Who is the manufacturer of Lunit INSIGHT CXR Triage?

Lunit, Inc. filed the 510(k) submission for Lunit INSIGHT CXR Triage (K211733).

What is the FDA product code for Lunit INSIGHT CXR Triage?

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

What is the regulatory pathway for Lunit INSIGHT CXR Triage?

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

Does Lunit INSIGHT CXR Triage use AI or machine learning?

Yes. Lunit INSIGHT CXR Triage (K211733) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for Lunit INSIGHT CXR Triage?

HealthCXR (K192320); Critical Care Suite (K183182).

Who can help prepare an FDA 510(k) submission like Lunit INSIGHT CXR Triage?

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 Lunit INSIGHT CXR Triage 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.

Lunit INSIGHT CXR Triage

K211733 · Lunit, Inc. · QFM · Nov 10, 2021 · Radiology

Device Facts

Record ID	K211733
Device Name	Lunit INSIGHT CXR Triage
Applicant	Lunit, Inc.
Product Code	QFM · Radiology
Decision Date	Nov 10, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2080
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

Lunit INSIGHT CXR Triage is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). Lunit INSIGHT CXR Triage uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS/workstation for worklist prioritization or triage. As a passive notification for prioritization-only software tool within standard of care workflow, Lunit INSIGHT CXR Triage does not send a proactive alert directly to the appropriately trained medical specialists. Lunit INSIGHT CXR Triage is not intended to direct attention to specific portions of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making.

Device Story

Software tool for radiological triage; analyzes frontal chest X-ray images for pleural effusion and pneumothorax. Uses AI algorithm to identify features suggestive of critical findings; provides case-level output to PACS/workstation for worklist prioritization. Operates in parallel to standard clinical workflow; does not send proactive alerts to specialists. De-identifies DICOM images; flags suspicious cases in worklist. Does not provide diagnostic information or direct attention to specific image regions. Used by radiologists/trained specialists to prioritize review of time-sensitive cases. Generates contextual technologist notification 15 minutes post-interpretation. Benefits patient by enabling earlier review of critical findings.

Clinical Evidence

Clinical pivotal studies using NIH and India datasets (1,708 radiographs). Pleural effusion: AUC 0.9686, 89.86% sensitivity, 93.48% specificity. Pneumothorax: AUC 0.9630, 88.92% sensitivity, 90.51% specificity. Performance time averaged ~20 seconds. Results demonstrate effective triage capabilities comparable to predicates.

Technological Characteristics

Software-only device; AI-based image analysis algorithm. Compatible with DICOM frontal chest X-ray images. Deployed on PACS, radiological imaging equipment, or cloud. Passive notification system; no image markup. Vendor-agnostic.

Indications for Use

Indicated for adult patients to analyze frontal chest X-ray images for suspected pleural effusion and/or pneumothorax to enable worklist prioritization. Not for standalone clinical decision-making; not for directing attention to specific image portions.

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

HealthCXR (K192320)
Critical Care Suite (K183182)

Reference Devices

red dot (K161556)

Related Devices

K243808 — Rayvolve PTX-PE · AZmed · Mar 21, 2025
K232410 — SmartChest · Milvue · May 10, 2024
K183182 — Critical Care Suite · Ge Medical Systems, LLC · Aug 12, 2019
K193300 — AIMI-Triage CXR PTX · Radlogics, Inc. · Apr 8, 2020
K191556 — Red Dot · Behold.Ai Technologies Limited · Feb 28, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Lunit Inc. % Colin Jacob 15th Floor, 27 Teheran-ro 2-gil Gangnam-gu, Seoul REPUBLIC OF KOREA Re: K211733 November 10, 2021 Trade/Device Name: Lunit INSIGHT CXR Triage Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QFM Dated: October 1, 2021 Received: October 1, 2021 Dear Colin Jacob: 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/cfpmp/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 (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, 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) K211733 Device Name Lunit INSIGHT CXR Triage #### Indications for Use (Describe) Lunit INSIGHT CXR Triage is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). Lunit INSIGHT CXR Triage uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS/workstation for worklist prioritization or triage. As a passive notification for prioritization-only software tool within standard of care workflow, Lunit INSIGHT CXR Triage does not send a proactive alert directly to the appropriately trained medical specialists. Lunit INSIGHT CXR Triage is not intended to direct attention to specific portions of an image. Its results are not intended to be used on a standalone basis for clinical decision-making. | 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}------------------------------------------------ ## 510(k) Summary ## K211733 # This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92. # Date Prepared: November 3, 2021 Submitter Lunit Inc., 15th Floor, 27 Teheran-ro 2-gil, Gangnam-gu, Seoul, Republic of Korea Phone: +82 2 2138 0827 Facsimile: +82 2 6969 5116 Contact Person: Colin S. Jacob | Name of Device: | Lunit INSIGHT CXR Triage | |----------------------------|--------------------------------------------------------------------| | Common or Usual Name: | Lunit INSIGHT CXR Triage | | Classification Name: | Radiological Computer-Assisted Prioritization Software for Lesions | | Classification Regulation: | 21 CFR 892.2080 | | Regulatory Class: | Class II | | Product Code: | QFM | #### Predicate Device The Lunit INSIGHT CXR Triage is substantially equivalent to the following devices: #### Primary Predicate Device | Manufacturer Name | Zebra Medical Vision, Ltd. | |-------------------|----------------------------| | Device Trade Name | HealthCXR | | 510(k) Number | K192320 | #### Secondary Predicate Device | Manufacturer Name | GE Medical Systems, LLC | |-------------------|-------------------------| | Device Trade Name | Critical Care Suite | | 510(k) Number | K183182 | {4}------------------------------------------------ # Device Description Lunit INSIGHT CXR Triage is a radiological computer-assisted prioritization software that utilizes AI-based image analysis algorithms to identify pre-specified critical findings (pleural effusion and/or pneumothorax) on frontal chest X-ray images and flag the images in the PACS/workstation to enable prioritized review by the appropriately trained medical specialists who are qualified to interpret chest radiographs. The software does not alter the order or remove cases from the reading queue. Chest radiographs are automatically received from the user's image system (e.g. Picture Archiving and Communication System (PACS)) or other radiological imaging equipment (e.g. X-ray systems) and processed by the Lunit INSIGHT CXR Triage for analysis. Following receipt of chest radiographs, the software device de-identifies a copy of each chest radiographs in DICOM format (.dcm) and automatically analyzes each image to identify features suggestive of pleural effusion and/or pneumothorax. Based on the analysis result, the software notifies PACS/workstation for the presence of the critical findings as indicating either "flag" or "(blank)". This would allow the appropriately trained medical specialists to group suspicious exams together that may potentially benefit for their prioritization. Chest radiographs without an identified anomaly are placed in the worklist for routine review, which is the current standard of care. Lunit INSIGHT CXR Triage can flag more than one critical finding per radiograph and the user may select the option to turn on and off notification of critical findings (pleural effusion and pneumothorax). When deployed on other radiological imaging equipment, Lunit INSIGHT CXR Triage automatically runs after image acquisition. It prioritizes and displays the analysis result through the worklist interface of PACS/workstation. Moreover, the analysis result can also be provided in the form of DICOM files containing information on the presence of suspicious radiologic findings. In parallel, the algorithms produce an on-device notification indicating which cases were prioritized by Lunit INSIGHT CXR Triage in PACS. The on-device notification does not provide any diagnostic information and it is not intended to inform any clinical decision, prioritization, or action to the technologist. Lunit INSIGHT CXR Triage works in parallel to and in conjunction with the standard care of workflow; therefore, the user enables to review the study containing critical findings earlier than others. As a passive notification for prioritization-only software tool within standard of care workflow, the software does not send a proactive alert directly to the appropriately trained medical specialists who are qualified to interpret chest radiographs. Lunit INSIGHT CXR Triage is not intended to direct attention to specific portions or anomalies of an image and it should not be used on a stand-alone basis for clinical decision-making. In parallel, an on-device, technologist notification is generated 15 minutes after interpretation by the user, indicating which cases were prioritized by Lunit INSIGHT CXR Triage in PACS. The technologist notification is contextual and does not provides any diagnostic information. The ondevice, technologist notification is not intended to inform any clinical decision, prioritization, or action. {5}------------------------------------------------ # Intended Use / Indications for Use Lunit INSIGHT CXR Triage is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). Lunit INSIGHT CXR Triage uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS/workstation for worklist prioritization or triage. As a passive notification for prioritization-only software tool within standard of care workflow, Lunit INSIGHT CXR Triage does not send a proactive alert directly to the appropriately trained medical specialists. Lunit INSIGHT CXR Triage is not intended to direct attention to specific portions of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making. There is a minor difference between the subject and primary predicate device HealthCXR (K192320) in their indications for use. The primary predicate device is indicated for use to analyze chest X-ray images for the presence of pleural effusion, while Lunit INSIGHT CXR Triage detects pleural effusion as well as pneumothorax. While the specific clinical finding differs, the intended use of the device which is to provide passive notification for triage and prioritization for time sensitive radiologic findings in the chest X-ray is the same. Additionally, the time sensitivity of additional potential finding of pneumothorax has been already established in a secondary predicate device; Critical Care Suite (K183182) and the detection of such potential finding in Lunit INSIGHT CXR Triage is supported by performance testing. ## Summary of Technological Characteristics Both the Lunit INSIGHT CXR Triage and the predicate devices are software only devices that use Artificial intelligence (AI) algorithms and are intended to aid in triage and prioritization of radiological images. At a high level, the subject and the predicate devices are based on the following same technological elements: - · Artificial Intelligence Algorithm(s) - · Triage and prioritization software The following technological differences exist between the subject and predicate devices: - · Clinical condition(s) Lunit INSIGHT CXR Triage detects suspected findings, pleural effusion as well as pneumothorax. In comparison, the primary predicate device detects suspected findings of pleural effusion alone. However, both devices identify time sensitive findings and provide passive notification and pleural effusion as well as pneumothorax have been accepted by FDA as appropriate for regulation as CAD t devices. Comparison of the key features of the subject, and predicate devices is provided in Table 1. {6}------------------------------------------------ # Performance Data The performance of Lunit INSIGHT CXR Triage was validated by clinical and nonclinical tests. All verification testing met the acceptance criteria (passed), demonstrating that the software fulfills its requirement specifications. # Nonclinical Tests The company conducted an internal validation test to assess the standalone performance of Lunit INSIGHT CXR Triage. The validation was completed to determine whether a distinction between target findings is properly completed by the subject device. A total of 1,385 images were collected according to the inclusion and exclusion criteria and classified into positive and negative groups by highly experienced board-certified radiologists. For each target finding, positive includes any case that contains at least one target finding in the image and negative represents the case that does not have the target finding, which includes cases without any findings and cases that contain findings other than the target radiologic finding. Summary of results: ROC AUC was 0.9864 (95% CI: 0.9815 - 0.9913) with 94.29% sensitivity and 95.72% specificity for pleural effusion. For pneumothorax, 0.9973 ROC AUC (95% CI: 0.9955 -0.9992), 96.08% sensitivity, and 99.14% specificity were reported. By confirming that the lower bound of ROC AUC exceeds 0.95 and the sensitivity and specificity for both target radiologic findings are above 0.80, the performance of the algorithm of Lunit INSIGHT CXR Triage is validated to demonstrate that the prespecified target performance is satisfied. # Clinical Tests Two individual clinical pivotal studies were conducted to evaluate the effectiveness of the Lunit INSIGHT CXR Triage. The studies were conducted with NIH chest X-ray dataset that represents the US population and India dataset collected respectively from multiple institutions in India (6 sites for pleural effusion and 3 sites for pneumothorax). A total of 1,708 anonymized chest radiographs (754 cases for pleural effusion and 954 cases for pneumothorax) collected from NIH chest X-ray dataset and multiple institutions in India were enrolled in the validation dataset for the standalone performance test and device performance time estimation. For pleural effusion, the results are as follow: ROC AUC 0.9686 (95% CI: 0.9547 - 0.9824), sensitivity 89.86% (95% CI: 86.72 - 93.00) and specificity 93.48% (95% CI: 91.06 - 95.91). For pneumothorax, the results are as follows: ROC AUC 0.9630 (95% CI: 0.9521 - 0.9739), Sensitivity 88.92% (95% CI: 85.60 - 92.24) and Specificity 90.51% (95% CI: 88.18 - 92.83). The performance for the primary predicate device indicated for pleural effusion (Zebra Medical Vision, HealthCXR) are as follows: ROC AUC was 0.9885 (95% CI: 0.9815 - 0.9956) with sensitivity 96.74% (95% CI: 92.79 -96.48) and specificity 93.17% (95% CI: 89.57 – 95.58). The performance data show that the lower bound of ROC AUC exceeds 0.95 and the lower bounds of both sensitivity and specificity are above Image /page/6/Picture/11 description: The image shows the word "Lunit" in a simple, sans-serif font. To the left of the word is a small, stylized graphic consisting of two circles connected by a diagonal line. The graphic is in a light blue color, while the text is in a darker shade of blue or black. The overall design is clean and modern. {7}------------------------------------------------ 0.85 for both pleural effusion and pneumothorax. Accordingly, the Lunit INSIGHT CXR Triage is demonstrated to achieve effective image analysis and triage capabilities. With regards to the device performance time, the company assessed the performance time of the Lunit INSIGHT CXR Triage that reflects the time it takes for the device to analyze the study and send a notification to the worklist. The performance time of the Lunit INSIGHT CXR Triage was 20.76 seconds (95% CI: 20.23 - 21.28) for pleural effusion and 20.45 seconds (95% CI: 19.99 - 20.92) for pneumothorax. As compared the device performance time of the Lunit INSIGHT CXR Triage with cleared commercial products (HealthCXR (Zebra, K192320) and red dot™ (Behold.AI, K161556)), the result was comparable with the primary predicate device and other 510(k) cleared products. In summary, the Lunit INSIGHT CXR Triage performed successfully in the clinical pivotal studies. The Lunit INSIGHT CXR Triage established standalone adequate detection performance and device performance time for pleural effusion and pneumothorax as compared to the primary predicate device. # Conclusions The Lunit INSIGHT CXR Triage is as safe and effective as the predicate devices. The Lunit INSIGHT CXR Triage has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor differences in indications do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the Lunit INSIGHT CXR Triage and its predicate devices raise no new issues of safety or effectiveness. The clinical and non-clinical performance data demonstrates that the Lunit INSIGHT CXR Triage is as safe and effective as the predicate devices. Thus, the Lunit INSIGHT CXR Triage support a decision is substantially equivalent to its predicate devices for triage and notification. {8}------------------------------------------------ Lunit, Inc. 15 Floor, 27 Teheran-ro 2-gil, Gangnam-gu, Seoul, 06241, Republic of Korea #### Traditional 510(k) Lunit INSIGHT CXR Triage Page 6 of 10 # Table 1 Substantial Equivalence Table | Technological Characteristics | Proposed Device: Lunit INSIGHT CXR Triage | Primary Predicate Device: HealthCXR (K192320) | Secondary Predicate Device: Critical Care Suite (K183182) | |------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device classification | Radiological Computer Assisted Prioritization Software Class II, QFM | Radiological Computer Assisted Prioritization Software Class II, QFM | Radiological Computer Assisted Prioritization Software Class II, QFM | | Indication for Use/Intended Use | Lunit INSIGHT CXR Triage is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). Lunit INSIGHT CXR Triage uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS/workstation for worklist prioritization or triage. As a passive notification for prioritization-only software tool within standard of care workflow, Lunit INSIGHT CXR Triage does not send a proactive alert directly to the appropriately trained medical specialists. Lunit INSIGHT CXR Triage is not intended to direct attention to specific portions of an image or to anomalies other than | 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. | Critical Care Suite is a computer aided triage and notification device that analyzes frontal chest x-ray images for the presence of pre- specified critical findings (pneumothorax). Critical Care Suite identifies images with critical finding to enable case prioritization or triage in the PACS/workstation. Critical Care Suite is intended for notification only and does not provide diagnostic information beyond the notification. Critical Care Suite should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. It is not intended to replace the review of the x-ray image by a qualified physician. Critical Care Suite is indicated for adult-size patients. | | Technological Characteristics | Proposed Device: Lunit INSIGHT CXR Triage | Primary Predicate Device: HealthCXR (K192320) | Secondary Predicate Device: Critical Care Suite (K183182) | | | pleural effusion and/or pneumothorax. Its results are not intended to be used on a stand-alone basis for clinical decision-making. | | | | Notification- only, parallel workflow tool | Yes | Yes | Yes | | User | Appropriately trained medical specialists who are qualified to interpret chest radiographs. | Radiologist | Radiologist | | Targeted clinical condition, anatomy, and modality | Pleural effusion, pneumothorax Chest/Lung Frontal Chest X-ray | Pleural effusion Chest/Lung Frontal Chest X-ray | Pneumothorax Chest/Lung Frontal Chest X-ray | | Algorithm for pre-specified critical findings detection | AI algorithm designed to detect pleural effusion and pneumothorax in chest X-ray images. Lunit INSIGHT CXR Triage uses a vendor agnostic algorithm compatible with DICOM chest X-ray images. | AI algorithm designed to detect pleural effusion in chest X-ray images. HealthCXR employs a vendor agnostic algorithm compatible with DICOM chest X-ray images. | AI algorithm designed to detect pneumothorax in frontal chest X-ray images. Critical Care Suite uses a vendor agnostic algorithm compatible with DICOM frontal chest X-ray images. | | Radiological images format | DICOM | DICOM | DICOM | | Computational Platform | Lunit INSIGHT CXR Triage is designed as a software module that can be deployed on several | HealthCXR is designed as a software module that can be deployed on | Critical Care Suite is designed as a software module that can be deployed on several computing and | | Technological Characteristics | Proposed Device: Lunit INSIGHT CXR Triage | Primary Predicate Device: HealthCXR (K192320) | Secondary Predicate Device: Critical Care Suite (K183182) | | | computing and X-ray imaging platforms such as radiological imaging equipment, PACS, On Premise or On Cloud. | PACS and Standalone desktop application, Zebra Worklist. | X-ray imaging platforms such as Digital Projection Radiographic Systems, PACS, On Premise or On Cloud. | | | When deployed on other radiological imaging equipment, Lunit INSIGHT CXR Triage automatically runs after image acquisition and prioritizes and displays the analysis result through the worklist interface of PACS/workstation. | Integration module notifies the PACS/workstation for prioritization through the worklist interface. | Critical Care Suite enables case prioritization or triage through direct communication of the Critical Care Suite notification during image transfer to the PACS. | | Device output in case of positive detection | No markup on original image. | No markup on original image. | No markup on original image | | | Secondary capture of the finding. | | | | | Upon image acquisition from other radiological imaging equipment (e.g. X-ray systems), an on-device, technologist notification indicating which cases were flagged by Lunit INSIGHT CXR Triage in PACS, is generated 15 minutes after interpretation by the user. The on- device notification is contextual and does not provide any diagnostic information. It is not intended to | | Upon image acquisition on a Digital Projection Radiographic System, an on-device, technologist notification is generated 15 minutes after exam closure, indicating which cases were prioritized by Critical Care Suite in PACS. The technologist notification is contextual and does not provides any diagnostic information. The on- device, technologist notification is not intended to inform any clinical decision, prioritization, or action. | | Republic of Korea | | | | | Technological Characteristics | Proposed Device: Lunit INSIGHT CXR Triage | Primary Predicate Device: HealthCXR (K192320) | Secondary Predicate Device: Critical Care Suite (K183182) | | | inform any clinical decision, prioritization, or action to the technologist. | | | | Notification (i.e., recipient, timing and means of notification) | Passive notification. Images with suspicion of pleural effusion and/or pneumothorax are flagged in PACS/workstation. | Passive notification. Images with suspicion of pleural effusion are flagged in PACS/workstation. | Passive notification. Images with suspicion of pneumothorax are flagged in PACS/workstation. | | Where generated results (i.e., DICOM files) are stored | PACS/Workstation | PACS/Workstation | PACS/Workstation | | Performance level – Timing of notification | The average time taken for the notification to travel from the Lunit INSIGHT CXR Triage to the point at which the result is displayed in the destination PACS/RIS/EPR worklist is 14.66 seconds. | Passive notification is visible upon transfer to the PACS with a delay of about 22 seconds for image transfer to the cloud, computation, and results transfer. | The average time to acquire, annotate, process and transfer an image from the x-ray system to PACS was measured and found to take 42 seconds on average. Exams arrive on PACS with the passive notification already incorporated, therefore there is no delay for image transfer or computation. The worklist prioritization happens immediately once the exam is received on the PACS.…