K Number

Device Name

BriefCase

Manufacturer

Aidoc Medical, Ltd.

Date Cleared

2019-05-31

(56 days)

Product Code

QAS

Regulation Number

892.2080

Intended Use

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of cervical spine CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of linear lucencies in the cervical spine bone in patterns compatible with fractures. BriefCase uses an artificial intelligence algorithm to analyse images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of 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 Description

BriefCase is a radiological computer-assisted triage and notification software device. The software system is based on an algorithm programmed component and is comprised 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 radiologist' desktop and provides the user interface in which notifications from the BriefCase software are received. DICOM images are received, saved, filtered and de-identified before processing. Series are processed chronologically by running an algorithm on each series to detect suspected findings and then notifications on flagged series are sent to the Worklist desktop application, thereby prompting preemptive triage and prioritization. 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., CSF). 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" 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 diagnosis beyond notification. Presenting the radiologist with notification facilitates earlier 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K180647

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The summary explicitly states that the device "uses an artificial intelligence algorithm to analyse images" and mentions "incorporating deep learning Al algorithms".

Therapeutic

No.
The device is described as a "radiological computer aided triage and notification software" intended to "assist with triage/prioritization of medical images" by flagging suspected findings. It explicitly states, "The device does not alter the original medical image and is not intended to be used as a diagnostic device." It also states, "The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment," and "Notified clinicians are responsible for viewing full images per the standard of care." These descriptions indicate it's an aid for workflow and prioritization, not a device that directly treats or diagnoses a condition.

Diagnostic

The "Intended Use / Indications for Use" section explicitly states: "The device does not alter the original medical image and is not intended to be used as a diagnostic device." Furthermore, it clarifies that notifications and compressed preview images are "for informational purposes only and not intended for diagnostic use beyond notification."

SaMD (Software as a Medical Device)

Yes

The device is described as a "radiological computer-assisted triage and notification software device" and its components are listed as software modules running on a standard operating system. It processes images and sends notifications, without mentioning any dedicated hardware components included with the device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
BriefCase's Function: BriefCase analyzes medical images (CT scans) of the cervical spine. It does not analyze biological samples from the patient.
Intended Use: The intended use is to assist in workflow triage and notification based on image analysis, not to perform a diagnostic test on a biological sample.
Device Description: The device description details software components and image processing, not laboratory equipment or reagents used for analyzing biological samples.

Therefore, BriefCase falls under the category of a medical device, specifically a radiological computer-aided triage and notification software, but it is not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The entire section for "Control Plan Authorized (PCCP) and relevant text" is marked as "Not Found."

Overview

Intended Use / Indications for Use

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

The results of 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.

Product codes

QAS

Device Description

DICOM images are received, saved, filtered and de-identified before processing. Series are processed chronologically by running an algorithm on each series to detect suspected findings and then notifications on flagged series are sent to the Worklist desktop application, thereby prompting preemptive triage and prioritization.

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., CSF). 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" 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 diagnosis beyond notification.

Presenting the radiologist with notification facilitates earlier 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Yes

Input Imaging Modality

CT images

Anatomical Site

cervical spine bone

Indicated Patient Age Range

Not Found

Intended User / Care Setting

hospital networks and trained radiologists

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Aidoc conducted a retrospective, blinded, multicenter, multinational study with the BriefCase software with the primary endpoint to evaluate the software's performance in identifying CTs containing cervical spine fracture in 186 cases from 3 clinical sites (2 US and 1 OUS). There were approximately an equal number of positive and negative cases (images with CSF versus without CSF) included in the analysis.

Sensitivity and specificity exceeded the 80% performance goal. Specifically, sensitivity was 91.7% (95% CI: 82.7%, 96.9%) and specificity was 88.6% (95% CI: 81.2%, 93.8%).

In addition, Briefcase's potential clinical benefit of worklist prioritization for true positive CSF cases was measured. For that purpose, Aidoc compared the standard-of-care metric of time-to-exam-open to the software's time-to-notification metric for CSF in two of the study sites where the timeto-exam-open information was available.

The BriefCase 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 worklist application.
The standard of care time-to-open-exam consists of the time from scan acquisition to when the radiologist first opened the exam for review.

The standard of care time-to-exam-open was compared to the BriefCase time-to-notification for 48 True Positive cases (i.e., identified as positive both by the reviewers as well as the BriefCase device), and the results are reported in the Table 2 below.

The BriefCase time-to-notification for CSF was 3.9 minutes (95% Cl: 3.8-4.1). In contrast, standard of care time-to-exam-open was much longer (58.4 minutes: 95% Cl 45.3-71.4). The mean difference of 54.4 minutes (95% Cl 41.3-67.5) for these two metrics is statistically significant and assuming the radiologist receives a notification on a true positive CSF case and acts on it immediately, it can on average save 54.4 minutes compared to the timeto-exam-open in a first in first out (FIFO) reading queue. The value of 54.4 is based on the study of 48 cases, from 2 medical centers (1 US, 1 OUS), and may vary in practice.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Sensitivity: 91.7% (95% CI: 82.7%, 96.9%)
Specificity: 88.6% (95% CI: 81.2%, 93.8%)
NPV: 99.0% (95% Cl: 98.3%-99.8%)
PPV: 47.2% (95% Cl: 31.3%-57.5%)

Predicate Device(s)

K180647

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.2080 Radiological computer aided triage and notification software.

(a)
Identification. Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations.
(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage (
e.g., improved time to review of prioritized images for pre-specified clinicians).(iii) Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts (
e.g., subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment.(iv) Stand-alone performance testing protocols and results of the device.
(v) Appropriate software documentation (
e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results).(2) Labeling must include the following:
(i) A detailed description of the patient population for which the device is indicated for use;
(ii) A detailed description of the intended user and user training that addresses appropriate use protocols for the device;
(iii) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality for certain subpopulations), as applicable;(iv) A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images;
(v) Device operating instructions; and
(vi) A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness (
e.g., improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (e.g., confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.

Summary

May 31, 2019

Image /page/0/Picture/1 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K190896

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 5, 2019 Received: April 5, 2019

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

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

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

510(k) Number (if known) K190896 Device Name

BriefCase

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Aidoc Medical, Ltd.'s BriefCase (K190896)

| Submitter: | Aidoc Medical, Ltd.
3 Aminadav St.
Tel-Aviv, Israel |
|----------------------|---------------------------------------------------------------------------|
| Phone: | +972-73-7946870 |
| Contact Person: | N. Epstein, Ph.D. |
| Date Prepared: | May 21, 2019 |
| Name of Device: | BriefCase for CSF Triage |
| Classification Name: | Radiological computer-assisted triage and notification software
device |
| Regulatory Class: | Class II |
| Product Code: | QAS (21 C.F.R. 892.2080) |
| Predicate Device: | BriefCase (K180647, for ICH triage) |

Device Description

Intended Use / Indications for Use

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

Comparison of Technological Characteristics

The subject BriefCase for CSF triage and predicate device BriefCase for ICH triage (K180647) are identical in all aspects and defer only with respect to the training of the algorithm on CSF and ICH images, respectively.

Both devices are radiological computer-aided triage and notification software programs. Both devices are artificial intelligence algorithms incorporated software packages for use with CT scanners, PACS, and radiology workstations. As noted above, both devices are intended to aid in triage and prioritization of radiological images. The predicate device processes head CTs and is indicated for intracranial hemorrhage triage, while the subject device also processes cervical spine images and is indicated for Cervical Spine Fracture triage. Both devices are intended to provide radiologists with notifications and unannotated preview images of suspect studies for the purpose of preemptive triage.

In addition, both software devices notify the attending radiologist of the availability of time sensitive radiological medical images for review based on computer aided image analysis. Both devices send notifications and compressed previews to the radiology workstations' desktop. Notifications are meant to prompt the radiologist to start preemptive triage of a flagged case, upon which he may decide after observing the unannotated, low quality preview on his desktop, to turn to the local PACS to perform evaluation of the original series earlier than would have been the case without BriefCase.

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. 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.

	Predicate Device	Subject Device
	Aidoc Briefcase for ICH triage (K180647)	Aidoc Briefcase for CSF triage
Intended Use / Indications for Use	BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of pathologies in head CT images, namely Intracranial Hemorrhage (ICH).
BriefCase uses an artificial intelligence	BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of cervical spine CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of linear lucencies in the cervical spine bone in patterns compatible with fractures.
	algorithm to analyze images and highlight cases with detected ICH on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH 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 are intended to be used in conjunction with other patient information and based on professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.	BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of 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	Radiologist	Radiologist
Anatomical region of interest	Head	Cervical spine
Data acquisition protocol	Non-contrast head CT scan	Non-contrast cervical spine CT scans
View DICOM data	DICOM Information about the patient, study and current image	DICOM Information about the patient, study and current image
Segmentation of region of interest	No; device does not mark, annotate, or direct users' attention to a specific location in the original image	No; device does not mark, annotate, or direct users' attention to a specific location in the original image
Algorithm	Artificial intelligence algorithm with database of images	Artificial intelligence algorithm with database of images
Notification/ Prioritization	Yes	Yes
Preview
images	Presentation of a small, compressed, black
and white preview image that is labeled
"Not for diagnostic use";
The device operates in parallel with the
standard of care, which remains the default
option for all cases.	Presentation of a small, compressed, black
and white preview image that is labeled
"Not for diagnostic use";
The device operates in parallel with the
standard of care, which remains the default
option for all cases.
Alteration of
original
image	No	No
Removal of
cases from
worklist
queue	No	No

Table 1. Key feature comparison

Performance Data

Pivotal Study Summary

Sensitivity and specificity exceeded the 80% performance goal. Specifically, sensitivity was 91.7% (95% CI: 82.7%, 96.9%) and specificity was 88.6% (95% CI: 81.2%, 93.8%).

Secondary Endpoint

In addition, Briefcase's potential clinical benefit of worklist prioritization for true positive CSF cases was measured. For that purpose, Aidoc compared the standard-of-care metric of time-to-examopen to the software's time-to-notification metric for CSF in two of the study sites where the timeto-exam-open information was available.

-The BriefCase 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 worklist application.
-The standard of care time-to-open-exam consists of the time from scan acquisition to when the radiologist first opened the exam for review.

The BriefCase time-to-notification for CSF was 3.9 minutes (95% Cl: 3.8-4.1). In contrast, standard of care time-to-exam-open was much longer (58.4 minutes: 95% Cl 45.3-71.4). The mean difference of 54.4 minutes (95% Cl 41.3-67.5) for these two metrics is statistically significant and assuming the radiologist receives a notification on a true positive CSF case and acts on it immediately, it can on average save 54.4 minutes compared to the time-to-exam-open in a first in first out (FIFO) reading queue. The value of 54.4 is based on the study of 48 cases, from 2 medical centers (1 US, 1 OUS), and may vary in practice.

Parameter	N	Mean estimate	Lower Confidence Limit	Upper Confidence Limit	Median
Time-to-exam-open in the standard of care	48	58.4	45.3	71.4	51.5
Time-to-notification of BriefCase CSF	48	3.9	3.8	4.1	3.9
Difference	48	54.4	-	-	47.9

Table 2. Time saving data

NPV was 99.0% (95% Cl: 98.3%-99.8%) and PPV was 47.2% (95% Cl: 31.3%-57.5%).

Thus, the reported time savings data demonstrates that radiologists may have the opportunity to be involved in the clinical workflow substantially earlier thanks to the notifications from the BriefCase device.

In summary, performance validation data, combined with real-world evidence, establish the achievement of effective preemptive triage by the BriefCase image analysis algorithm as well as effective notification functionality of the BriefCase application, as compared to the standard of care for improved time-to-exam-open of a notified case.

Conclusions

The subject BriefCase for CSF triage and the predicate BriefCase for ICH triage devices are both intended to aid in prioritization and triage of radiological images for the indications of Cervical Spine Fracture and Intracranial Hemorrhage, respectively. The labeling of both devices clearly states that the devices are not for diagnostic use. Both devices are software packages with similar technological characteristics and principles of operation, incorporating deep learning Al algorithms that process images, and software to send notifications and unannotated compressed preview images to the radiologists' workstation. In both devices, the labeling instructs the user to further evaluate and diagnose based only on the original images in the local PACS.

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, and do not remove images from the standard of care FIFO queue, thus not disturbing standard interpretation of the images by the attending radiologists. Both devices achieve reduction of the standard of care timeto-exam-open to several minutes, which is the BriefCase' time-to-notification, and thus contribute similarly to the standard of care workflow turnaround time reduction through preemptive triage.

The BriefCase device for CSF triage is thus substantially equivalent to the BriefCase for ICH triage.