(123 days)
Not Found
Yes
The device description explicitly states that Viz AAA uses an "artificial intelligence machine learning (Al/ML) software algorithm" for image analysis.
No.
The device is described as a "radiological computer-assisted triage and notification software device" intended to assist in workflow prioritization by flagging studies with suspected abdominal aortic aneurysms for informational purposes, not for diagnosis or treatment. It does not provide therapy.
No
The device is explicitly stated as "not intended for diagnostic use" and its purpose is for "workflow triage" and "study list prioritization," with "vascular specialists who read the original medical images are responsible for the diagnostic decision."
Yes
The device description explicitly states that Viz AAA is a "combination of software modules" and describes its components as "image analysis software algorithm" and "mobile application software module." There is no mention of any accompanying hardware components required for its function beyond standard computing infrastructure for receiving and processing images.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Viz AAA's Function: Viz AAA analyzes medical images (CTA scans) of the abdomen. It does not analyze biological samples from the patient.
- Intended Use: The intended use clearly states it's a "radiological computer-assisted triage and notification software device for analysis of CTA images." It's for workflow triage and prioritizing studies, not for performing a diagnostic test on a biological sample.
- Disclaimer: The text explicitly states that the device "does not alter the original medical image and is not intended to be used as a diagnostic device." It also emphasizes that the results are for "informational purposes only and not intended for diagnostic use" and that vascular specialists are responsible for the diagnostic decision.
Therefore, Viz AAA falls under the category of medical imaging software or a clinical decision support tool, not an in vitro diagnostic device.
No
The letter does not 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
Viz AAA is a radiological computer-assisted triage and notification software device for analysis of CTA images of the abdomen. The device is intended to assist hospital networks and vascular specialists in workflow triage by flagging and prioritizing studies with suspected abdominal aortic aneurysms during routine patient care.
Viz AAA uses an artificial intelligence algorithm to analyze images and highlight studies with suspected abdominal aortic 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 AAA, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Vascular specialists who read the original medical images are responsible for the diagnostic decision. Viz AAA 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 AAA is limited to detecting aneurysms at least 3 cm in diameter. Viz AAA is intended to identify infra-renal, fusiform abdominal aortic aneurysms.
# Product codes (comma separated list FDA assigned to the subject device)
QFM
# Device Description
Viz AAA is a radiological computer-assisted triage and notification software device for analysis of CTA images of the abdomen. The software automatically receives and analyzes CT angiogram (CTA) imaging of the abdomen for the presence of an aortic aneurysm using an artificial intelligence algorithm and highlights suspect patient imaging in a standalone application for study list prioritization or triage by vascular or endovascular specialists in parallel to standard of care image interpretation.
Viz AAA is a combination of software modules that consists of an image analysis software algorithm and mobile application software module. The Viz AAA Image Analysis Algorithm is an artificial intelligence machine learning (AI/ML) software algorithm that analyzes CTA images of the abdomen for an aortic aneurysm. Images acquired during patient care are forwarded to Viz.ai's Backend server where they are analyzed by the Viz AAA artificial intelligence algorithm for an abdominal aortic aneurysm.
Viz AAA includes a mobile software module that enables the end user to view cases identified by the Viz AAA algorithm to contain a suspected abdominal aortic aneurysm. The Viz AAA 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 AAA Mobile Software module is enabled, studies determined by the algorithm to contain a suspected abdominal aortic 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 AAA, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Vascular or endovascular specialists 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
Abdomen
# Indicated Patient Age Range
Not Found
# Intended User / Care Setting
hospital networks and vascular specialists; Vascular or Endovascular Specialists
# 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
466 CTA scans were obtained from the two clinical sites in the U.S. There were approximately twice the number of negative than positive cases, 299 (64.16%) without abdominal aortic aneurysm, and 167 (35.84%) scans with an abdominal aortic aneurysm included in the analysis. Ground truth was established by trained radiologists with fellowship in vascular radiology.
# Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The study assessed the device's sensitivity and specificity using a database of 466 CTA scans (167 positive and 299 negative for abdominal aortic aneurysm). Sensitivity was 96% [0.92, 0.98] and specificity was 95% [0.92, 0.97], both exceeding the pre-specified performance goal of 80% for their lower bounds. The AUC was 0.99 [0.98 - 1.00], surpassing the secondary performance goal of 0.95. Performance was also stratified by health care system, patient age, patient sex, aneurysm location (infra-renal), aneurysm diameter (at least 3 cm), aneurysm type (fusiform), CT scanner manufacturer and model, scanner detector rows, slice thickness, imaging protocol, and presence of metal artifact. The study demonstrated that the device can effectively identify and notify patients with a suspected abdominal aortic aneurysm for worklist prioritization.
# Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity (N=167): 96% [0.92, 0.98]
Specificity (N=299): 95% [0.92, 0.97]
AUC: 0.99 [0.98 - 1.00]
# 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.
[K213319](https://510k.innolitics.com/search/K213319)
# 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 shows the logo of the U.S. Food & 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. % Pooja Shah Regulatory Affairs Specialist 201 Mission St., 12th Floor SAN FRANCISCO CA 94105
March 17, 2023
Re: K223443 Trade/Device Name: Viz AAA Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QFM Dated: February 10, 2023 Received: February 10, 2023
Dear Pooja Shah:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
K223443
Device Name
Viz AAA
Indications for Use (Describe)
Viz AAA is a radiological computer-assisted triage and notification software device for analysis of CTA images of the abdomen. The device is intended to assist hospital networks and vascular specialists in workflow triage by flagging and prioritizing studies with suspected abdominal aortic aneurysms during routine patient care.
Viz AAA uses an artificial intelligence algorithm to analyze images and highlight studies with suspected abdominal aortic 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 AAA, in coniunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Vascular specialists who read the original medical images are responsible for the diagnostic decision. Viz AAA is limited to analysis of imaging data and should not be used inlieu of full patient evaluation or relied upon to make or confirm diagnosis.
Viz AAA is limited to detecting aneurysms at least 3 cm in diameter. Viz AAA is intended to identify infra-renal, fusiform abdominal aortic aneurysms.
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 a stylized letter 'V' or a series of stacked, curved lines. The logo consists of five distinct segments. The top segment is a wide, inverted 'V' shape. Below that are three curved lines that decrease in size from top to bottom, creating a sense of depth or perspective. The bottom segment is a smaller, curved line that mirrors the shape of the ones above it.
510(k) SUMMARY
Viz.ai, Inc.'s Viz AAA
- Applicant Name: Viz.ai, Inc. 201 Mission St, 12th Floor San Francisco, CA 94105
- Contact Person: Pooja Shah Regulatory Affairs Specialist 201 Mission St, 12th Floor San Francisco, CA 94105 Tel. (415) 663 - 6130 pooja.shah@viz.ai
- Date Prepared: March 3, 2023
Device Name and Classification
Name of Device: Viz AAA
- 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(s)
| Manufacturer | Device Name | Application No. |
|---|---|---|
| Viz.ai, Inc. | Viz ANEURYSM, Viz ANX | K213319 |
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Image /page/4/Picture/0 description: The image shows a blue logo. The logo is shaped like a stylized letter V. The V is made up of several curved lines and shapes. The logo is simple and modern.
Device Description
Viz AAA is a radiological computer-assisted triage and notification software device for analysis of CTA images of the abdomen. The software automatically receives and analyzes CT angiogram (CTA) imaging of the abdomen for the presence of an aortic aneurysm using an artificial intelligence algorithm and highlights suspect patient imaging in a standalone application for study list prioritization or triage by vascular or endovascular specialists in parallel to standard of care image interpretation.
Viz AAA is a combination of software modules that consists of an image analysis software algorithm and mobile application software module. The Viz AAA Image Analysis Algorithm is an artificial intelligence machine learning (Al/ML) software algorithm that analyzes CTA images of the abdomen for an aortic aneurysm. Images acquired during patient care are forwarded to Viz.ai's Backend server where they are analyzed by the Viz AAA artificial intelligence algorithm for an abdominal aortic aneurysm.
Viz AAA includes a mobile software module that enables the end user to view cases identified by the Viz AAA algorithm to contain a suspected abdominal aortic aneurysm. The Viz AAA 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 AAA Mobile Software module is enabled, studies determined by the algorithm to contain a suspected abdominal aortic 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 AAA, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Vascular or endovascular specialists who read the original medical images are responsible for the diagnostic decision.
Intended Use / Indications for Use
Viz AAA is a radiological computer-assisted triage and notification software device for analysis of CTA images of the abdomen. The device is intended to assist hospital networks and vascular or endovascular specialists in workflow triage by flagging and prioritizing studies with suspected abdominal aortic aneurysms during routine patient care.
Viz AAA uses an artificial intelligence algorithm to analyze images and highlight studies with suspected abdominal aortic 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
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Image /page/5/Picture/0 description: The image shows a blue logo that resembles a stylized letter 'V'. The logo is composed of several curved and angular shapes. The top part of the 'V' is formed by two separate angular shapes, while the lower part consists of three curved lines stacked on top of each other, creating a sense of depth and dimension. The overall design is modern and minimalist.
for diagnostic use. The results of Viz AAA, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Vascular or endovascular specialists who read the original medical images are responsible for the diagnostic decision. Viz AAA 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 AAA is limited to detecting aneurysms at least 3 cm in diameter. Viz AAA is intended to identify infra-renal, fusiform abdominal aortic aneurysms.
Summary of Technological Characteristics
The subject device. Viz AAA, is substantially equivalent to the predicate device, Viz ANEURYSM (Viz ANX) (K213319). In comparing the technological characteristics, both the subject and predicate devices use an artificial intelligence algorithm and mobile software module to identify and highlight suspected clinical findings in a standalone application for study list prioritization. Where the subject and predicate differ is that the software algorithm for the subject device identifies suspected aortic aneurysm findings in CTA imaging of the abdomen whereas the predicate device's algorithm identifies suspected aneurysms in CTA imaging of the head.
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 which can be viewed through a mobile application, and neither device removes patient imaging from a reading queue. Where the devices differ is that the subject device uses a different visual than the predicate to notify users of suspected findings specific to abdominal aortic aneurysms in patient imaging. The visual used to notify the user of the different clinical finding by the subject device does not raise new or different questions of safety and effectiveness as they are displayed to the user through the user interface using the same conventions.
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.
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Image /page/6/Picture/0 description: The image shows a stylized letter 'V' in blue. The 'V' is composed of several horizontal lines that are thicker in the middle and taper towards the ends. The overall design is simple and modern.
| Subject Device | Predicate Device | |
|---|---|---|
| Viz AAA | Viz ANEURYSM (Viz ANX) | |
| Application No. | K223443 | K213319 |
| Product Code | QFM | QFM |
| Regulation No. | 21 C.F.R. § 892.2080 | 21 C.F.R. § 892.2080 |
| Intended Use/ | ||
| Indications for | ||
| Use | Viz AAA is a radiological computer- | |
| assisted triage and notification | ||
| software device for analysis of CTA | ||
| images of the abdomen. The device | ||
| is intended to assist hospital | ||
| networks and vascular or | ||
| endovascular specialists in | ||
| workflow triage by flagging and | ||
| prioritizing studies with suspected | ||
| abdominal aortic aneurysms during | ||
| routine patient care. | ||
| Viz AAA uses an artificial | ||
| intelligence algorithm to analyze | ||
| images and highlight studies with | ||
| suspected abdominal aortic | ||
| 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 | ||
| AAA, in conjunction with other | ||
| clinical information and professional | ||
| judgment, are to be used to assist | ||
| with triage/prioritization of medical | ||
| images. Vascular or endovascular | ||
| specialists who read the original | ||
| medical images are responsible for | 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. | ||
| the diagnostic decision. Viz AAA 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 AAA is limited to detecting | ||
| aneurysms at least 3 cm in | ||
| diameter. Viz AAA is intended to | ||
| identify infra-renal, fusiform | ||
| abdominal aortic aneurysms. | Viz ANEURYSM is limited to detecting | |
| aneurysms at least 4mm in diameter. | ||
| Anatomical | ||
| Region | Abdomen | Head |
| Diagnostic | ||
| Application | Notification-only, highlighting for | |
| prioritization and review. | Notification-only, highlighting for | |
| prioritization and review. | ||
| Notification/ | ||
| Prioritization | Yes | Yes |
| Intended User | Vascular or Endovascular | |
| Specialists | Radiologists | |
| 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 | ||
| Supported | ||
| Imaging Modality | Computed Tomography | |
| Angiography (CTA) | Computed Tomography Angiography | |
| (CTA) | ||
| Alteration of | ||
| Original Image | No | No |
| Results of Image | ||
| Analysis | Internal, no image marking | Internal, no image marking |
| Preview Images | Initial assessment; non-diagnostic | |
| purposes | Initial assessment; non-diagnostic | |
| purposes | ||
| Results returned | ||
| in Standalone | ||
| Application | Yes | Yes |
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Image /page/7/Picture/0 description: The image shows a stylized blue logo. The logo is composed of several curved lines that are arranged in a way that resembles the letter 'V'. The lines are thick and have a consistent width. The logo has a modern and minimalist design.
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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 an abstract representation of wings or a chevron. The logo has a modern and minimalist design.
Performance Data
466 CTA scans were obtained from the two clinical sites in the U.S. There were approximately twice the number of negative than positive cases, 299 (64.16%) without abdominal aortic aneurysm, and 167 (35.84%) scans with an abdominal aortic aneurysm included in the analysis.
Sensitivity and specificity were calculated for the image database, comparing Viz AAA's output to ground truth as established by trained radiologists with fellowship in vascular radiology. Sensitivity and specificity were reported to be 96% [0.92, 0.98] and 95% [0.92, 0.97], 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.
| Performance (95% C.I.) | |
|---|---|
| Sensitivity (N=167) | 96% [0.92, 0.98] |
| Specificity (N=299) | 95% [0.92, 0.97] |
| Table 1: Device Sensitivity and Specificity | |
|---|---|
| --------------------------------------------- | -- |
The area under the receiver operating characteristic curve (AUC) was reported as 0.99 [0.98 - 1.00], demonstrating the clinical utility and potential benefits of the classifier based on the imaging study results. Because the point estimate of the AUC was greater than 0.95, the study exceeded the secondary performance goal for device AUC.
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Image /page/9/Picture/0 description: The image shows a blue logo with a stylized letter V. The logo is composed of several curved and angular shapes that create the impression of a stylized letter V. The logo is simple and modern, and the blue color gives it a sense of trust and reliability.
Image /page/9/Figure/1 description: The image is a Receiver Operating Characteristic (ROC) curve for Viz AAA, which plots the sensitivity against 1-specificity. The ROC curve has an area under the curve (AUC) of 0.99, indicating high accuracy. A vertical dotted line represents a threshold for aneurysm score at 0.03.
Stratification of Device Performance
In addition, a secondary analysis reported the device performance when stratified into subgroups by patient demographics, disease characteristics, and technical factors:
| Device Performance by Health Care System | ||
|---|---|---|
| Health Care System | ||
| (Clinical Site) | Sensitivity [95% CI] | Specificity [95% CI] |
| Site 001 | 0.94 | |
| [0.85, 0.98] | 0.96 | |
| [0.92, 0.99] | ||
| Site 002 | 0.97 | |
| [0.92, 0.99] | 0.94 | |
| [0.89, 0.98] |
| Table 2: Performance Stratified by Health Care System (Clinical Site) |
|---|
10
Image /page/10/Picture/0 description: The image shows a stylized blue logo. The logo is composed of several curved and angled shapes that resemble a stylized letter 'V' or a bird in flight. The shapes are arranged in a symmetrical pattern, with the largest shape at the top and smaller shapes stacked below it. The logo has a modern and abstract design.
Table 3: Performance Stratified by Age
| Device performance by Patient Age | ||
|---|---|---|
| Age Group (years) | Sensitivity [95% CI] | Specificity [95% CI] |
| =70 | 0.96 | |
| [0.91, 0.99] | 0.94 | |
| [0.88, 0.97] |
Table 4: Performance Stratified by Sex
| Device Performance by Patient Sex | |||
|---|---|---|---|
| Sex | Sensitivity [95% CI] | Specificity [95% CI] | |
| Male | 0.96 | ||
| [0.91, 0.99] | 0.95 | ||
| [0.90, 0.98] | |||
| Female | 0.94 | ||
| [0.80, 0.99] | 0.96 | ||
| [0.91, 0.99] |
Table 5: Performance Stratified by Abdominal Aortic Aneurysm Location
| Device Performance by Aneurysm Location | |
|---|---|
| Location | Sensitivity [95% CI] |
| Infra-renal | 0.97 [0.93, 0.99] |
11
Image /page/11/Picture/0 description: The image shows a stylized blue logo. The logo is composed of several curved lines arranged in a 'V' shape. The top of the 'V' is formed by two separate curved shapes, and the rest of the 'V' is made up of three horizontal curved lines that are stacked on top of each other.
Table 6: Performance Stratified by Abdominal Aortic Aneurysm Diameter
| Device Performance by Aneurysm Diameter | |
|---|---|
| Diameter Range (mm) | Sensitivity [95% CI] |
| 3.0 - 3.9 | 0.91 [0.80, 0.97] |
| 4.0 - 4.9 | 0.98 [0.91, 1.00] |
| 5.0 - 5.3 | 1.00 [0.78, 1.00] |
| >= 5.4 | 0.97 [0.87, 1.00] |
Table 7: Performance Stratified by Aneurysm Type
| Device Performance by Aneurysm Type | ||
|---|---|---|
| Type | Sensitivity [95% CI] | |
| Fusiform | 0.97 [0.94, 0.99] |
Table 8: Performance Stratified by CT Scanner Manufacturer
| Device Performance by Manufacturer | ||
|---|---|---|
| Manufacturer | Sensitivity [95% CI] | Specificity [95% CI] |
| GE MEDICAL | ||
| SYSTEMS | 0.94 | |
| [0.84, 0.98] | 0.95 | |
| [0.89, 0.98] | ||
| SIEMENS | 0.97 | |
| [0.91, 0.99] | 0.96 | |
| [0.92, 0.98] | ||
| TOSHIBA | 1.00 | |
| [0.63, 1.00] | 0.88 | |
| [0.64, 0.99] |
12
Image /page/12/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 representation of wings or feathers. The logo has a modern and minimalist design.
Table 9: Performance Stratified by CT Scanner Manufacturer and Model
| Device Performance by Manufacturer and Model | |||
|---|---|---|---|
| Manufacturer | Model | Sensitivity [95% CI] | Specificity [95% CI] |
| GE MEDICAL | |||
| SYSTEMS | Discovery 610 | 0.85 | |
| [0.65, 0.96] | 0.97 | ||
| [0.88, 1.00] | |||
| InteleViewer | 1.00 | ||
| [0.29, 1.00] | 1.00 | ||
| [0.29, 1.00] | |||
| LightSpeed Pro 32 | 1.00 | ||
| [0.4,0 1.00] | 0.91 | ||
| [0.59, 1.00] | |||
| Optima CT660 | 1.00 | ||
| [0.4,0 1.00] | 1.00 | ||
| [0.59, 1.00] | |||
| Revolution EVO | 1.00 | ||
| [0.80, 1.00] | 0.90 | ||
| [0.70, 0.99] | |||
| Revolution Maxima | 1.00 | ||
| [0.4,0 1.00] | 1.00 | ||
| [0.16, 1.00] | |||
| Model N/A | 1 | ||
| [0.40, 1.00] | N/A | ||
| Siemens | InteleViewer | 1.00 | |
| [0.48, 1.00] | 1.00 | ||
| [0.54, 1.00] | |||
| Perspective | 0.83 | ||
| [0.36, 1.00] | 0.83 | ||
| [0.52, 0.98] | |||
| SOMATOM Definition | |||
| AS | 1.00 | ||
| [0.92, 1.00] | 0.98 | ||
| [0.93, 1.00] | |||
| SOMATOM Definition | |||
| Flash | 0.95 | ||
| [0.75, 1.00] | 0.97 | ||
| [0.86, 1.00] | |||
| SOMATOM | |||
| Perspective | 1.00 | ||
| [0.74, 1.00] | 0.80 | ||
| [0.44, 0.97] | |||
| Sensation 40 | 0.80 | ||
| [0.28, 0.99] | 1.0 | ||
| [0.29, 1.00] | |||
| Sensation 64 | N/A | 1.0 | |
| [0.29, 1.00] | |||
| Model N/A | 1 | ||
| [0.40. 1.00] | 1 | ||
| [0.03, 1.00] | |||
| Device Performance by Manufacturer and Model | |||
| Manufacturer | Model | Sensitivity [95% CI] | Specificity [95% CI] |
| Toshiba | Aquilion ONE | 1.00 | |
| [0.63, 1.00] | 0.88 | ||
| [0.64, 0.99] |
13
Image /page/13/Picture/0 description: The image shows a blue logo with a stylized letter 'V'. The 'V' is formed by several curved and angular shapes, creating a layered or segmented effect. The overall design is modern and abstract, with a clean and simple aesthetic. The logo appears to be isolated on a white background.
Table 10: Performance by CT Scanner Row Detectors
| Device Performance by Scanner Detector Rows | ||
|---|---|---|
| Detector Rows | Sensitivity [95% CI] | Specificity [95% CI] |
| 2.5 | 0.98 | |
| [0.91, 1.00] | 0.96 | |
| [0.91, 0.99] |
Table 12: Performance by Imaging Protocol
| Type | Sensitivity [95% CI] | Specificity [95% CI] |
|---|---|---|
| Abdomen | 1.00 | |
| [0.85, 1.00] | 0.93 | |
| [0.76, 0.99] | ||
| Abdomen-Pelvis | 0.99 | |
| [0.92, 1.00] | 0.96 | |
| [0.92, 0.99] | ||
| Chest-Abdomen | 0.94 | |
| [0.71, 1.00] | 0.94 | |
| [0.80, 0.99] | ||
| Chest-Abdomen-Pelvis | 0.9 | |
| [0.55, 1.00] | 0.98 | |
| [0.88, 1.00] | ||
| Undetermined | 0.92 | |
| [0.81, 0.98] | 0.94 | |
| [0.84, 0.99] |
Table 13: Performance by Presence of Metal Artifact
| Presence of Metal Artifact | Sensitivity (95% C.I.) | Specificity (95% C.I.) |
|---|---|---|
| No metallic artifact | 0.98 [0.93, 1.00] | 0.94 [0.89, 0.97] |
| Metal is present, not obscuring the aorta | 0.95 [0.87, 0.99] | 0.98 [0.94, 1.00] |
| Metal is present obscuring the aorta | 0.67 [0.22, 0.96] | 0.93 [0.66, 1.00] |
15
Image /page/15/Picture/0 description: The image shows a stylized blue logo. The logo is composed of several horizontal lines and curved shapes that resemble a stylized letter 'V'. The shapes are arranged in a way that creates a sense of depth and dimension. The logo is simple, modern, and visually appealing.
Conclusions
The subject device and the predicate have the same intended use and similar indications, technological characteristics, and principles of operation. The subject device differs in that it identifies a different suspected finding in CTA imaging of the abdomen and has a unique mobile module for suspected abdominal aortic aneurysm findings. These differences do not present new or different questions of safety or effectiveness with respect to the predicate device. Viz.ai has provided supportive clinical data and software testing which demonstrates that the subject device can perform effective identification and notification of patients with a suspected abdominal aortic aneurysm for worklist prioritization. Thus, Viz AAA is substantially equivalent to the predicate.