(111 days)
Not Found
Yes
The document explicitly states that the device uses an "artificial intelligence algorithm" to analyze CT scans.
No
The device is a workflow tool that prioritizes CT scans for review; it does not provide treatment or a diagnosis, which are characteristic functions of a therapeutic device.
No
The device is explicitly stated as a "software workflow tool" and not for stand-alone clinical decision-making or diagnosis. Its primary function is to prioritize worklists.
Yes
The device description explicitly states that Zebra's HealthICH solution is a "software product" and details its function as analyzing CT scans and providing notifications to a PACS/workstation for worklist prioritization. It does not mention any accompanying hardware components that are part of the device itself.
Based on the provided information, the Zebra Head CT triage device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description clearly states that this device analyzes non-contrast head CT scans, which are medical images, not biological specimens.
- The intended use is for workflow prioritization and triage of medical images. While it identifies suspected findings, its primary function is to help radiologists review scans with potential issues sooner, not to perform a diagnostic test on a biological sample.
- The device does not provide a diagnosis or recommend treatment. This is a key characteristic of many IVDs, which are often used to aid in diagnosis or guide treatment decisions based on the analysis of specimens.
In summary, the Zebra Head CT triage device is a software tool for image analysis and workflow management in radiology, not a device used for testing biological samples in vitro.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The Zebra Head CT triage device is a software workflow tool designed to aid the clinical assessment of adult non-contrast head CT cases with features suggestive of intracranial hemorrhage in the medical care environment. HealthICH analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. HealthICH is not intended to direct attention to specific portions of an image or to anomalies other than intracranial hemorrhage. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out hemorrhage or otherwise preclude clinical assessment of CT cases.
Product codes
QAS
Device Description
Zebra's HealthICH solution is a software product that automatically identifies suspected finding suggestive of Intracranial Hemorrhage and notifies the PACS/workstation of the presence of this critical finding in the scan. This notification allows for worklist prioritization of the identified scan and assists clinicians in viewing the prioritized scan before others. The device aim is to aid in the prioritization and triage of radiological medical images only.
Zebra's HealthICH Triage Device uses an artificial intelligence algorithm to analyze CT scans. The HealthICH is indicated for the analysis of non-contrast head CT scans. The algorithm output does not include an image and therefore it does not mark, highlight or direct users' attention to a specific location on the original CT scan.
The Zebra's HealthICH device works in parallel to and in conjunction with the standard of care workflow. After a head CT scan has been performed, a copy of the study is automatically retrieved and processed by the HealthICH device. The device performs the analysis of the study and return a notification about a suspected finding suggestive of Intracranial Hemorrhage to the PACS/workstation which prioritizes it through its worklist interface. The clinician is then able to review the study earlier than in standard of care workflow.
The primary benefit of the product is the ability to reduce the time it takes to notify physician to the presence of a critical finding such as suspected Intracranial Hemorrhage in the head CT scan.
The software does not recommend treatment or provide a diagnosis. It is designed as tool to assist the medical staff and hospital networks in workflow triaging by highlighting and prioritizing studies containing suspected findings. The final diagnosis is provided by a radiologist or other qualified physician after examining the original scan as determined by the clinical standard of care. The software is intended for use by radiologists and other qualified medical staff who read head CT scans on a regular basis
The following modules compose the HealthICH software:
Data input and validation: Following retrieval of a study, the validation feature assessed the input data (i.e. age, modality, view) to ensure compatibility for processing by the algorithm.
HealthICH algorithm: Once a study has been validated, the algorithm analyzes the head CT for identification of suspected finding suggestive of intracranial hemorrhage.
IMA Integration feature:
HealthICH interacts with users through the PACS/workstation via the Zebra Imaging Analytics platform (IMA). It does not have a Graphical User Interface (GUI). The HealthICH sends the results of the study analysis to the Zebra Imaging Analytics Platform, which then distributes the HealthICH results to the PACS/workstation for prioritization
Error codes feature: In the case of a study failure during data validation or the analysis by the algorithm, an error is provided to the Zebra Imaging Analytics Platform
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes, Artificial Intelligence algorithm.
Input Imaging Modality
CT
Anatomical Site
Head
Indicated Patient Age Range
Adult (subjects aging from 18-102 years old)
Intended User / Care Setting
radiologists and other qualified medical staff who read head CT scans on a regular basis in the medical care 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
The data included a retrospective cohort of 427 anonymized head CT cases from USA and Israel, including intracranial hemorrhage positive (n=199) and negative cases (n=228), as well as confounding imaging factors. The data included cases of both genders (Male N-242, Female N=185) and subjects aging from 18-102 years old.
The validation set was truthed (ground truth) by two US Board Certified neuro-radiologists (truthers). In the event that the two ground truthers did not agree, a third, more senior US Board Certified neuro-radiologist reviewed the axial CT series and determined ground truth (presence or absence of ICH).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the HealthICH device has been validated in retrospective stand-alone performance study that was carried out in a simulated synthetics work-flow consisting of truthed validation data. The data included a retrospective cohort of 427 anonymized head CT cases from USA and Israel, including intracranial hemorrhage positive (n=199) and negative cases (n=228), as well as confounding imaging factors.
The standalone performance testing demonstrated the substantial equivalence of the HealthICH software effectiveness as compared to the predicate device (Accipiolx, K182177).
The HealthICH triage time (per-case "processing time") was reported as an average 48.67 seconds (95% CI: 47.06, 50.28). This is similar to that reported by the predicate (4.1 minutes (95% CI: 3.8-4.3 minutes).
The subject device had a reported overall agreement of 93% (95% CI: 90.66, 95.60) compared to the ground truth, as calculated for the cohort of 199 ICH-positive and 228 ICH-negative cases (N=427).
No adverse events were reported.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
HealthICH sensitivity and specificity of 94.47% (95% CI: 90.32-97.21%) and 92.54% (95% CI: 88.33-95.60%), respectively.
Predicate sensitivity and specificity of 92% (95% CI: 87.29-95.68%) and 86% (95% CI: 80.18-90.81%), respectively.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2080 Radiological computer aided triage and notification software.
(a)
Identification. Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations.
(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage (
e.g., improved time to review of prioritized images for pre-specified clinicians).(iii) Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts (
e.g., subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment.(iv) Stand-alone performance testing protocols and results of the device.
(v) Appropriate software documentation (
e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results).(2) Labeling must include the following:
(i) A detailed description of the patient population for which the device is indicated for use;
(ii) A detailed description of the intended user and user training that addresses appropriate use protocols for the device;
(iii) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality for certain subpopulations), as applicable;(iv) A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images;
(v) Device operating instructions; and
(vi) A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness (
e.g., improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (e.g., confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.
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Zebra Medical Vision Ltd. % Flair Bar VP Operations Shefayim Commercial Center, PO Box 25 Shefayim, 6099000 ISRAEL
June 13, 2019
Re: K190424
Trade/Device Name: HealthICH Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QAS Dated: May 14, 2019 Received: May 17, 2019
Dear Flair Bar:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190424
Device Name HealthICH
Indications for Use (Describe)
The Zebra Head CT triage device is a software workflow tool designed to aid the clinical assessment of adult non-contrast head CT cases with features suggestive of intracranial hemorrhage in the medical care environment. HealthICH analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. HealthICH is not intended to direct attention to specific portions of an image or to anomalies other than intracranial hemorrhage. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out hemorrhage or otherwise preclude clinical assessment of CT cases.
| 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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Image /page/3/Picture/0 description: The image shows the Zebra Medical Vision logo. The logo consists of a yellow horizontal line, a stylized black and white zebra-striped "Z" symbol, and the word "zebra" in black, with the words "MEDICAL.VISION" in smaller black letters below it. The logo is clean and modern, with a focus on the company's name and its connection to medical imaging.
5. 510 (k) Summary
510(K) Summary - HealthICH Zebra Medical Vision Ltd.
510(k) Number – K190424
I. Applicant's Name: Zebra Medical Vision Ltd. Shefayim Commercial Center PO Box 25 Shefayim, 6099000 ISRAEL Telephone: +972-9-8827795 Fax: +972-9-8827795
Date Prepared: May 14, 2019
II. Device
Trade Name: HealthICH
Classification Name: Radiological Computer-Assisted Triage and Notification Software
Regulation Number: 892.2080
Classification: Class II, Radiology
Product Code: QAS
III. Predicate Device:
The HealthICH device is substantially equivalent to the following device:
| Proprietary Name | Accipiolx |
|---|---|
| Premarket Notification | K182177 |
| Classification Name | Radiological Computer-Assisted Triage and Notification |
| Software | |
| Regulation Number | 21 CFR 892.2080 |
| Product Code | QAS |
| Regulatory Class | II |
IV. Device Description
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Image /page/4/Picture/0 description: The image shows the logo for Zebra Medical Vision. The logo consists of a stylized letter Z made of black and white stripes, followed by the word "zebra" in black lowercase letters. Below the word "zebra" are the words "MEDICAL.VISION" in smaller black letters.
Zebra's HealthICH solution is a software product that automatically identifies suspected finding suggestive of Intracranial Hemorrhage and notifies the PACS/workstation of the presence of this critical finding in the scan. This notification allows for worklist prioritization of the identified scan and assists clinicians in viewing the prioritized scan before others. The device aim is to aid in the prioritization and triage of radiological medical images only.
Zebra's HealthICH Triage Device uses an artificial intelligence algorithm to analyze CT scans. The HealthICH is indicated for the analysis of non-contrast head CT scans. The algorithm output does not include an image and therefore it does not mark, highlight or direct users' attention to a specific location on the original CT scan.
The Zebra's HealthICH device works in parallel to and in conjunction with the standard of care workflow. After a head CT scan has been performed, a copy of the study is automatically retrieved and processed by the HealthICH device. The device performs the analysis of the study and return a notification about a suspected finding suggestive of Intracranial Hemorrhage to the PACS/workstation which prioritizes it through its worklist interface. The clinician is then able to review the study earlier than in standard of care workflow.
The primary benefit of the product is the ability to reduce the time it takes to notify physician to the presence of a critical finding such as suspected Intracranial Hemorrhage in the head CT scan.
The software does not recommend treatment or provide a diagnosis. It is designed as tool to assist the medical staff and hospital networks in workflow triaging by highlighting and prioritizing studies containing suspected findings. The final diagnosis is provided by a radiologist or other qualified physician after examining the original scan as determined by the clinical standard of care. The software is intended for use by radiologists and other qualified medical staff who read head CT scans on a regular basis
The following modules compose the HealthICH software:
Data input and validation: Following retrieval of a study, the validation feature assessed the input data (i.e. age, modality, view) to ensure compatibility for processing by the algorithm.
HealthICH algorithm: Once a study has been validated, the algorithm analyzes the head CT for identification of suspected finding suggestive of intracranial hemorrhage.
IMA Integration feature:
HealthICH interacts with users through the PACS/workstation via the Zebra Imaging Analytics platform (IMA). It does not have a Graphical User Interface (GUI). The HealthICH sends the results of the study analysis to the Zebra Imaging Analytics Platform, which then distributes the HealthICH results to the PACS/workstation for prioritization
Error codes feature: In the case of a study failure during data validation or the analysis by the algorithm, an error is provided to the Zebra Imaging Analytics Platform
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Image /page/5/Picture/0 description: The image shows the Zebra Medical Vision logo. The logo consists of a yellow horizontal line on the left, followed by a stylized black and white zebra-like symbol. To the right of the symbol is the word "zebra" in black, with the words "MEDICAL.VISION" in smaller font underneath.
V. Intended Use/Indication for Use:
The Zebra Head CT triage device is a software workflow tool designed to aid the clinical assessment of adult non-contrast head CT cases with features suggestive of intracranial hemorrhage in the medical care environment. HealthICH analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. HealthICH is not intended to direct attention to specific portions of an image or to anomalies other than intracranial hemorrhage. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out hemorrhage or otherwise preclude clinical assessment of CT cases.
VI. Comparison of Technological Characteristics Compared to Predicate Device:
The technological characteristics, e.g., overall design, mechanism of action, mode of operation, performance characteristics, etc.. and the intended use of the HealthICH device are substantially equivalent to the predicate device cited above.
| Technological
Characteristics | Proposed Device:
HealthICH | Predicate Device:
Accipiolx (K182177) | Summary |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Intended Use | The Zebra Head CT triage device is
a software workflow tool designed
to aid the clinical assessment of
adult non-contrast head CT cases
with features suggestive of
intracranial hemorrhage in the
medical care
environment. HealthICH analyzes
cases using an artificial intelligence
algorithm to identify suspected
findings. It makes case-level output
available to a PACS/workstation for
worklist prioritization or triage.
HealthICH is not intended to direct
attention to specific portions of an
image or to anomalies other than
intracranial hemorrhage. Its results
are not intended to be used on a
stand-alone basis for clinical
decision-making nor is it intended
to rule out hemorrhage or otherwise
preclude clinical assessment of CT
cases. | Accipiolx is a software
workflow tool designed to
aid in prioritizing the clinical
assessment of adult non-
contrast head CT cases with
features suggestive of acute
intracranial hemorrhage in
the acute care environment.
Accipiolx analyzes cases
using an artificial intelligence
algorithm to identify
suspected findings. It makes
case-level output available to
a PACS/workstation for
worklist prioritization or
triage.
Accipiolx is not intended to
direct attention to specific
portions of an image or to
anomalies other than acute
intracranial hemorrhage. Its
results are not intended to be
used on a stand-alone basis
for clinical decision-making
nor is it intended to rule out
hemorrhage or otherwise | Same |
| | | preclude clinical assessment
of CT cases. | |
| Notification-
only, parallel
workflow
tool | Yes | Yes | Same |
| User | Prespecified clinical users
(clinicians) | Prespecified clinical users
(clinicians) | Same |
| Radiological
images format | DICOM | DICOM | Same |
| Identify patients
with
prespecified
clinical
condition | Yes | Yes | Same |
| Clinical
condition | Intracranial hemorrhage | Intracranial hemorrhage | Same |
| Alert to finding | Yes; flagged for review | Yes; flagged for review | Same |
| Independent of
standard of care
workflow | Yes; No cases are removed
from worklist | Yes; No cases are removed
from worklist | Same |
| Modality | CT | CT | Same |
| Body part | Head | Head | Same |
| Artificial
Intelligence
algorithm | Yes | Yes | Same |
| Limited to
analysis of
imaging data | Yes | Yes | Same |
| Aids prompt
identification of
cases with
indicated
findings | Yes | Yes | Same |
| Where results
are received | PACS / Workstation | PACS / Workstation | Same |
A comparison of the technological characteristics with the predicate device is summarized below.
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Image /page/6/Picture/0 description: The image shows the logo for Zebra Medical Vision. The logo consists of a stylized letter Z on the left and the word "zebra" in lowercase letters on the right. Below the word "zebra" are the words "MEDICAL.VISION" in smaller letters. The logo is black and white.
VII. Performance Data:
The HealthICH has been evaluated and verified in accordance with software specifications and applicable performance standards through Software Development and Validation & Verification Process to ensure performance according to specifications, User Requirements and Federal Regulations and Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
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Image /page/7/Picture/0 description: The image shows the Zebra Medical Vision logo. The logo consists of a stylized black and white zebra stripe pattern on the left, followed by the word "zebra" in black lowercase letters. Below the word "zebra" are the words "MEDICAL.VISION" in smaller black uppercase letters. The logo is clean and modern, and the zebra stripe pattern is eye-catching.
The performance of the HealthICH device has been validated in retrospective stand-alone performance study that was carried out in a simulated synthetics work-flow consisting of truthed validation data. The data included a retrospective cohort of 427 anonymized head CT cases from USA and Israel, including intracranial hemorrhage positive (n=199) and negative cases (n=228), as well as confounding imaging factors. The data included cases of both genders (Male N-242, Female N=185) and subjects aging from 18-102 years old.
The validation set was truthed (ground truth) by two US Board Certified neuro-radiologists (truthers). In the event that the two ground truthers did not agree, a third, more senior US Board Certified neuro-radiologist reviewed the axial CT series and determined ground truth (presence or absence of ICH). The stand-alone detection accuracy was measured on this cohort respective to ground truth. The triage effectiveness was evaluated by the standalone per-case processing time of the device.
The standalone performance testing demonstrated the substantial equivalence of the HealthICH software effectiveness as compared to the predicate device (Accipiolx, K182177). Specifically, the HealthICH triage time (per-case "processing time") was reported as an average 48.67 seconds (95% CI: 47.06, 50.28). This is similar to that reported by the predicate (4.1 minutes (95% CI: 3.8-4.3 minutes).
Additionally, the HealthICH triage accuracy was similar to that reported by the predicate (HealthICH sensitivity and specificity of 94.47% (95% CI: 90.32-97.21%) and 92.54% (95% CI: 88.33-95.60%), respectively, and predicate sensitivity and specificity of 92% (95% CI: 87.29-95.68%) and 86% (95% CI: 80.18-90.81%), respectively). Furthermore, the subject device had a reported overall agreement of 93% (95% CI: 90.66, 95.60) compared to the ground truth, as calculated for the cohort of 199 ICH-positive and 228 ICH-negative cases (N=427). Users should note that in clinical practice, the ratio between positive and negative cases varies due to the natural prevalence, and therefore overall agreement may differ. No adverse events were reported.
The performance testing of the HealthICH device establishes that the subject device is both safe and effective. This established that the HealthICH device meets its intended use statement and is substantially equivalent to the predicate device.
VIII. Conclusion:
The subject HealthICH device and the Accipiolx predicate device are both software-only devices intended to aid in triage of radiological images, independent of care workflow. The labeling of both devices are limited to the categorization of exams and are not to be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.
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, and do not remove cases from the standard of care. The minor differences between the subject device and the predicate raise no new issues of safety or effectiveness. In addition, performance testing demonstrates that the HealthICH performs
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Image /page/8/Picture/0 description: The image shows the Zebra Medical Vision logo. The logo consists of a yellow horizontal line, a stylized black and white zebra-striped "Z" symbol, and the word "zebra" in black, with the words "MEDICAL.VISION" underneath in a smaller font. The logo is clean and modern, with a focus on the company's name and its connection to medical imaging.
as intended. The HealthICH device is therefore substantially equivalent to the Accipiolx predicate device.