K Number
K192320
Device Name
HealthCXR
Date Cleared
2019-11-26

(92 days)

Product Code
Regulation Number
892.2080
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zebra HealthCXR device is a software workflow tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of pleural effusion in the medical care environment. HealthCXR analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/worldion for worklist prioritization or triage. HealthCXR is not intended to direct attention to specific portions or anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out pleural effusion or otherwise preclude clinical assessment of X-Ray cases.
Device Description
The HealthCXR solution is a software product that automatically identifies suspected findings on chest x-rays (e.g. pleural effusion) and notifies 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 prioritization and triage of radiological medical images only. The software is automatic and is capable of analyzing PA or AP chest x-rays. If a suspected finding is found in a scan, the alert is automatically sent to the PACS/workstation used by the radiologist or to a standalone desktop application in parallel with the ongoing standard of care. The PACS/workstation prioritizes and displays the study through its worklist interface. The standalone desktop application, Zebra Worklist, includes a compressed preview image meant for informational purposed only and is not intended for diagnostic use. The HealthCXR device works in parallel to and in conjunction with the standard care of workflow. After a chest x-ray has been performed, a copy of the study is automatically retrieved and processed by the HealthCXR device performs the analysis of the study and returns a notification about the relevant pathology to the PACS/workstation which prioritizes it through the worklist interface or alternatively, the Zebra Worklist will notify the user through the standalone desktop application. The clinician is then able to review the study earlier than in standard of care workflow. The software does not recommend treatment or provide a diagnosis. It is meant as a tool to assist in improved workload prioritization of critical cases. The final diagnosis is provided by a radiologist after reviewing the scan itself. The following modules compose the HealthCXR software for Pleural Effusion: 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. Pleural Effusion algorithm: Once a study has been validated, the algorithm analyzes the frontal chest x-ray for detection of suspected finding suggestive of pleural effusion. IMA Integration feature: The study analysis and the results of a successful study analysis is provided to IMA, to then be sent 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 system.
More Information

Not Found

Yes
The "Intended Use" and "Mentions AI, DNN, or ML" sections explicitly state that the device uses an "artificial intelligence algorithm".

No
Explanation: The device is a software workflow tool designed to aid in worklist prioritization or triage of Chest X-Ray cases and is not intended for treatment or diagnosis.

No

The device is explicitly stated not to be for stand-alone clinical decision-making or diagnosis; its purpose is to aid in workload prioritization and triage.

Yes

The device description explicitly states that HealthCXR is a "software product" and details its function as analyzing images and providing notifications to existing PACS/workstations or a standalone desktop application. There is no mention of accompanying hardware components required for its primary function.

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

  • IVDs analyze biological specimens: In Vitro Diagnostics are designed to examine samples taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
  • This device analyzes medical images: The HealthCXR device analyzes Chest X-ray images, which are medical images, not biological specimens.
  • The intended use is image analysis for workflow prioritization: The primary purpose of HealthCXR is to analyze images to identify potential findings and prioritize cases for review by a radiologist. It does not perform tests on biological samples.

Therefore, while it is a medical device that uses AI for analysis, it falls under the category of medical image analysis software, not In Vitro Diagnostics.

No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device.

Intended Use / Indications for Use

The Zebra HealthCXR device is a software workflow tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of pleural effusion in the medical care environment. HealthCXR analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/worldion for worklist prioritization or triage. HealthCXR is not intended to direct attention to specific portions or anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out pleural effusion or otherwise preclude clinical assessment of X-Ray cases.

Product codes (comma separated list FDA assigned to the subject device)

QFM

Device Description

The HealthCXR solution is a software product that automatically identifies suspected findings on chest x-rays (e.g. pleural effusion) and notifies 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 prioritization and triage of radiological medical images only.

The software is automatic and is capable of analyzing PA or AP chest x-rays. If a suspected finding is found in a scan, the alert is automatically sent to the PACS/workstation used by the radiologist or to a standalone desktop application in parallel with the ongoing standard of care. The PACS/workstation prioritizes and displays the study through its worklist interface. The standalone desktop application, Zebra Worklist, includes a compressed preview image meant for informational purposed only and is not intended for diagnostic use.

The HealthCXR device works in parallel to and in conjunction with the standard care of workflow. After a chest x-ray has been performed, a copy of the study is automatically retrieved and processed by the HealthCXR device performs the analysis of the study and returns a notification about the relevant pathology to the PACS/workstation which prioritizes it through the worklist interface or alternatively, the Zebra Worklist will notify the user through the standalone desktop application. The clinician is then able to review the study earlier than in standard of care workflow.

The software does not recommend treatment or provide a diagnosis. It is meant as a tool to assist in improved workload prioritization of critical cases. The final diagnosis is provided by a radiologist after reviewing the scan itself.

The following modules compose the HealthCXR software for Pleural Effusion:
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.
Pleural Effusion algorithm: Once a study has been validated, the algorithm analyzes the frontal chest x-ray for detection of suspected finding suggestive of pleural effusion.
IMA Integration feature: The study analysis and the results of a successful study analysis is provided to IMA, to then be sent 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 system.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Mentions artificial intelligence algorithm. Mentions AI.

Input Imaging Modality

X-Ray

Anatomical Site

Chest

Indicated Patient Age Range

adult

Intended User / Care Setting

Radiologist / 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 554 anonymized Chest X-ray cases from the USA and Israel, including 276 cases positive for Pleural Effusion and 278 cases negative for Pleural Effusion, as well as confounding imaging factors. The validation data set was truthed (ground truth) by three US Board-Certified Radiologists (truthers).

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance study for triage of time sensitive chest X-Ray cases. The data included a retrospective cohort of 554 anonymized Chest X-ray cases from the USA and Israel, including 276 cases positive for Pleural Effusion and 278 cases negative for Pleural Effusion, as well as confounding imaging factors. The stand-alone detection accuracy was measured on this cohort respective to the ground truth. Overall, the HealthCXR was able to demonstrate an area under the curve (AUC) of 0.9885 (95% CI: [0.9815, 0.9956]). The device establishes effective triage based on an AUC >95%. The HealthCXR device mean processing time was 27.76 seconds for the "Equal Sensitivity and Specificity" operating point, and 20.18 seconds for the "High Specificity" operating point, a timing performance that is substantially equivalent to the predicate.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

The first operating point showed a sensitivity of 96.74% (95% CI: [92.79; 96.48]) and a specificity of 93.17% (95% CI: [89.57; 95.58]). The second, "high-specificity" operating point, reported a sensitivity of 93.84% (95% CI: [90.36;96.12%) and a specificity of 97.12%% (95% CI: [94.43 ;98.53]).

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.

K190362

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

November 26, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Zebra Medical Vision, Ltd. % Flair Bar VP Operations Shefayim Commercial Center PO Box 25 Shefayim, 6099000 ISRAEL

Re: K192320

Trade/Device Name: HealthCXR Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer-assisted prioritization software Regulatory Class: Class II Product Code: QFM Dated: November 3, 2019 Received: November 6, 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

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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,

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

2

Indications for Use

510(k) Number (if known) K192320

Device Name HealthCXR

Indications for Use (Describe)

The Zebra HealthCXR device is a software workflow tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of pleural effusion in the medical care environment. HealthCXR analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/worldion for worklist prioritization or triage. HealthCXR is not intended to direct attention to specific portions or anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out pleural effusion or otherwise preclude clinical assessment of X-Ray 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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3

Image /page/3/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 head in the center, and the word "zebra" in black on the right. Below the word "zebra" is the text "MEDICAL.VISION" in a smaller font.

5. 510 (k) Summary

510(K) Summary - HealthCXR Zebra Medical Vision Ltd.

510(k) Number – K192320

I. Applicant's Name: Flair Bar, VP Operations Zebra Medical Vision Ltd. Shefayim Commercial Center PO Box 25 Shefayim, 6099000 ISRAEL Telephone: +972-9-8827795 Fax: +972-9-8827795

Date Prepared: November 22, 2019

  • II. Device
    Trade Name: HealthCXR

Classification Name: QFM - Radiological Computer-Assisted Prioritization Software

Regulation Number: 892.2080

Classification:

Class II, Radiology

III. Predicate Device:

The HealthCXR device is substantially equivalent to the following device:

Proprietary NameHealthPNX
Premarket NotificationK190362
Classification NameRadiological Computer-Assisted Prioritization Software
Regulation Number21 CFR 892.2080
Product CodeQFM
Regulatory ClassII

IV. Device Description

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Image /page/4/Picture/0 description: The image contains the logo for Zebra Medical Vision. The logo consists of a stylized black and white zebra stripe design to the left, followed by the word "zebra" in black lowercase letters. Below "zebra" is the text "MEDICAL.VISION" in smaller, uppercase letters. To the left of the zebra stripe design is a yellow horizontal bar.

The HealthCXR solution is a software product that automatically identifies suspected findings on chest x-rays (e.g. pleural effusion) and notifies 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 prioritization and triage of radiological medical images only.

The software is automatic and is capable of analyzing PA or AP chest x-rays. If a suspected finding is found in a scan, the alert is automatically sent to the PACS/workstation used by the radiologist or to a standalone desktop application in parallel with the ongoing standard of care. The PACS/workstation prioritizes and displays the study through its worklist interface. The standalone desktop application, Zebra Worklist, includes a compressed preview image meant for informational purposed only and is not intended for diagnostic use.

The HealthCXR device works in parallel to and in conjunction with the standard care of workflow. After a chest x-ray has been performed, a copy of the study is automatically retrieved and processed by the HealthCXR device performs the analysis of the study and returns a notification about the relevant pathology to the PACS/workstation which prioritizes it through the worklist interface or alternatively, the Zebra Worklist will notify the user through the standalone desktop application. The clinician is then able to review the study earlier than in standard of care workflow.

The software does not recommend treatment or provide a diagnosis. It is meant as a tool to assist in improved workload prioritization of critical cases. The final diagnosis is provided by a radiologist after reviewing the scan itself.

The following modules compose the HealthCXR software for Pleural Effusion:

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.

Pleural Effusion algorithm: Once a study has been validated, the algorithm analyzes the frontal chest x-ray for detection of suspected finding suggestive of pleural effusion.

IMA Integration feature: The study analysis and the results of a successful study analysis is provided to IMA, to then be sent 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 system.

V. Intended Use/Indication for Use:

The Zebra HealthCXR device is a software workflow tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of pleural effusion in the medical care

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Image /page/5/Picture/0 description: The image shows the Zebra Medical Vision logo. The logo consists of a stylized black and white zebra-striped "Z" symbol to the left of the word "zebra" in black, with the words "MEDICAL.VISION" in smaller black font below it. There is a yellow horizontal bar to the left of the zebra symbol.

environment. HealthCXR 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. HealthCXR is not intended to direct attention to specific portions or anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out pleural effusion or otherwise preclude clinical assessment of X-Ray cases.

Technological Characteristics Compared to Predicate Device: VI.

The technological characteristics, e.g., overall design, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the HealthCXR device are substantially equivalent to the predicate device cited above.

A comparison of the technological characteristics with the predicate is summarized below.

| Technological
Characteristics | Proposed Device
HealthCXR | Predicate Device
HealthPNX (K190362) | Summary |
|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use/Intended Use | The Zebra HealthCXR device is a
software workflow tool designed
to aid the clinical assessment of
adult Chest X-Ray cases with
features suggestive of pleural
effusion in the medical care
environment. HealthCXR
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.
HealthCXR is not intended to
direct attention to specific
portions or anomalies of an
image. Its results are not intended
to be used on a stand-alone basis
for clinical decision-making nor
is it intended to rule out Pleural
Effusion or otherwise preclude
clinical assessment of X-Ray
cases. | The Zebra Pneumothorax
device is a software
workflow tool designed to
aid the clinical assessment of
adult Chest X-Ray cases with
features suggestive of
Pneumothorax in the medical
care environment.
HealthPNX 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. HealthPNX is not
intended to direct attention to
specific portions or
anomalies of the image. Its
results are not intended to be
used on a stand-alone basis
for clinical decision-making
nor is it intended to rule out
Pneumothorax or otherwise
preclude clinical assessment
of X-Ray cases. | Similar expect for lesion
type |
| Notification-only,
parallel workflow
tool | Yes | Yes | Same |
| User | Radiologist | Radiologist | Same |
| Radiological images
format | DICOM | DICOM | Same |
| Identify patients with
prespecified
clinical condition | Yes | Yes | Same |
| Clinical condition | Pleural Effusion | Pneumothorax | Different but as per the
product classification
definition, both identify
“time sensitive imaging.” |
| Alert to finding | Yes; notification flagged for
review on hospital worklist or
Zebra list | Yes; notification flagged for
review on hospital worklist. | Similar, HealthCXR can
be directly integrated for
notification on the
hospital worklist or on
the Zebra list application.
Both notifications
operate in parallel with
the standard of care. |
| Independent of
standard of care
workflow | Yes; No cases are removed
from worklist | Yes; No cases are removed
from worklist | Same |
| Modality | X-Ray | X-Ray | Same |
| Body part | Chest | Chest | 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 |
| Preview Image | Presentation of a preview of the
study for initial assessment, not
meant for diagnostic purposes.
The device operated in parallel
with the standard of care, which
remains the default option for all
cases. | Presentation of notification
for initial assessment not
meant for diagnostic
purposes. The device
operates in parallel with the
standard of care, which
remains the default option for
all cases. | Similar, HealthCXR
provides an additional
thumbnail view of the
original exam as preview
only on the Zebra list or
Radiology Assistant, not
for diagnostic use. |
| Multiple operating
points | Yes; 2 optional operating points | No; single operating point | Different, but both
operating points are
substantially equivalent
to the performance
predicate device and
comply with DEN
170073 Special control
1(iii) |
| Where results are | PACS / Workstation | PACS / Workstation | Same |
| received | | | |

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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 "Z" symbol on the left, followed by the word "zebra" in lowercase letters. Below the word "zebra" are the words "MEDICAL.VISION" in smaller font. The logo is black and white.

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Image /page/7/Picture/0 description: The image shows the logo for Zebra Medical Vision. The logo consists of a stylized "Z" symbol on the left, followed by the word "zebra" in lowercase letters. Below the word "zebra" is the text "MEDICAL.VISION" in smaller capital letters. The logo is simple and modern, and the use of black and white gives it a clean and professional look.

VII. Performance Data:

Safety and performance of HealthCXR 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".

The performance of the HealthCXR device has been validated in a performance study for triage of time sensitive chest X-Ray cases. The data included a retrospective cohort of 554 anonymized Chest X-ray cases from the USA and Israel, including 276 cases positive for Pleural Effusion and 278 cases negative for Pleural Effusion, as well as confounding imaging factors. The validation data set was truthed (ground truth) by three US Board-Certified Radiologists (truthers). The stand-alone detection accuracy was measured on this cohort respective to the ground truth.

The HealthCXR device detection accuracy met the accuracy performance goals for AUC. sensitivity, and specificity for two defined operating points. Overall, the HealthCXR was able to demonstrate an area under the curve (AUC) of 0.9885 (95% CI: [0.9815, 0.9956]), which is both comparable to the predicate device, and exceeds the required technical method under the QFM product code. The device establishes effective triage based on an AUC >95%. The sensitivity and specificity of the HealthCXR was reported for two operating points, the first for equal sensitivity and specificity and the second operating point for a higher specificity. At both operating points, the HealthCXR performance met the performance goal and was found to be substantially equivalent to the predicate device, HealthPNX (K190362). The first operating point showed a sensitivity of 96.74% (95% CI: [92.79; 96.48]) and a specificity of 93.17% (95% CI: [89.57; 95.58]). The second, "high-specificity" operating point, reported a sensitivity of 93.84% (95% CI: [90.36;96.12%) and a specificity of 97.12%% (95% CI: [94.43 ;98.53]).

In addition, we assessed the performance time of the HealthCXR that reflects the time it takes for the device to analyze the study and send a notification to the worklist. The HealthCXR device mean processing time was 27.76 seconds for the "Equal Sensitivity and Specificity" operating point, and 20.18 seconds for the "High Specificity" operating point, a timing performance that is substantially equivalent to the predicate. This establishes that the HealthCXR meets its intended use statement.

VIII. Conclusion

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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 symbol, and the word "zebra" in black, with the words "MEDICAL.VISION" in smaller letters below it. The logo is clean and modern, and the colors are bright and eye-catching.

The subject HealthCXR device and the HealthPNX predicate device are both software-only devices intended to aid in triage of radiological images, independent of standard 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 HealthCXR performs as intended. The HealthCXR device is therefore substantially equivalent to the HealthPNX predicate.