(137 days)
Not Found
Yes
The device description explicitly states that Viz ANEURYSM uses an "artificial intelligence algorithm" and an "artificial intelligence machine (Al/ML) software algorithm" to analyze images.
No.
The device is described as a "radiological computer-assisted triage and notification software device" intended to "assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected aneurysms." It explicitly states that it is "not intended for diagnostic use" and "does not alter the original medical image and is not intended to be used as a diagnostic device," nor does it provide "therapy" or "treatment." Its purpose is to prioritize cases for human review, not to directly treat or diagnose a patient's condition.
No
The document explicitly states multiple times that the device is "not intended for diagnostic use" and that "Radiologists who read the original medical images are responsible for the diagnostic decision." The device is intended for "workflow triage by flagging and prioritizing studies with suspected aneurysms."
Yes
The device description explicitly states it is a "combination of software modules" and details an image analysis algorithm and a mobile application software module. It relies on receiving images and processing them through software, with no mention of accompanying hardware components being part of the device itself.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The text explicitly states that Viz ANEURYSM analyzes CT images of the head, which are medical images, not biological specimens.
- The intended use is for workflow triage and prioritization of medical images. While the device assists radiologists, its primary function is to flag and prioritize studies, not to perform a diagnostic test on a biological sample.
- The device is not intended for diagnostic use. The text repeatedly emphasizes that the preview images and the device's results are for informational purposes only and not for diagnostic use. The responsibility for the diagnostic decision remains with the radiologist reviewing the original medical images.
Therefore, Viz ANEURYSM falls under the category of a medical device, specifically a radiological computer-assisted triage and notification software, rather than an In Vitro Diagnostic.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" explicitly states "Not Found".
Intended Use / Indications for Use
Viz ANEURYSM (Viz ANX) is a radiological computer-assisted triage and notification software device for analysis of CT images of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected aneurysms during routine patient care.
Viz ANEURYSM uses an artificial intelligence algorithm to analyze images and highlight studies with suspected aneurysms in a standalone application for study list prioritization or triage in parallel to ongoing standard of care. The device generates compressed preview images that are meant for informational purposes only and not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
Analyzed images are available for review through the standalone application. When viewed through the standalone application the images are for informational purposes only and not for diagnostic use. The results of Viz ANEURYSM, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Radiologists who read the original medical images are responsible for the diagnostic decision. Viz ANEURYSM 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.
Viz ANEURYSM is limited to detecting aneurysms at least 4mm in diameter.
Product codes (comma separated list FDA assigned to the subject device)
QFM
Device Description
Viz ANEURYSM (Viz ANX) is a radiological computer-assisted triage and notification software device for analysis of CTA images of the head. The software automatically receives and analyzes CT angiogram (CTA) imaging of the head for image features that indicate the presence of an aneurysm using an artificial intelligence algorithm, and prioritizes patient imaging in a standalone application for workflow triage and review by a radiologist in parallel to standard of care image interpretation.
Viz ANEURYSM is a combination of software modules that consists of an image analysis software algorithm and mobile application software module. The Viz ANEURYSM Image Analysis Algorithm is an artificial intelligence machine (AI/ML) software algorithm that analyzes CTA images of the head for an aneurysm. Images acquired during patient care are forwarded to Viz.ai's Backend server where they are analyzed by the Viz ANEURYSM artificial intelligence algorithm for an aneurysm.
Viz ANEURYSM includes a mobile software module that enables the end user to view cases identified by the Viz ANEURYSM algorithm to contain a suspected aneurysm. The Viz ANEURYSM mobile software module is implemented into Viz.ai's generic non-diagnostic DICOM image mobile viewing application, Viz VIEW, which displays CTA scans that are sent to the Backend server. When the Viz ANEURYSM mobile software module is enabled, studies determined by the algorithm to contain a suspected aneurysm are highlighted in the standalone mobile application for study list prioritization or triage in parallel to ongoing standard of care. The user can also view compressed preview images and a non-diagnostic preview of the analyzed CTA scan of the patient through the mobile application.
The preview images and additional patient imaging available through the standalone mobile application are meant for informational purposes only and not intended for diagnostic use. The results of Viz ANEURYSM, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Radiologists who read the original medical images are responsible for the diagnostic decision.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Computed Tomography Angiography (CTA)
Anatomical Site
Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained radiologists in workflow triage.
Hospital networks and trained radiologists in workflow triage.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
315 scans were used in the analysis to assess the device performance in the detection of aneurysms at least 4mm in diameter. Of the 315 scans included in the analysis, 67 scans were positive (21.3%) and 248 scans were negative (78.7%).
Sensitivity and specificity were calculated in the image database, comparing the Viz ANEURYSM's output to ground truth as established by trained neuro-radiologists. Sensitivity and specificity were 93% (83% - 98%) and 89% (85% - 93%), respectively. Because the lower bound of each confidence interval exceeded 80%, the study met the pre-specified performance goals of 80% for sensitivity and specificity.
In addition, the area under the receiver operating characteristic curve (AUC) was 0.967 (95% CI: 0.936 - 0.997), demonstrating the clinical utility and potential benefits of the classifier based on the imaging study results.
In the study, for true positive cases where the standard of care time-to-notification was available, the Viz ANEURYSM time-to-notification was faster than the standard of care timeto-notification for all 20 cases used in the time analysis (time differences ranged from 6.6 to 174.5 minutes). The average time to notification of the device was 219.8 seconds (3.67 minutes) on average, with a median of 203.44 seconds (3.39 minutes). This was faster than the Standard of Care time-to-notification which showed an average duration of 2613.0 seconds (43.6 minutes), with a median of 1620.0 seconds (27.0 minutes). This data generally demonstrates that radiologists have the opportunity to be made aware of cases for workflow prioritization and triage in a timely manner from the Viz ANEURYSM software.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 0.93 [0.83, 0.98]
Specificity: 0.89 [0.85, 0.93]
AUC: 0.967 (95% CI: 0.936 - 0.997)
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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Viz.ai, Inc. % Mr. Gregory Ramina Director of Regulatory Affairs 201 Mission St, 12th Floor SAN FRANCISCO CA 94105
Re: K213319
February 18, 2022
Trade/Device Name: Viz ANEURYSM, Viz ANX Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QFM Dated: January 18, 2022 Received: January 19, 2022
Dear Mr. Ramina:
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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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 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 Assistant 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
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510(k) Number (if known)
K213319
Device Name
Viz ANEURYSM, Viz ANX
Indications for Use (Describe)
Viz ANEURYSM (Viz ANX) is a radiological computer-assisted triage and notification software device for analysis of CT images of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected aneurysms during routine patient care.
Viz ANEURYSM uses an artificial intelligence algorithm to analyze images and highlight studies with suspected aneurysms in a standalone application for study list prioritization or triage in parallel to ongoing standard of care. The device generates compressed preview images that are meant for informational purposes only and not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
Analyzed images are available for review through the standalone application. When viewed through the standalone application the images are for informational purposes only and not for diagnostic use. The results of Viz ANEURYSM, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Radiologists who read the original medical images are responsible for the diagnostic decision. Viz ANEURYSM 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.
Viz ANEURYSM is limited to detecting aneurysms at least 4mm in diameter.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows a blue logo that resembles the letter 'V' or an abstract bird. The logo is composed of several curved lines stacked on top of each other, creating a sense of depth and movement. The color is a consistent shade of blue, giving the logo a clean and modern appearance. The overall design is simple yet distinctive, making it easily recognizable.
510(k) SUMMARY Viz.ai, Inc.'s Viz ANEURYSM (Viz ANX)
Applicant Name: Viz.ai, Inc. 201 Mission St, 12th Floor San Francisco, CA 94105
- Contact Person: Gregory Ramina Director of Regulatory Affairs 201 Mission St, 12th Floor San Francisco, CA 94105 Tel. (415) 663-6130 Greg@viz.ai
- Date Prepared: January 11, 2022
Device Name and Classification
| Name of Device: | Viz ANEURYSM, Viz ANX |
|---|---|
| Common or Usual Name: | Radiological Computer-Assisted Triage and Notification Software |
| Classification Panel: | Radiology |
| Regulation No: | 21 C.F.R. § 892.2080 |
| Regulatory Class: | Class II |
| Product Code: | QFM |
Predicate Device
| Manufacturer | Device Name | Application No. |
|---|---|---|
| Shanghai United Imaging | ||
| Intelligence Co., Ltd. | uAl EasyTriage-Rib | K193271 |
Device Description
Viz ANEURYSM (Viz ANX) is a radiological computer-assisted triage and notification software device for analysis of CTA images of the head. The software automatically receives and analyzes CT angiogram (CTA) imaging of the head for image features that indicate the presence of an aneurysm using an artificial intelligence algorithm, and prioritizes patient imaging in a standalone application for workflow triage and review by a radiologist in parallel to standard of care image interpretation.
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Image /page/4/Picture/0 description: The image shows a blue logo that resembles a stylized letter 'V' or a series of stacked, curved lines. The logo consists of five distinct shapes. The top shape is a wide, inverted 'V'. Below that are three curved lines that decrease in size from top to bottom, and the bottom shape is a small, curved line that mirrors the shape of the others. The overall design is simple and modern.
Viz ANEURYSM is a combination of software modules that consists of an image analysis software algorithm and mobile application software module. The Viz ANEURYSM Image Analysis Algorithm is an artificial intelligence machine (Al/ML) software algorithm that analyzes CTA images of the head for an aneurysm. Images acquired during patient care are forwarded to Viz.ai's Backend server where they are analyzed by the Viz ANEURYSM artificial intelligence algorithm for an aneurysm.
Viz ANEURYSM includes a mobile software module that enables the end user to view cases identified by the Viz ANEURYSM algorithm to contain a suspected aneurysm. The Viz ANEURYSM mobile software module is implemented into Viz.ai's generic non-diagnostic DICOM image mobile viewing application, Viz VIEW, which displays CTA scans that are sent to the Backend server. When the Viz ANEURYSM mobile software module is enabled, studies determined by the algorithm to contain a suspected aneurysm are highlighted in the standalone mobile application for study list prioritization or triage in parallel to ongoing standard of care. The user can also view compressed preview images and a non-diagnostic preview of the analyzed CTA scan of the patient through the mobile application.
The preview images and additional patient imaging available through the standalone mobile application are meant for informational purposes only and not intended for diagnostic use. The results of Viz ANEURYSM, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Radiologists who read the original medical images are responsible for the diagnostic decision.
Intended Use / Indications for Use
Viz ANEURYSM (Viz ANX) is a radiological computer-assisted triage and notification software device for analysis of CT images of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected aneurysms during routine patient care.
Viz ANEURYSM uses an artificial intelligence algorithm to analyze images and highlight studies with suspected aneurysms in a standalone application for study list prioritization or triage in parallel to ongoing standard of care. The device generates compressed preview images that are meant for informational purposes only and not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
Analyzed images are available for review through the standalone application. When viewed through the standalone application the images are for informational purposes only and not for diagnostic use. The results of Viz ANEURYSM, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Radiologists who read the original medical images are responsible for the diagnostic decision. Viz ANEURYSM 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.
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Image /page/5/Picture/0 description: The image shows a stylized blue logo. The logo is composed of several curved and angular shapes arranged vertically. The overall shape resembles a stylized letter 'V' or an abstract symbol. The logo has a modern and clean design.
Viz ANEURYSM is limited to detecting aneurysms at least 4mm in diameter.
Summary of Technological Characteristics
The subject device, Viz ANEURYSM, is substantially equivalent to the predicate device, uAl EasyTriage-Rib (K193271). In comparing the technological characteristics, both the subject and predicate devices use an artificial intelligence algorithm to identify clinical findings in CT imaging. Where the subject and predicate differ is that the software algorithm for the subject device identifies suspected aneurysm findings in CTA imaging of the head whereas the predicate device's algorithm identifies rib fractures in CT imaging of the chest.
Both the subject and the predicate devices provide findings through standalone software applications that allow the user to view preview images and patients identified with a suspected finding by their respective software algorithms in parallel to the standard of care. Both devices produce preview images and neither device removes images from a reading queue. Where the subject device and predicate device differ is that the subject device identifies patients for prioritization through a standalone mobile application whereas the provides prioritization on a standalone application on the radiologist workstation. The differences in standalone applications do not raise different or new questions of safety or effectiveness because the subject device's standalone mobile application includes a non-diagnostic warning to inform the user of the viewing limitations and both standalone applications are intended to facilitate the preemptive review of the case by the radiologists who can then turn to PACS to review the original medical images.
Both devices have the same technical and clinical limitations, namely, both are limited to analysis of imaging data and are intended to be used in conjunction with other clinical information and professional judgment to assist in performing triage and prioritization and not as the sole-basis for decision making.
| Subject Device | Predicate Device | |
|---|---|---|
| Viz ANEURYSM | uAl EasyTriage-Rib | |
| Application No. | K213319 | K193271 |
| Product Code | QFM | QFM |
| Regulation No. | 21 C.F.R. § 892.2080 | 21 C.F.R. § 892.2080 |
| Intended Use / | ||
| Indications for Use | Viz ANEURYSM (Viz ANX) is a radiological | |
| computer-assisted triage and notification | ||
| software device for analysis of CT images of the | ||
| head. The device is intended to assist hospital | ||
| networks and trained radiologists in workflow | ||
| triage by flagging and prioritizing studies with | ||
| suspected aneurysms during routine patient | ||
| care. | uAl EasyTriage-Rib is a radiological computer- | |
| assisted triage and notification software device | ||
| for analysis of CT chest images. The device is | ||
| intended to assist hospital networks and trained | ||
| radiologists in workflow triage by flagging and | ||
| prioritizing trauma studies with suspected | ||
| positive findings of multiple (3 or more) acute rib | ||
| fracture(s). | ||
| Subject Device | Predicate Device | |
| Viz ANEURYSM uses an artificial intelligence | ||
| algorithm to analyze images and highlight | ||
| studies with suspected aneurysms in a | ||
| standalone application for study list prioritization | ||
| or triage in parallel to ongoing standard of care. | ||
| The device generates compressed preview | ||
| images that are meant for informational purposes | ||
| only and not intended for diagnostic use. The | ||
| device does not alter the original medical image | ||
| and is not intended to be used as a diagnostic | ||
| device. | ||
| Analyzed images are available for review | ||
| through the standalone application. When | ||
| viewed through the standalone application the | ||
| images are for informational purposes only and | ||
| not for diagnostic use. The results of Viz | ||
| ANEURYSM, in conjunction with other clinical | ||
| information and professional judgment, are to be | ||
| used to assist with triage/prioritization of medical | ||
| images. Radiologists who read the original | ||
| medical images are responsible for the | ||
| diagnostic decision. Viz ANEURYSM 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. | ||
| Viz ANEURYSM is limited to detecting | ||
| aneurysms at least 4mm in diameter. | uAl EasyTriage-Rib uses an artificial intelligence | |
| algorithm to analyze images and highlight | ||
| studies with suspected multiple (3 or more) acute | ||
| rib fracture(s) in a standalone application for | ||
| study list prioritization or triage in parallel to | ||
| ongoing standard of care. The user is presented | ||
| with notifications of 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 uAl EasyTriage-Rib, in conjunction | ||
| with other clinical information and professional | ||
| judgment, are to be used to assist with | ||
| triage/prioritization of medical images. Notified | ||
| radiologists who read the original medical | ||
| images are responsible for the diagnostic | ||
| decision. | ||
| Anatomical Region | Head | Chest |
| Independent | ||
| Standard of Care | ||
| Workflow | Yes | Yes |
| Notification/ | ||
| Prioritization | Yes | Yes |
| Identify patients | ||
| with pre-specified | ||
| clinical condition | Yes | Yes |
| Clinical Condition | Aneurysm | Multiple (3 or more) acute rib fractures. |
| Intended User | Radiologist | Radiologist |
| DICOM Compatible | Yes | Yes |
| Data Acquisition | Acquires medical image data from DICOM | |
| compliant imaging devices and modalities. | Acquires medical image data from DICOM | |
| compliant imaging devices and modalities. | ||
| Subject Device | Predicate Device | |
| Supported Imaging | ||
| Modality | Computed Tomography Angiography (CTA) | Computed Tomography (CT) |
| Alteration of | ||
| Original Image | No | No |
| Artificial | ||
| Intelligence | ||
| Algorithm | Yes | Yes |
| Results of Image | ||
| Analysis | Internal, no image marking | Internal, no image marking |
| Preview Images | Initial assessment; non-diagnostic purposes | Initial assessment; non-diagnostic purposes |
| View DICOM Data | DICOM Information about the patient, study and | |
| current image. | DICOM Information about the patient, study and | |
| current image. | ||
| Results Returned | ||
| in Standalone | ||
| Application | Yes | Yes |
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Image /page/6/Picture/0 description: The image shows a blue logo on a white background. The logo is shaped like a stylized letter "V" or an abstract funnel. It consists of several horizontal, curved lines that are stacked on top of each other, creating a sense of depth and dimension. The color is a consistent shade of blue.
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Image /page/7/Picture/0 description: The image shows a blue logo with a stylized letter 'V' shape. The 'V' is formed by several horizontal lines that curve slightly, creating a layered effect. The logo is simple and modern, with a clean design and a consistent color scheme.
Performance Data
315 scans were used in the analysis to assess the device performance in the detection of aneurysms at least 4mm in diameter. Of the 315 scans included in the analysis, 67 scans were positive (21.3%) and 248 scans were negative (78.7%).
Sensitivity and specificity were calculated in the image database, comparing the Viz ANEURYSM's output to ground truth as established by trained neuro-radiologists. Sensitivity and specificity were 93% (83% - 98%) and 89% (85% - 93%), respectively. Because the lower bound of each confidence interval exceeded 80%, the study met the pre-specified performance goals of 80% for sensitivity and specificity.
| Table 1. Primary Endpoint Results | |
|---|---|
| Point Estimate [95% CI] | |
| Sensitivity | |
| (Positives = 67) | 0.93 [0.83, 0.98] |
| Specificity | |
| (Negatives = 248) | 0.89 [0.85, 0.93] |
Table 1: Primary Endpoint Results
In addition, the area under the receiver operating characteristic curve (AUC) was 0.967 (95% CI: 0.936 - 0.997), demonstrating the clinical utility and potential benefits of the classifier based on the imaging study results.
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Image /page/8/Picture/0 description: The image shows a stylized blue logo. The logo is composed of several curved and angular shapes arranged vertically. The overall shape resembles a stylized letter 'V' or a bird in flight. The logo has a modern and minimalist design.
Image /page/8/Figure/1 description: The image is a Receiver Operating Characteristic (ROC) curve for Aneurysm detection. The ROC curve, shown in orange, plots the sensitivity against 1 - specificity, and has an area under the curve (AUC) of 0.97. A dashed blue line represents the line of no discrimination. A vertical dotted line indicates a threshold for the Aneurysm Score at 1.5.
Figure 1: Viz ANEURYSM ROC curve with an AUC of .97
In the study, for true positive cases where the standard of care time-to-notification was available, the Viz ANEURYSM time-to-notification was faster than the standard of care timeto-notification for all 20 cases used in the time analysis (time differences ranged from 6.6 to 174.5 minutes). The average time to notification of the device was 219.8 seconds (3.67 minutes) on average, with a median of 203.44 seconds (3.39 minutes). This was faster than the Standard of Care time-to-notification which showed an average duration of 2613.0 seconds (43.6 minutes), with a median of 1620.0 seconds (27.0 minutes). This data generally demonstrates that radiologists have the opportunity to be made aware of cases for workflow prioritization and triage in a timely manner from the Viz ANEURYSM software.
Stratification of Device Performance
In addition, a secondary analysis reported the device performance when stratified into subgroups:
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Image /page/9/Picture/0 description: The image shows a blue logo that resembles a stylized letter 'V' or a bird in flight. The logo is composed of several curved and angular shapes arranged in a symmetrical pattern. The shapes are all filled with the same shade of blue, creating a cohesive and modern design. The logo appears clean and minimalist, suitable for a tech company or a brand focused on innovation.
Table 2: Device Performance per Clinical Site
| Clinical Site | Sensitivity [95% CI] | Specificity [95% CI] |
|---|---|---|
| Site 001 | 0.91 [0.76, 0.98] | 0.87 [0.80, 0.92] |
| Site 002 | 0.94 [0.80, 0.99] | 0.92 [0.85, 0.96] |
Table 3: Device Performance per Age
| Age Range (Years) | Sensitivity [95% CI] | Specificity [95% CI] |
|---|---|---|