A VIEW provides CT values for pulmonary tissue from CT thoracic datasets. This software can be used to support the physician quantitatively in the diagnosis, followup evaluation of CT lung tissue images by providing image segmentation of sub-structures in the left and right lung (e.g., the five lobes and airway), volumetric and structural analysis, density evaluations and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data sets. A VIEW is not meant for primary image Interpretation in mammography.

Device Description

The AVIEW is a software product which can be installed on a PC. It shows images taken with the interface from various storage devices using DICOM 3.0 which is the digital image and communication standard in medicine. It also offers functions such as reading, manipulation, analyzing, post-processing, saving and sending images by using the software tools.

AI/ML Overview

The provided text describes the AVIEW software, a medical device for processing CT thoracic datasets, and its substantial equivalence to predicate devices. However, the document does not contain the specific details required to fully address your request regarding acceptance criteria and the study that proves the device meets them.

Here's a breakdown of what information is available and what is missing:

Information Available:

Indications for Use: AVIEW "provides CT values for pulmonary tissue from CT thoracic datasets. This software can be used to support the physician quantitatively in the diagnosis, followup evaluation of CT lung tissue images by providing image segmentation of sub-structures in the left and right lung (e.g., the five lobes and airway), volumetric and structural analysis, density evaluations and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data sets. AVIEW is not meant for primary image Interpretation in mammography."
Performance Data: "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria."
Tests Conducted:
- Unit test
- System test
- DICOM test
- LAA analysis test
- LAA size analysis test
- Airway wall measurement test
- Reliability test
- CT image compatibility test
Conclusion: The device is deemed "substantially equivalent to the predicate device" based on "technical characteristics, general functions, application, and intended use," and "nonclinical tests demonstrate that the device is safe and effective."

Information Missing (and why based on the document):

A table of acceptance criteria and the reported device performance: While various tests are listed (e.g., LAA analysis test, Airway wall measurement test), the document explicitly states these are "nonclinical tests." It does not provide specific quantitative acceptance criteria or corresponding reported device performance values for these tests. The nature of these tests appears to be functional and reliability-focused rather than clinical performance metrics. For example, it doesn't state "AVIEW achieved X% accuracy for LAA analysis against ground truth Y" or "Airway wall measurement deviation was within Z mm."
Sample size used for the test set and the data provenance: The document mentions "CT thoracic datasets" but does not specify the sample size for any test set or the provenance (e.g., country of origin, retrospective/prospective nature) of the data used for testing.
Number of experts used to establish the ground truth for the test set and their qualifications: The document states, "Results produced by the software tools are dependent on the interpretation of trained and licensed radiologists, clinicians and referring physicians as an adjunctive to standard radiology practices for diagnosis." However, it does not specify how many, if any, experts were used to establish ground truth for the test set, nor their specific qualifications, for the performance testing cited.
Adjudication method for the test set: No information is provided regarding any adjudication methods (e.g., 2+1, 3+1) used for establishing ground truth for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: The document explicitly states that AVIEW is "not meant for primary image Interpretation in mammography" and that its results "are dependent on the interpretation of trained and licensed radiologists, clinicians and referring physicians as an adjunctive to standard radiology practices for diagnosis." This suggests it's an assistive tool, but no MRMC study comparing human readers with and without AI assistance, or any effect size, is mentioned. The "Performance Data" section focuses on "nonclinical tests" for software functionality.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The provided detail about "LAA analysis test," "LAA size analysis test," and "Airway wall measurement test" implies standalone algorithmic performance was assessed in these nonclinical tests. However, specific performance metrics (e.g., accuracy, precision, recall) from a standalone evaluation are not provided.
The type of ground truth used: For the mentioned performance tests (e.g., LAA, airway wall measurement), the type of ground truth used is not explicitly specified. It's implied that these are technical validations against known values or established methods, but whether this involved expert consensus on clinical cases, pathology, or outcomes data is not detailed.
The sample size for the training set: No information is provided about a training set or its size, as the document refers to "Verification, validation and testing activities" as "nonclinical tests" demonstrating substantial equivalence, not a machine learning model's development.
How the ground truth for the training set was established: Since no training set information is provided, this cannot be answered.

In summary, the document serves as an FDA 510(k) clearance letter and summary, which primarily focuses on demonstrating "substantial equivalence" to predicate devices through technical characteristics and "nonclinical tests" for functionality and reliability. It does not provide the detailed clinical performance study data that would include specific acceptance criteria, sample sizes (for test or training sets), expert qualifications, or ground truth establishment methods typical for AI-based diagnostic/assistive tools evaluated for quantitative clinical outcomes.

Summary

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October 31, 2018

Coreline Soft Co., Ltd. % Priscilla Chung Regulatory Affairs Consulting LK Consulting Group USA, Inc 690 Roosevelt IRVINE, CA 92620

Re: K171199

Trade/Device Name: AVIEW Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: October 9, 2018 Received: October 12, 2018

Dear Priscilla Chung:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed Michael by Michael D. D. O'hara - o'hara -s Date: 2018.10.31 For S 16:54:04 -04'00' Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171199

Device Name AVIEW

Indications for Use (Describe)

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

(K171199)

1. Date: 10/09/2018

2. Applicant / Submitter

Coreline Soft Co., Ltd. 4, 5F (Yeonnam-dong), 49, World Cup buk-ro 6-gil, Mapo-gu, Seoul, 03991, Republic of Korea

3. U.S. Designated Agent

Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt Irvine CA 92620 Tel: 714.202.5789 Fax: 714.409.3357 Email: juhee.c@LKconsultingGroup.com

4. Trade/Proprietary Name:

AVIEW

5. Common Name:

Image Processing Software

6. Classification:

System, image processing, radiological (21CFR 892.2050, Product code LLZ, Class 2, Radiology)

7. Device Description:

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8. Indication for Use:

A VIEW provides CT values for pulmonary tissue from CT thoracic datasets. This software can be used to support the physician quantitatively in the diagnosis, followup evaluation and documentation of CT lung tissue images by providing image segmentation of sub-structures in the left and right lung (e.g., the five lobes and airway), volumetric and structural analysis, density evaluations and reporting tools. AVIEW is also used to store, transfer, inquire and display CT data sets. AVIEW is not meant for primary image Interpretation in mammography.

9. Predicate Device:

Primary Predicate Device: Vitrea CT Lung Density Analysis Software (K151919)
Reference Predciate Device: Vitrea, Version 7.0 Medical image Processing Software (K150258)

10. Substantial Equivalence:

A VIEW has the same intended use and the principle of operation, and also has similar features to the predicate devices. Vitrea (K150258 and K151919).

There might be slight differences in features and menu, but these differences between the predicate device and the proposed device are not so significant since they do not raise any new or potential safety risks to the user or patient and questions of safety or effectiveness. Based on the results of software validation and verification tests, we conclude that the proposed device is substantially equivalent to the predicate devices.

	Subject Device	Primary PredicateDevice	Reference Device
Device Name	AVIEW	Vitrea CT Lung DensityAnalysis Software	Vitrea, Version 7.0Medical image ProcessingSoftware
Classification Name	System, ImageProcessing, Radiological	System, X-ray,Tomography, Computed	System, ImageProcessing, Radiological
Regulatory Number	21 CFR 892.2050	21 CFR 892.1750	21 CFR 892.2050
Product Code	LLZ	JAK	LLZ
Classification	Class II	Class II	Class II
Review Panel	Radiology	Radiology	Radiology
510K number	K171199	K151919	K150258
Indications for Use	AVIEW provides CTvalues for pulmonarytissue from CT thoracicdatasets. This software	The Vitrea Lung DensityAnalysis softwareprovides CT values forthe pulmonary tissue from	Vitrea is a medicaldiagnostic system thatallows the processing,review, analysis,
	can be used to supportthe physicianquantitatively in thediagnosis, followupevaluation anddocumentation of CTlung tissue images byproviding imagesegmentation of sub-structures in the left andright lung (e.g., the fivelobes and airway),volumetric and structuralanalysis, densityevaluations and reportingtools. AVIEW is alsoused to store, transfer,inquire and display CTdata sets. AVIEW is notmeant for primary imageInterpretation inmammography.	CT thoracic datasets.Three-dimensional(3D)segmentation of the leftlung and right lung,volumetric analysis,density evaluation andreporting tools areintegrated in a specificworkflow to offer thephysician a quantitativesupport for diagnosis andfollow-up evaluation oflung tissue images.	communication and mediainterchange of multi-dimensional digitalimages acquired from avariety of imagingdevices. Vitrea is notmeant for primary image.Interpretation inmammography.
Platform	IBM-compatible PC orPC network	IBM-compatible PC orPC network	IBM-compatible PC orPC network
Operation System	Microsoft Window 7, 8,10	Microsoft Window XP,Window VISTA, Window7, 8	Microsoft Window XP,Window VISTA, Window7, 8
User Interface	Monitor, Mouse,Keyboard	Monitor, Mouse,Keyboard	Monitor, Mouse,Keyboard
Image Input Sources	Images can be scanned,loaded from cardreaders, or importedfrom a radiographicimaging device	Images can be scanned,loaded from digitalcameras or card readers,or imported from aradiographic imagingdevice	Images can be scanned,loaded from digitalcameras or card readers,or imported from aradiographic imagingdevice
32 bit / 64 bit	64 bit	32 / 64 bit	32 / 64 bit
Image format	DICOM	DICOM	DICOM
Image MeasurementTools	Ruler (line and 3D),Tapeline (curve, poly and3D), Angle (3-point, 4point, and 3D), pixelvalues, area of ROI(rectangle, circle, ellipse),volume	Ruler (linear),Tapeline(curve), Angle (3-point, 4 point, and 3D),pixel values, area of aregion of interest,	Ruler (linear),Tapeline(curve), Angle (3-point, 4 point, and 3D),pixel values, area of aregion of interest,
Image viewing	Axial, sagittal, andcoronal image, obliqueslice, cube view	Axial, sagittal and coronalimages, oblique slice,cube view	Axial, sagittal and coronalimages, oblique slice,cube view
Image manipulation	Panning, rotating,zooming, windowing,inverting, Coloring,Oblique, Note (textoverlay)	Panning, rotating,zooming, windowing,inverting, text overlay,volume of interest overlay	Panning, rotating,zooming, windowing,inverting, text overlay,volume of interest overlay
	(volume of interestoverlay)
General Description	AVIEW is an imageprocessing software as amedical device. It assistsin analyzing pulmonaryCT datasets anddisplaying the analysisresults.	Vitrea CT Lung DensityAnalysis assists inanalyzing lung densitiesand volumes. It semi-automatically segmentslung tissues withquantifiable controls andrenderings to aidcommunication with thepulmonologist.	Vitrea is a medicaldiagnostic system thatallows the processing,review, analysis,communication, andmedia interchange ofmulti-dimensional digitalimages acquired from avariety of imagingdevices.
DICOM	This receives DICOMdata from CT by DICOMcommunication ConductsDICOM datacommunication withPACS. It also importsDICOM file directly,saves by using exportfunction.	Retrieve image data overthe network via DICOM	Retrieve image data overthe network via DICOM
Lung Analysis Functions	Semi-automaticsegmentation of lungs,lobes and airwaysVisualization of multi-planar reconstructed(MPR) images and 3Drendered images, withcolor-defined HounsfieldUnit (HU) rangesCalculation of LAA(Lower Attenuation Area)index with HU densityhistogram, volumemeasurements andpercentile indexCalculation of LAAcluster size distributionwith D-slopeGraphical visualization ofthe above quantificationresults for reportingExport of quantificationresults to CSV tablesVisualization of LAA%for each of 5 lobesMeasurements of theairway branches, such as,lumen area and wall area	Semi-automatic right lung,left lung, and airwaysegmentationVisualization of lungdensity with color-definedHounsfield Unit (HU)rangeLung density resultquantification with HUdensity range, volumemeasurements, lung densityindex, and the PD15%measurementDensity graph/histogram ofthe classified lung voxels'relative frequenciesOverlay of densityquantification results anddensity graph histogram forreportingExport of density valuesand curves to CSV tablesor copy to clipboard forinsertion into a reportComparison of upper andlower lung density indexratios	N/A

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11. Technological Characteristics:

A VIEW is a software device that does not contact the patient, nor does it control any life sustaining devices. Results produced by the software tools are dependent on the interpretation of trained and licensed radiologists, clinicians and referring physicians as an adjunctive to standard radiology practices for diagnosis.

12. Performance Data:

Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria. A summary of the conducted tests is as below:

। Unit test
System test -
DICOM test -
-LAA analysis test
LAA size analysis test -
Airway wall measurement test -
-Reliability test
CT image compatibility test -

13. Conclusion:

The new device and predicate device are substantially equivalent in the areas of technical characteristics, general functions, application, and intended use. The new device does not introduce a fundamentally new scientific technology, and the nonclinical tests demonstrate that the device is safe and effective. Therefore, it is our opinion that the AVIEW described in this submission is substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).