(90 days)
Not Found
Yes
The intended use section explicitly states that the device uses an "artificial intelligence algorithm" to analyze images.
No
The device is a radiological computer-aided triage and notification software, intended to assist in workflow triage by flagging and communicating suspected positive cases. It does not perform any direct therapeutic action.
No
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 diagnosis device." Additionally, the "Device Description" section notes that the image preview is "not for diagnostic use" and "not intended for primary diagnosis beyond notification."
Yes
The device description explicitly states it is a "radiological computer-assisted triage and notification software device" and details its software components and modules. There is no mention of accompanying hardware that is part of the medical device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: BriefCase analyzes radiological images (CT scans) of the chest and abdomen. It does not interact with or analyze any biological samples.
- The intended use is image triage and notification: The primary purpose of BriefCase is to assist with workflow triage and notification of potential findings in medical images, not to perform a diagnostic test on a biological sample.
Therefore, BriefCase falls under the category of medical image analysis software, not an In Vitro Diagnostic device.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of chest and abdominal CT images. The device is intended to assist hospital networks and appropriately trained medical specialists within the standard-of-care bone health setting in workflow triage by flagging and communication of suspected positive cases of Vertebral Compression Fractures (VCFx) findings.
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone application in parallel to the ongoing standard of care image interpretation. The device does not alter the original medical image and is not intended to be used as a diagnosis 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
QFM
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/Orchestrator) for image acquisition: (2) Aidoc Cloud Server (ACS) for image processing; and (3) Aidoc Desktop Application for workflow integration.
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 desktop application feed displays all incoming suspect cases, each notified case in a line. Hovering over a line in the feed pops up a compressed, low-quality, grayscale, unannotated image that is captioned "not for diagnostic use", "for prioritization only" 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 users with worklist prioritization 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
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone application in parallel to the ongoing standard of care image interpretation.
Both devices are artificial intelligence, deep-learning algorithms incorporating software packages for use with PACS and radiology workstations.
Input Imaging Modality
CT
Anatomical Site
chest and abdominal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital networks and appropriately trained medical specialists within the standard-of-care bone health setting
Description of the training set, sample size, data source, and annotation protocol
The cases collected for the pivotal dataset were all distinct in time or center from the cases used to train the algorithm.
Description of the test set, sample size, data source, and annotation protocol
Aidoc conducted a retrospective, blinded, multicenter, study with the BriefCase software to evaluate the software’s performance in identifying Vertebral Compression Fractures in chest and abdominal CT images in 318 cases from 5 US-based clinical sites, compared to the ground truth as determined by three senior board-certified radiologists.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Aidoc conducted a retrospective, blinded, multicenter, study with the BriefCase software to evaluate the software's performance in identifying Vertebral Compression Fractures in chest and abdominal CT images in 318 cases from 5 US-based clinical sites, compared to the ground truth as determined by three senior board-certified radiologists.
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 time-to-notification compared to the predicate device. Positive Value (PPV), Negative Predictive Value (NPV), Positive Likelihood Ratio (PLR), and Negative Likelihood Ratio (NLR) will also be assessed.
AUC was 97.6% (95% Cl: 96.1%, 99.1%), Sensitivity was 95.11% (95% Cl: 90.92%, 97.74%) and Specificity was 93.28% (95% Cl: 87.63%, 96.88%). 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.
The BriefCase mean time-to-notification for Vertebral Compression Fractures was 117.2 seconds (95% Cl: 98.64-135.85). The time-to-notification for the HealthVCF triage was 61.36 seconds.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
AUC was 97.6% (95% Cl: 96.1%, 99.1%)
Sensitivity was 95.11% (95% Cl: 90.92%, 97.74%)
Specificity was 93.28% (95% Cl: 87.63%, 96.88%).
NPV was 99.5% (95% CI: 99.1%- 99.8%)
PPV was 55.2% (95% CI: 39.6%).
PLR was 14.1606 (95% Cl: 7.528-26.637)
NLR was 0.0524 (95% Cl: 0.028- 0.099)
Predicate Device(s)
HealthVCF (K192901)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2080 Radiological computer aided triage and notification software.
(a)
Identification. Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations.
(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage (
e.g., improved time to review of prioritized images for pre-specified clinicians).(iii) Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts (
e.g., subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment.(iv) Stand-alone performance testing protocols and results of the device.
(v) Appropriate software documentation (
e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results).(2) Labeling must include the following:
(i) A detailed description of the patient population for which the device is indicated for use;
(ii) A detailed description of the intended user and user training that addresses appropriate use protocols for the device;
(iii) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality for certain subpopulations), as applicable;(iv) A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images;
(v) Device operating instructions; and
(vi) A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness (
e.g., improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (e.g., confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.
0
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Aidoc Medical, Ltd. % John J. Smith, M.D., J.D. Partner Hogan Lovells U.S. LLP 555 Thirteenth Street NW WASHINGTON DC 20004
Re: K222692
December 5, 2022
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: QFM Dated: November 10, 2022 Received: November 10, 2022
Dear John Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb
Jessica Lamb, PhD Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of 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
510(k) Number (if known)
Device Name
BriefCase
Indications for Use (Describe)
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of chest and abdominal CT images. The device is intended to assist hospital networks and appropriately trained medical specialists within the standard-of-care bone health setting in workflow triage by flagging and communication of suspected positive cases of Vertebral Compression Fractures (VCFx) findings.
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone application in parallel to the ongoing standard of care interpretation. The device does not alter the original medical image and is not intended to be used as a diagnosis 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the logo for Aidoc. The logo is in blue, with the letters "aidoc" in a sans-serif font. There is a small orange circle to the right of the "c" in "aidoc". The logo is simple and modern.
K222692
510(k) Summary Aidoc Medical, Ltd.'s BriefCase
Submitter:
| Aidoc Medical, Ltd.
3 Aminadav St.
Tel-Aviv, Israel
| Phone: | +972-73-7946870 |
|---|---|
| Contact Person: | Amalia Schreier, LL.M. |
| Date Prepared: | September 6, 2022 |
| Name of Device: | BriefCase |
| Classification Name: | Radiological computer-assisted triage and notification software |
| device | |
| Requlatory Class: | Class II |
| Product Code: | QFM (21 C.F.R. 892.2080) |
| Primary Predicate Device: | HealthVCF (K192901) |
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/Orchestrator) for image acquisition: (2) Aidoc Cloud Server (ACS) for image processing; and (3) Aidoc Desktop Application for workflow integration.
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 desktop application feed displays all incoming suspect cases, each notified case in a line. Hovering over a line in the feed pops up a compressed, low-quality, grayscale, unannotated image that is captioned "not for diagnostic use", "for prioritization only" 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 users with worklist prioritization 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.
4
Intended Use / Indications for Use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of chest and abdominal CT images. The device is intended to assist hospital networks and appropriately trained medical specialists within the standard-of-care bone health setting in workflow triage by flaqging and communication of suspected positive cases of Vertebral Compression Fractures (VCFx) findings.
BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone application in parallel to the ongoing standard of care image interpretation. The device does not alter the original medical image and is not intended to be used as a diagnosis 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 Vertebral Compression Fractures (VCFx) triage and primary predicate HealthVCF triage (K192901) are very similar, as explained below.
Both devices are radiological computer-aided triage and notification software programs. Both devices are artificial intelligence, deep-learning algorithms incorporating software packages for use with PACS and radiology workstations. The predicate HealthVCF evaluates images from CT scanners as does the proposed Briefcase for Vertebral Compression Fractures (VCFx). The predicate and subject devices run on chest and abdomen CTs. The predicate and subject devices both present nondiagnostic slices preview images.
The proposed device for Vertebral Compression Fractures has similar technology and design as the predicate device, and similar indications for use, i.e., both devices are intended to aid in prioritization and triage of time-critical radiological images. The subject and predicate HealthVCF devices 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 neither removes cases from the standard of care reading queue nor deprioritizes 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 predicate devices is provided below.
5
| | Predicate Device HealthVCF
(K192901) | Subject Device
Aidoc Briefcase for
Vertebral Compression
Fractures (VCFx) Triage |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use / Indications for
Use | HealthVCF is a passive
notification for prioritization-
only, parallel-workflow software
tool used by clinicians to
prioritize specific patients
within the standard-of-care
bone health setting for
suspected vertebral
compression fractures.
HealthVCF uses an artificial
intelligence algorithm to
analyze chest and abdominal
CT scans and flags those that
are suggestive of the presence
of at least one vertebral
compression at the exam level.
These flags are viewed by the
clinician in Bone Health and
Fracture Liaison Service
programs in the medical setting
via a worklist application on
their Picture Archiving and
Communication System
(PACS). HealthVCF does not
send a proactive alert directly
to the user. | BriefCase is a radiological
computer aided triage and
notification software indicated
for use in the analysis of chest
and abdominal CT images. The
device is intended to assist
hospital networks and
appropriately trained medical
specialists within the standard-
of-care bone health setting in
workflow triage by flagging and
communication of suspected
positive cases of Vertebral
Compression Fractures (VCFx)
findings.
BriefCase uses an artificial
intelligence algorithm to
analyze images and highlight
cases with detected findings on
a standalone application in
parallel to the ongoing standard
of care image interpretation.
The device does not alter the
original medical image and is
not intended to be used as a
diagnosis device. |
| | HealthVCF does not provide
diagnostic information beyond
triage and prioritization, it does
not remove cases from the
radiology worklist, and should
not be used in place of full
patient evaluation, or relied
upon to make or confirm
diagnosis. | 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. |
| | Predicate Device HealthVCF
(K192901) | Subject Device
Aidoc Briefcase for
Vertebral Compression
Fractures (VCFx) Triage |
| User population | Bone Health Clinicians | Hospital networks and
appropriately trained medical
specialists within the standard-
of-care bone health setting. |
| Anatomical region of interest | Chest and abdomen | Chest and abdomen |
| Data acquisition protocol | Chest and abdominal CT scans | Chest and abdominal CT scans |
| Notification-only, parallel
workflow tool | Yes | Yes |
| Interference with standard
workflow | No | No |
| Algorithm | Artificial intelligence algorithm | Artificial intelligence algorithm |
| Structure | Data input and
validation (to ensure
compatibility for
processing by the
algorithm)
HealthVCF algorithm.
Zebra Worklist. | AHS module (orchestrator,
image acquisition);
ACS module (image
processing));
Aidoc Desktop application
for workflow integration
(feed and non-diagnostic
Image Viewer) |
Table 1. Key Feature Comparison
6
Performance Data
Pivotal Study Summary
Aidoc conducted a retrospective, blinded, multicenter, study with the BriefCase software to evaluate the software's performance in identifying Vertebral Compression Fractures in chest and abdominal CT images in 318 cases from 5 US-based clinical sites, compared 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.
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 time-to-notification compared to the predicate device. Positive Value (PPV), Negative Predictive Value (NPV), Positive Likelihood Ratio (PLR), and Negative Likelihood Ratio (NLR) will also be assessed.
7
Primary Endpoint
AUC was 97.6% (95% Cl: 96.1%, 99.1%), Sensitivity was 95.11% (95% Cl: 90.92%, 97.74%) and Specificity was 93.28% (95% Cl: 87.63%, 96.88%). 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 software in the five medical centers was compared to the equivalent metric of the predicate devices.
- -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 desktop application.
The BriefCase time-to-notification was measured for all True Positive cases (i.e., identified as positive both by the reviewers as well as the BriefCase device) and is given in Table 2 below. The table also displays the same metric reported for the predicate HealthVCF.
The time-to-notification results obtained for the subject BriefCase device show comparability with the primary predicate with regard to the standard of care review. The BriefCase mean time-to-notification for Vertebral Compression Fractures was 117.2 seconds (95% Cl: 98.64-135.85). The time-to-notification for the HealthVCF triage was 61.36 seconds.
| Time -to-notification | N | Mean Estimate | 95% Lower CL | 95% Upper CL | Median | IQR |
|---|---|---|---|---|---|---|
| Predicate K192901 Processing Time | unknown | 61.36 | unknown | unknown | unknown | unknown |
| BriefCase Time-to-notification | 184 | 117.2 | 98.64 | 135.85 | 71.5 | 99.5 |
Table 2. Time-to- Notification Comparison for BriefCase and Predicate Devices
NPV was 99.5% (95% CI: 99.1%- 99.8%) and PPV was 55.2% (95% CI: 39.6%).
PLR was 14.1606 (95% Cl: 7.528-26.637) and NLR was 0.0524 (95% Cl: 0.028- 0.099).
Thus, the reported similar time-to-notification data demonstrates that when using the subject BriefCase for Vertebral Compression Fractures triage the radiologists may have the same benefit in time saving as with the HealthVCF triage.
8
As can be seen in Table 3 the mean age of patients whose scans were reviewed for VCFx was 65.7 years, with a standard deviation of 16.9 years. Gender distribution was 46.5% male, and 53.5% female (Table 4). Scanner distribution can also be found in Table 5 below.
Table 3. Descriptive Statistics for Age
| Mean | Std | Min | Median | Max | N | |
|---|---|---|---|---|---|---|
| Age (Years) | 65.7 | 16.9 | 18 | 68 | 90 | 318 |
Table 4. Frequency Distribution of Gender
| Ground
Truth
| Results | Gender | All | ||||
|---|---|---|---|---|---|---|
| Male | Female | N | % | |||
| N | % | N | % | |||
| Positive | 92 | 28.9% | 92 | 28.9% | 184 | 57.9% |
| Negative | 56 | 17.6% | 78 | 24.5% | 134 | 42.1% |
| All | 148 | 46.5% | 170 | 53.5% | 318 | 100.0% |
Table 5. Frequency Distribution of Manufacturer
| Manufacturer | N | % |
|---|---|---|
| GE MEDICAL | ||
| SYSTEMS | 114 | 35.9% |
| SIEMENS | 91 | 28.6% |
| TOSHIBA | 57 | 17.9% |
| Philips | 56 | 17.6% |
| Total | 318 | 100% |
9
Conclusions
The subject BriefCase for Vertebral Compression Fractures and the predicate HealthVCF triage are intended to aid in prioritization and triage of radiological images for the indications of vertebral compression fractures. Both devices are software packages with substantially equivalent technological characteristics and principles of operation, incorporating Al alqorithms that process images, and software to send notifications and display unannotated compressed low-quality preview images. In both devices, the labeling clearly states that the devices are not for diagnostic use and for prioritization only and 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, 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 device for Vertebral Compression Fractures triage is thus substantially equivalent to the primary predicate HealthVCF triage.