StrokeSENS LVO

K212261 · Circle Neurovascular Imaging, Inc. · QAS · Oct 14, 2021 · Radiology

Device Facts

• Record ID: K212261
• Device Name: StrokeSENS LVO
• Applicant: Circle Neurovascular Imaging, Inc.
• Product Code: QAS · Radiology
• Decision Date: Oct 14, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2080
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images. StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected LVO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO that requires review. The notification system is intended to be used in parallel to the standard of care workflow to notify clinicians of the existence of the case earlier that they may have been notified as part of the standard of care workflow. Notifications may include a compressed preview of images. Notifications are meant for informational purposes only and are not intended for diagnostic use beyond notification. The StrokeSENS LVO device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of StrokeSENS LVO are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage / prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care.

Device Story

StrokeSENS LVO is a CADt software for acute stroke management. It receives DICOM-formatted head CTA images from scanners or PACS. A machine learning-based processing engine analyzes images to detect LVO. If a suspected LVO is identified, the system sends an automated notification (email/workstation) to neurovascular specialists, including a compressed image preview. The device operates in parallel to standard clinical workflows to expedite triage. It does not alter original images or provide a final diagnosis. Clinicians use the notification to prioritize review of full images on a diagnostic viewer. The device benefits patients by potentially reducing time to notification and subsequent clinical intervention.

Clinical Evidence

Retrospective study on 400 independent studies (217 LVO, 183 non-LVO). Primary endpoints: sensitivity and specificity. Results: mean sensitivity 89.4% (95% CI: 85.3%-93.5%), mean specificity 87.4% (95% CI: 82.6%-92.2%). Mean processing time 0.75 minutes (SD ±0.17). Dataset included diverse scanner vendors, slice thicknesses, and challenging cases.

Technological Characteristics

DICOM-compliant software system consisting of a Processing Engine and a Radiological Software Platform. Uses a locked machine learning binary classifier algorithm. Standards: ISO 13485:2016, IEC 62304:2015, IEC 62366:2015, ISO 14971:2019, NEMA 3.1-3.20 (2011).

Indications for Use

Indicated for hospital networks and trained clinicians to assist in workflow triage by flagging and communicating suspected Large Vessel Occlusion (LVO) in head CTA images. Not for diagnostic use; intended for use in parallel to standard of care.

Regulatory Classification

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.

Special Controls

Radiological computer aided triage and notification software must comply with the following special controls: 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. Standalone 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. 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.

*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.

Predicate Devices

• ContaCT (DEN170073)

Submission Summary (Full Text)

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Circle Neurovascular Imaging, Inc % Kyle Mayr Official Correspondent Circle Cardiovascular Imaging, Inc. 800 5th Ave SW Suite 1100 Calgary, Alberta T2P 3T6 Canada

October 21, 2021

Re: K212261

Trade/Device Name: StrokeSENS LVO Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QAS

Dear Kyle Mayr:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 14, 2021. Specifically, FDA is updating this SE Letter to indicate the correct official correspondent contact name and address as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jessica Lamb, OHT7: Office of In Vitro Diagnostics and Radiological Health, 301-796-6167, iessica.lamb(@fda.hhs.gov.

Sincerely.

Jessica Lamb

For

Jessica Lamb Assistant Director Mammography Ultrasound and Imaging Software Branch 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

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Circle Neurovascular Imaging, Inc. % John Smith Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW WASHINGTON DC 20004

October 14, 2021

## Re: K212261

Trade/Device Name: StrokeSENS LVO Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: OAS Dated: July 16, 2021 Received: July 20, 2021

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 (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

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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 [phone] or 301-796-7100).

Sincerely.

Jessica Lamb

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K212261

Device Name StrokeSENS LVO

#### Indications for Use (Describe)

StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow trage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images.

StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected LVO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected L VO that requires review. The notification system is intended to the standard of care workflow to notify clinicians of the existence of the case earlier that they may have been notified as part of the standard of care workflow.

Notifications may include a compressed preview of images. Notifications are meant for informational purposes only and are not intended for diagnostic use beyond notification. The StrokeSENS LVO device does not alter the original medical image and is not intended to be used as a diagnostic device.

The results of StrokeSENS LVO are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage / prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| <span style="padding-right: 5px;"></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="padding-right: 5px;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |

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Image /page/4/Picture/0 description: The image shows the logo for Circle Neurovascular Imaging. The logo features a brain-shaped design made of green circles on the left side. To the right of the brain design, the word "CIRCLE" is written in large, bold, black letters. Below "CIRCLE", the words "NEUROVASCULAR IMAGING" are written in smaller, black letters.

# 5.1 510k Summary - StrokeSENS LVO

K212261

#### I. SUBMITTER

| Submitter's Name: | |
|-------------------|--|
| Address: | |
| Date Prepared: | |
| Telephone Number: | |
| Fax Number: | |
| Contact Person: | |
| Email: | |

Circle Neurovascular Imaging, Inc. Suite 1100 - 800 5th Ave SW, Calgary, AB, Canada, T2P 3T6 July 16, 2021 [phone] [phone] Kyle Mayr [e-mail]

II. DEVICE

Name of the Device: Short Brand Name: Common or Usual Name: Classification Name: Proposed Classification:

StrokeSENS LVO StrokeSENS LVO Medical Image Processing Software Radiological Computer-Assisted Triage And Notification Software Device Class II Special Controls Product Code: QAS Regulation Number: 21 CFR 892.2080

#### III. PREDICATE DEVICE

ContaCT, manufactured by Viz.Al (DEN170073)

#### IV. DEVICE DESCRIPTION

StrokeSENS LVO is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVQ) in head CTA images. StrokeSENS LVO uses a software alqorithm based on machine learning to identify suspected LVO findings. In the case of a suspected LVO, the system will send a notification to a preconfigured destination(s), notifying the clinicians of a suspected LVQ that requires review.

#### Clinical Characteristics and Procedures of Use

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Image /page/5/Picture/0 description: The image is a logo for Circle Neurovascular Imaging. The logo features a cluster of green circles on the left side, resembling a brain. To the right of the circles, the word "CIRCLE" is written in large, bold, black letters. Below "CIRCLE", the words "NEUROVASCULAR IMAGING" are written in smaller, black letters.

After a CT Angiography (CTA) head scan is performed, the images are automatically routed to StrokeSENS LVO where they are processed and analyzed for characteristics suggestive of LVO. The notification system is comprised of an on-screen notice of a suspected LVQ to the user and an outbound notification to a neurovascular specialist. The notification states that a suspected LVO is present, and that the user should review the images in a diagnostic radiological viewer. In the case of a neqative finding, no notification is sent, and the standard of care workflow remains in place.

## Technological Characteristics

StrokeSENS LVO DICOM-compliant software system consists of two main components: 1) the StrokeSENS LVO Processing Engine and 2) a compatible Radiological Software Platform:

- 1. The StrokeSENS LVO Processing Engine is responsible for receiving, processing, and analyzing image data and communicating results. Primarily, the Processing Engine consists of a software algorithm (a sequence of instructions/operations) that is responsible for analyzing contrast-enhanced CT (CTA) image data of the head to identify characteristics that are consistent with LVO. The software algorithm is a binary classifier, providing a binary output of either positive or negative for suspected LVO, based on a pre-defined threshold. The output is returned to the Radiological Software Platform for the purposes of triage and notification. The Processing Engine is integrated into, or installed adjacent to, a compatible Radiological Software Platform.
- 2. The compatible Radiological Software Platform is configured to retrieve/receive contrast-enhanced head CT (CTA) images from the CT scanner or PACS, and automatically transmit, or make available, a copy of the image data for processing and analysis by the LVO Processing Engine. After successful processing of a case via the StrokeSENS LVO Processing Engine, the results are returned to the Radiological Software Platform for the intended purpose of triage and notification.

## V. INDICATIONS FOR USE/ INTENDED USE

#### 1. Indications for use

StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images.

StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected LVQ, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO that requires review. The notification system is

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Image /page/6/Picture/0 description: The image is a logo for Circle Neurovascular Imaging. The logo features a cluster of green circles on the left side, resembling a brain. To the right of the circles, the word "CIRCLE" is written in large, bold, black letters. Below "CIRCLE", the words "NEUROVASCULAR IMAGING" are written in smaller, black letters.

intended to be used in parallel to the standard of care workflow to notify clinicians of the existence of a potential LVO earlier than being notified as part of the standard of care workflow.

Notifications may include a compressed preview of images. Notifications are meant for informational purposes only and are not intended for diagnostic use beyond notification. The StrokeSENS LVO device does not alter the original medical image and is not intended to be used as a diagnostic device.

The results of StrokeSENS LVO are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage / prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care.

#### 2. Special Conditions for Use Statement(s):

For prescription use only. US Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.

# VI. COMPARISON WITH PREDICATE DEVICE

StrokeSENS LVO is considered to be substantially equivalent to Viz.Al: ContaCT (hereafter "ContaCT"), a commercially available device manufactured by Viz.Al, Inc. The subject and predicate devices are both radiological computer-assisted triage and notification software programs. Both devices use machine learning software implementations to analyze CTA images to aid in the prioritization, triage, and notification of suspected large vessel occlusion (LVQ) cases. Both software devices notify a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis performed by the device's algorithm, in parallel to the standard of care workflow. The subject and predicate devices are similar in that neither device alters the original image database or marks up / alters the CTA input images. The subject and predicate device differ in that the subject device generates an email notification that links to the StrokeSENS platform radiological viewing software or other compatible radiological viewing software whereas the predicate generates a notification that is sent to a mobile application.

StrokeSENS LVO has the same general intended use and similar indications, technological characteristics, and principles of operation as the previously cleared predicate device, with minor differences in the notification mechanism. The minor differences do not raise new questions on the safety and effectiveness of the device; therefore the subject device is as safe and effective as the predicate device. A summary substantial equivalence chart comparing the similarities and differences between the StrokeSENS LVO and its predicate device is provided below, as table 5.1-1.

| Feature /<br>Characteristic | Subject Device | Predicate Device | |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| General information | | | |
| Device name | StrokeSENS LVO | ContaCT | |
| Manufacturer | Circle Neurovascular Imaging | Viz.Al | |
| 510(k) number | K212261 | DEN170073 | |
| Device Class | II | II | |
| Device classification | QAS | QAS | |
| Regulation Name | Radiological Computer-Assisted<br>Triage And Notification Software | Radiological Computer-Assisted Triage<br>And Notification Software | |
| Regulation number | 21 CFR 892.2080 | 21 CFR 892.2080 | |
| Indications for Use /<br>Intended Use | StrokeSENS LVO is a<br>radiological computer-aided<br>triage and notification (CADt)<br>software indicated for use in the<br>analysis of CTA head images.<br>The device is intended to assist<br>hospital networks and trained<br>clinicians in workflow triage by<br>flagging and communication of<br>suspected positive findings of<br>Large Vessel Occlusion (LVO) in<br>head CTA images.<br><br>StrokeSENS LVO uses a<br>software algorithm to identify<br>suspected LVO findings. In the<br>case of a suspected LVO, the<br>system will send a notification to<br>a pre-configured destination(s),<br>notifying the clinicians of the<br>existence of a suspected LVO<br>that requires review. The<br>notification system is intended to<br>be used in parallel to the standard<br>of care workflow to notify<br>clinicians of the existence of the<br>case earlier that they may have<br>been notified as part of the<br>standard of care workflow.<br><br>Notifications may include a<br>compressed preview of images.<br>Notifications are meant for<br>informational purposes only and<br>are not intended for diagnostic<br>use beyond notification. The<br>StrokeSENS LVO device does<br>not alter the original medical | ContaCT is a notification-only, parallel<br>workflow tool for use by hospital networks<br>and trained clinicians to identify and<br>communicate images of specific patients<br>to a specialist, independent of standard of<br>care workflow.<br><br>ContaCT uses an artificial intelligence<br>algorithm to analyze images for findings<br>suggestive of a pre-specified clinical<br>condition and to notify an appropriate<br>medical specialist of these findings in<br>parallel to standard of care image<br>interpretation. Identification of suspected<br>findings is not for diagnostic use beyond<br>notification. Specifically, the device<br>analyzes CT angiogram images of the<br>brain acquired in the acute setting, and<br>sends notifications to a neurovascular<br>specialist that a suspected large vessel<br>occlusion has been identified and<br>recommends review of those images.<br><br>Images can be previewed through a<br>mobile application. Images that are<br>previewed through the mobile application<br>are compressed and are for informational<br>purposes only and not intended for<br>diagnostic use beyond notification.<br>Notified clinicians are responsible for<br>viewing non-compressed images on a<br>diagnostic viewer and engaging in<br>appropriate patient evaluation and<br>relevant discussion with a treating<br>physician before making care-related<br>decisions or requests. ContaCT is limited<br>to analysis of imaging data and should not<br>be used in-lieu of full patient evaluation or<br>relied upon to make or confirm diagnosis. | |
| | image and is not intended to be<br>used as a diagnostic device.<br>The results of StrokeSENS LVO<br>are intended to be used in<br>conjunction with other patient<br>information and based on<br>professional judgement, to assist<br>with triage / prioritization of<br>medical images. Notified<br>clinicians are responsible for<br>viewing full images per standard<br>of care. | | |
| Clinical Characteristics | | | |
| User Population | Hospital Networks and trained<br>clinicians | Same | |
| Clinical<br>application/Anatomical<br>Region | Acute Stroke / Head | Same | |
| Relationship to<br>standard of care<br>workflow | In Parallel / Concurrently | Same | |
| Technological Characteristics | | | |
| Input data type | CTA data in DICOM format<br>(vendor independent) | CTA data in DICOM format (vendor<br>independent) | |
| Algorithm<br>Implementation | Artificial Intelligence / Machine<br>Learning<br>Algorithms are static and locked.<br>Algorithms are not dynamic or<br>learning while in the market. | Same | |
| Alteration of original<br>image database | No | Same | |
| Notification / Workflow | Email, Workstation, Mobile<br>Notification message of<br>Suspected LVO | Mobile<br>Notification message of Suspected LVO | |
| DICOM compliant | Yes | Same | |

Table 5.1-1. Feature comparison table of StrokeSENS LVO with the predicate device, ContaCT.

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Image /page/7/Picture/0 description: The image is a logo for Circle Neurovascular Imaging. The logo features a cluster of green circles on the left side, resembling a brain. To the right of the circles, the word "CIRCLE" is written in large, bold, black letters. Below "CIRCLE", the words "NEUROVASCULAR IMAGING" are written in smaller, black letters.

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Image /page/8/Picture/0 description: The image shows the logo for Circle Neurovascular Imaging. The logo features a green brain-shaped design made of circles on the left side. To the right of the brain design is the word "CIRCLE" in large, bold, black lett…