CTA) images series pertaining to patient with suspected Aortic Dissection (AD) findings, in 396 and 298 clinical anonymized cases, respectively.
The data was provided from multiple US clinical sites: 230 and 200 US cities, for PE and AD, respectively. There were 190 (48%) positive PE (images with PE) cases and 137 (46%) positive AD (images with AD) cases included in the analyses.
Device sensitivities and specificities were compared to ground truth established by concurrence of several US-board-certified radiologist readers.
Sensitivity and Specificity for the "PE" prioritization and triage application were found to be 91.1% [95% CI: 86.1% - 94.7 %] and 91.8% [95% Cl: 87.1% - 95.1%], respectively.
Regarding the "AD" prioritization and triage application, Sensitivity and Specificity of 96.4% (95% Cl: 91.7% - 98.8%] and 97.5% [95% Cl: 93.8% - 99.3%], respectively, were obtained.
All 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 90.6% [95% Cl: 82.2% -95.9%] and 89.9% [95% Cl: 82.2% - 95.1%], respectively.
7
The results of the standalone assessment study demonstrated an overall agreement (Accuracy) of 91.4% and 97% for the "PE" and "AD" tested cases, respectively, when compared to the ground truth (operators' visual assessments).
Regarding Matthews correlation coefficient (MCC), the found values were 0.83 and 0.94, which represent very good predictions.
Additionally, both "PE" and "AD" prioritization and triage effectiveness were evaluated by the standalone per-case processing time of the device (time-to-notification), with the results are presented in Table 1 below:
| Time-to-
Notification | MEAN ±
SD
(seconds) | MEDIAN
(seconds) | Lower
Confidence
Limit
(seconds) | Upper
Confidence
Limit
(seconds) | MIN
(seconds) | MAX
(seconds) |
|---------------------------------|---------------------------|---------------------|-------------------------------------------|-------------------------------------------|------------------|------------------|
| CINA CHEST -
PE
(N = 396) | $63 \pm 16.1$ | 60.8 | 61.5 | 64.6 | 36.6 | 122.7 |
| CINA CHEST -
AD
(N = 298) | $36.5 \pm 9.1$ | 34.1 | 35.4 | 37.5 | 17.8 | 90.5 |
Table 1: Time-to-Notification for PE and AD Image Processing Applications
The standalone triage effectiveness assessment demonstrated substantial equivalence of the CINA CHEST triage applications when compared to the predicate (BriefCase) and reference (CINA) devices. Specifically, mean "time-to-notification" were estimated to be 63 [95% Cl: 61.5 – 64.6] seconds and 36.5 [95% Cl: 35.4 – 37.5] seconds for CINA CHEST – PE and CINA CHEST – AD, respectively. This is similar to the times reported by the predicate BriefCase device (mean 3.9 [95% Cl: 3.7 - 4.1] minutes) and the reference CINA device (21.6 ± 4.4 seconds and 34.7 ± 10.7 seconds, for ICH and LVO, respectively).
The performance testing of the CINA CHEST device establishes that the subject device is as safe and effective as the predicate and reference devices. This establishes that the CINA CHEST device meets its intended use and is substantially equivalent to the predicate and reference devices.
VIII. Substantial Equivalence
The subject CINA CHEST for PE and AD prioritization and triage and the predicate device BriefCase device for PE triage are both intended to aid in prioritization and triage of radiological images of time sensitive findings for patient detection and diagnosis (i.e. Pulmonary Embolism and Aortic Dissection) based on the analysis of medical images acquired from radiological signal acquisition systems. The CINA reference device provides the CINA Platform in which the subject CINA CHEST PE and AD prioritization and triage applications can be integrated, deployed and used. The labeling of the subject and the predicate devices clearly states that the devices are not for diagnostic use. All devices are
8
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.
The subject CINA CHEST, the predicate device BriefCase and the reference device CINA 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 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 PE and/or AD.
The standalone performance and effectiveness assessment studies demonstrated that the CINA CHEST device performs as intended is therefore substantially equivalent to the BriefCase predicate and CINA reference devices.
Table 2 compares the key features of the subject and the predicate and reference devices.
| | Subject device: CINA
CHEST Software | Predicate device: Aidoc
BriefCase Software
(K190072) | Reference device:
Avicenna.AI CINA
software (K200855) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
/ Indications
for Use | CINA CHEST is a
radiological computer
aided triage and
notification software
indicated for use in the
analysis of Chest and
Thoraco-abdominal CT
angiography. The device
is intended to assist
hospital networks and
trained radiologists in
workflow triage by
flagging and
communicating
suspected positive
findings of (1) Chest CT
angiography for
Pulmonary Embolism
(PE) and (2) Chest or
Thoraco-abdominal CT | BriefCase is a
radiological computer
aided triage and
notification software
indicated for use in the
analysis of non-enhanced
head CT and CTPA
images.
The device is intended to
assist hospital networks
and trained radiologists in
workflow triage by
flagging and
communication of
suspected positive
findings of Intracranial
Hemorrhage (ICH) and
Pulmonary Embolism
(PE) pathologies. For the
PE pathology, the | 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 |
| Subject device: CINA
CHEST Software | Predicate device: Aidoc
BriefCase Software
(K190072) | Reference device:
Avicenna.AI CINA
software (K200855) | |
| angiography for Aortic
Dissection (AD).
CINA CHEST uses an
artificial intelligence
algorithm to analyze
images and highlight
cases with detected PE
and AD 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 PE or AD
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
CHEST 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 | software is only intended
to be used on single-
energy exam.
BriefCase uses an
artificial intelligence
algorithm to analyze
images and highlight
cases with detected
findings 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 findings.
Notifications include
compressed 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. | 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. | |
| | Subject device: CINA
CHEST Software | Predicate device: Aidoc
BriefCase Software
(K190072) | Reference device:
Avicenna.AI CINA
software (K200855) |
| | full images per the
standard of care. | | |
| User
population | Radiologist | Radiologist | Radiologist |
| Anatomical
region of
interest | Chest | Head and chest | Head |
| Data
acquisition
protocol | Chest and Thoraco-
abdominal CT
angiography | Non contrast head CT
scan and CTPA (single
energy exams only) | 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 | 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 small,
compressed, black and
white preview image that
is labeled "not for
diagnostic use";
The device operates in
parallel with the standard
of care, which remains
the default option for all | Presentation of a small,
compressed, black and
white preview image that
is labeled "not for
diagnostic use";
The device operates in
parallel with the standard
of care, which remains
the default option for all | 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. |
| | Subject device: CINA
CHEST Software | Predicate device: Aidoc
BriefCase Software
(K190072) | Reference device:
Avicenna.AI CINA
software (K200855) |
| | cases. | cases. | |
| Alteration of
original
image | No | No | No |
| Removal of
cases from
worklist
queue | No | No | No |
| Structure | - PE and AD image
processing applications
- Compatibility of use
with the CINA Platform
reference device
(worklist and Image
Viewer) | - AHS module (image
acquisition), - ACS module (image
processing), - Aidoc Worklist
application for workflow
integration (worklist and
non-diagnostic basic
Image Viewer). | - LVO and ICH image
processing applications - CINA Platform (worklist
and Image Viewer) |
Table 2: Comparison of Key Features between CINA CHEST and Predicate Device (Aidoc BriefCase) and Reference Device (Avicenna.Al CINA)
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