BriefCase-Triage

K243548 · Aidoc Medical , Ltd. · QFM · Dec 11, 2024 · Radiology

Device Facts

• Record ID: K243548
• Device Name: BriefCase-Triage
• Applicant: Aidoc Medical , Ltd.
• Product Code: QFM · Radiology
• Decision Date: Dec 11, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2080
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of CT images with or without contrast that include the ribs, in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspect cases of three or more acute Rib fracture (RibFx) pathologies. BriefCase-Triage uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected RibFx findings. Notifications include compressed preview images that are meant for informational purposes only, and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of BriefCase-Triage 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

Software-based radiological triage tool; processes DICOM CT images (with/without contrast) containing ribs; utilizes deep-learning AI algorithm to detect suspected acute rib fractures (3+); operates in parallel to standard-of-care (SOC) workflow; does not alter original images; does not remove/deprioritize cases from SOC reading queue. Deployed on Linux-based cloud server; integrates with PACS/radiology workstations. Upon detection, sends pop-up notification to clinician desktop application; provides compressed, low-quality, unannotated grayscale preview image for prioritization only. Clinicians must review full original images in PACS for diagnosis. Benefits include reduced turnaround time for critical cases via preemptive triage.

Clinical Evidence

Retrospective, blinded, multicenter study (n=308 cases) across 5 US sites. Primary endpoint: AUC > 0.95. Results: AUC 97.2% (95% CI: 95.5-99.0%), Sensitivity 95.2% (95% CI: 89.1-98.4%), Specificity 95.1% (95% CI: 91.2-97.6%). Secondary endpoint: Time-to-notification (mean 41.4s) showed improvement over predicate (70.1s). NPV 99.4%, PLR 19.149, NLR 0.051. Performance goals met for default and four additional operating points.

Technological Characteristics

Radiological computer-aided triage software; deep-learning AI algorithm; cloud-hosted on Linux-based server; DICOM-compliant; integrates with PACS and radiology workstations via image communication platform. Outputs compressed, low-quality, grayscale preview images. No hardware components.

Indications for Use

Indicated for adults and transitional adolescents (aged 18+) undergoing CT imaging (with/without contrast) of the ribs to assist hospital networks and medical specialists in triaging cases with three or more acute rib fractures.

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-Triage for RibFx (K230020)

Reference Devices

• BriefCase-Triage for CSF (K242837)

Submission Summary (Full Text)

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Aidoc Medical, Ltd. % John J. Smith Partner Hogan Lovells U.S. LLP 555 Thirteenth Street NW WASHINGTON, DISTRICT OF COLUMBIA 20004

December 11, 2024

Re: K243548

Trade/Device Name: BriefCase-Triage Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QFM Dated: November 15, 2024 Received: November 15, 2024

Dear John J. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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

Jessica Lamb Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Submission Number (if known)

#### K243548

Device Name

BriefCase-Triage

#### Indications for Use (Describe)

BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of CT images with or without contrast that include the ribs, in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspect cases of three or more acute Rib fracture (RibFx) pathologies.

BriefCase-Triage uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected RibFx findings. Notifications include compressed preview images that are meant for informational purposes only, and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

The results of BriefCase-Triage 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) |
|-------------------------------------------------|
|-------------------------------------------------|

> 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 the logo for "Amdoc". The logo is written in a sans-serif font, and the letters are a dark blue color. There is a small orange circle to the right of the letter "c".

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

#### Submitter:

| Aidoc Medical, Ltd.<br>3 Aminadav St.<br>Tel-Aviv, Israel<br>Phone: | [phone] |
|---------------------------------------------------------------------|---------------------------------------------------------------------------|
| Contact Person: | Amalia Schreier, LL.M |
| Date Prepared: | December 11 , 2024 |
| Name of Device: | BriefCase-Triage |
| Classification Name: | Radiological computer-assisted triage and notification software<br>device |
| Regulatory Class: | Class II |
| Product Code: | QFM |
| Primary Predicate Device: | BriefCase-Triage for RibFx (K230020) |
| Reference Device: | BriefCase-Triage for CSF (K242837) |

#### Device Description

BriefCase-Triage is a radiological computer-assisted triage and notification software device. The software is based on an algorithm programmed component and is intended to run on a linuxbased server in a cloud environment.

The BriefCase-Triage receives filtered DICOM Images, and processes them chronologically by running the algorithms on each series to detect suspected cases. Following the Al processing, the output of the algorithm analysis is transferred to an image review software (desktop application). When a suspected case is detected, the user receives a pop-up notification and is presented with a compressed, low-quality, grayscale image that is captioned "not for diagnostic use, for prioritization only" which is displayed as a preview function. This preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification.

Presenting the users with worklist prioritization facilitates efficient triage by prompting the user 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.

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The algorithm was trained during software development on images of the pathology. As is customary in the field of machine learning, deep learning algorithm development consisted of training on labeled ("tagged") images. In that process, each image in the training dataset was tagged based on the presence of the critical finding.

## Intended Use / Indications for Use

BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of CT images with or without contrast that include the ribs, in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspect cases of three or more acute Rib fracture (RibFx) pathologies.

BriefCase-Triage uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected RibFx findings. Notifications include compressed preview images that are meant for informational purposes only, and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

The results of BriefCase-Triage 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.

## Summary of Technological Characteristics

The subject BriefCase-Triage for RibFx and the algorithm analysis module for the primary predicate BriefCase-Triage for RibFx (K230020) are identical in most aspects and differ mostly with respect to changes in algorithm training process and their algorithm performance.

Both the primary predicate and subject devices are radiological computer-aided triage and notification software programs. Both devices are artificial intelligence, deep-learning algorithms incorporated in software packages for use with DICOM compliant CT scanners, PACS, and radiology workstations.

Both devices are intended to aid in triage and prioritization of radiological images and utilize the same design of deep learning algorithm trained on medical images. Both devices are intended to provide the specialists with notifications and unannotated, compressed, low-quality, and grayscale preview images of suspect studies for the purpose of preemptive triage.

The subject and predicate BriefCase-Triage devices raise the same types of safety and effectiveness questions, namely, accurate triage of findings within the processed study. It is important to note that, like the predicate, the subject device neither removes cases from the standard of care reading queue nor de-prioritized cases. 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 the primary predicate devices is provided below.

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| | Subject Device<br>Aidoc BriefCase-Triage for RibFx | Predicate Device<br>Aidoc BriefCase-Triage for RibFx<br>(K230020) |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use /<br>Indication<br>s for Use | BriefCase-Triage is a radiological<br>computer aided triage and notification<br>software indicated for use in the analysis<br>of CT images with or without contrast<br>that include the ribs, in adults or<br>transitional adolescents aged 18 and<br>older. The device is intended to assist<br>hospital networks and appropriately<br>trained medical specialists in workflow<br>triage by flagging and communicating<br>suspect cases of three or more acute Rib<br>fracture (RibFx) pathologies.<br><br>BriefCase-Triage uses an artificial<br>intelligence algorithm to analyze images<br>and highlight cases with detected<br>findings in parallel to the ongoing<br>standard of care image interpretation.<br>The user is presented with notifications<br>for cases with suspected RibFx findings.<br>Notifications include compressed<br>preview images that are meant for<br>informational purposes only, and not<br>intended for diagnostic use beyond<br>notification. The device does not alter the<br>original medical image and is not<br>intended to be used as a diagnostic<br>device.<br><br>The results of BriefCase-Triage are<br>intended to be used in conjunction with<br>other patient information and based on<br>their professional judgment, to assist<br>with triage/prioritization of medical<br>images. Notified clinicians<br>are<br>responsible for viewing full images per<br>the standard of care. | BriefCase is a radiological computer aided<br>triage and notification software indicated<br>for use in the analysis of chest CTs (with or<br>without contrast) images, in adults or<br>transitional adolescents aged 18 and older.<br>The device is intended to assist hospital<br>networks and appropriately trained medical<br>specialists in workflow triage by flagging<br>and communicating suspect cases of three<br>or more acute Rib fracture (RibFx)<br>pathologies.<br><br>BriefCase uses an artificial intelligence<br>algorithm to analyze images and highlight<br>cases with detected findings in parallel to<br>the ongoing standard of care image<br>interpretation. The user is presented with<br>notifications for cases with suspected<br>RibFx findings. Notifications include<br>compressed preview images that are<br>meant for informational purposes only, and<br>not intended for diagnostic use beyond<br>notification. The device does not alter the<br>original medical image and is not intended<br>to be used as a diagnostic device.<br><br>The results of BriefCase are intended to be<br>used in conjunction with other patient<br>information and based on their professional<br>judgment, to assist with triage/prioritization<br>of medical images. Notified clinicians are<br>responsible for viewing full images per the<br>standard of care. |
| | Subject Device<br>Aidoc BriefCase-Triage for RibFx | Predicate Device<br>Aidoc BriefCase-Triage for RibFx<br>(K230020) |
| User<br>population<br>n | Hospital networks and appropriately<br>trained medical specialists | Hospital networks and appropriately<br>trained medical specialists |
| Anatomic<br>al region<br>of interest | Ribs | Chest |
| Data<br>acquisitio<br>n protocol | CT images with or without contrast that<br>include the ribs | Chest CTs (with or without contrast) |
| Notificatio<br>n-only<br>(/notificati<br>on alerts),<br>parallel<br>workflow<br>tool | Yes | Yes |
| Images<br>format | DICOM | DICOM |
| Interferen<br>ce with<br>standard<br>workflow | No. No cases are removed from<br>desktop app or deprioritized | No. No cases are removed from<br>desktop app or deprioritized |
| | Subject Device<br>Aidoc BriefCase-Triage for RibFx | Predicate Device<br>Aidoc BriefCase-Triage for RibFx<br>(K230020) |
| Inclusion/<br>Exclusion<br>criteria for<br>clinical<br>performance<br>testing | Inclusion Criteria CT images with or without contrast that include the ribs Single energy exams Performed on CT scanners with 64 or greater number of detectors Scans performed on adults/transitional adults ≥ 18 years of age Slice thickness; 0.5 mm to 5.0 mm axial slices Exclusion Criteria All studies that are technically inadequate, including studies with motion artifacts, severe metal artifacts, or inadequate field of view | Inclusion Criteria Chest CT with or without contrast Single energy exams. Performed on CT scanners with 64 or greater number of detectors Scans performed on adults/transitional adults ≥ 18 years of age Slice thickness; 0.5 mm to 5.0 mm axial slices Exclusion Criteria All studies that are technically inadequate, including studies with motion artifacts, severe metal artifacts, or inadequate field of view |
| Additional<br>Operating<br>Points | 4 Additional Operating Points | 2 Additional Operating Points |
| Algorithm | Artificial intelligence algorithm with database of images. | Artificial intelligence algorithm with database of images. |
| Structure | Integrated with image routing module via image communication platform (ICP) (image acquisition). Algorithm module (image processing) Integrated with desktop application for workflow integration (feed and non-diagnostic Image Viewer). | Integrated with image routing module via image communication platform (ICP) (image acquisition). Algorithm module (image processing) Integrated with desktop application for workflow integration (feed and non-diagnostic Image Viewer). |

## Table 1. Key Feature Comparison

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#### Performance Data

#### Pivotal Study Summary

Aidoc conducted a retrospective, blinded, multicenter study with the BriefCase-Triage software to evaluate the software's performance in identifying CT images with or without contrast that include the ribs containing three or more acute Rib fractures (RibFx) in 308 cases from 5 US-based clinical sites. The study compared the software's performance to the ground truth, as determined by three senior board-certified radiologists. The cases collected for the pivotal dataset were all distinct in time or center from the cases used to train the algorithm, as was used for the most recent clearance (K230020). Test pivotal study data was sequestered from algorithm development activities, and use of the data is managed by appropriate Quality Management System procedures.

Primary endpoints were pre-specified standalone performance goal (PG) of area under the curve (AUC) > 0.95 for the study level receiver operating characteristic (ROC) curve. Secondary endpoints were BriefCase-Triage time-to-notification compared to the predicate device. Positive Value (PPV), Negative Predictive Value (NPV), Positive Likelihood Ratio (PLR), and Negative Likelihood Ratio (NLR) were also assessed.

## Primary Endpoint

AUC was 97.2% (95% Cl: 95.5%-99.0%), Sensitivity was 95.2% (95% Cl: 89.1%-98.4%) and Specificity was 95.1% (95% Cl: 91.2%-97.6%). As the AUC exceeded 0.95 and sensitivity and specificity both exceeded 80%, the study's primary endpoints were met.

Lower confidence limits for AUC, sensitivity and specificity were all above the pre-specified performance goals, demonstrating that the pre-specified performance goals were met.

## Secondary Endpoint

In addition, the time-to-notification metric observed for the BriefCase-Triage software, when integrated with a compatible image communication platform, was compared to the equivalent metric of the predicate devices. The BriefCase-Triage time-to-notification includes the time to get the DICOM exam, de-identify it, upload it to the cloud, analyze and send a notification on a positive suspect case back to the desktop application.

The BriefCase-Triage time-to-notification was measured for all True Positive cases (i.e., identified as positive both by the reviewers as well as the BriefCase-Triage device) and is given in Table 2 below. The Table also displays the same metric reported for the predicate BriefCase-Triage for RibFx.

The time-to-notification results obtained for the subject BriefCase-Triage device show comparability with the primary predicate with regard to time savings to the standard of care review. The BriefCase-Triage mean time-to-notification for the subject RibFx triage was 41.4 seconds (95% Cl: 40.4-42.5). The time-to-notification for the predicate RibFx was 70.1 seconds (95% CI: 64.9-75.4).

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Table 2. Time-to- notification comparison for BriefCase-Triage devices (Seconds)

| Time -to-notification | Mean Estimate<br>(seconds) | N | 95% Lower<br>CL | 95% Upper<br>CL | Median |
|-----------------------------------------------------------------------------------|----------------------------|-----|-----------------|-----------------|--------|
| Predicate K230020<br>Processing Time | 70.1 | 104 | 64.9 | 75.4 | 66 |
| BriefCase-Triage +<br>Image<br>Communication<br>Platform Time-To-<br>Notification | 41.4 | 104 | 40.4 | 42.5 | 39.5 |

NPV was 99.4% (95% CI: 98.7%- 99.8%) and 68.3% (95% CI: 54.1%- 79.8%).

PLR was 19.149 (95% Cl: 10.594-35.595) and NLR was 0.051 (95% Cl: 0.021-0.119).

Thus, the reported similar time-to-notification data demonstrates that when using the subject BriefCase-Triage for RibFx the clinician may have the same benefit in time saving as with the predicate BriefCase-Triage for RibFx.

As can be seen in Table 3 the mean age of patients whose scans were reviewed for RibFx was 65.1 years, with a standard deviation of 15.5 years. Gender distribution was 51.3% male, and 45.5% female (Table 4). Scanner distribution can also be found in Table 5 below.

| | Mean | Std | Min | Median | Max | N |
|----------------|------|------|-----|--------|-----|-----|
| Age<br>(Years) | 65.1 | 15.5 | 20 | 66 | 90 | 308 |

## Table 3. Descriptive Statistics for Age

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| Ground<br>Truth<br>Results | Gender | | | | All | |
|----------------------------|--------|-------|------|-------|-----|--------|
| | Female | | Male | | | |
| | N | % | N | % | N | % |
| Positive | 36 | 12.1% | 61 | 20.5% | 97 | 32.6% |
| Negative | 104 | 34.9% | 97 | 32.6% | 201 | 67.4% |
| All | 140 | 47.0% | 158 | 53.0% | 298 | 100.0% |

## Table 4. Frequency Distribution of Gender *

* 10 cases were unknown for gender (3 negative and 7 positive).

Table 5. Frequency Distribution of Manufacturer

| Manufacturer | N | % |
|-----------------------|-----|-------|
| GE MEDICAL<br>SYSTEMS | 150 | 48.7% |
| Philips | 64 | 20.8% |
| SIEMENS | 53 | 17.2% |
| TOSHIBA | 41 | 13.3% |
| Total | 308 | 100% |

## Table 6. Frequency Distribution of slice thickness

| Thickness<br>(mm) | N | % |
|-------------------|-----|-------|
| 0.5-1 | 56 | 18.2% |
| 1-2 | 151 | 49.0% |
| 2-5 | 101 | 32.8% |
| Total | 308 | 100% |

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#### Clinical Subgroups and Confounders:

Pathologies present in negative; Neoplastic; Heart & vascular; Chronic diseases; Inflammatory: Trauma; None of the above.

#### Additional Operating Points:

In addition to the default operating point that was selected to maximize both sensitivity and specificity, four additional operating points (AOP) were selected to maximize specificity while maintaining a lower bound 95% confidence interval of 80% for sensitivity and spectively:

| Operating Points | Sensitivity % (95% CI) | Specificity % (95% CI) |
|------------------|------------------------------------------------|----------------------------------|
| AOP1 | 98.1% (95% CI: 93.2%-<br>99.8%) | 90.2% (95% CI: 85.3%-<br>93.9%) |
| AOP2 | 97.12% (95% CI: 91.8%-<br>99.4%) | 92.16% (95% CI: 87.6%-<br>95.5%) |
| AOP3 | 92.3% (95% CI: 85.4%-<br>96.6%) | 95.1% (95% CI: 91.2%-<br>97.6%) |
| AOP4 | Sensitivity was 88.5% (95%<br>CI: 80.7%-93.9%) | 95.1% (95% CI: 91.2%-<br>97.6%) |

## Table 7. Additional Operating Points

In summary, performance goals were achieved for the default and four additional operating points. Combined with the comparison results of time-to-notification metric with the predicate device, these data establish the achievement by the subject BriefCase-Triage of preemptive triage in the range of several minutes.

## Conclusions

The subject BriefCase-Triage for RibFx and the predicate BriefCase-Triage for RibFx (K230020) are intended to aid in prioritization and triage of radiological images for the indications for suspected positive findings of incidental pulmonary embolism pathologies. Both devices are software packages consisting of deep learning Al algorithms that process images and produce analysis results, which are displayed to the user by a prioritization alert and a compressed, low-quality, gravscale, unannotated preview image. In both devices, the labeling clearly states that the devices are not for diagnostic use and instructs the user to further evaluate and diagnose based only on the original images in the local PACS.

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Both devices operate in parallel to the standard of care workflow in the sense that they do not change the original image, do not provide any marking on the output preview, do not remove images from the standard of care FIFO queue and do not de-prioritize cases, thus not disturbing standard interpretation of the images. Both devices notify the radiologist of time-sensitive critical cases within the range of several minutes, and thus contribute similarly to the standard of care workflow turnaround time reduction through preemptive triage.

The subject BriefCase-Triage device for RibFx is thus substantially equivalent to the primary predicate BriefCase-Triage for RibFx (K230020).