Who is the manufacturer of Rapid ICH?

Ischemaview, Inc. filed the 510(k) submission for Rapid ICH (K221456).

What is the FDA product code for Rapid ICH?

QAS. It is classified under 21 CFR 892.2080 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Rapid ICH?

510(k) clearance (submission type: Traditional).

Does Rapid ICH use AI or machine learning?

Yes. Rapid ICH (K221456) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like Rapid ICH?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Rapid ICH get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Rapid ICH

K221456 · Ischemaview, Inc. · QAS · Sep 12, 2022 · Radiology

Device Facts

Record ID	K221456
Device Name	Rapid ICH
Applicant	Ischemaview, Inc.
Product Code	QAS · Radiology
Decision Date	Sep 12, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2080
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

Rapid ICH is a radiological computer aided triage and notification software 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, for IPH, IVH, SAH, and SDH Intracranial Hemorrhages (CH). Rapid ICH uses an artificial intelligence algorithm to analyze images and highlight cases with detected ICH on a server or 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, which 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 is a a diagnostic device. The results of Rapid ICH are intended to be used in conjunction and based on professional judgment, to assist with trage /prioritization of medical images. Notified radiologists are responsible for viewing full images per the standard of care.

Device Story

Rapid ICH is a radiological computer-aided triage and notification software; operates within the Rapid Platform. Inputs: non-enhanced head CT (NCCT) images. Processing: AI/ML algorithm analyzes images for suspected intracranial hemorrhage (ICH); identifies IPH, IVH, SAH, and SDH. Outputs: priority notifications to clinicians (PACS, workstation, email, mobile) including compressed preview images. Usage: hospital networks; operated by radiologists. Context: runs in parallel to standard of care; does not alter original images. Benefit: reduces time-to-exam-open by prioritizing worklists for suspected positive cases; assists in clinical triage/prioritization.

Clinical Evidence

Retrospective, blinded, multicenter, multinational study (N=314; 148 positive, 166 negative). Primary endpoint: sensitivity 96.8% (95% CI: 92.6%-98.6%), specificity 100% (95% CI: 97.7%-100%). AUC 0.98632. Secondary endpoint: time-to-notification (0.65 min) vs. standard of care time-to-exam-open (72.58 min).

Technological Characteristics

AI/ML/Neural Network software module. Operates on non-enhanced CT images. Standards: EN ISO 14971:2012 (risk management), IEC 62304:2015 (software lifecycle), NEMA PS 3.1-3.20 (DICOM). Connectivity: server or standalone desktop application; integrates with PACS/workstations.

Indications for Use

Indicated for analysis of non-enhanced head CT images to assist radiologists and hospital networks in triage/prioritization by flagging suspected intracranial hemorrhage (IPH, IVH, SAH, SDH). Not for diagnostic use; intended for use in parallel with standard of care.

Regulatory Classification

Identification

Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.

Special Controls

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

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

Predicate Devices

Rapid ICH (K193087)

Related Devices

K203260 — syngo.CT Brain Hemorrhage · Siemens Medical Solutions USA, Inc. · Jan 28, 2022
K180647 — BriefCase · Aidoc Medical , Ltd. · Aug 1, 2018
K250694 — Scaida BrainCT-ICH (v1.0) · Mlhealth 360 · Nov 25, 2025
K193087 — Rapid ICH · Ischemaview Incorporated · Mar 31, 2020
K232431 — syngo.CT Brain Hemorrhage · Siemens Medical Solutions USA, Inc. · Mar 22, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is the Department of Health & Human Services logo. The right side of the logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. iSchemaView Inc. % James Rosa SVP Regulatory and Quality 1120 Washington Ave., Ste 200 GOLDEN CO 80401 Re: K221456 September 12, 2022 Trade/Device Name: Rapid ICH Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QAS Dated: August 15, 2022 Received: August 17, 2022 Dear James Rosa: 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 and Part 809); 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, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K221456 Device Name Rapid ICH #### Indications for Use (Describe) Rapid ICH is a radiological computer aded triage and notification software 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, for IPH, IVH, SAH, and SDH Intracranial Hemorrhages (CH). Rapid ICH uses an artificial intelligence algorithm to analyze images and highlight cases with detected ICH on a server or 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, which 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 is a a diagnostic device. The results of Rapid ICH are intended to be used in conjunction and based on professional judgment, to assist with trage /prioritization of medical images. Notified radiologists 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Section 5: 510(k) Summary #### 510(k) Summary #### iSchemaView, Inc.'s Rapid ICH This document contains the 510(k) summary for the iSchemaView Rapid ICH. The content of this summary is based on the requirements of 21 CFR Section 807.92(c). #### Applicant Name and Address: | Name: | iSchemaView, Inc. | |-------------------|------------------------------------------------------------------| | Address: | 1120 Washington Ave., Ste. 200 Golden, CO 80401 | | Official Contact: | Jim Rosa Phone: (303) 704-3374 Email: rosa@ischemaview.com | ### Summary Preparation Date: August 17, 2022 #### Device Name and Classification: | Trade Name: | Rapid ICH | |--------------------------|--------------------------------------------------------------| | Common Name: | Radiological computer aided triage and notification software | | Classification: | II | | Product Code: | QAS | | Regulation No: | 21 C.F.R. §892.2080 | | Classification Panel: | Radiology Devices | #### Predicate Devices: iSchemaView's Rapid ICH device is claimed to be substantially equivalent to the following legally marketed predicate device: iSchemaView's Rapid ICH (K193087). #### Device Description: Rapid ICH is a radiological computer-assisted triage and notification software device. The Rapid ICH module is a non-enhanced CT (NCCT) processing module which operates within the integrated Rapid Platform to provide triage and notification of suspected intracranial hemorrhage. The Rapid ICH module is an AI/ML module. The output of the module is a priority notification to clinicians indicating the suspicion of ICH based on positive findings. The Rapid ICH module uses the basic services supplied by the Rapid Platform including DICOM processing, job management, imaging module execution and imaging output including the notification and compressed image. #### Indications for Use: Rapid ICH is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT images. {4}------------------------------------------------ Section 5: 510(k) Summary 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, for IPH, IVH, SAH, and SDH Intracranial Hemorrhages (ICH). Rapid ICH 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 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 Rapid ICH 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 radiologists are responsible for viewing full images per the standard of care. ### Comparison of Technological Characteristics: Rapid ICH does not raise new questions of safety or effectiveness compared to the previously cleared Rapid ICH (K193087). Both devices are radiological computer-aided triage and notification software applications for use with non-contrast CT input. The minor change causing this filing, is the use of additional data for training and validation; there are no further differences. Thus, the Rapid ICH software is substantially equivalent. The following table summarizes and compares data on the Rapid ICH (K193087) to the subject device of this Traditional 510(k) submission. A table comparing the key features of the subject and predicate devices is provided below. | Substantial Equivalence Table | | | |-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Comparison Feature | Rapid ICH (K193087) | Rapid ICH – Subject Device | | Indications for Use | Rapid ICH 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). Rapid ICH uses an artificial intelligence algorithm to analyze images and highlight cases with detected ICH on a standalone | Rapid ICH 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, for IPH, IVH, SAH, and SDH Intracranial Hemorrhages (ICH). Rapid ICH uses an artificial intelligence algorithm to analyze | | | desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of Rapid ICH 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. | images and highlight cases with detected ICH on a server or 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, which 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 Rapid ICH 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 radiologists are responsible for viewing full images per the standard of care. | | Stroke/Head | Stroke/Head | Stroke/Head | | Removal of cases from worklist queue | No | No | | Primary Imaging Modalities | NCCT | NCCT | | Technical Implementati on | AI/ML/Neural Network | AI/ML/Neural Network | | Segmentation of ROI | No, the device does not highlight or direct a user's attention to a specific location in the image file. | No, the device does not highlight or direct a user's attention to a specific location in the image file. | | Preview Images | Presentation of a preview of the study for initial assessment not meant for diagnostic purposes. | Presentation of a preview of the study for initial assessment not meant for diagnostic purposes. | | | The device operates in parallel with the standard of care, which remains. | The device operates in parallel with the standard of care, which remains. | | Primary User(s) | Clinician | Radiologist | | Alteration of original image data | No | No | | Alters Standard of Care Workflow | In parallel to | In parallel to | | Notification/ Prioritization | Yes - PACS, Workstation, email, mobile | Yes - PACS, Workstation, email, mobile | {5}------------------------------------------------ Section 5: 510(k) Summary {6}------------------------------------------------ Section 5: 510(k) Summary ### Performance Standards: Rapid ICH has been developed in conformance with the following standards, as applicable: | EN ISO 14971:2012 | Application of Risk Management to Medical Devices | |--------------------|--------------------------------------------------------| | IEC 62304:2015 | Medical device software – Software lifecycle processes | | NEMA PS 3.1 - 3.20 | Digital Imaging and Communications in Medicine (DICOM) | #### Performance Data: iSchemaView conducted a retrospective, blinded, multicenter, multinational study with the Rapid ICH software with the primary endpoint to evaluate the software's performance in identifying NCCT head images containing intracranial hemorrhage (ICH) findings in 314 (ICH Pos:148, Neg:166) cases. Sensitivity and specificity exceeded the 80% performance goal. Specifically, sensitivity was observed to be 96.8% (95% CI: 92.6% - 98.6%) and specificity was observed to be 100% (95% CI: 97.7% - 100%) overall. AUC is 0.98632 when using Rapid estimated Volume as the predictor of Suspected ICH: {7}------------------------------------------------ Section 5: 510(k) Summary Image /page/7/Figure/2 description: This image shows a Receiver Operating Characteristic curve. The x-axis is labeled '1-Specificity False Positive' and ranges from 0 to 1.00. The y-axis is labeled 'Sensitivity True Positive' and ranges from 0 to 1.00. The AUC is 0.98632. In addition, a secondary endpoint measure was Rapid ICH's potential clinical benefit of worklist prioritization for true positive ICH cases. For that purpose, iSchemaView is using the predefined process timeline as defined in the predicate. The Rapid ICH time-to-notification includes the time to get the DICOM exam, de-identify it (if required), analyze and send a notification back to the PACS/Workstation, email and mobile. The standard of care time-to-open-exam consisted of the time from the initial scan of the patient to when the radiologist first opened the exam for review. Rapid ICH time-to-notification has been documented for all 314 cases. One hundred four-nine (149) cases have been identified as true positive (i.e., identified as positive by Rapid ICH and the ground truth) and the time-to-exam-open is referenced from the predicate. As shown in the table below, the predicate analysis demonstrated that standard of care time-toexam-open (72.6 minutes: 95% CI 45.0-100.2) is significantly longer than the parallel time-tonotification of the Rapid ICH software (0.65 minutes: 95% CI 0.63 - 0.67). | Parameter | Mean | 95% CI Lower | 95% CI Upper | |-----------------------------------------------|-------|-----------------|-----------------| | Time to open in standard of care (Minutes) | 72.58 | 45.02 | 100.14 | | Time to notification of Rapid ICH (Minute) | 0.65 | 0.63 | 0.67 | | Difference (Minutes) | 71.93 | NA | NA | {8}------------------------------------------------ Section 5: 510(k) Summary ## Performance across subtype differentiation shows: | Performance Metrics by Gender | | | | | | |-------------------------------|-------------|----|----------|-----------------|-----------------| | Gender | Measure | N | Estimate | Lower 95% CI | Upper 95% CI | | Female | Sensitivity | 63 | 1.000 | 0.943 | 1.000 | | Female | Specificity | 64 | 1.000 | 0.943 | 1.000 | | Male | Sensitivity | 72 | 0.932 | 0.849 | 0.970 | | Male | Specificity | 97 | 1.000 | 0.962 | 1.000 | ## Performance Metrics by Age Groups | Age Group | Measure | N | Estimate | Lower 95% CI | Upper 95% CI | |---------------|-------------|----|----------|-----------------|-----------------| | Age ≤ 50 | Sensitivity | 27 | 0.926 | 0.766 | 0.979 | | | Specificity | 26 | 1.000 | 0.871 | 1.000 | | 50 < Age < 70 | Sensitivity | 54 | 0.963 | 0.875 | 0.990 | | | Specificity | 62 | 1.000 | 0.942 | 1.000 | | Age ≥ 70 | Sensitivity | 63 | 0.984 | 0.915 | 0.997 | | | Specificity | 70 | 1.000 | 0.948 | 1.000 | #### Performance by ICH Subtype | Subtype | N | Se | Se LCL | Se UCL | |----------|----|-------|--------|--------| | IPH | 45 | 1.000 | 0.921 | 1.000 | | IVH | 4 | 1.000 | 0.510 | 1.000 | | IPH, IVH | 41 | 1.000 | 0.914 | 1.000 | | SAH | 11 | 1.000 | 0.741 | 1.000 | | SDH | 19 | 0.895 | 0.686 | 0.971 | | Multiple | 24 | 1.000 | 0.862 | 1.000 | | Other | 9 | 0.667 | 0.354 | 0.879 | ## Performance Metrics by Volume | Volume Group | Measure | N | Estimate | Lower 95% CI | Upper 95% CI | |--------------|-------------|-----|----------|-----------------|-----------------| | All | Sensitivity | 159 | 0.937 | 0.888 | 0.965 | | Vol ≥ 0.4 | Sensitivity | 153 | 0.967 | 0.926 | 0.986 | | Vol ≥ 1 | Sensitivity | 145 | 0.966 | 0.922 | 0.985 | | Vol ≥ 5 | Sensitivity | 112 | 1.000 | 0.967 | 1.000 | {9}------------------------------------------------ Section 5: 510(k) Summary ### Performance Metrics by Slice Thickness | Slice Thickness | Measure | N | Estimate | Lower 95% CI | Upper 95% CI | |---------------------------|-------------|----|----------|-----------------|-----------------| | Slice Thickness ≤ 2.5 | Sensitivity | 47 | 0.936 | 0.828 | 0.978 | | | Specificity | 67 | 1.000 | 0.946 | 1.000 | | 2.5 < Slice Thickness < 5 | Sensitivity | 39 | 0.974 | 0.868 | 0.995 | | | Specificity | 34 | 1.000 | 0.898 | 1.000 | | Slice Thickness = 5 | Sensitivity | 67 | 0.985 | 0.920 | 0.997 | | | Specificity | 60 | 1.000 | 0.940 | 1.000 | # Performance Metrics by Manufacturer | Manufacturer | Measure | N | Estimate | Lower 95% CI | Upper 95% CI | |--------------|-------------|----|----------|-----------------|-----------------| | GE | Sensitivity | 74 | 0.973 | 0.907 | 0.993 | | GE | Specificity | 25 | 1.000 | 0.867 | 1.000 | | PHILIPS | Sensitivity | 21 | 0.950 | 0.764 | 0.991 | | PHILIPS | Specificity | 57 | 1.000 | 0.937 | 1.000 | | TOSHIBA | Sensitivity | 30 | 0.967 | 0.833 | 0.994 | | TOSHIBA | Specificity | 31 | 1.000 | 0.890 | 1.000 | | SIEMENS | Sensitivity | 28 | 1.000 | 0.879 | 1.000 | | SIEMENS | Specificity | 48 | 1.000 | 0.926 | 1.000 | ### Performance within Make/Model of Scanners | Make/Model | Measure | N | Estimate | Lower 95% CI | Upper 95% CI | |-----------------------------------------|-------------|----|----------|-----------------|-----------------| | GE MEDICAL SYSTEMS LightSpeed VCT | Sensitivity | 22 | 0.909 | 0.722 | 0.975 | | GE MEDICAL SYSTEMS LightSpeed VCT | Specificity | 15 | 1.000 | 0.796 | 1.000 | | GE MEDICAL SYSTEMS Other | Sensitivity | 52 | 1.000 | 0.931 | 1.000 | | GE MEDICAL SYSTEMS Other | Specificity | 10 | 1.000 | 0.722 | 1.000 | | Philips iCT 256 | Sensitivity | 3 | 1.000 | NA | NA | | Philips iCT 256 | Specificity | 32 | 1.000 | 0.893 | 1.000 | | Philips Ingenuity CT | Sensitivity | 4 | 0.500 | NA | NA | | Philips Ingenuity CT | Specificity | 25 | 1.000 | 0.867 | 1.000 | | Philips Other | Sensitivity | 14 | 1.000 | 0.785 | 1.000 | | Philips Other | Specificity | 0 | NA | NA | NA | | SIEMENS SOMATOM Definition AS+ | Sensitivity | 14 | 1.000 | 0.785 | 1.000 | | SIEMENS SOMATOM Definition AS+ | Specificity | 29 | 1.000 | 0.883 | 1.000 | | SIEMENS Other | Sensitivity | 14 | 1.000 | 0.785 | 1.000 | | SIEMENS Other | Specificity | 19 | 1.000 | 0.832 | 1.000 | {10}------------------------------------------------ | Make/Model | Measure | N | Estimate | Lower 95% CI | Upper 95% CI | |------------------|-------------|----|----------|-----------------|-----------------| | TOSHIBA Aquilion | Sensitivity | 20 | 0.950 | 0.764 | 0.991 | | | Specificity | 20 | 1.000 | 0.839 | 1.000 | | TOSHIBA Other | Sensitivity | 11 | 1.000 | 0.741 | 1.000 | | | Specificity | 11 | 1.000 | 0.741 | 1.000 | Section 5: 510(k) Summary Performance within Reconstruction Methods of Make/Model of Scanners | Make/Model | Measure | N | Estimate | Lower 95% CI | Upper 95% CI | |--------------|-------------|----|----------|-----------------|-----------------| | GE Standard | Sensitivity | 74 | 0.973 | 0.907 | 0.993 | | | Specificity | 22 | 1.000 | 0.851 | 1.000 | | Philips UB | Sensitivity | 18 | 0.889 | 0.672 | 0.969 | | | Specificity | 57 | 1.000 | 0.937 | 1.000 | | Siemens H40s | Sensitivity | 17 | 1.000 | 0.816 | 1.000 | | | Specificity | 17 | 1.000 | 0.816 | 1.000 | | Other | Sensitivity | 45 | 0.978 | 0.884 | 0.996 | | | Specificity | 65 | 0.996 | 1.000 | 0.944 | In summary, performance validation data, combined with real-world evidence, establish the achievement of effective triage by the Rapid ICH image analysis algorithm as well as effective notification functionality of the Rapid ICH application, as compared to the standard of care for improved time-to-exam-open of a notified case. #### Prescriptive Statement: Caution: Federal law restricts this device to sale by or on the order of a physician. #### Safety & Effectiveness: Rapid ICH has been designed, verified and validated in compliance with 21 CFR, Part 820.30 requirements. The device has been designed to meet the requirements associated with EN ISO 14971:2012 (risk management) and the software development process conforms to ISO 62304:2015. The Rapid ICH performance has been validated through the use of phantoms and retrospective case data based on expert reader truthing of the data. #### Conclusion: In conclusion, iSchemaView's Rapid ICH is substantially equivalent in technological characteristics, safety, and performance characteristics to the legally marketed predicate device, Rapid ICH (K193087).