(159 days)
Yes
The document explicitly states that the device "uses an artificial intelligence algorithm" and "utilizes AI-based image analysis algorithms".
No
The device is described as a "radiological computer-assisted triage and notification software" and its intended use is for "worklist prioritization or triage." It analyzes images to identify potential critical findings and flags them for review by medical specialists, but it is not intended to provide any treatment or therapy.
No.
The device is clearly stated as a "triage and notification software" and is "not intended to be used on a standalone basis for clinical decision-making" nor does it "send a proactive alert directly to the appropriately trained medical specialists." Its main function is for worklist prioritization, flagging images for prioritized review, but not for direct diagnosis.
Yes
The device description explicitly states that both the subject device and the predicate devices are "software only devices". The functionality described involves receiving and processing digital images and providing output to existing PACS/workstation systems, without mentioning any dedicated hardware components included with the device itself.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- This device analyzes medical images: The Lunit INSIGHT CXR Triage analyzes chest X-ray images, which are medical images, not biological samples.
- The intended use is image analysis for prioritization: The device's purpose is to analyze images for the presence of critical findings to prioritize the review of those images by medical specialists. It does not perform any analysis on biological material.
Therefore, based on the definition of an IVD, the Lunit INSIGHT CXR Triage, which analyzes medical images, does not fall into this category. It is a medical device, specifically a radiological computer-assisted triage and notification software.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
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 standalone basis for clinical decision-making.
Product codes
QFM
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Frontal Chest X-ray
Anatomical Site
Chest/Lung
Indicated Patient Age Range
Adult
Intended User / Care Setting
Appropriately trained medical specialists who are qualified to interpret chest radiographs.
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
Nonclinical Tests:
Total of 1,385 images collected according to 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.
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests:
Study type: Internal validation test (standalone performance)
Sample size: 1,385 images
Key results:
Pleural Effusion: ROC AUC was 0.9864 (95% CI: 0.9815 - 0.9913)
Pneumothorax: 0.9973 ROC AUC (95% CI: 0.9955 -0.9992)
The performance of the algorithm of Lunit INSIGHT CXR Triage is validated to demonstrate that the prespecified target performance is satisfied 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.
Clinical Tests:
Study type: Two individual clinical pivotal studies
Sample size: 1,708 anonymized chest radiographs (754 cases for pleural effusion and 954 cases for pneumothorax)
Key results:
Pleural effusion: ROC AUC 0.9686 (95% CI: 0.9547 - 0.9824)
Pneumothorax: ROC AUC 0.9630 (95% CI: 0.9521 - 0.9739)
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).
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 0.85 for both pleural effusion and pneumothorax.
Device performance time:
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Nonclinical Tests:
Pleural Effusion: 94.29% sensitivity and 95.72% specificity
Pneumothorax: 96.08% sensitivity, and 99.14% specificity
Clinical Tests:
Pleural effusion: sensitivity 89.86% (95% CI: 86.72 - 93.00) and specificity 93.48% (95% CI: 91.06 - 95.91)
Pneumothorax: Sensitivity 88.92% (95% CI: 85.60 - 92.24) and Specificity 90.51% (95% CI: 88.18 - 92.83)
Predicate device HealthCXR (K192320):
Sensitivity 96.74% (95% CI: 92.79; 96.48)
Specificity 93.17% (95% CI: 89.57; 95.58)
Predicate device Critical Care Suite (K183182):
Specificity 93.5% (95% CI [91.1%, 95.8%])
Sensitivity 84.3% (95% CI [80.6%, 88.0%])
Sensitivity on large pneumothorax 96.3% (95% CI [93.3%, 99.2%])
Sensitivity on small pneumothorax 75% (95% CI [69.2%, 80.8%])
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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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)
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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.
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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.
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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.
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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. |
| Technological
Characteristics | Proposed Device:
Lunit INSIGHT CXR Triage | Primary Predicate Device:
HealthCXR (K192320) | Secondary Predicate Device:
Critical Care Suite (K183182) |
| Performance
level –
accuracy of
classification | Pleural Effusion | ROC AUC > 0.95 | ROC AUC > 0.95 |
| | ROC AUC > 0.95 | AUC: 0.9885 (95% CI: [0.9815, 0.9956]) | AUC: 0.9607 (95% CI [0.9491, 0.9724]) |
| | AUC: 0.9686 (95% CI: [0.9547, 0.9824]) | First operating point | Specificity 93.5% (95% CI [91.1%, 95.8%]) |
| | Sensitivity 89.86% (95% CI: [86.72, 93.00]) | Sensitivity 96.74% (95% CI: [92.79; 96.48]) | Sensitivity 84.3% (95% CI [80.6%, 88.0%]) |
| | Specificity 93.48% (95% CI: [91.06, 95.91]) | Specificity 93.17% (95% CI: [89.57; 95.58]) | AUC on large pneumothorax 0.9888 (95% CI [0.9810, 0.9965]) |
| | Pneumothorax | "High-specificity" operating
point | Sensitivity on large pneumothorax
96.3% (95% CI [93.3%, 99.2%]) |
| | ROC AUC > 0.95 | Sensitivity 93.84% (95% CI:
[90.36;96.12]) | AUC on small pneumothorax 0.9389
(95% CI [0.9209, 0.9570]) |
| | AUC: 0.9630 (95% CI: [0.9521, 0.9739]) | Specificity 97.12% (95% CI:
[94.43;98.53]) | Sensitivity on small pneumothorax
75% (95% CI [69.2%, 80.8%]) |
| Sensitivity 88.92% (95% CI: [85.60, 92.24]) | | | |
| Specificity 90.51% (95% CI: [88.18, 92.83]) | | | |
Image /page/8/Picture/5 description: The image contains the word "Lunit" in a sans-serif font. To the left of the word is a teal-colored graphic that resembles a network connection or a molecule. A thin teal line is above the word.
9
Lunit, Inc.
15 Floor, 27 Teheran-ro 2-gil, Gangnam-gu, Seoul, 06241,
Republic of Korea
Traditional 510(k) Lunit INSIGHT CXR Triage
Page 7 of 10
Image /page/9/Picture/4 description: The image shows the word "Lunit" in a sans-serif font. The "L" is in black, while the rest of the word is in a lighter shade of gray. To the left of the word is a blue graphic consisting of two circles connected by a line, positioned above a blue line that extends over the word.
10
Lunit, Inc.
15 Floor, 27 Teheran-ro 2-gil,
Gangnam-gu, Seoul, 06241,
Republic of Korea
Traditional 510(k) Lunit INSIGHT CXR Triage
Page 8 of 10
11
Lunit, Inc.
15 Floor, 27 Teheran-ro 2-gil, Gangnam-gu, Seoul, 06241,
Republic of Korea
Traditional 510(k) Lunit INSIGHT CXR Triage
Page 9 of 10
12
Lunit, Inc.
15 Floor, 27 Teheran-ro 2-gil, Gangnam-gu, Seoul, 06241,
Republic of Korea
Traditional 510(k) Lunit INSIGHT CXR Triage
Page 10 of 10