(147 days)
Not Found
Yes
The document explicitly states that the device "uses deep learning-based AI algorithms" and "uses deep learning methods" to analyze images.
No
The device is described as a "notification-only workflow tool" and is for "notification purposes only, not diagnostic purposes." It helps identify patients with suspected intracranial hemorrhage and notifies medical specialists, but it does not treat or directly alleviate a disease or condition.
No
The device explicitly states multiple times that it is "for notification purposes only, not diagnostic purposes" and "should not be used as a substitute for a full patient assessment or relied upon to make or confirm a diagnosis."
Yes
The device description explicitly states that "Hyper Insight - ICH is software as a medical device (SaMD)". The summary focuses on the software's functionality, algorithms, and performance in analyzing images, without mentioning any associated hardware components that are part of the medical device itself. While it integrates with third-party worklist applications and mobile apps for notification/preview, these are described as external systems the software interacts with, not components of the Hyper Insight - ICH device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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.
- Device Function: The Hyper Insight - ICH analyzes medical images (non-contrast brain CT scans) to identify suspected intracranial hemorrhage. It does not analyze biological samples from the patient.
- Intended Use: The intended use is clearly stated as a "notification-only workflow tool" for identifying images and sharing findings with specialists. It explicitly states that the identification is "for notification purposes only, not diagnostic purposes."
- Limitations: The description emphasizes that the device "should not be used as a substitute for a full patient assessment or relied upon to make or confirm a diagnosis."
The device falls under the category of medical imaging analysis software, specifically a type of Computer-Aided Triage and Notification (CADt) device, as indicated by the reference to the predicate device (Viz ICH, K193658) which is also a CADt.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is marked as "Not Found".
Intended Use / Indications for Use
Hyper Insight - ICH is a notification-only workflow tool for trained clinicians to identify patients' brain CT images and share them with medical specialists in parallel with standard patient care workflow. Hyper Insight - ICH uses deep learning-based Al algorithms to analyze images to find suspected intracranial hemorrhage and notifies and shares the findings to medical specialists. Identification of images with suspected intracranial hemorrhage is for notification purposes only, not diagnostic purposes.
In particular, this medical device analyzes non-contrast brain CT images, and if a suspected intracranial hemorrhage is identified, it sends a notification to medical specialists, who are advised to review these images may be previewed through the mobile app but are for informational purposes only and are not intended to be used for diagnostic purposes other than notifications and previews. The medical specialist who received the notification is responsible for reading the image in a diagnostic viewer.
Hyper Insight - ICH is limited to the purpose of analysis of image data and should not be used as a substitute for a full patient assessment or relied upon to make or confirm a diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
QAS
Device Description
Hyper Insight - ICH is software as a medical device (SaMD) that detects intracranial hemorrhage (ICH) condition by analyzing non-contrast CT images. The software needs to be integrated with a third-party worklist application to receive analysis requests and the corresponding DICOM images and return the ICH findings (whether suspected ICH is found) to the worklist to alert the radiologists.
For ICH patients, immediate emergency diagnosis and treatment is critical for saving their lives and later recovery. Thus, it is very important to triage and identify ICH patients in a speedy manner to prioritize their treatment. Computed tomography (CT) is a non-invasive and effective diagnosis imaging approach to detect ICH. Acute Intracranial hemorrhage can be recognized on non-contrast CT scans since blood has higher density (Hounsfield unit, HU) than other brain tissues but lower than that of bones. Radiologists can identify ICH and determine the location and severity of any such bleeding from the intensity patterns presented in the images.
To help radiologists triage and prioritize reading of images for patients with ICH, Hyper Insight - ICH uses deep learning methods to automatically detect acute ICH in non-contrast head CT scans.
The software analyzes the input image and returns a binary prediction as to whether the exam suggests the presence of acute ICH. The Hyper Insight-ICH device is for notification purposes only and should be not used for final diagnosis.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Non-Contrast Head CT
Anatomical Site
Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained clinicians including Radiologist, emergency medicine physicians, neurosurgeons, neurologist. Clinical/Hospital Environment
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
394 brain Computed Tomography images were obtained from 13 clinical sites in the U.S. There were approximately equal numbers of 'yes' or 'no' analysis results (198 with intracranial hemorrhage and 196 without intracranial hemorrhage). The dataset was established by trained neuro-radiologists.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
SK Inc. conducted a retrospective study to evaluate the efficacy of radiological computer aided triage and notification software (CADt), which supports medical specialist to promptly diagnose and treat with suspected intracranial hemorrhage by providing notification, when analyzed as a patient with suspected intracranial hemorrhage. To this study, the clinical sensitivity of the investigational medical device "Hyper Insight-ICH' was evaluated against the reading results of intracranial hemorrhage from brain CT images by the Reference Standard Establishment Committee. The results of this non-clinical testing show that the strength of the Hyper Insight-ICH is sufficient for its intended use and is substantially equivalent to legally marketed predicate device.
394 brain Computed Tomography images were obtained from 13 clinical sites in the U.S. There were approximately equal numbers of 'yes' or 'no' analysis results (198 with intracranial hemorrhage and 196 without intracranial hemorrhage). Sensitivity and specificity were calculated in the image database, comparing the Viz ICH's output to ground truth as established by trained neuro-radiologists. Sensitivity and specificity were 95.45% (95% CI) and 98.47% (95% CI), respectively. Because the lower bound of each confidence interval exceeded 80%, the study met the pre-specified performance goals of 80% for sensitivity and specificity.
In addition, the area under the receiver operating characteristic curve (AUC) was 0.9864 demonstrating the clinical utility and potential benefits of the Hyper Insight - ICH based on the imaging study results.
In the study, the average time to analyzing the brain CT image and notify the result of the intracranial hemorrhage identification to the mobile (DICOM VIEWER) was analyzed was 16.39 ± 5.46 seconds (0.27 ± 0.091 minutes), which is lower than the average time to notification seen in the predicate device of 0.49 ± 0.15 minutes. This data will allow medical personnel to quickly and accurately identify patients suspected of intracranial hemorrhage through notifications and determine priority triage, providing them an opportunity to participate early in the clinical workflow.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity (%): 95.45
95% Confidence Interval: [91.55, 97.90]
Specificity (%): 98.47
95% Confidence Interval: [95.59, 99.68]
AUC of ROC: 0.9864 [0.9738, 0.9989]
Average time to alerting a specialist: 16.39 ± 5.46 seconds
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
SK Inc. % Hannah Taggart Regulatory Associate Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
July 1, 2024
Re: K240353
Trade/Device Name: Hyper Insight - ICH Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological Computer Aided Triage And Notification Software Regulatory Class: Class II Product Code: QAS Dated: May 30, 2024 Received: May 30, 2024
Dear Hannah Taggart:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K240353
Device Name Hyper Insight - ICH
Indications for Use (Describe)
Hyper Insight - ICH is a notification-only workflow tool for trained clinicians to identify patients' brain CT images and share them with medical specialists in parallel with standard patient care workflow. Hyper Insight - ICH uses deep learning-based Al algorithms to analyze images to find suspected intracranial hemorrhage and notifies and shares the findings to medical specialists. Identification of images with suspected intracranial hemorrhage is for notification purposes only, not diagnostic purposes.
In particular, this medical device analyzes non-contrast brain CT images, and if a suspected intracranial hemorrhage is identified, it sends a notification to medical specialists, who are advised to review these images may be previewed through the mobile app but are for informational purposes only and are not intended to be used for diagnostic purposes other than notifications and previews. The medical specialist who received the notification is responsible for reading the image in a diagnostic viewer.
Hyper Insight - ICH is limited to the purpose of analysis of image data and should not be used as a substitute for a full patient assessment or relied upon to make or confirm a diagnosis.
| 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
K240353 510(K) SUMMARY
| Submitter's Name: | SK Inc. |
|---|---|
| Submitter's Address: | SK U-Tower, 9 Seongnam-daero, Bundang-gu, Seongnam-si, Gyeonggi-do, 13558 |
| Republic of Korea | |
| Submitter's Telephone: | +82-2-6400-0114 |
| Contact Person: | Hannah Taggart, MS |
| Empirical Technologies | |
| 1-719-457-1152 | |
| htaggart@empiricaltech.com | |
| Image: Empirical Technologies logo | |
| Date Summary was Prepared: | June 25, 2024 |
| Trade or Proprietary Name: | Hyper Insight - ICH |
| Device Classification Name: | Radiological Computer-Assisted Triage And Notification Software |
| Classification & Regulation #: | Class II per 21 CFR §892.2080 |
| Product Code: | QAS |
| Classification Panel: | Radiology |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
Hyper Insight - ICH is software as a medical device (SaMD) that detects intracranial hemorrhage (ICH) condition by analyzing non-contrast CT images. The software needs to be integrated with a third-party worklist application to receive analysis requests and the corresponding DICOM images and return the ICH findings (whether suspected ICH is found) to the worklist to alert the radiologists.
For ICH patients, immediate emergency diagnosis and treatment is critical for saving their lives and later recovery. Thus, it is very important to triage and identify ICH patients in a speedy manner to prioritize their treatment. Computed tomography (CT) is a non-invasive and effective diagnosis imaging approach to detect ICH. Acute Intracranial hemorrhage can be recognized on non-contrast CT scans since blood has higher density (Hounsfield unit, HU) than other brain tissues but lower than that of bones. Radiologists can identify ICH and determine the location and severity of any such bleeding from the intensity patterns presented in the images.
To help radiologists triage and prioritize reading of images for patients with ICH, Hyper Insight - ICH uses deep learning methods to automatically detect acute ICH in non-contrast head CT scans.
The software analyzes the input image and returns a binary prediction as to whether the exam suggests the presence of acute ICH. The Hyper Insight-ICH device is for notification purposes only and should be not used for final diagnosis.
INDICATIONS FOR USE
Hyper Insight - ICH is a notification-only workflow tool for trained clinicians to identify patients' brain CT images and share them with medical specialists in parallel with standard patient care workflow. Hyper Insight - ICH uses deep learning-based AI algorithms to analyze images to find suspected intracranial hemorrhage and notifies and shares the findings to medical specialists. Identification of images with suspected intracranial hemorrhage is for notification purposes only, not diagnostic purposes.
In particular, this medical device analyzes non-contrast brain CT images, and if a suspected intracranial hemorrhage is identified, it sends a notification to medical specialists, who are advised to review these images. Images may be previewed through the mobile app but are for informational purposes only and are not intended to be used for diagnostic purposes other than notifications and previews. The medical specialist who received the notification is responsible for reading the image in a diagnostic viewer.
Hyper Insight - ICH is limited to the purpose of analysis of image data and should not be used as a substitute for
4
a full patient assessment or relied upon to make or confirm a diagnosis.
TECHNOLOGICAL CHARACTERISTICS
The predicates included in this submission were selected based on the best practices described in the FDA Draft Guidance document Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:
- Indications for Use ●
- Intended End User .
- Input/Output of Software ●
- . Performance Data
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Product Code | Predicate Type |
|---|---|---|---|---|
| K193658 | Viz ICH | Viz.ai, Inc. | QAS | Primary |
Predicate Device Comparison
| | Subject Name
(Subject Device) | Viz.ai, Inc. Viz ICH
(K193658) |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Hyper Insight - ICH is a notification-only workflo
w tool for trained clinicians to identify patients' br
ain CT images and share them with medical speci
alists in parallel with standard patient care workflo
w. Hyper Insight - ICH uses deep learning-based
AI algorithms to analyze images to find suspected
intracranial hemorrhage and notifies and shares the
findings to medical specialists. Identification of im
ages with suspected intracranial hemorrhage is for
notification purposes only, not diagnostic purposes.
In particular, this medical device analyzes non-cont
rast brain CT images, and if a suspected intracrani
al hemorrhage is identified, it sends a notification
to medical specialists, who are advised to review t
hese images. Images may be previewed through th
e mobile app but are for informational purposes o
nly and are not intended to be used for diagnostic
purposes other than notifications and previews. T
he medical specialist who received the notification
is responsible for reading the image in a diagnosti
c viewer.
Hyper Insight - ICH is limited to the purpose of
analysis of image data and should not be used as
a substitute for a full patient assessment or relied
upon to make or confirm a diagnosis. | Viz ICH is a notification-only, parallel workflow tool f
or use by hospital networks and trained clinicians to id
entify and communicate images of specific patients to a
specialist, independent of standard of care workflow.
Viz ICH uses an artificial intelligence algorithm to anal
yze images for findings suggestive of a prespecified cli
nical condition and to notify an appropriate medical spe
cialist of these findings in parallel to standard of care i
mage interpretation. Identification of suspected findings
is not for diagnostic use beyond notification. Specificall
y, the device analyzes non-contrast CT images of the b
rain acquired in the acute setting and sends notification
s to a neurovascular or neurosurgical specialist that a s
uspected intracranial hemorrhage has been identified and
recommends review of those images. Images can be p
reviewed through a mobile application. Images that are
previewed through the mobile application may be comp
ressed and are for informational purposes only and not
intended for diagnostic use beyond notification. Notified
clinicians are responsible for viewing non-compressed i
mages on a diagnostic viewer and engaging in appropri
ate patient evaluation and relevant discussion with a tre
ating physician before making care-related decisions or
requests. Viz ICH is limited to analysis of imaging dat
a and should not be used in-lieu of full patient evaluati
on or relied upon to make or confirm diagnosis. Viz I
CH is contraindicated for analyzing non-contrast CT sca
ns that are acquired on scanners from manufacturers ot
her than General Electric (GE) or its subsidiaries (i.e.
GE Healthcare). This contraindication applies to NCCT
scans that conform to all applicable Patient Inclusion C
riteria, are of adequate technical image quality, and wo
uld otherwise be expected to be analyzed by the device
for a suspected ICH. |
| Product Code | QAS | QAS |
| Environment of use | Clinical/Hospital Environment | Clinical/Hospital Environment |
| Intended Clinical | Radiologist, emergency medicine physicians, neuros | Radiologist, emergency medicine physicians, neurosurge |
| End User | urgeons, neurologist | ons, neurologist |
| Anatomical Region | Head | Head |
| Clinical Condition | Acute Intercranial Hemorrhage (ICH) | Intercranial Hemorrhage (ICH) |
5
| | Subject Name
(Subject Device) | Viz.ai, Inc. Viz ICH
(K193658) |
|--------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Independent of
standard of care
workflow | Yes, No cases are removed from worklist | Yes |
| | | |
| | | |
| AI Used | Yes | Yes |
| Input Image
Modality | Non-Contrast Head CT | Non-Contrast Head CT |
| | | |
| Alteration of Image | No | No |
| DICOM Compatible | Yes | Yes |
| Transfer, store, and
process DICOM im
ages | Yes | Yes |
| | | |
| | | |
| Data Acquisition | Acquires medical image data from DICOM compli
ant imaging devices and modalities. | Acquires medical image data from DICOM compliant i
maging devices and modalities. |
| | | |
| Results of Image
Analysis | Internal, no image marking | Internal, no image marking |
| | | |
| Preview Images | Initial assessment; non-diagnostic | Initial assessment; non-diagnostic |
| View DICOM Data | DICOM Information about the patient, study and c
urrent image. | DICOM Information about the patient, study and curren
t image. |
| | | |
| Image viewing and
manipulation
(window,pan,zoom) | Yes | Yes |
| | | |
| | | |
| Output | AI findings (Suspected ICH or Case Processed) | Suspected ICH (Yes or No) |
| Clinical SoC
Workflow | In parallel to | In parallel to |
| | | |
| Results Receiver | PACS/Workstation | PACS/Workstation |
Overall Performance Data Comparison
| Performance | Subject Device | K193658 |
|---|---|---|
| Sensitivity (%) | 95.45 | 93 |
| 95% Confidence Interval | [91.55, 97.90] | [87, 97] |
| Specificity (%) | 98.47 | 90 |
| 95% Confidence Interval | [95.59, 99.68] | [84, 94] |
| AUC of ROC | 0.9864 [0.9738, 0.9989] | 0.96 |
| Average time to alerting a specialist | 16.39±5.46 seconds | 0.49±0.15 minutes |
Age Subgroup Performance Data Comparison
| Subject Device | K193658 | |||
|---|---|---|---|---|
| Age Range (years) | Sensitivity | |||
| [95% CI] | Specificity | |||
| [95% CI] | Sensitivity | |||
| [95% CI] | Specificity | |||
| [95% CI] | ||||
| 70 | 94.39 | |||
| [88.19, 97.91] | 100.00 | |||
| [90.75, 100.00] | 0.94 | |||
| [0.84, 0.99] | 0.88 | |||
| [0.76, 0.95] |
6
Gender Subgroup Performance Data Comparison
| Gender | Subject Device | K193658 | ||
|---|---|---|---|---|
| Sensitivity | Specificity | Sensitivity | Specificity | |
| [95% Cl] | [95% Cl] | [95% Cl] | [95% Cl] | |
| Male | 97.25 | 100.00 | 0.9 | 0.9 |
| [92.17, 99.43] | [95.55, 100.00] | [0.8, 0.96] | [0.8, 0.96] | |
| Female | 93.26 | 97.39 | 0.95 | 0.89 |
| [85.90, 97.49] | [92.57, 99.46] | [0.86, 0.99] | [0.8, 0.95] |
ICH Subtype Performance Data Comparison
| ICH Subtype | Subject Device | K193658 |
|---|---|---|
| Sensitivity | ||
| [95% CI] | Sensitivity | |
| [95% CI] | ||
| Intraparenchymal Hemorrhage | ||
| (IPH) | 97.30 | |
| [90.58, 99.67] | 0.98 | |
| [0.91, 1.0] | ||
| Intraventricular Hemorrhage (I VH) | 97.67 | |
| [87.71, 99.94] | 1.00 | |
| [0.74, 1.0] | ||
| Subarachnoid Hemorrhage (SA H) | 97.65 | |
| [91.76, 99.71] | 0.60 | |
| [0.26, 0.88] | ||
| Subdural Hemorrhage (SDH) | 94.69 | |
| [88.80, 98.03] | 0.85 | |
| [0.62, 0.97] | ||
| Extradural Hemorrhage (EDH) | 100.00 | |
| [80.49, 100.00] | N/A | |
| SDH or EDH | 97.30 | |
| [90.58, 99.67] | 0.85 | |
| [0.62, 0.97] |
Slice Thickness Subgroup Performance Data Comparison
| Subject Device | K193658 | |||
|---|---|---|---|---|
| Slice Thickness | Sensitivity | |||
| [95% CI] | Specificity | |||
| [95% CI] | Sensitivity | |||
| [95% CI] | Specificity | |||
| [95% CI] | ||||
| 2.5mm |