BriefCase

K213886 · Aidoc Medical , Ltd. · QAS · Apr 26, 2022 · Radiology

Device Facts

• Record ID: K213886
• Device Name: BriefCase
• Applicant: Aidoc Medical , Ltd.
• Product Code: QAS · Radiology
• Decision Date: Apr 26, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2080
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced chest CTs (not dedicated CTPA protocol) in adults or transitional adolescents age 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspect cases of incidental Pulmonary Embolism (iPE) pathologies. The device is intended to be used on singleenergy exams only. BriefCase uses an artificial intelligence algorithm to analyze images and flag suspect cases on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for suspect cases. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.

Device Story

BriefCase is a radiological triage software; inputs are DICOM contrast-enhanced chest CT images. System comprises Aidoc Hospital Server (AHS), Aidoc Cloud Server (ACS), and desktop Worklist Application. Algorithm analyzes images for incidental Pulmonary Embolism (iPE); flags suspect cases; sends notifications to clinician desktop. Notifications include patient info and compressed, non-diagnostic preview images. Device operates in parallel to standard-of-care (SOC) workflow; does not alter original images; does not remove cases from SOC queue. Used in hospital networks by radiologists/specialists to prioritize worklists. Benefits include reduced time-to-exam-open for critical findings; facilitates earlier clinical intervention.

Clinical Evidence

Retrospective, blinded, multicenter study (3 sites, 159 cases: 78 positive, 81 negative) evaluating performance on Philips and Toshiba CT scanners. Primary endpoints: sensitivity 89.7% (95% CI: 80.8%, 95.5%) and specificity 90.1% (95% CI: 81.5%, 95.6%). Secondary endpoints: time-to-notification (4.7 min) vs. standard-of-care time-to-exam-open (223.3 min). PPV 19.5%, NPV 99.7%. No significant interaction with center, gender, or age.

Technological Characteristics

Software-based triage system; runs on Windows Server 2012 64-bit. Components: AHS (acquisition), ACS (processing), Worklist Application (UI). Uses deep learning AI algorithms. DICOM 3.0 compliant. Connectivity: networked integration with PACS/workstations. No hardware components. Non-diagnostic preview images are compressed grayscale.

Indications for Use

Indicated for adults and transitional adolescents (age 18+) undergoing contrast-enhanced chest CT (non-CTPA protocol) for triage of incidental Pulmonary Embolism (iPE). Intended for single-energy exams only. Contraindicated for technically inadequate studies (motion/metal artifacts, inadequate FOV).

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

• BriefCase (K203508)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Aidoc Medical, Ltd. % John J. Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 Thirteenth Street NW WASHINGTON DC 20004

April 26, 2022

Re: K213886

Trade/Device Name: BriefCase Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QAS Dated: April 1, 2022 Received: April 1, 2022

Dear Dr. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Jessica Lamb, Ph.D. 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

Enclosure

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/20/2023 See PRA Statement on last page

#### 510(k) Number (if known)

### K213886

Device Name

#### BriefCase

Indications for Use (Describe)

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced chest CTs (not dedicated CTPA protocol) in adults or transitional adolescents age 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspect cases of incidental Pulmonary Embolism (iPE) pathologies. The device is intended to be used on singleenergy exams only.

BriefCase uses an artificial intelligence algorithm to analyze images and flag suspect cases on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for suspect cases. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

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

| 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) |

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

#### 510(k) Summary Aidoc Medical, Ltd.'s BriefCase K213886

### Submitter:

| Aidoc Medical, Ltd.<br>3 Aminadav St.<br>Tel-Aviv, Israel<br>Phone: | [phone] |
|---------------------------------------------------------------------|---------------------------------------------------------------------------|
| Contact Person: | N. Epstein, Ph.D. |
| Date Prepared: | April 1, 2022 |
| Name of Device: | BriefCase |
| Classification Name: | Radiological computer-assisted triage and notification software<br>device |
| Regulatory Class: | Class II |
| Product Code: | QAS (21 C.F.R. 892.2080) |
| Predicate Device: | BriefCase (K203508, for iPE triage) |

## Device Description

BriefCase is a radiological computer-assisted triage and notification software device. The software system is based on an algorithm programmed component and consists of a standard off-the-shelf operating system, the Microsoft Windows server 2012 64bit, and additional applications, which include PostgreSQL, DICOM module and the BriefCase Image Processing Application. The device consists of the following three modules: (1) Aidoc Hospital Server (AHS); (2) Aidoc Cloud Server (ACS); and (3) Aidoc Worklist Application that is installed on the user's desktop and provides the interface in which notifications from the BriefCase software are received and the worklist is presented.

DICOM images are received, saved, filtered and de-identified before processing. Filtration matches metadata fields with keywords. Series are processed chronologically by running the algorithms on each series to detect suspected cases. The software then flags suspect cases by sending notifications to the Worklist desktop application, thereby prompting triage and prioritization by the user. As the BriefCase software platform harbors several triage algorithms, the user may opt to filter out notifications by pathology, e.g., a chest radiologist may choose to filter out notifications on LVO cases, and a neuro-radiologist would opt to divert PE notifications. Where several medical centers are linked to a shared PACS, a user may read cases for a certain center but not for another, and thus may opt to filter out notification by center. Activating the filter does not impact the order in which notifications are presented in the Aidoc worklist application.

The Worklist Application displays the pop-up text notifications of new studies with suspected findings when they come in. Notifications are in the form of a small pop-up containing patient name, accession number and the relevant pathology (e.g., iPE). A list of all incoming cases with suspected findings is also displayed. Hovering over a notification or a case in the worklist pops up a compressed, small black and white, unmarked image that is captioned "not for diagnostic use"

{4}------------------------------------------------

and is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diaqnosis beyond notification.

Presenting the users with notification facilitates earlier triage by prompting them to assess the relevant original images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.

# Intended Use / Indications for Use

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced chest CTs (not dedicated CTPA protocol) in adults or transitional adolescents age 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspect cases of incidental Pulmonary Embolism (iPE) pathologies. The device is intended to be used on singleenergy exams only.

BriefCase uses an artificial intelligence algorithm to analyze images and flaq suspect cases on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for suspect cases. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

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

# Comparison of Technological Characteristics

The subject BriefCase for iPE triage and the predicate device BriefCase for iPE triage (K203508) are identical in all aspects. The subject device is intended for use with additional CT scanners. Specifically, the predicate device was cleared for use with GE and Siemens CT scanners. In this submission, additional performance data were generated for using the BriefCase iPE device with Philips and Toshiba CT scanners.

Both devices are radiological computer-aided triage and notification software programs. Both devices are artificial intelligence algorithms incorporated software packages for use with DICOM 3.0 compliant CT scanners, PACS, and radiology workstations. Both devices are intended to aid in triage and prioritization of radiological contrast-enhanced chest images containing suspected incidental Pulmonary Embolism (iPE) findings. Both devices are intended to provide the users with notifications and unannotated preview images of suspect studies for the purpose of preemptive triage.

Both software devices notify the users of the availability of time sensitive radiological images for review based on computer aided image analysis. Both devices send notifications and low-quality compressed previews to the user's desktop. Both devices feature a notifications filter in the user interface. Notifications are for informational purpose only and are meant to prompt the user to triage the flagged case, upon which he may decide after observing the unannotated, low quality preview on his desktop app, to turn to the local PACS to perform evaluation of the original series earlier than would have been the case without BriefCase.

{5}------------------------------------------------

Thus, the subject and predicate BriefCase raise the same types of safety and effectiveness questions, namely, accurate detection of findings within the processed study. It is important to note that, like the predicate, the subject device does not remove cases from the standard of care reading queue and does not modify them. Both devices operate in parallel with the standard of care, which remains the default option for all cases.

A table comparing the key features of the subject and predicate devices is provided below.

| Table 1. Key feature comparison | | |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate Device<br>Aidoc Briefcase iPE triage (K203508) | Subject Device<br>Aidoc Briefcase iPE triage (K213886) |
| Intended Use /<br>Indications for<br>Use | BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced chest CTs (but not dedicated CTPA protocol). The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive cases of incidental Pulmonary Embolism (IPE) pathologies. For the iPE pathology, the software is only intended to be used on single-energy exams. The device is intended to work with GE and Siemens scanners only.<br><br>BriefCase uses an artificial intelligence algorithm to analyze images and flag suspect cases on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for suspect cases. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.<br><br>The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care. | BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced chest CTs (not dedicated CTPA protocol) in adults or transitional adolescents age 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspect cases of incidental Pulmonary Embolism (IPE) pathologies. The device is intended to be used on single-energy exams only.<br><br>BriefCase uses an artificial intelligence algorithm to analyze images and flag suspect cases on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for suspect cases. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device<br><br>The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care. |
| User population | Appropriately trained medical specialists | Appropriately trained medical specialists |
| Anatomical<br>region of<br>interest | Chest | Chest |
| Inclusion/<br>Exclusion<br>criteria | Inclusion criteria | Inclusion Criteria |
| | Contrast-enhanced chest CTs (not<br>dedicated CTPA protocol. | Contrast-enhanced chest CTs (not<br>dedicated CTPA protocol. |
| | Single energy exams. | Single energy exams. |
| | Scans performed with a 64 slice or<br>greater number of detectors. | Scans performed with a 64 slice or<br>greater number of detectors. |
| | Scans performed on adults/transitional<br>adults ≥ 18 years of age. | Scans performed on adults/ transitional<br>adolescents ≥ 18 years of age. |
| | Slice thickness; 0.5 -<br>2.0 mm axial. | Slice thickness; 0.5 -<br>2.0 mm axial. |
| | Exclusion Criteria | Exclusion Criteria |
| | All studies that are technically inadequate,<br>including studies with motion artifacts,<br>severe metal artifacts, or inadequate field<br>of view. | All studies that are technically inadequate<br>including studies with motion artifacts<br>severe metal artifacts, or inadequate field of<br>view. |
| Data acquisition<br>protocol | Contrast-enhanced chest CTs (not<br>dedicated CTPA protocol) | Contrast-enhanced chest CTs (not<br>dedicated CTPA protocol) |
| View DICOM<br>data | DICOM Information about the patient,<br>study and current image | DICOM Information about the patient, study<br>and current image |
| Segmentation of<br>region of<br>interest | No; device does not mark, annotate, or<br>direct users' attention to a specific location<br>in the original image | No; device does not mark, annotate, or<br>direct users' attention to a specific location<br>in the original image |
| Algorithm | Artificial intelligence algorithm with<br>database of images | Artificial intelligence algorithm with<br>database of images |
| Notification/<br>Prioritization | Yes | Yes |
| Preview images | Presentation of a low-quality, compressed,<br>grayscale preview image that is captioned<br>"Not for diagnostic use". | Presentation of a low-quality, compressed,<br>grayscale preview image that is captioned<br>"Not for diagnostic use". |
| Alteration of<br>original image | No | No |
| Removal of<br>cases from<br>worklist queue | No. The device operates in parallel with<br>the standard of care, which remains the<br>default option for all cases. | No. The device operates in parallel with the<br>standard of care, which remains the default<br>option for all cases. |
| Structure | AHS module/Orchestrator (image<br>acquisition).<br>- ACS module (image processing).<br>- Aidoc Worklist application for workflow<br>integration (worklist and non-diagnostic<br>basic Image Viewer). | AHS module/Orchestrator (image<br>acquisition).<br>- ACS module (image processing).<br>- Aidoc Worklist application for workflow<br>integration (worklist and non-diagnostic<br>Image Viewer). |

Table 1. Kev feature comparison

{6}------------------------------------------------

# Performance Data

# Pivotal Study Summary

Aidoc conducted a retrospective, blinded, multicenter study with the BriefCase software with the primary endpoint to evaluate the software's performance in identifying Contrast-enhanced chest CTs (not dedicated CTPA protocol, acquired through Philips and Toshiba scanners), containing Incidental Pulmonary Embolism in 159 cases from 3 clinical study sites (2 in the US, 1 OUS). There were 78 positive cases and 81 negative cases (images with iPE versus without iPE) included in the analysis.

# Primary Endpoints

Sensitivity and specificity exceeded the 80% performance goal. Specifically, sensitivity was 89.7 % (95% Cl: 80.8%, 95.5%) and specificity was 90.1% (95% Cl: 81.5%, 95.6%). The primary

{7}------------------------------------------------

## endpoints were met.

## Secondary Endpoints

Time saving data were presented in the original iPE 510(k) Summary (K201020) and remain applicable to this device. In summary, the contribution of the BriefCase software is in reducing the time span until an exam is opened to several minutes for cases with suspect findings (4.7 min BriefCase time to notification compared to 223.3 min time-to-exam-open in the standard of care).

Positive/Negative Predictive Values, and Positive/Negative Likelihood Ratios are given below.

### Table 2. PPV/NPV with Associated Two-sided 95% Confidence Limits (population prevalence of positive = 2.6%', Confidence limits computed using the "exact" Clopper-Pearson method

| Parameter | Estimate | 95%<br>Lower CL…