(89 days)
Yes
The device description explicitly states that it uses "deep learning algorithms" and a "deep learning model" to identify suspected incidental pulmonary embolisms. Deep learning is a subset of machine learning.
No.
The device is a computer-aided triage and notification software that assists in workflow by flagging suspected findings. It is explicitly stated that the device does not alter images and "is not intended to be used as a diagnostic device." Additionally, it performs no direct treatment or therapy.
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." It is described as a triage and notification software for workflow assistance, not for generating a diagnosis.
Yes
The device description explicitly states "CINA-iPE is a radiological computer aided triage and notification software device" and details its function as software running on standard hardware, processing images, and generating results for transfer to other systems. It does not include or require specific proprietary hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that CINA-iPE analyzes radiological images (CT scans) of patients. It does not process blood, tissue, urine, or any other biological specimen.
- The device's function is image analysis and workflow triage. Its purpose is to flag potential findings on medical images to assist radiologists in prioritizing cases. This is distinct from the function of an IVD, which is to provide information about a patient's health status based on the analysis of biological samples.
Therefore, CINA-iPE falls under the category of a medical device, specifically a radiological computer-aided triage and notification software, rather than an In Vitro Diagnostic.
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.
Intended Use / Indications for Use
CINA-iPE is a radiological computer-aided triage and notification software indicated for use in patients undergoing contrast-enhanced CT scans (not dedicated CTPA protocol) for other clinical indications than pulmonary embolism suspicion, including at least a part of the lung. The device is intended to assist hospital networks and appropriately trained radiologists in workflow triage by flagging and communicating suspected positive findings for incidental Pulmonary Embolism (iPE). The device is indicated for adults and transitional adolescents (18 to 21 years old but treated as adults).
CINA-iPE uses an artificial intelligence algorithm to analyze images and highlight cases with detected incidental PE on a standalone application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected incidental PE findings. The device is not designed to detect PE in subsegmental arteries.
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-iPE are intended to be used in conjunction with other patient information and based on their 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 (comma separated list FDA assigned to the subject device)
QAS
Device Description
CINA-iPE is a radiological computer aided triage and notification software device.
CINA-iPE runs on a standard "off the shelf" server/workstation and consists of an Image Processing Application, which can be integrated, deployed, and used with the CINA Platform (cleared under K200855) or other medical image communications devices. CINA-iPE receives contrast-enhanced CT scans (not dedicated CTPA protocol) including at least a part of the lung identified by the CINA Platform or other medical image communications device, processes them using deep learning algorithms involving the execution of multiple computational steps to identify the suspected presence of an incidental pulmonary embolism and generates results files to be transferred by CINA Platform or a similar medical image communications device for output to a PACS system or worklist prioritization.
To identify the suspected presence of pulmonary embolisms, the device uses a deep learning model trained end-to-end on 5.429 cases acquired from US and France, representing a distribution of PE sizes, locations and acquisition protocols, including multiple scanner models from Siemens, Philips, GE and Canon/Toshiba. Additional models are used to locate the aorta and main pulmonary artery, enabling assessment of the contrast timing. The lung's parenchyma is segmented to evaluate both the presence of the lungs in the field of view and to limit the region of interest for detecting the presence of pulmonary embolisms.
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 an incidental Pulmonary Embolism (iPE), then active notifications on the flagged series are sent to the Worklist Application.
The Worklist Application displays the active notification of new studies with suspected findings when they come in. All the contrast-enhanced CT studies received by CINA-iPE device are displayed in the worklist and those on which the algorithms have detected finding are marked with an icon (i.e., passive notification). In addition, a compressed, grayscale, unannotated 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 diagnostic use beyond notification.
Presenting the radiologist with notification facilitates earlier triage by allowing prioritization of images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care image interpretation practice alone.
The CINA platform is an example of medical image communications platform for integrating and deploying the CINA-iPE image processing application. The medical image communications device (i.e., the technical platform) 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 medical image communications server includes the Worklist client application in which notifications from the CINA-iPE Image Processing application are received.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
contrast-enhanced CT scans
Anatomical Site
lung, Chest or exams including at least a part of the lung
Indicated Patient Age Range
adults and transitional adolescents (18 to 21 years old but treated as adults).
Intended User / Care Setting
appropriately trained radiologists in workflow triage / hospital networks
Description of the training set, sample size, data source, and annotation protocol
The device uses a deep learning model trained end-to-end on 5.429 cases acquired from US and France, representing a distribution of PE sizes, locations and acquisition protocols, including multiple scanner models from Siemens, Philips, GE and Canon/Toshiba.
Description of the test set, sample size, data source, and annotation protocol
Avicenna. Al conducted a retrospective, multinational and blinded study with the CINA-IPE application with the primary endpoint to evaluate the software's performance in identifying incidental pulmonary embolisms (iPE) on contrast-enhanced CT images performed for another clinication than for pulmonary embolism (PE) evaluation (i.e. not dedicated CTPA protocol), in 381 clinical anonymized cases. The dataset included 53.5% Male and 46.7% Female. Mean ± SD age of patients included in the study was 64.5 ± 15.8 yo (range: 18 - 99 yo).
The validation data was acquired from different regions across the U.S. to account for race/ethnicity in the intended U.S. patient population. Additional scanner parameters considered were slice thickness, number of detector rows, and kVp ranges. The data was provided from multiple U.S. and OUS clinical sites, with 56.4% (215) cases coming from U.S. clinical sources. The independence of the standalone validation dataset from the training data was ensured using data from independent sites and different time periods. There were 181 (47.5%) positive iPE (images with PE) cases and 200 (52.5%) negative iPE cases included in the analyses. The data was acquired primarily by 4 different scanner makers (GE-31.5%, Philips-28.3%, Siemens-26%, and Canon-13.9%) and 39 different scanner models.
Groundtruth was established by consensus of three US-board-certified expert radiologists.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Retrospective, multinational and blinded study.
Sample Size: 381 clinical anonymized cases.
Standalone Performance:
- Device Sensitivity [95% Cl] and Specificity [95% Cl] were computed against the groundtruth established by consensus of three US-board-certified expert radiologists.
- Global Sensitivity: 87.8% [95%C1: 82.2% -92.2%]
- Global Specificity: 92.0% [95%C1: 87.3% - 95.4%]
Key Results: - These findings achieved the 80% performance goal of the study.
- Sensitivity for arterial segments:
- Main (N = 55): 96.3% [87.5% - 99.6%]
- Interlobar (N = 73): 94.5% [86.6% - 98.5%]
- Lobar (N = 127): 92.9% [87.0% - 96.7%]
- Segmental (N = 179): 88.3% [82.6% - 92.6%]
- Time-to-Notification for CINA-iPE Image Processing Applications (N = 381):
- Mean ± SD: 1.5 ± 0.5 minutes
- Median: 1.4 minutes
- 95% Cl: [1.4 - 1.5] minutes
- Min: 0.3 minutes
- Max: 2.7 minutes
- Time-to-Notification for True Positive cases (N = 159):
- Mean ± SD: 1.5 ± 0.4 minutes
- Median: 1.5 minutes
- 95% Cl: [1.4 - 1.6] minutes
- Min: 0.7 minutes
- Max: 3.1 minutes
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity, Specificity, Time-to-Notification
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.
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Image /page/0/Picture/0 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 ADMINISTRATION" in blue text.
Avicenna.AI % John Smith Partner Hogan Lovells US LLP 555 13th St. NW Washington, District of Columbia 20005
Re: K233968
March 13, 2024
Trade/Device Name: CINA-iPE Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QAS Dated: December 15, 2023 Received: December 15, 2023
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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-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. Ph.D. Assistant Director Imaging Software Review 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
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Indications for Use
510(k) Number (if known) K233968
Device Name CINA-iPE
Indications for Use (Describe)
CINA-iPE is a radiological computer-aided triage and notification software indicated for use in patients undergoing contrast-enhanced CT scans (not dedicated CTPA protocol) for other clinical indications than pulmonary embolism suspicion, including at least a part of the lung. The device is intended to assist hospital networks and appropriately trained radiologists in workflow triage by flagging and communicating suspected positive findings for incidental Pulmonary Embolism (iPE). The device is indicated for adults and transitional adolescents (18 to 21 years old but treated as adults).
CINA-iPE uses an artificial intelligence algorithm to analyze images and highlight cases with detected incidental PE on a standalone application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected incidental PE findings. The designed to detect PE in subsegmental arteries.
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-iPE are intended to be used in conjunction with other patient information and based on their 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K233968
510(K) SUMMARY
AVICENNA.AI's CINA-IPE
Submitter
Applicant:
AVICENNA.AI ZI Athelia, 297 Av. du Mistral Bât. A, 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: March 12, 2024
Device Identification
| Name of Device: | CINA-IPE |
|---|---|
| Classification Name: | Radiological computer aided triage and |
| notification software | |
| Regulation No: | 21 CFR § 892.2080 |
| Product Code: | QAS |
| Regulatory Class: | Class II |
| Classification Panel: | Radiology |
Predicate Device
The CINA-iPE device is substantially equivalent to the following predicate device with regard to indications for use, performance, and technological characteristics:
| 510(k): | K213886 |
|---|---|
| Trade Name: | BriefCase |
| Manufacturer: | Aidoc Medical, Ltd. |
| Classification Name: | Radiological computer aided triage and notification software |
| Regulation No: | 21 CFR § 892.2080 |
| Product Code: | QAS |
| Regulatory Class: | Class II |
4
Device Description
CINA-iPE is a radiological computer aided triage and notification software device.
CINA-iPE runs on a standard "off the shelf" server/workstation and consists of an Image Processing Application, which can be integrated, deployed, and used with the CINA Platform (cleared under K200855) or other medical image communications devices. CINA-iPE receives contrast-enhanced CT scans (not dedicated CTPA protocol) including at least a part of the lung identified by the CINA Platform or other medical image communications device, processes them using deep learning algorithms involving the execution of multiple computational steps to identify the suspected presence of an incidental pulmonary embolism and generates results files to be transferred by CINA Platform or a similar medical image communications device for output to a PACS system or worklist prioritization.
To identify the suspected presence of pulmonary embolisms, the device uses a deep learning model trained end-to-end on 5.429 cases acquired from US and France, representing a distribution of PE sizes, locations and acquisition protocols, including multiple scanner models from Siemens, Philips, GE and Canon/Toshiba. Additional models are used to locate the aorta and main pulmonary artery, enabling assessment of the contrast timing. The lung's parenchyma is segmented to evaluate both the presence of the lungs in the field of view and to limit the region of interest for detecting the presence of pulmonary embolisms.
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 an incidental Pulmonary Embolism (iPE), then active notifications on the flagged series are sent to the Worklist Application.
The Worklist Application displays the active notification of new studies with suspected findings when they come in. All the contrast-enhanced CT studies received by CINA-iPE device are displayed in the worklist and those on which the algorithms have detected finding are marked with an icon (i.e., passive notification). In addition, a compressed, grayscale, unannotated 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 diagnostic use beyond notification.
Presenting the radiologist with notification facilitates earlier triage by allowing prioritization of images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care image interpretation practice alone.
The CINA platform is an example of medical image communications platform for integrating and deploying the CINA-iPE image processing application. The medical image communications device (i.e., the technical platform) 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 medical image communications server includes the Worklist client application in which notifications from the CINA-iPE Image Processing application are received.
5
Intended Use / Indications for Use
CINA-iPE is a radiological computer-aided triage and notification software indicated for use in patients underqoing contrast-enhanced CT scans (not dedicated CTPA protocol) for other clinical indications than pulmonary embolism suspicion, including at least a part of the device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings for incidental Pulmonary Embolism (iPE). The device is indicated for adults and transitional adolescents (18 to 21 years old but treated as adults).
CINA-iPE uses an artificial intelligence algorithm to analyze images and highlight cases with detected incidental PE on a standalone application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected incidental PE findings. The device is not designed to detect PE in subsegmental arteries.
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-iPE 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.
Summary of Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Software Verification and Validation Testing
CINA-IPE complies with DICOM (Digital Imaging and Communications in Medicine) - Developed by the American College of Radiology and the National Electrical Manufacturers Association. NEMA PS 3.1 - 3.20.
Avicenna.Al conducted extensive performance validation testing and software verification and validation testing of the CINA-IPE device as standalone software. CINA-IPE is tested against its user needs and intended use by the successful execution of planned software verification and validation testing included in this submission.
Software performance, validation and verification testing demonstrated that the CINA-IPE met all design requirements and specifications associated with the intended use of the software.
Standalone Performance Testing
Avicenna. Al conducted a retrospective, multinational and blinded study with the CINA-IPE application with the primary endpoint to evaluate the software's performance in identifying incidental pulmonary embolisms (iPE) on contrast-enhanced CT images performed for another clinication than for pulmonary embolism (PE) evaluation (i.e. not dedicated CTPA protocol), in 381 clinical anonymized cases. The dataset included 53.5% Male and 46.7% Female. Mean ± SD age of patients included in the study was 64.5 ± 15.8 yo (range: 18 - 99 yo).
6
Multiple subgroups of interest were considered in the analysis. In fact, the validation data was acquired from different regions across the U.S. to account for race/ethnicity in the intended U.S. patient population. Additional scanner parameters considered were slice thickness, number of detector rows, and kVp ranges. Detailed subgroup analysis were reported in the labeling.
The data was provided from multiple U.S. and OUS clinical sites, with 56.4% (215) cases coming from U.S. clinical sources. The independence of the standalone validation dataset from the training data was ensured using data from independent sites and different time periods. There were 181 (47.5%) positive iPE (images with PE) cases and 200 (52.5%) negative iPE cases included in the analyses. The data was acquired primarily by 4 different scanner makers (GE-31.5%, Philips-28.3%, Siemens-26%, and Canon-13.9%) and 39 different scanner models.
Device Sensitivity [95% Cl] and Specificity [95% Cl] were computed against the groundtruth established by consensus of three US-board-certified expert radiologists.
As a primary endpoint, the global Sensitivity and Specificity were found to be 87.8% [95%C1: 82.2% -92.2%] and 92.0% [95%C1: 87.3% - 95.4%], respectively. These findings achieved the 80% performance goal of the study and are similar to the results reported for the predicate BriefCase device (Aidoc Medical) which demonstrated Sensitivity and Specificity of 89.7% (95%C1: 80.8% - 95.5%) and 90.1% [95%Cl: 81.5% - 95.6%], respectively.
Additionally, subgroup analysis was reported in terms of sensitivity 195%CII for each lesion location (main, interlobar, lobar and segmental) as presented in the following Table:
| Arterial Segment | Sensitivity
[95% CI] |
|------------------------|--------------------------|
| Main
(N = 55) | 96.3%
[87.5% - 99.6%] |
| Interlobar
(N = 73) | 94.5%
[86.6% - 98.5%] |
| Lobar
(N = 127) | 92.9%
[87.0% - 96.7%] |
| Segmental
(N = 179) | 88.3%
[82.6% - 92.6%] |
Table 1: Stratified statistical analysis (Sensitivity [95%Cl]) regarding arterial segments.
Please note that cases with more than one PE location were included in more than one category (e.g., a case with a main and a lobar PE was included in the "main" category and in the "lobar" category) Finally, the CINA-iPE prioritization and triage effectiveness were evaluated by the standalone percase processing time of the device (time-to-notification). The results are presented in Table 2 below:
7
| Time-to-Notification
| (minutes) | MEAN ± SD | MEDIAN | 95% Cl | MIN | MAX |
|---|---|---|---|---|---|
| CINA-iPE | |||||
| All cases | |||||
| (N = 381) | 1.5 ± 0.5 | 1.4 | [1.4 - 1.5] | 0.3 | 2.7 |
| CINA-iPE | |||||
| True Positive cases | |||||
| (N = 159) | 1.5 ± 0.4 | 1.5 | [1.4 - 1.6] | 0.7 | 3.1 |
Table 2: Time-to-Notification for CINA-iPE Image Processing Applications
The mean [95% C1] time-to-notification for all included cases (n = 381) was estimated to be 1.5 [95% Cl: 1.4 - 1.5] minutes for CINA-iPE. When taking into account only true positive cases (n = 159), the mean [95% Cl] time-to-notification was 1.5 [95% Cl: 1.4 - 1.6] minutes for CINA-iPE and 4.7 [95% Cl: 4.4 - 5.1] minutes for the predicate device.
The performance testing of the CINA-iPE device establishes that the subject device is as safe and effective as the predicate device and compatible with the same clinical use, since the performance demonstrated the clinical effectiveness of the subject device and its ability to provide effective prioritization and triage that was substantially equivalent to that of the predicate device. This establishes that the CINA-iPE device achieves its intended use and is substantially equivalent to the predicate BriefCase device.
Substantial Equivalence
The subject CINA-iPE and the predicate BriefCase device are both intended to aid in prioritization and triage of radiological images of time sensitive findings for patient detection and diagnosis (i.e., incidental Pulmonary Embolism) based on the analysis of medical images acquired from radiological signal acquisition systems. The CINA device provides the CINA Platform in which the subject CINAiPE prioritization and triage application 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 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-iPE and the predicate BriefCase device 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 and predicate 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 incidental pulmonary embolism.
The standalone performance and effectiveness assessment studies demonstrated that the CINA-iPE device performs as intended and substantially equivalent to the BriefCase predicate device.
The table below compares the key features of the subject and the predicate devices.
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| Ltd) | ||
|---|---|---|
| Subject device: CINA-IPE Software | Predicate device: BriefCase Software (K213886) | |
| Intended Use / Indications for Use | CINA-iPE is a radiological computer-aided triage and notification software indicated for use in patients undergoing contrast-enhanced CT scans (not dedicated CTPA protocol) for other clinical indications than pulmonary embolism suspicion, including at least a part of the lung. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings for incidental Pulmonary Embolism (IPE). The device is indicated for adults and transitional adolescents (18 to 21 years old but treated as adults). | |
| CINA-IPE uses an artificial intelligence algorithm to analyze images and highlight cases with detected incidental PE on a standalone application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected incidental PE findings. The device is not designed to detect PE in subsegmental arteries. | ||
| 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-iPE are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical | BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced chest CTs (not dedicated CTPA protocol) in adults or transitional adolescents age 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspect cases of incidental Pulmonary Embolism (IPE) pathologies. The device is intended to be used on single energy exams only. | |
| BriefCase uses an artificial intelligence algorithm to analyze images and flag suspect cases on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for suspect cases. 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 their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care. | ||
| Subject device: CINA-IPE Software | Predicate device: BriefCase Software | |
| (K213886) | ||
| images. Notified clinicians are | ||
| ultimately responsible for reviewing | ||
| full images per the standard of care. | ||
| User | ||
| population | Radiologist | Appropriately trained medical specialists |
| Anatomical | ||
| region of | ||
| interest | Chest or exams including at least a | |
| part of the lung | Chest | |
| Data | ||
| acquisition | ||
| protocol | Contrast-enhanced CT scans (not | |
| dedicated CTPA protocol) containing | ||
| at least a part of the lung | Contrast-enhanced chest CTs (but not | |
| dedicated CTPA protocol) | ||
| View DICOM | ||
| data | DICOM information about the | |
| patient, study and current image | DICOM information about the patient, | |
| study and current image | ||
| Segmentatio | ||
| n 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 compressed, | |
| grayscale, unannotated image that is | ||
| marked "not for diagnostic use" is | ||
| displayed as a preview function. | Presentation of a low-quality, | |
| compressed grayscale preview image | ||
| that is captioned "Not for diagnostic use". | ||
| Alteration of | ||
| original | ||
| image | No | No |
| Removal of | ||
| cases from | ||
| worklist | ||
| queue | No. The device operates in parallel | |
| with the standard of care, which | ||
| remains the default option for all | ||
| cases. | No. The device operates in parallel with | |
| the standard of care, which remains the | ||
| default option for all cases. | ||
| Structure | -iPE image processing application |
- Compatibility of use with the CINA
Platform device (worklist and Image
Viewer) or other medical image
communications device, | -AHS module/Orchestrator (image
acquisition). - ACS module (image processing).
- Aidoc Worklist application for workflow
integration (worklist and non-diagnostic
basic Image Viewer) |
Table 3: Comparison of key features between CINA-iPE and the predicate device (Aidoc Medical
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Conclusion
CINA-iPE and BriefCase have the same intended use and substantially similar indications, technological characteristics, and principles of operation. The following is a summary of the substantial equivalence comparison:
- -The predicate device is legally marketed.
- CINA-iPE has the same intended use as the predicate device, i.e., Aidoc Medical, Ltd.'s - BriefCase, and therefore it may be found substantially equivalent.
- -CINA-iPE and the predicate device have very similar indications for use.
- CINA-iPE has similar technological characteristics as the predicate and reference devices, i.e., the deployment of an artificial intelligence algorithm with a database of images.
- -Standalone performance study demonstrates that the CINA-iPE and the predicate BriefCase raise the same types of safety and effectiveness questions, namely, accurate detection of findings within the processed study.
Accordingly, the subject CINA-iPE device is substantially equivalent to the predicate BriefCase device.