(205 days)
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal 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 Intra-abdominal free gas (IFG) pathologies.
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.
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) for image acquisition; (2) Aidoc Cloud Server (ACS) for image processing; and (3) Aidoc Worklist Application for workflow integration, 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 user may opt to filter out notifications by pathology, e.g. a chest radiologist may choose to filter out notifications on Large Vessel Occlusion (LVQ) cases, and a neuro-radiologist would opt to divert Pulmonary Embolism (PE) notifications. In addition, where several medical centers are linked to a shared PACS, a user may read cases for a certain center but not for another, and thus may opt to filter out notification by center. Activating the filter does not impact the order in which notifications are presented in the Aidoc worklist application.
The Worklist Application displays the pop-up text notifications of new studies with suspected findings when they come in. Notifications are in the form of a small pop-up containing patient name, accession number and the relevant pathology (e.g., IFG). 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.
Here's an analysis of the provided text, outlining the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Performance Goal as stated in text) | Reported Device Performance (95% Confidence Interval) |
|---|---|---|
| Sensitivity | > 80% | 91.0% (81.5%, 96.7%) |
| Specificity | > 80% | 88.9% (81.7%, 94.0%) |
| Time-to-Notification (Median for True Positive IFG Cases) | - (Desired to be significantly faster than standard of care) | 4.2 minutes (3.7-5.0 minutes) |
| Time Saved (Mean difference compared to standard of care Time-to-Exam-Open for True Positive IFG Cases) | - (Desired to be clinically significant) | 89.7 minutes (45.5-133.9 minutes) |
Note: The document explicitly states "Sensitivity and specificity exceeded the 80% performance goal." This implies the 80% threshold was the acceptance criterion for these metrics. For time-to-notification and time saved, while no explicit numerical acceptance criterion is given, the text highlights the statistical significance and clinical benefit of the time savings, demonstrating the device's fulfillment of its intended purpose to assist in workflow triage and prioritization.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 184 cases (67 positive for IFG, 117 negative for IFG)
- Data Provenance: Retrospective, blinded, multicenter, multinational study. Cases were collected from 3 clinical study sites (2 in the US and 1 Outside the US, OUS).
- Supplemental Data: An additional supplemental dataset with cases from various scanner manufacturers was also provided to demonstrate consistent performance across scanners.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the exact number of experts used to establish the ground truth for the test set or their specific qualifications (e.g., "radiologist with 10 years of experience"). It only mentions that the study involved a "retrospective, blinded, multicenter, multinational study with the BriefCase software with the primary endpoint to evaluate the software's performance in identifying abdominal CTs containing Intra-abdominal Free Gas...". The implication is that the ground truth was derived from expert review, but details are not provided.
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method used (e.g., 2+1, 3+1). It refers to the ground truth being established by "reviewers" in the context of True Positive cases, but the process of reaching a consensus or final ground truth decision is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human readers' improvement with AI vs. without AI assistance was not reported. The study focused on the standalone performance of the AI algorithm and the time-to-notification compared to the standard of care "time-to-exam-open." The time savings analysis suggests a potential for improved workflow efficiency but does not directly measure improved reader performance or diagnostic accuracy when assisted by AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance study of the algorithm only was done. The reported sensitivity (91.0%) and specificity (88.9%) are metrics of the algorithm's performance in identifying IFG cases independently. The "time-to-notification" metric also pertains to the algorithm's speed in generating a notification.
7. The Type of Ground Truth Used
The ground truth used was expert consensus (implied from "identified as positive both by the reviewers as well as the BriefCase device"). This is based on the interpretation of abdominal CT images by medical professionals, though the specific process of consensus building is not detailed.
8. The Sample Size for the Training Set
The document does not specify the sample size used for the training set. It mentions the algorithm is "trained on IFG and ICH images" but provides no further details on the training data.
9. How the Ground Truth for the Training Set Was Established
The document does not specify how the ground truth for the training set was established. It only broadly states the algorithm is "trained on IFG and ICH images."
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June 19, 2020
Aidoc Medical, Ltd. % John J. Smith, M.D., J.D. Regulatory Counsel Hogan Lovells US LLP 555 Thirteenth Street. NW WASHINGTON DC 20004
Re: K193298
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: June 1, 2020 Received: June 1, 2020
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
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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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) K193298
Device Name
BriefCase
Indications for Use (Describe)
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal 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 Intra-abdominal free gas (IFG) pathologies.
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. .
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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510(k) Summarv Aidoc Medical, Ltd.'s BriefCase (K193298)
Submitter:
| Aidoc Medical, Ltd.3 Aminadav St.Tel-Aviv, IsraelPhone: | +972-73-7946870 |
|---|---|
| Contact Person: | N. Epstein, Ph.D. |
| Date Prepared: | June 1, 2020 |
| Name of Device: | BriefCase |
| Classification Name: | Radiological computer-assisted triage and notification softwaredevice |
| Regulatory Class: | Class II |
| Product Code: | QAS (21 C.F.R. 892.2080) |
| Predicate Device: | BriefCase (K180647, for ICH triage) |
Device Description
BriefCase is a radiological computer-assisted triage and notification software device. The software system is based on an algorithm programmed component and 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) for image acquisition; (2) Aidoc Cloud Server (ACS) for image processing; and (3) Aidoc Worklist Application for workflow integration, 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 user may opt to filter out notifications by pathology, e.g. a chest radiologist may choose to filter out notifications on Large Vessel Occlusion (LVQ) cases, and a neuro-radiologist would opt to divert Pulmonary Embolism (PE) notifications. In addition, where several medical centers are linked to a shared PACS, a user may read cases for a certain center but not for another, and thus may opt to filter out notification by center. Activating the filter does not impact the order in which notifications are presented in the Aidoc worklist application.
The Worklist Application displays the pop-up text notifications of new studies with suspected findings when they come in. Notifications are in the form of a small pop-up containing patient name, accession number and the relevant pathology (e.g., IFG). 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
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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.
Intended Use / Indications for Use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected findings of Intraabdominal Free Gas (IFG) pathologies.
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.
Comparison of Technological Characteristics
The subject BriefCase for IFG 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 IFG 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. 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 abdominal images and is indicated for Intra-abdominal Free Gas (IFG) 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 images for review based on computer aided image analysis. Both devices send notifications and low-quality compressed previews to the radiology workstations' desktop. Notifications are informational purpose only and 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 and does not modify them. Both devices operate in parallel with the standard of care, which remains the default option for all cases.
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A table comparing the key features of the subject and predicate devices is provided below.
| Predicate DeviceAidoc Briefcase for ICH triage (K180647) | Subject DeviceAidoc Briefcase for IFG 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 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 eyond 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 is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal 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 Intra-abdominal Free Gas (IFG) pathologies.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 | Abdomen |
| Data acquisition | Non-contrast head CT scan | Abdominal CT scan |
| View DICOMdata | DICOM Information about the patient,study and current image | DICOM Information about the patient,study and current image |
| Segmentationof region ofinterest | No; device does not mark, annotate,or direct users' attention to a specificlocation in the original image | No; device does not mark, annotate, ordirect users' attention to a specificlocation in the original image |
| Algorithm | Artificial intelligence algorithm withdatabase of images | Artificial intelligence algorithm withdatabase of images |
| Notification/Prioritization | Yes | Yes |
| Preview images | Presentation of a small, compressed,black and white preview image that islabeled "Not for diagnostic use";The device operates in parallel withthe standard of care, which remainsthe default option for all cases. | Presentation of a small, compressed,black and white preview image that islabeled "Not for diagnostic use";The device operates in parallel with thestandard of care, which remains thedefault option for all cases. |
| Alteration oforiginal image | No | No |
| Removal ofcases fromworklist queue | No | No |
Table 1. Kev feature comparison
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Performance Data
Pivotal Study Summary
Aidoc conducted a retrospective, blinded, multicenter, multinational study with the BriefCase software with the primary endpoint to evaluate the software's performance in identifying abdominal CTs containing Intra-abdominal Free Gas in 184 cases from 3 clinical study sites (2 US and 1 OUS). There were 67 positive cases and 117 negative cases (images with IFG versus without IFG) included in the analysis.
Sensitivity and specificity exceeded the 80% performance qoal. Specifically, sensitivity was 91.0% (95% Cl: 81.5%, 96.7%) and specificity was 88.9% (95% Cl: 81.7%, 94.0%).
In addition, a supplemental dataset was provided with additional cases from various scanner manufacturers and demonstrated consistent performance for the device across scanners.
Secondary Endpoint
Briefcase's potential clinical benefit of worklist prioritization for true positive IFG cases was evaluated by comparing the standard-of-care metric of time-to-exam-open to the software's timeto-notification metric for IFG, in the study sites where the time-to-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 metric was compared to the BriefCase time-to-notification in two of the study sites (both in the US) for 22 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.
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The BriefCase time-to-notification for IFG was 4.4 minutes (95% Cl: 3.7-5.0; Median: 4.2, IQR: 2.5). In contrast, standard of care time-to-exam-open was much longer 94.1 minutes (95% Cl: 49.9-138.2; Median: 50.1, IQR: 79.9). The mean difference of 89.7 minutes (95% Cl: 45.5-133.9; Median: 47.4, IQR: 76.7) for these two metrics is statistically significant and assuming the radiologist receives a notification on a true positive IFG case and acts on it immediately, it can on average save more than one hour compared to the time-to-exam-open in a first in first out (FIFO) reading queue. The value of 89.7 is based on the study of 22 cases from 2 study sites and may vary in practice.
| Parameter | N | Meanestimate | LowerConfidenceLimit | UpperConfidenceLimit | Median | IQR |
|---|---|---|---|---|---|---|
| Time-to-exam-open inthe standardof care | 22 | 94.1 | 49.9 | 138.2 | 50.1 | 79.9 |
| Time-to-notification ofBriefCase IFG | 22 | 4.4 | 3.7 | 5.0 | 4.2 | 2.5 |
| Difference | 22 | 89.7 | 45.5 | 133.9 | 47.4 | 76.7 |
Table 2. Time saving data
NPV and PPV are presented in Table 3 by a range of prevalence. NLR and PLR are also reported in Table 4.
| AssumedPrevalence | Parameter | n | Estimate | 95%Lower CL | 95%Upper CL |
|---|---|---|---|---|---|
| 0.03 | Negative Predictive Value | 110 | 99.7% | 99.5% | 99.9% |
| 0.03 | Positive Predictive Value | 74 | 20.2% | 7.7% | 26.3% |
| 0.05 | Negative Predictive Value | 110 | 99.5% | 99.1% | 99.9% |
| 0.05 | Positive Predictive Value | 74 | 30.1% | 15.0% | 38.4% |
| 0.07 | Negative Predictive Value | 110 | 99.2% | 98.7% | 99.8% |
| 0.07 | Positive Predictive Value | 74 | 38.1% | 22.1% | 47.7% |
| 0.09 | Negative Predictive Value | 110 | 99.0% | 98.4% | 99.8% |
| 0.09 | Positive Predictive Value | 74 | 44.8% | 28.7% | 55.0% |
| Prevalence | Sensitivity | Specificity | NPV | PPV |
|---|---|---|---|---|
| 0.1% | 99% | 99% | 99.99% | 9.01% |
| 99.9% | 99.999% | 90.91% | ||
| 99.99% | 100.00% | 99.01% | ||
| 99.999% | 100.00% | 99.90% | ||
| 99.9999% | 100.00% | 99.99% | ||
| 1% | 99% | 99% | 99.90% | 50.00% |
| 99.9% | 99.99% | 90.91% | ||
| 99.99% | 99.99% | 99.00% | ||
| 99.999% | 99.99% | 99.90% | ||
| 99.9999% | 99.99% | 99.99% | ||
| 10% | 99% | 99% | 99.00% | 90.91% |
| 99.9% | 99.00% | 99.89% | ||
| 99.99% | 99.00% | 99.99% | ||
| 99.999% | 99.00% | 100.00% | ||
| 99.9999% | 99.00% | 100.00% |
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| Parameter | n | Estimate | 95% Lower CL | 95% Upper CL |
|---|---|---|---|---|
| NLR | 184 | 0.1 | 0.0 | 0.2 |
| PLR | 184 | 8.2 | 4.9 | 13.8 |
Table 4. NLR and PLR
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. Performance validation data suggest that when using the subject BriefCase for IFG triage, the radiologists may have the same benefit in time saving as with using the BriefCase for ICH triage.
Conclusions
The subject BriefCase for IFG 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 Intraabdominal Free Gas and Intracranial Hemorrhage, respectively. Both devices are software packages with similar technological characteristics and principles of operating 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 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.
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 notify the radiologist of time-sensitive critical findings within the range of several minutes, and thus contribute similarly to the standard of care workflow turnaround time reduction through preemptive triage.
The BriefCase device for IFG triage is thus substantially equivalent to the BriefCase for ICH triage.
§ 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.