AVIEW RT ACS

• K Number: K220408
• Device Name: AVIEW RT ACS
• Manufacturer: Coreline Soft Co.,Ltd
• Date Cleared: 2022-11-10 ( 269 days)
• Product Code: QKB , LLZ
• Regulation Number: 892.2050
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K191928 , K182624
• Predicate For: N/A

Intended Use

AVIEW RT ACS provides deep-learning-based auto-segmented organs and generates contours in RT-DICOM format from CT images which could be used as an initial contour for the clinicians to approve and edit by the radiation oncology department for treatment planning or other professions where a segmented mask of organs is needed.

• a. Deep learning contouring from four body parts (Head & Neck, Breast, Abdomen, and Pelvis)
• b. Generates RT-DICOM structure of contoured organs
• c. Rule-based auto pre-processing
  Receive/Send/Export medical images and DICOM data
  Note that the Breast (Both right and left lung, Heart) were validated with non-contrast CT. Head & Neck (Both right and left Eyes, Brain and Mandible), Abdomen (Both right and Liver), and Pelvis (Both right and left Femur and Bladder) were validated with Contrast CT only.

Device Description

The AVIEW RT ACS provides deep-learning-based auto-segmented organs and generates contours in RT-DICOM format from CT images. This software could be used by the radiation oncology department planning, or other professions where a segmented mask of organs is needed.

• Deep learning contouring: it can automatically contour the organ-at-risk (OARs) from four body parts (Head ● & Neck, Breast, Abdomen, and Pelvis)
• . Generates RT-DICOM structure of contoured organs
• . Rule-based auto pre-processing
  Receive/Send/Export medical images and DICOM data

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The general acceptance criterion for the AVIEW RT ACS device appears to be comparable performance to a predicate device (MIM-MRT Dosimetry) in terms of segmentation accuracy, as measured by Dice Similarity Coefficient (DSC) and 95% Hausdorff Distance (HD). While explicit numerical acceptance thresholds are not stated in the provided text (e.g., "DSC must be greater than X"), the study is structured as a comparative effectiveness study. The expectation is that the AVIEW RT ACS performance should be at least equivalent to, if not better than, the predicate device.

The study's tables (Tables 1-30) consistently show the AVIEW RT ACS achieving higher average DSC values (closer to 1, indicating better overlap) and generally lower average 95% HD values (closer to 0, indicating less maximum distance between contours), across various organs, demographic groups, and scanner parameters, compared to the predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Metric / Organ (Examples)	Acceptance Criterion (Implicit)	AVIEW RT ACS Performance (Mean ± SD, [95% CI])	Predicate Device Performance (Mean ± SD, [95% CI])	Difference (AVIEW - Predicate)	Meets Criteria?
Overall DSC	Should be comparable to or better than predicate device.	(See tables below for individual organ results)	(See tables below for individual organ results)	Mostly positive	Yes
Overall 95% HD (mm)	Should be comparable to or better than predicate device (i.e., lower HD).	(See tables below for individual organ results)	(See tables below for individual organ results)	Mostly negative (indicating better AVIEW)	Yes
Brain DSC	Comparable to or better than predicate.	0.97 ± 0.01 (0.97, 0.98)	0.96 ± 0.01 (0.96, 0.96)	0.01	Yes
Brain 95% HD (mm)	Comparable to or better than predicate (lower HD).	6.92 ± 20.46 (-1.1, 14.94)	4.61 ± 2.17 (3.76, 5.46)	2.31	Mixed (Higher HD for AVIEW, but wide CI)
Heart DSC	Comparable to or better than predicate.	0.94 ± 0.03 (0.93, 0.95)	0.78 ± 1.20 (0.70, 8.56)	0.16	Yes (Significantly better)
Heart 95% HD (mm)	Comparable to or better than predicate (lower HD).	6.19 ± 4.21 (4.73, 7.65)	18.90 ± 5.09 (17.14, 20.67)	-12.71	Yes (Significantly better)
Liver DSC	Comparable to or better than predicate.	0.96 ± 0.01 (0.96, 0.97)	0.87 ± 0.06 (0.85, 0.90)	0.09	Yes
Liver 95% HD (mm)	Comparable to or better than predicate (lower HD).	7.17 ± 12.07 (2.54, 11.81)	24.62 ± 15.16 (18.79, 30.44)	-17.44	Yes (Significantly better)
Bladder DSC	Comparable to or better than predicate.	0.88 ± 0.14 (0.84, 0.93)	0.52 ± 0.26 (0.44, 0.60)	0.36	Yes (Significantly better)
Bladder 95% HD (mm)	Comparable to or better than predicate (lower HD).	10.55 ± 20.56 (3.74, 17.36)	30.48 ± 22.76 (22.94, 38.02)	-19.93	Yes (Significantly better)

Note: The tables throughout the document provide specific performance metrics for individual organs and sub-groups (race, vendors, slice thickness, kernel types). The general conclusion from these tables is that the AVIEW RT ACS consistently performs as well as or better than the predicate device across most metrics and categories.

Study Details for Acceptance Criteria Proof:

1. Sample Size Used for the Test Set: 120 cases.

   • Data Provenance: The dataset included cases from both South Korea and the USA. It was constructed with various ethnicities (White, Black, Asian, Hispanic, Latino, African, American, etc.), and from four major vendors (GE, Siemens, Toshiba, and Philips).
   • Retrospective/Prospective: Not explicitly stated, but the mention of a data set constructed for validation suggests a retrospective collection.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

   • Number of Experts: 3 radiation oncology physicians.
   • Qualifications: All were trained by "The Korean Society for Radiation Oncology," board-certified by the "Ministry of Health and Welfare," with a range of 9-21 years of experience in radiotherapy. The experts included attending assistant professors (n=2) and professors (n=1) from three institutions.

3. Adjudication Method for the Test Set:

   • The method was a sequential editing process:
     1. One expert manually delineated the organs.
     2. The segmentation results from the first expert were then sequentially edited by the other two experts.
     3. The first expert made corrections.
     4. The result was then received by another expert who finalized the gold standard.
   • This can be considered a form of sequential consensus or collaborative review rather than a strict N+1 or M+N+1 method.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • Yes, a comparative effectiveness study was done. The study directly compares the AVIEW RT ACS against a predicate device (MIM-MRT Dosimetry).
   • Effect Size of Human Readers Improvement with AI vs. Without AI Assistance:
     • The study does not measure the improvement of human readers with AI assistance. Instead, it evaluates the standalone performance of the AI device against the standalone performance of a predicate AI device, both compared to expert-generated ground truth. The "human readers" (the three experts) were used solely to create the ground truth, not to evaluate their performance with or without AI assistance.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, a standalone performance study was done. The study compares the auto-segmentation results of the AVIEW RT ACS directly to the expert-derived "gold standard" and also compares it to the auto-segmentation of the predicate device. This is purely an algorithm-only evaluation.

6. The Type of Ground Truth Used:

   • Expert Consensus. The ground truth was established by three radiation oncology physicians through a sequential delineation and editing process to create a "robust gold standard."

7. The Sample Size for the Training Set:

   • Not specified within the provided text. The document refers only to the validation/test set.

8. How the Ground Truth for the Training Set Was Established:

   • Not specified within the provided text. Since the training set size and characteristics are not mentioned, neither is the method for establishing its ground truth.

Summary

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Coreline Soft Co., Ltd. % Hyeyi Park RA Manager 4,5F (Yeonnam-dong), 49, World Cup buk-ro-6-gil, Mapo-gu. Seoul. 03991 REPUBLIC OF KOREA

November 10, 2022

Re: K220408

Trade/Device Name: AVIEW RT ACS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QKB Dated: October 7, 2022 Received: October 11, 2022

Dear Hyeyi Park:

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

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

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Julie Sullivan -S

Julie Sullivan, Ph.D. Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220408

Device Name AVIEW RT ACS

Indications for Use (Describe)

AVIEW RT ACS provides deep-learning-based auto-segmented organs and generates contours in RT-DICOM format from CT images which could be used as an mittal contour for the clinicians to approve and edit by the radiation oncology department for treatment planning or other professions where a segmented mask of organs is needed.

• a. Deep learning contouring from four body parts (Head & Neck, Breast, Abdomen, and Pelvis)
• b. Generates RT-DICOM structure of contoured organs
• c. Rule-based auto pre-processing

Receive/Send/Export medical images and DICOM data

Note that the Breast (Both right and left lung, Heart) were validated with non-contrast CT. Head & Neck (Both right and left Eyes, Brain and Mandible), Abdomen (Both right and Liver), and Pelvis (Both right and left Femur and Bladder) were validated with Contrast CT only.

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

K220408

SUBMITTER 1

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

Phone: [phone] Fax: [phone]

Contact Person: hyeyi. Park Date Prepared: 02.10.2022

2 DEVICE

Name of Device: AVIEW RT ACS Common or Usual Name: Medical Imaging Software Classification Name: Radiological Image Processing Software For Radiation Therapy (21CFR 892.2050) Regulatory Class: II Product Code: QKB

PREDICATE DEVICE 3

MIM-MRT Dosimetry by MIM Software Inc. (K182624)

Name of Device: MIM-MRT Dosimetry Common or Usual Name: Medical Imaging Software Classification Name: System, image processing, radiological (21CFR 892.2050) Regulatory Class: II Product Code: LLZ

This predicate has not been subject to a design-related recall

REFERENCE DEVICE 4

AccuContour™ by Xiamen Manteia Technology LTD. (K191928)

Name of Device: AccuContour™ Common or Usual Name: Medical Imaging Software Classification Name: Radiological Image Processing Software For Radiation Therapy (21CFR 892.2050) Regulatory Class: II Product Code: QKB

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This reference device has not been subject to a design-related recall

5 DEVICE DESCRIPTION

The AVIEW RT ACS provides deep-learning-based auto-segmented organs and generates contours in RT-DICOM format from CT images. This software could be used by the radiation oncology department planning, or other professions where a segmented mask of organs is needed.

• Deep learning contouring: it can automatically contour the organ-at-risk (OARs) from four body parts (Head ● & Neck, Breast, Abdomen, and Pelvis)
• . Generates RT-DICOM structure of contoured organs
• . Rule-based auto pre-processing

Receive/Send/Export medical images and DICOM data

INDICATIONS FOR USE 6

AVIEW RT ACS provides deep-learning-based auto-segmented organs and generates contours in RT-DICOM format from CT images which could be used as an initial contour for the clinicians to approve and edit by the radiation oncology department for treatment planning or other professions where a segmented mask of organs is needed.

• a. Deep learning contouring from four body parts (Head & Neck, Breast, Abdomen, and Pelvis)
• Generates RT-DICOM structure of contoured organs b.
• c. Rule-based auto pre-processing

Receive/Send/Export medical images and DICOM data

Note that the Breast (Both right and left lung, Heart) were validated with non-contrast CT. Head & Neck (Both right and left Eyes, Brain, and Mandible), Abdomen (Both right and Liver), and Pelvis (Both right and left Femur and Bladder) were validated with Contrast CT only.

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COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH 8 THE PREDICATE DEVCIE

AVIEW RT ACS has the same intended use and the principle of operation and has similar features to the predicate devices.

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.

Characteristic	Subject Device	Primary Predicate Device	Reference Device
Device Name	AVIEW RT ACS	MIM-MRT Dosimetry	AccuContour
Classification Name	RadiologicalImageProcessing Software ForRadiation Therapy	RadiologicalImage ProcessingSystem	RadiologicalImageProcessing Software ForRadiation Therapy
Regulatory Number	21 CFR 892.2050	21 CFR 892.2050	21 CFR 892.2050
Product Code	QKB	LLZ	QKB
Review Panel	Radiology	Radiology	Radiology
510k Number	-	K182624	K191928
Indications for use	AVIEW RT ACS
	AVIEW RT ACS provides deep-learning-based auto-segmented organs and generatescontours in RT-DICOM format from CT images which could be used as an initial contourfor the clinicians to approve and edit by the radiation oncology department for treatmentplanning or other professions where a segmented mask of organs is needed.a. Deep learning contouring from four body parts (Head & Neck, Breast, Abdomen,and Pelvis)
	b. Generates RT-DICOM structure of contoured organsc. Rule-based auto pre-processingReceive/Send/Export medical images and DICOM dataNote that the Breast (Both right and left lung, Heart) were validated with non-contrast and
	contrast CT. Head & Neck (Both right and left Eyes, Brain and Mandible), Abdomen (Bothright and left Kidney and Liver), and Pelvis (Both right and left Femur and Bladder) werevalidated with Contrast CT only.
	MIM-MRT Dosimetry
	MIM software is used by trained medical professionals as a tool to aid in evaluation andinformation management of digital medical images. The medical image modalities include,but are not limited to, CT, MRI, CR, DX, MG, US, SPECT, PET and XA as supported byACR/NEMA DICOM 3.0. MIM assists in the following indications:
	• Receive, transmit, store, retrieve, display, print, and process medical images and DICOMobjects.
	• Create, display and print reports from medical images.
	• Registration, fusion display, and review of medical images for diagnosis, treatmentevaluation, and treatment planning.
	• Evaluation of cardiac left ventricular function and perfusion, including left ventricularenddiastolic volume, end-systolic volume, and ejection fraction.
	• Localization and definition of objects such as tumors and normal tissues in medicalimages.
	• Creation, transformation, and modification of contours for applications including, butnot limited to, quantitative analysis, aiding adaptive therapy, transferring contours toradiation therapy treatment planning systems, and archiving contours for patient follow-

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	up and management.• Quantitative and statistical analysis of PET/SPECT brain scans by comparing to otherregistered PET/SPECT brain scans.• Planning and evaluation of permanent implant brachytherapy procedures (not includingradioactive microspheres).• Calculating absorbed radiation dose as a result of administering radionuclide.• When using device clinically, the user should only use FDA approved radiopharmaceuticals.If using with unapproved ones, this device should only be used for research purposes.
	Lossy compressed mammographic images and digitized film screen images must not bereviewed for primary image interpretations. Images that are printed to film must be printedusing an FDA-approved printer for the diagnosis of digital mammography images.Mammographic images must be viewed on a display system that has been cleared by theFDA for the diagnosis of digital mammography images. The software is not to be used formammography CAD.
	AccuContourIt is used by radiation oncology department to register multimodality images and segment
	(non-contrast) CT images, to generate needed information for treatment planning,treatment evaluation and treatment adaptation.
	AVIEW RT ACS
	The AVIEW RT ACS provides deep-learning-based auto-segmented organs and generates
	contours in RT-DICOM format from CT images. This software could be used by the radiationoncology department for treatment planning, or other professions where a segmented mask
	of organs is needed.
	• Deep learning contouring: it can automatically contour the organ-at-risk (OARS)
	from four body parts (Head & Neck, Breast, Abdomen, and Pelvis)
	• Generates RT-DICOM structure of contoured organs
	• Rule-based auto pre-processing
	Receive/Send/Export medical images and DICOM data
	MIM-MRT Dosimetry
	MIM - MRT Dosimetry extends features of MIM SurePlan. It is designed for use in medical
	imaging and operates on both Windows and Mac computer systems. MIM - MRT Dosimetryextends the functionality of the MIM - Y90 Dosimetry (K172218) software and utilizes
	functionality of MIM -SPECTRA Quant (K180815). Both of these are predicates for this
	submission. The following functions have been added to allow calculations of absorbed dose
	as a result of administering a radionuclide.
General Description	• Allows for quantification of planar images
	• Allows for calculation of time-integrated activity coefficients
	• Allows for voxel-based dose calculation of radionuclides
	• Allows for correction of dose for tissue density
	Accu Contour
	The proposed device, AccuContourTM, is a standalone software which is used by radiationoncology department to register multimodality images and segment (non-contrast) CT
	images, to generate needed information for treatment planning, treatment evaluation and
	treatment adaptation.
	The product has two image process functions:
	(1) Deep learning contouring: it can automatically contour the organ-at-risk, including head
	and neck,
	thorax, abdomen and pelvis (for both male and female),
	(2) Automatic Registration, and
	(3) Manual Contour.It also has the following general functions:
	Receive/Send/Export medical images and DICOM data

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	• Patient management.• Review of processed images.
	Open and save of files.
Operating SystemImage format	WindowsDICOM	Windows and MAC systemDICOM	WindowsDICOM
DataCommunications	Receive, transmit, store,retrieve and process medicalimages and DICOM objects	Receive, transmit, store,retrieve, display, print, andprocess medical images andDICOM objects.	Receive, add/edit/delete,transmit, input/export,medical images and DICOMdata
Algorithm	Deep Learning	Atlas-based	Deep Learning
CompatibleModality	CT Images	Non-Contrast CT	Non-Contrast CT
Segmentation ofOrgan	Head & Neck, Breast,Abdomen, Pelvis	Head & Neck, Breast,Abdomen, Pelvis	Head & Neck, Thorax,Abdomen & Pelvis
Automatedworkflow	Automatically processesinput image data contourorgans and DICOM sendsgenerated RT Structure set	Creation, transformation,and modification of contoursfor applications including,but not limited to,quantitative analysis, aidingadaptive therapy, transferringcontours to radiation therapytreatment planning systems,and archiving contours forpatient follow-up andmanagement	AccuContour automaticallyprocesses input image data
Data anonymization	Replaces the patient's nameand ID with user definedprefix and suffixes and IDsand strips the birth date,referring physician name,and any private DICOM tagsthat exist.	Replaces the patient's nameand ID with randomizedgeneric names and IDs andstrips the birth date, referringphysician name, and anyprivate DICOM tags thatexist.	No information publiclyavailable.
Target Population	Any patient type for whomscanned with CT modalityimages and segment CTimages are available.	Any patient type for whomrelevant modalities such asCT and MR, as supported byACR/NEMA DICOM 3.0.	Any patient type for whomRelevant multimodalityimages and segment (non-contrast) CT images areavailable.
SegmentationPerformance	The segmentationperformance was validatedmulti-race and multi-vendorusing datasets from SouthKorea and the USA usingfour major vendors (GE,Siemens, Toshiba andPhillips). The segmentationaccuracy is evaluated usingDICE coefficient	Contour Evaluation: Atlas-based segmentation studieshave shown the accuracy ofmulti-atlas segmentationwith an overall average dicesimilarity index of 0.81 forthe contours tested: right andleft lung, trachea, heart, andesophagus	The segmentationperformance was validatedusing datasets from Chinaand the USA using threemajor vendors (GE, Siemensand Phillips). Thesegmentation accuracy isevaluated using DICEcoefficient

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PERFORMANCE DATA 9

9.1 Handware and software verification and Validation

This Medical device is not new; therefore, a clinical study was not considered necessary prior to release. Additionally, there was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing

Verification, validation, and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified device passed all of the tests based on pre-determined Pass/Fail criteria.

• Unit Test -
  Conducting Unit Test using Google C++ Unit Test Framework on major software components identified by software development team. List of Unit Test includes Functional test condition for software component unit, Performance test condition, and part of algorithm analysis for image processing algorithm.

• System Test -
  In accordance with the document 'integration Test Cases' discussed in advanced by software development team and test team, test is conducted by installing software with recommended system specification. Despite Test case recognized in advance was not in existence. New software error discovered by 'Exploratory Test' conducted by test team will be registered and managed as new test case after discussion between development team and test team.

Discovered software error will be classified into 3 categories as severity and managed.

• V Major defects, which are impacting the product's intended use and no workaround is available.

• Moderate defects, which are typically related to user-interface or general quality of product, while workaround is available.

• く Minor defects, which aren't impacting the product's intended use. Not significant.

Success standard of System Test is not finding 'Major', 'Moderate' defect.

• Performance Test -
  • · DICOM Test Report
  • · DICOM Conformance Statement
  • · Thin Client Server Compatibility Test Report
  • Compare Standalone Performacne Test

    • The purpose of this test is to compare and verify the AVIEW RT ACS performance and the performance of the predicate device. The test process involves generating a robust gold standard. Three radiation oncology physicians segmented the organs to be used for validation. There were 3 experts, all trained by the "The Korean Society for Radiation Oncology", board-certified by the "Ministry of Health and Welfare", with a range of 9-21 years of experience in radiotherapy to participate in this test. The experts were attending assistant professors (n=2), and professors (n=1) from three institutions. First, the 1 expert manually delineated the organs. Second, segmentation results generated by 1 expert are sequentially edited by 2 experts. In the editing process, the first expert makes corrections, and the result is received by another expert completes the gold standard by finalizing it. This process was performed by a panel of three radiation oncology physicians' experiences. And the results of auto-segmentation of gold-standard and AVIEW RT ACS and auto-segmentation of predicate device are analyzed and evaluated using

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DSC and 95% HD, respectively. The data set information used in the test is 120cases (each 60cases) including both Korean and U.S, Gender: F 70, M 50, Age: 20-89 years. The TCIA data was constructed with various ethnics (White, Black, Asian, Hispanic, Latino, African, American, etc.), the result can be obtained by performing generalization without performance difference according to ethnic

• Breast (Both right and left lung, Heart) were validated with non-contrast and contrast CT.

• A Head & Neck(Both right and left Eyes, Brain and Mandible), Abdomen(Both right and left Kidney and Liver), and Pelvis(Both right and left Femur and Bladder) were validated with Contrast CT only.

• DSC and 95% HD(mm) for

  • ◆ Total DSC & HD analysis.

Table 1 DSC for each oragn
Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (25)	0.97 ± 0.01(0.97, 0.98)	0.96 ± 0.01 (0.96, 0.96)	0.01
	Rt. Eye (25)	0.79 ± 0.10 (0.75, 0.83)	0.80 ± 0.06 (0.77, 0.82)	-0.01
	Lt. eye (25)	0.72 ± 0.12 (0.67, 0.76)	0.76 ± 0.12 (0.72, 0.81)	-0.04
	Mandible (25)	0.90 ± 0.05 (0.89, 0.93)	0.83 ± 0.07 (0.80, 0.86)	0.07
Breast	Heart (32)	0.94 ± 0.03 (0.93, 0.95)	0.78 ± 1.20 (0.70, 8.56)	0.16
	Rt. Lung (31)	0.98 ± 0.01 (0.97, 0.98)	0.96 ± 0.02 (0.95, 0.97)	0.02
	Lt. Lung (31)	0.97 ± 0.02 (0.96, 0.98)	0.96 ± 0.03 (0.95, 0.97)	0.01
Abdomen	Liver (26)	0.96 ± 0.01 (0.96, 0.97)	0.87 ± 0.06 (0.85, 0.90)	0.09
	Rt. Kidney (26)	0.90 ± 0.03 (0.89, 0.91)	0.75 ± 0.18 (0.68, 0.82)	0.15
	Lt. kidney (26)	0.90 ± 0.05 (0.88, 0.92)	0.79 ± 0.12 (0.75, 0.84)	0.11
Pelvis	Bladder (35)	0.88 ± 0.14 (0.84, 0.93)	0.52 ± 0.26 (0.44, 0.60)	0.36
	Rt. Femur head(37)	0.87 ± 0.14 (0.83, 0.90)	0.58 ± 0.11 (0.54, 0.61)	0.29
	Lt. Femur head(37)	0.86 ± 0.10 (0.83, 0.90)	0.55 ± 0.11(0.51, 0.58)	0.31

Table 2. 95% HD (mm) for each oragn ●

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (25)	6.92 ± 20.46 (-1.1, 14.94)	4.61 ± 2.17 (3.76, 5.46)	2.31
	Rt. Eye (25)	3.68 ± 1.50 (3.09, 4.27)	4.38 ± 1.36 (3.85, 4.91)	-0.70
	Lt. eye (25)	6.38 ± 11.11 (2.03, 10.74)	7.74 ± 10.83 (3.50, 11.99)	-1.36
	Mandible (25)	2.01 ± 1.23 (1.53, 2.49)	24.00 ± 93.61 (-12.69, 60.70)	-21.99
Breast	Heart (32)	6.19 ± 4.21 (4.73, 7.65)	18.90 ± 5.09 (17.14, 20.67)	-12.71
	Rt. Lung (31)	2.88 ± 1.67 (2.30, 3.47)	7.03 ± 2.94 (6.00, 8.06)	-4.14
	Lt. Lung (31)	4.97 ± 13.49 (0.22, 9.72)	4.83 ± 6.21 (2.64, 7.02)	0.14
Abdomen	Liver (26)	7.17 ± 12.07 (2.54, 11.81)	24.62 ± 15.16 (18.79, 30.44)	-17.44
	Rt. Kidney (26)	6.84 ± 9.14 (3.33, 10.35)	14.63 ± 13.07 (9.60, 19.65)	-7.79

{10}------------------------------------------------

	Lt. kidney (26)	$5.34 \pm 4.30$(3.69, 6.99)	$15.18 \pm 10.71$ (11.06,19.26)	-9.84
Pelvis	Bladder (35)	$10.55 \pm 20.56$(3.74, 17.36)	$30.48 \pm 22.76$ (22.94,38.02)	-19.93
	Rt. Femur head(37)	$10.02 \pm 8.94$ (7.10,12.93)	$43.65 \pm 30.38$ (33.72,53.57)	-33.63
	Lt. Femur head(37)	$11.75 \pm 12.42$ (7.64,15.86)	$46.14 \pm 24.84$ (37.91,54.37)	-34.39

DSC and 95% HD(mm) were obtained by race, vendors, slice thickness and kernel for sub-group analysis.

				◆ Dice Similarity Coefficient Comparison (DSC)
--	--	--	--	------------------------------------------------	--	--

					Table 3. DSC for Korean Population each organ.
--	--	--	--	--	------------------------------------------------	--	--

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (10)	0.97 ± 0.01 (0.97, 0.98)	0.96 ± 0.01 (0.95, 0.96)	0.01
	Rt. Eye (10)	0.81 ± 0.07 (0.76, 0.86)	0.80 ± 0.07 (0.76, 0.84)	0.01
	Lt. eye (10)	0.77 ± 0.09 (0.71, 0.82)	0.79 ± 0.06 (0.75, 0.83)	-0.02
	Mandible (10)	0.90 ± 0.03 (0.89, 0.93)	0.81 ± 0.09 (0.76, 0.87)	0.09
Breast	Heart (21)	0.95 ± 0.02 (0.94, 0.96)	0.81 ± 0.10 (0.76, 0.85)	0.14
	Rt. Lung (21)	0.97 ± 0.01 (0.97, 0.98)	0.96 ± 0.02 (0.95, 0.97)	0.01
	Lt. Lung (21)	0.96 ± 0.02 (0.96, 0.97)	0.95 ± 0.03 (0.94, 0.97)	0.01
Abdomen	Liver (10)	0.95 ± 0.01 (0.94, 0.96)	0.88 ± 0.08 (0.83, 0.93)	0.07
	Rt. Kidney (10)	0.89 ± 0.03 (0.87, 0.91)	0.75 ± 0.24 (0.60, 0.90)	0.14
	Lt. kidney (10)	0.88 ± 0.06 (0.84, 0.92)	0.80 ± 0.16 (0.70, 0.90)	0.08
Pelvis	Bladder (17)	0.92 ± 0.07 (0.89, 0.95)	0.47 ± 0.27 (0.34, 0.59)	0.45
	Rt. Femur head(19)	0.88 ± 0.07 (0.84, 0.91)	0.56 ± 0.11 (0.51, 0.61)	0.32
	Lt. Femur head(19)	0.87 ± 0.78 (0.84, 0.91)	0.52 ± 0.13 (0.46, 0.58)	0.35

Table 4. DSC for U.S Population each organ. ●

Part	Organ	AVIEW	Predicate device	Difference
Head& Neck	Brain (15)	0.97 ± 0.01 (0.96, 0.98)	0.96 ± 0.01 (0.96, 0.97)	0.01
	Rt. Eye (15)	0.78 ± 0.12 (0.72, 0.84)	0.80 ± 0.06 (0.77, 0.83)	-0.02
	Lt. eye (15)	0.68 ± 0.13 (0.62 ± 0.75)	0.75 ± 0.14 (0.68, 0.82)	-0.07
	Mandible (15)	0.91 ± 0.06 (0.88, 0.94)	0.84 ± 0.06 (0.81, 0.87)	0.07
Breast	Heart (11)	0.93 ± 0.04 (0.90, 0.95)	0.71 ± 0.09 (0.65, 0.76)	0.22
	Rt. Lung (10)	0.98 ± 0.0 (0.98, 0.99)	0.96 ± 0.01 (0.96, 0.97)	0.02
	Lt. Lung (10)	0.97 ± 0.03 (0.95, 0.99)	0.96 ± 0.03 (0.95, 0.98)	-0.01
Abdom en	Liver (16)	0.97 ± 0.01 (0.96, 0.97)	0.87 ± 0.05 (0.85, 0.90)	1.0
	Rt. Kidney (16)	0.91 ± 0.01 (0.91, 0.92)	0.75 ± 0.14 (0.68, 0.82)	0.16

{11}------------------------------------------------

	Lt. kidney (16)	0.91 ± 0.02 (0.90, 0.92)	0.79 ± 0.09 (0.74, 0.83)	0.12
Pelvis	Bladder (18)	0.85 ± 0.19 (0.76, 0.94)	0.58 ± 0.22 (0.48, 0.69)	0.27
	Rt. Femur head(18)	0.80 ± 0.12 (0.80,0.91)	0.60 ± 0.10 (0.55,0.65)	0.20
	Lt. Femur head(18)	0.85 ± 0.13 (0.79 ±0.91)	0.57 ± 0.09 (0.53, 0.62)	0.27

� Hausdorff Distance Comparison (95% HD)

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (10)	13.19 ± 32.27 (6.81, 33.19)	4.33 ± 1.33 (3.51, 5.16)	8.86
	Rt. Eye (10)	3.18 ± 1.01 (2.55, 3.81)	4.14 ± 1.36 (3.30, 4.99)	-0.96
	Lt. eye (10)	3.53 ± 1.40 (2.66, 4.40)	5.22 ± 2.33 (3.78, 6.66)	-1.69
	Mandible(10)	2.02 ± 0.53 (1.69, 2.35)	6.15 ± 5.71 (2.61, 9.69)	-4.13
Breast	Heart (21)	5.24 ± 2.57 (4.15, 6.34)	18.16 ± 4.72 (16.14, 20.18)	-12.92
	Rt. Lung(21)	3.41 ± 1.76 (2.66, 4.16)	6.87 ± 3.19 (5.50, 8.23)	-3.46
	Lt. Lung(21)	2.79 ± 0.52 (2.57, 3.01)	3.24 ± 0.96 (2.83, 3.65)	-0.45
Abdomen	Liver (10)	4.29 ± 1.50 (3.26, 5.22)	21.14 ± 17.22 (10.46, 31.81)	-16.85
	Rt. Kidney(10)	4.74 ± 1.77 (3.65, 5.84)	15.24 ± 17.44 (4.43, 26.05)	-10.49
	Lt. kidney(10)	6.24 ± 3.35 (2.30, 10.18)	12.34 ± 10.54 (5.80, 18.87)	-6.10
Pelvis	Bladder (17)	4.90 ± 6.03 (2.19, 7.61)	33.96 ± 26.33 (22.13, 45.80)	-29.06
	Rt. Femurhead (19)	9.52 ± 6.64 (6.61, 12.43)	41.34 ± 8.74 (37.51, 45.17)	-31.82
	Lt. Femurhead (19)	9.93 ± 6.83 (6.94, 12.92)	49.19 ± 32.97 (34.73, 63.64)	-39.26

Table 6. 95% HD (mm) for U.S Population each organ ●

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (15)	$2.74 \pm 1.09 (2.19, 3.29)$	$4.79 \pm 2.62 (3.47, 6.12)$	-2.05
	Rt. Eye (15)	$4.01 \pm 1.71 (3.15, 4.87)$	$4.53 \pm 1.38 (3.84, 5.23)$	-0.52
	Lt. eye (15)	$8.29 \pm 14.16 (1.12, 15.45)$	$9.42 \pm 13.78 (2.45, 16.40)$	-1.13
	Mandible (15)	$2.00 \pm 1.56 (1.21, 2.79)$	$35.91 \pm 120.91 (-25.28, 97.10)$	-33.91
Breast	Heart (11)	$8.00 \pm 6.03 (4.43, 11.56)$	$20.31 \pm 5.71 (16.94, 23.69)$	-12.31
	Rt. Lung (10)	$1.78 \pm 0.66 (1.36, 2.19)$	$7.37 \pm 2.43 (5.86, 8.88)$	-5.59
	Lt. Lung (10)	$9.56 \pm 23.90 (-5.25, 24.97)$	$8.18 \pm 10.41 (1.72, 14.63)$	1.38
Abdomen	Liver (16)	$8.98 \pm 15.24 (1.51, 16.45)$	$26.79 \pm 13.86 (20.00, 33.58)$	-17.81
en	Rt. Kidney (16)	$8.15 \pm 11.51 (3.61, 5.94)$	$14.25 \pm 10.08 (9.31, 19.19)$	-6.10
	Lt. kidney (16)	$4.77 \pm 2.38 (3.61, 5.94)$	$16.96 \pm 10.75 (11.69, 22.22)$	-12.19

{12}------------------------------------------------

Pelvis
	Bladder (18)	$17.37 \pm 28.73 (3.29, 31.44)$	$27.01 \pm 18.47 (17.96, 36.06)$	-9.64
	Rt. Femur head (18)	$10.57 \pm 11.16 (5.10, 16.04)$	$46.09 \pm 43.22 (24.91, 67.27)$	-35.52
	Lt. Femur head (18)	$13.91 \pm 16.86 (5.38, 22.44)$	$42.52 \pm 8.23 (38.35, 46.68)$	-28.61

◆ DSC & 95% HD (mm) Comparison by vendors, slice thickness and kernel

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (4)	0.97 ± 0.01 (0.97, 0.98)	0.96 ± 0.0 (0.96, 0.97)	0.01
	Rt. Eye (4)	0.85 ± 0.05 (0.80, 0.90)	0.77 ± 0.05 (0.72, 0.82)	0.08
	Lt. eye (4)	0.78 ± 0.04 (0.71, 0.86)	0.77 ± 0.05 (0.72, 0.82)	0.01
	Mandible (4)	0.91 ± 0.04 (0.87, 0.94)	0.81 ± 0.13 (0.68, 0.94)	0.10
Breast	Heart (9)	0.94 ± 0.02 (0.93, 0.96)	0.75 ± 0.10 (0.69, 0.82)	0.19
	Rt. Lung (9)	0.97 ± 0.01 (0.96, 0.98)	0.95 ± 0.02 (0.94, 0.97)	-0.02
	Lt. Lung (9)	0.96 ± 0.02 (0.95, 0.97)	0.95 ± 0.02 (0.94, 0.97)	0.01
Abdomen	Liver (16)	0.96 ± 0.01 (0.96, 0.97)	0.86 ± 0.06 (0.84, 0.89)	0.10
	Rt. Kidney (16)	0.91 ± 0.02 (0.90, 0.92)	0.77 ± 0.12 (0.72, 0.83)	0.14
	Lt. kidney (16)	0.91 ± 0.03 (0.89, 0.92)	0.78 ± 0.08 (0.74, 0.82)	0.13
Pelvis	Bladder (18)	0.90 ± 0.07 (0.87, 0.93)	0.55 ± 0.27 (0.42, 0.67)	0.35
	Rt. Femur head (19)	0.90 ± 0.06 (0.87, 0.93)	0.56 ± 0.10 (0.51, 0.60)	0.34
	Lt. Femur head (19)	0.89 ± 0.09 (0.85, 0.93)	0.53 ± 0.13 (0.47, 0.58)	0.36

● Table 7. DSC for organ by SIEMENS vendors.

● Table 8. 95% HD (mm) for each organ by SIEMENS vendors.

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (4)	28.16 ± 51.23 (-22.04,78.36)	3.28 ± 0.45 (2.84, 3.72)	24.88
	Rt. Eye (4)	2.77 ± 0.37 (2.42, 3.13)	4.75 ± 1.50 (3.29, 6.22)	-1.98
	Lt. eye (4)	3.26 ± 0.53 (2.74, 3.78)	5.30 ± 2.18 (3.16 ± 7.44)	-2.04
	Mandible (4)	1.91 ± 0.51 (1.42, 2.41)	5.04 ± 4.11 (1.01, 9.08)	-3.13
Breast	Heart (9)	5.92 ± 2.97 (3.98, 7.86)	20.17 ± 3.52 (17.86, 22.47)	-14.25
	Rt. Lung (9)	2.73 ± 0.61 (2.33, 3.13)	7.30 ± 2.63 (5.58, 9.02)	-4.58
	Lt. Lung (9)	2.97 ± 0.26 (2.80, 3.14)	3.63 ± 1.25 (2.81, 4.45)	-0.65
Abdomen	Liver (16)	9.10 ± 15.19 (1.66, 16.55)	29.04 ± 14.54 (21.92, 36.16)	-19.93
	Rt. Kidney (16)	8.40 ± 11.42 (2.81, 14.00)	15.54 ± 9.83 (10.73, 20.36)	-7.14
	Lt. kidney (16)	5.47 ± 3.29 (3.86, 7.08)	18.94 ± 10.02 (14.03, 23.85)	-13.47
Pelvis	Bladder (18)	7.04 ± 9.22 (2.65, 11.42)	23.99 ± 17.93 (15.71, 32.27)	-16.95
	Rt. Femur head (19)	8.01 ± 6.47 (5.10, 10.92)	50.42 ± 3.59 (32.13, 68.71)	-42.41
	Lt. Femur head (19)	8.57 ± 7.05 (5.40, 11.74)	41.98 ± 9.27 (37.70, 46.27)	-33.41

Table 9. DSC for each oragn by GE vendors ●

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (2)	$0.96 \pm 0.01 (0.96, 0.97)$	$0.97 \pm 0.0 (0.96, 0.97)$	-0.01
	Rt. Eye (2)	$0.70 \pm 0.08 (0.64, 0.76)$	$0.81 \pm 0.04 (0.78, 0.84)$	-0.11
	Lt. eye (2)	$0.61 \pm 0.12 (0.53, 0.69)$	$0.78 \pm 0.06 (0.74, 0.81)$	-0.17
	Mandible (2)	$0.88 \pm 0.07 (0.83, 0.93)$	$0.81 \pm 0.06 (0.65, 0.76)$	0.07

{13}------------------------------------------------

Breast	Heart (12)	0.93 ± 0.04 (0.90, 0.95)	0.71 ± 0.09 (0.65, 0.76)	0.22
	Rt. Lung (12)	0.98 ± 0.0 (0.98, 0.99)	0.96 ± 0.01 (0.96, 0.97)	0.02
	Lt. Lung (12)	0.97±0.03 (0.95, 0.99)	0.96 ± 0.03 (0.95, 0.98)	0.01
	Abdomen	Liver (3)	0.97	0.85
Rt. Kidney (3)		0.91	0.50	0.41
Lt. kidney (3)		0.89	0.88	0.01
Pelvis	Bladder (9)	0.72 ± 0.31 (0.45, 1.0)	0.52 ± 0.25 (0.31, 0.74)	0.20
	Rt. Femur head (9)	0.84 ± 0.13 (0.73, 0.95)	0.60 ± 0.12 (0.49, 0.71)	0.24
	Lt. Femur head (9)	0.81±0.15 (0.68, 0.94)	0.56±0.11 (0.46, 0.65)	0.25

● Table 10. 95% HD (mm) for each oragn by GE vendors

Table 10. 95% HD (mm) for each oragn by GE vendors
Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (2)	3.37 ± 1.12 (2.60, 4.14)	4.01 ± 0.77 (3.48, 4.55)	-0.64
	Rt. Eye (2)	5.18 ± 1.16 (4.37, 5.98)	4.57 ± 1.37 (3.62, 5.52)	0.61
	Lt. eye (2)	5.63 ± 1.06 (4.89, 6.36)	6.27 ± 3.77 (3.66, 8.89)	-0.64
	Mandible (2)	2.64 ± 1.93 (1.30, 3.97)	64.50 ± 165.04 (16.94, 23.69)	-61.86
Breast	Heart (12)	8.00 ± 6.03 (4.43, 11.56)	20.31 ± 5.71 (16.94, 23.69)	-12.31
	Rt. Lung (12)	1.78 ± 0.66 (1.36, 2.19)	7.37 ± 2.43 (5.86, 8.88)	-5.59
	Lt. Lung (12)	9.56 ± 23.90 (-5.25, 24.37)	8.18 ± 10.41 (1.72, 14.63)	-1.38
Abdomen	Liver (3)	3.27	32.82	-29.55
	Rt. Kidney (3)	3.27	5.88	-2.61
	Lt. kidney (3)	3.27	6.55	-3.28
Pelvis	Bladder (9)	14.13 ± 11.93 (3.68, 24.59)	36.66 ± 31.09 (9.40, 63.91)	-22.53
	Rt. Femur head (9)	10.68 ± 9.53 (2.33, 19.04)	32.41 ± 12.58 (21.93, 43.44)	-21.73
	Lt. Femur head (9)	19.93 ± 22.34 (0.35, 39.51)	44.61 ± 11.01 (34.96, 54.26)	-24.68

● Table 11. DSC for each organ by PHILIPS vendors

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (11)	0.98 ± 0.01 (0.97, 0.98)	0.96 ± 0.01(0.95, 0.96)	0.02
	Rt. Eye (11)	0.83 ± 0.09 (0.77, 0.88)	0.81 ± 0.07 (0.77, 0.86)	0.02
	Lt. eye (11)	0.74 ± 0.10 (0.69, 0.80)	0.76 ± 0.17 (0.67, 0.85)	0.02
	Mandible (11)	0.93 ± 0.03 (0.91, 0.94)	0.85 ± 0.06 (0.82, 0.89)	0.08
Breast	Heart	N/A	N/A
	Rt. Lung	N/A	N/A
	Lt. Lung	N/A	N/A
Abdomen	Liver (6)	0.95 ± 0.02 (0.94, 0.97)	0.89 ± 0.08 (0.83, 0.95)	0.06
	Rt. Kidney (6)	0.88 ± 0.04 (0.85, 0.91)	0.67 ± 0.30 (0.43, 0.90)	0.21
	Lt. kidney (6)	0.87 ± 0.07 (0.81, 0.93)	0.75 ± 0.19 (0.59, 0.90)	0.12
Pelvis	Bladder (4)	0.88 ± 0.05 (0.83, 0.93)	0.31 ± 0.18 (0.14, 0.48)	0.57

{14}------------------------------------------------

core:line

Rt. Femurhead (4)	$0.79 \pm 0.16$ (0.63, 0.94)	$0.64 \pm 0.15$ (0.50, 0.79)	0.15
Lt. Femurhead (4)	$0.77 \pm 0.14$ (0.63, 0.90)	$0.63 \pm 0.13$ (0.50, 0.75)	0.14

Table 12. 95% HD (mm) for each organ by PHILIPS vendors. ●

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (11)	2.57 ± 0.85 (2.07, 3.08)	5.30 ± 2.94 (3.56, 7.04)	-2.73
	Rt. Eye (11)	3.11 ± 1.31 (2.34, 3.88)	3.97 ± 1.43 (3.12, 4.81)	-0.86
	Lt. eye (11)	8.80 ± 16.77 (-1.10,18.71)	9.96 ± 16.13 (0.43, 19.49)	-1.16
	Mandible(11)	1.72 ± 0.67 (1.33, 2.12)	5.18 ± 5.27 (2.06, 8.29)	-3.46
Breast	Heart	N/A	N/A
	Rt. Lung	N/A	N/A
	Lt. Lung	N/A	N/A
Abdomen	Liver (6)	4.18 ± 1.95 (2.62, 5.74)	18.06 ± 15.21 (5.89, 30.24)	-13.88
en	Rt. Kidney(6)	4.54 ± 1.78 (3.12, 5.96)	17.55 ± 22.23 (-0.24, 35.34)	-13.01
	Lt. kidney(6)	6.30 ± 7.42 (0.36, 12.24)	11.38 ± 11.62 (2.07, 20.68)	-5.08
Pelvis	Bladder (4)	8.72 ± 5.85 (2.10, 15.34)	38.68 ± 8.49 (29.07, 48.29)	-29.96
	Rt. Femurhead (4)	14.44 ± 18.68 (-6.70,35.58)	24.39 ± 23.29 (-1.96, 50.75)	-9.95
	Lt. Femurhead (4)	54.37 ± 59.01 (-12.40,121.14)	37.60 ± 5.32 (31.58, 43.61)	16.77

● Table 13. DSC for each organ by TOSHIBA vendors

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (2)	0.96 ± 0.02 (0.93, 0.99)	0.95 ± 0.01 (0.94, 0.97)	0.01
	Rt. Eye (2)	0.86 ± 0.05 (0.78, 0.93)	0.75 ± 0.03 (0.71, 0.79)	0.11
	Lt. eye (2)	0.84 ± 0.06 (0.76, 0.93)	0.74 ± 0.03 (0.70, 0.77)	0.10
	Mandible (2)	0.94 ± 0.0 (0.93, 0.94)	0.85 ± 0.01 (0.84, 0.86)	0.09
Breast	Heart (12)	0.95 ± 0.02 (0.94, 0.96)	0.85 ± 0.09 (0.80, 0.90)	0.10
	Rt. Lung(12)	0.97 ± 0.01 (0.96, 0.98)	0.96 ± 0.02 (0.95, 0.97)	0.01
	Lt. Lung(12)	0.97 ± 0.01 (0.96, 0.98)	0.95 ± 0.04 (0.93, 0.98)	0.02
Abdomen	Liver (3)	0.95 ± 0.01 (0.94, 0.96)	0.92 ± 0.04 (0.87, 0.97)	0.03
	Rt. Kidney(3)	0.92 ± 0.02 (0.90, 0.94)	0.89 ± 0.04 (0.84, 0.94)	0.03
	Lt. kidney(3)	0.93 ± 0.03 (0.90, 0.96)	0.91 ± 0.04 (0.86, 0.96)	0.02
Pelvis	Bladder (9)	0.95 ± 0.02 (0.93, 0.96)	0.52 ± 0.26 (0.35, 0.69)	0.43
	Rt. Femurhead (9)	0.85 ± 0.10 (0.78, 0.91)	0.56 ± 0.09 (0.50, 0.62)	0.29
	Lt. Femurhead (9)	0.88 ± 0.07 (0.84, 0.92)	0.58 ± 0.08 (0.53, 0.63)	0.30

● Table 14. 95% HD (mm) for each organ by TOSHIBA vendors.

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (2)	$2.53 \pm 2.08 (-0.36, 5.41)$	$5.86 \pm 1.89 (3.24, 8.48)$	-3.33
	Rt. Eye (2)	$2.62 \pm 0.40 (2.06, 3.18)$	$5.10 \pm 0.26 (4.73, 5.46)$	-2.48
	Lt. eye (2)	$2.35 \pm 0.79 (1.26, 3.44)$	$6.31 \pm 0.44 (5.70, 6.93)$	-3.96
	Mandible (2)	$1.28 \pm 0.31 (0.85, 1.71)$	$3.50 \pm 0.57 (2.71, 4.28)$	-2.22
Breast	Heart (12)	$4.74 \pm 2.22 (3.48, 5.99)$	$16.66 \pm 5.07 (13.79, 19.53)$	-11.92

{15}------------------------------------------------

	Rt. Lung(12)	$3.93 \pm 2.16 (2.71, 5.15)$	$6.54 \pm 3.63 (4.48, 8.59)$	-2.61
	Lt. Lung(12)	$2.65 \pm 0.62 (2.30, 3.00)$	$2.94 \pm 0.55 (2.63, 3.25)$	-0.29
Abdomen	Liver (3)	$4.17 \pm 1.36 (2.63, 5.74)$	$11.39 \pm 11.38 (-1.48, 24.27)$	-7.22
en	Rt. Kidney(3)	$4.30 \pm 2.32 (1.68, 6.91)$	$6.81 \pm 3.43 (2.94, 10.69)$	-2.51
	Lt. kidney(3)	$3.39 \pm 1.05 (2.20, 4.47)$	$5.59 \pm 3.12 (2.06, 9.12)$	-2.2
Pelvis	Bladder (9)	$3.80 \pm 1.03 (3.13, 4.47)$	$36.27 \pm 29.82 (16.79, 55.76)$	-32.47
	Rt. Femurhead (9)	$12.40 \pm 9.95 (5.90, 18.90)$	$42.77 \pm 7.46 (37.89, 47.64)$	-30.37
	Lt. Femurhead (9)	$11.57 \pm 10.16 (4.94, 18.21)$	$42.54 \pm 6.74 (38.13, 46.94)$	-30.37

● Table 15. DSC for each organ by ≥1, ≤2 slice thickness

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (9)	0.97 ± 0.01 (0.96, 0.98)	0.96 ± 0.01 (0.95, 0.96)	0.01
	Rt. Eye (9)	0.86 ± 0.07 (0.78, 0.87)	0.80 ± 0.06 (0.76, 0.84)	0.06
	Lt. eye (9)	0.79 ± 0.08 (0.74, 0.84)	0.80 ± 0.06 (0.76, 0.84)	-0.01
	Mandible (9)	0.91 ± 0.03 (0.89, 0.93)	0.81 ± 0.09 (0.75, 0.87)	0.1
Breast	Heart (1)	0.93	0.69	0.24
	Rt. Lung (1)	0.98	0.97	0.01
	Lt. Lung (1)	0.97	0.97	0.00
Abdomen	Liver (5)	0.97 ± 0.01 (0.95, 0.98)	0.88 ± 0.02 (0.86, 0.91)	0.09
	Rt. Kidney (5)	0.90 ± 0.01 (0.87, 0.93)	0.76 ± 0.17 (0.61, 0.91)	0.14
	Lt. kidney (5)	0.88 ± 0.08 (0.80, 0.95)	0.86 ± 0.08 (0.79, 0.93)	0.02
Pelvis	Bladder (3)	0.88 ± 0.06 (0.81, 0.95)	0.05 ± 0.24 (0.24, 0.77)	0.38
	Rt. Femur head (3)	0.76 ± 0.10 (0.88, 0.65)	0.71 ± 0.08 (0.59, 0.82)	0.05
	Lt. Femur head (3)	0.71 ± 0.02 (0.69, 0.74)	0.72 ± 0.03 (0.68, 0.75)	-0.01

. Table 16. 95% HD (mm) for each organ by ≥1, ≤2 slice thickness

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (9)	$14.24 \pm 34.04 (-8.0, 36.48)$	$4.48 \pm 1.39 (3.55, 5.36)$	9.76
	Rt. Eye (9)	$3.15 \pm 1.06 (2.46, 3.84)$	$4.23 \pm 1.32 (3.37, 5.09)$	-1.08
	Lt. eye (9)	$3.58 \pm 1.60 (2.54, 4.63)$	$5.57 \pm 3.64 (3.29, 8.04)$	-1.99
	Mandible (9)	$1.93 \pm 0.60 (1.53, 2.32)$	$6.06 \pm 5.98 (2.15, 9.97)$	-4.13
Breast	Heart (1)	8	15.93	-7.93
	Rt. Lung (1)	2	5.33	-3.33
	Lt. Lung (1)	2	2.18	-0.18
Abdomen	Liver (5)	$14.72 \pm 25.47 (-7.61, 37.05)$	$30.88 \pm 19.29 (13.97, 47.79)$	-16.16
	Rt. Kidney (5)	$13.10 \pm 17.17 (-1.95, 28.15)$	$18.69 \pm 15.09 (5.46, 31.91)$	-5.59
	Lt. kidney (5)	$7.50 \pm 7.90 (0.58, 14.42)$	$13.08 \pm 9.35 (4.88, 21.27)$	-5.58
Pelvis	Bladder (3)	$10.11 \pm 6.48 (1.13, 19.09)$	$33.06 \pm 9.55 (46.29, 19.82)$	-22.95
	Rt. Femur head (3)	$16.16 \pm 16.74 (-7.04, 39.36)$	$16.27 \pm 21.85 (-14.01, 46.56)$	-0.11
	Lt. Femur head (3)	$73.29 \pm 64.05 (-15.48, 162.06)$	$34.0 \pm 8.21 (22.62, 45.38)$	39.29

{16}------------------------------------------------

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (9)	0.98 ± 0.01 (0.97, 0.98)	0.96 ± 0.01 (0.95, 0.96)	0.02
	Rt. Eye (9)	0.84 ± 0.08 (0.79, 0.90)	0.79 ± 0.08 (0.74, 0.84)	0.05
	Lt. eye (9)	0.74 ± 0.1 (0.67, 0.80)	0.72 ± 0.18 (0.61, 0.84)	0.02
	Mandible (9)	0.94 ± 0.03 (0.92, 0.96)	0.88 ± 0.03 (0.85, 0.90)	0.06
Breast	Heart (20)	0.95 ± 0.02 (0.94, 0.96)	0.81 ± 0.10 (0.77, 0.86)	0.14
	Rt. Lung (20)	0.97 ± 0.01 (0.97, 0.98)	0.96 ± 0.02 (0.95, 0.97)	0.01
	Lt. Lung (20)	0.97 ± 0.02 (0.96, 0.97)	0.95 ± 0.03 (0.94, 0.97)	0.02
Abdomen	Liver (15)	0.96 ± 0.01 (0.95, 0.96)	0.88 ± 0.07 (0.84, 0.92)	0.08
	Rt. Kidney (15)	0.90 ± 0.02 (0.89, 0.92)	0.75 ± 0.02 (0.65, 0.85)	0.15
en	Lt. kidney (15)	0.91 ± 0.04 (0.89, 0.92)	0.78 ± 0.13 (0.71, 0.85)	0.13
Pelvis	Bladder (24)	0.89 ± 0.16 (0.83, 0.95)	0.48 ± 0.28 (0.37, 0.59)	0.41
	Rt. Femur head (24)	0.88 ± 0.09 (0.84, 0.91)	0.57 ± 0.10 (0.53, 0.61)	0.31
	Lt. Femur head (24)	0.88 ± 0.09 (0.84, 0.91)	0.54 ± 0.12 (0.50, 0.59)	0.34

. Table 17. DSC for each organ by >2, ≤3 slice thickness

● Table 18. 95% HD (mm) for each organ by >2, ≤3 slice thickness

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (9)	2.29 ± 0.67 (1.85, 2.73)	5.28 ± 3.29 (3.13, 7.43)	-2.99
	Rt. Eye (9)	2.91 ± 1.12 (2.18, 3.64)	4.56 ± 1.58 (3.53, 5.60)	-1.65
	Lt. eye (9)	9.77 ± 18.56 (-2.35, 21.9)	11.80 ± 17.47 (0.38, 23.21)	-2.03
	Mandible (9)	1.45 ± 0.51 (1.11, 1.79)	3.71 ± 1.71 (2.59, 4.82)	-2.26
Breast	Heart (20)	5.11 ± 2.56 (3.99, 6.23)	18.12 ± 4.84 (16.0, 20.24)	-13.01
	Rt. Lung (20)	3.48 ± 1.77 (2.71, 4.26)	6.94 ± 3.25 (5.52, 8.67)	-3.46
	Lt. Lung (20)	2.83 ± 0.50 (2.61, 3.04)	3.29 ± 0.95 (2.87, 3.70)	-0.46
Abdomen	Liver (15)	3.99 ± 1.51 (3.22, 4.75)	20.99 ± 16.1 (12.85, 29.14)	-17
	Rt. Kidney (15)	3.99 ± 1.16 (3.40, 4.57)	13.43 ± 14.1 (6.32, 20.55)	-9.44
	Lt. kidney (15)	4.35 ± 2.85 (2.91, 5.79)	14.46 ± 10.63 (9.08, 19.83)	-10.11
Pelvis	Bladder (24)	6.81 ± 8.68 (3.34, 10.29)	30.16 ± 24.80 (20.02, 40.30)	-23.35
	Rt. Femur head (24)	10.01 ± 8.79 (6.63, 13.39)	41.54 ± 8.85 (38.07, 45.01)	-31.53
	Lt. Femur head (24)	10.51 ± 9.74 (6.76, 14.25)	41.95 ± 8.57 (38.59, 45.31)	-31.44

						Table 19. DSC for each oragan. by >3. <4 slice thickness
--	--	--	--	--	--	----------------------------------------------------------

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (7)	0.96 ± 0.01 (0.96, 0.97)	0.96 ± 0.00 (0.96, 0.97)	0.00
	Rt. Eye (7)	0.68 ± 0.07 (0.63, 0.74)	0.81 ± 0.05 (0.78, 0.85)	-0.13
	Lt. eye (7)	0.59 ± 0.1 (0.51, 0.66)	0.78 ± 0.06 (0.74, 0.82)	-0.19
	Mandible (7)	0.87 ± 0.07 (0.82, 0.92)	0.80 ± 0.06 (0.76, 0.84)	0.07
Breast	Heart (10)	0.94 ± 0.02 (0.93, 0.95)	0.70 ± 0.09 (0.64, 0.75)	0.24
	Rt. Lung(10)	0.98 ± 0.0 (0.98, 0.99)	0.96 ± 0.01 (0.96, 0.97)	0.02
	Lt. Lung(10)	0.97 ± 0.03 (0.95, 0.99)	0.96 ± 0.03 (0.95, 0.98)	0.01
Abdom	Liver (1)	0.97 ± 0.01 (0.95, 0.98)	0.92	0.05

{17}------------------------------------------------

en	Rt. Kidney (1)	$0.90 \pm 0.01 (0.87, 0.93)$	0.89	0.01
	Lt. kidney (1)	$0.88 \pm 0.08 (0.80, 0.95)$	0.88	0.00
Pelvis	Bladder (2)	$0.88 \pm 0.06 (0.81, 0.95)$	$0.37 \pm 0.17 (0.13, 0.60)$	0.51
	Rt. Femur head (2)	$0.76 \pm 0.10 (0.88, 0.65)$	$0.63 \pm 0.24 (0.29, 0.96)$	0.13
	Lt. Femur head (2)	$0.71 \pm 0.02 (0.69, 0.74)$	$0.52 \pm 0.19 (0.26, 0.79)$	0.19

Table 20. 95% HD (mm) for each oragan. By >3, ≤4 slice thickness ●

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (7)	3.45 ± 1.18 (2.58, 4.33)	3.94 ± 0.80 (3.35, 4.54)	-0.49
	Rt. Eye (7)	5.35 ± 1.15 (4.5, 6.2)	4.32 ± 1.27 (3.38, 5.27)	1.03
	Lt. eye (7)	5.63 ± 1.15 (4.78, 6.48)	5.2 ± 2.41 (3.41, 6.98)	0.43
	Mandible (7)	2.83 ± 2.0 (1.36, 4.31)	73.16 ± 176.29 (-57.43,203.76)	-70.33
Breast	Heart (10)	8.13 ± 6.34 (4.2, 12.06)	19.84 ± 5.79 (16.25, 23.43)	-11.71
	Rt. Lung(10)	1.61 ± 0.43 (1.33, 1.89)	7.37 ± 2.43 (5.86, 8.88)	-5.76
	Lt. Lung(10)	10.26 ± 25.24 (-6.23,26.75)	8.18 ± 10.41 (1.72, 14.63)	2.08
Abdomen	Liver (1)	3.27	32.82	-29.55
	Rt. Kidney(1)	3.27	5.88	-2.61
	Lt. kidney(1)	3.27	6.55	-3.28
Pelvis	Bladder (2)	18.16 ± 14.90 (-2.49,38.81)	68.99 ± 15.60 (47.37, 90.61)	-50.83
	Rt. Femurhead (2)	14.21 ± 10.85 (-0.82,29.24)	19.92 ± 4.20 (14.11, 25.74)	-5.71
	Lt. Femurhead (2)	32.33 ± 36.47 (-18.22,82.87)	50.32 ± 16.58 (27.34, 73.29)	-17.99

● Table 21. DSC for each oragan. by >4, ≤5slice thickness

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain	N/A	N/A
	Rt. Eye	N/A	N/A
	Lt. eye	N/A	N/A
	Mandible	N/A	N/A
Breast	Heart (1)	0.82	0.81	0.01
	Rt. Lung	N/A	N/A
	Lt. Lung	N/A	N/A
Abdomen	Liver (5)	0.96 ± 0.0 (0.96, 0.97)	0.84 ± 0.04 (0.81, 0.87)	0.12
	Rt. Kidney(5)	0.91 ± 0.02 (0.89, 0.92)	0.72 ± 0.16 (0.57, 0.86)	0.19
	Lt. kidney(5)	0.91 ± 0.01 (0.89, 0.92)	0.74 ± 0.08 (0.67, 0.81)	0.17
	Pelvis	Bladder (6)	0.91 ± 0.09 (0.84, 0.98)	0.69 ± 0.12 (0.59, 0.78)
Rt. Femurhead (6)		0.90 ± 0.06 (0.85, 0.95)	0.55 ± 0.06 (0.50, 0.60)	0.35
Lt. Femurhead (6)		0.90 ± 0.05 (0.86, 0.95)	0.55 ± 0.05 (0.51, 0.59)	0.35

● Table 22. 95% HD (mm) for each oragan. by >4, ≤5 slice thickness

{18}------------------------------------------------

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain	N/A	N/A
	Rt. Eye	N/A	N/A
	Lt. eye	N/A	N/A
	Mandible	N/A	N/A
Breast	Heart (1)	6.68	25	-18.32
	Rt. Lung	N/A	N/A
	Lt. Lung	N/A	N/A
Abdomen	Liver (5)	9.97 ± 11.42 (-0.04, 19.98)	27.57 ± 5.71 (22.57, 32.58)	-17.6
	Rt. Kidney(5)	9.86 ± 11.31 (-0.05, 19.77)	15.91 ± 10.03 (7.12, 24.70)	6.05
	Lt. kidney(5)	6.56 ± 3.48 (3.51, 9.60)	21.18 ± 12.75 (10.0, 32.36)	-14.62
Pelvis	Bladder (6)	5.1 ± 3.86 (2.01, 8.19)	19.33 ± 6.58 (14.06, 24.60)	-14.23
	Rt. Femurhead (6)	9.07 ± 8.89 (1.96, 16.19)	42.35 ± 5.09 (38.28, 46.42)	-33.28
	Lt. Femurhead (6)	8.71 ± 9.21 (1.35, 16.08)	42.84 ± 4.11 (36.55, 46.13)	-34.13

. Table 23. DSC for each oragan. By soft kernel

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (12)	0.97 ± 0.01 (0.96, 0.98)	0.96 ± 0.01 (0.95, 0.96)	0.01
	Rt. Eye (12)	0.82 ± 0.09 (0.77, 0.88)	0.78 ± 0.06 (0.75, 0.82)	0.04
	Lt. eye (12)	0.73 ± 0.14 (0.65, 0.81)	0.73 ± 0.15 (0.64, 0.81)	0.00
	Mandible(12)	0.92 ± 0.05 (0.89, 0.95)	0.85 ± 0.06 (0.82, 0.89)	0.07
Breast	Heart (17)	0.95 ± 0.02 (0.94, 0.95)	0.80 ± 0.12 (0.75, 0.86)	0.15
	Rt. Lung(17)	0.98 ± 0.01 (0.97, 0.98)	0.96 ± 0.01 (0.96, 0.97)	0.02
	Lt. Lung(17)	0.97 ± 0.01 (0.97, 0.98)	0.96 ± 0.03 (0.94, 0.97)	0.01
Abdomen	Liver (4)	0.96 ± 0.01 (0.94, 0.97)	0.88 ± 0.08 (0.80, 0.96)	0.08
	Rt. Kidney(4)	0.92 ± 0.02 (0.91, 0.94)	0.80 ± 0.17 (0.64, 0.97)	0.12
	Lt. kidney(4)	0.93 ± 0.02 (0.91, 0.96)	0.85 ± 0.12 (0.73, 0.97)	0.08
Pelvis	Bladder (15)	0.91 ± 0.08 (0.87, 0.95)	0.47 ± 0.25 (0.34, 0.59)	0.44
	Rt. Femurhead (14)	0.83 ± 0.11 (0.77, 0.89)	0.61 ± 0.12 (0.55, 0.67)	0.22
	Lt. Femurhead (14)	0.84 ± 0.10 (0.79, 0.89)	0.58 ± 0.09 (0.53, 0.63)	0.26

. Table 24. 95% HD (mm) for each oragan. By soft kernel

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (12)	$2.84 \pm 1.40 (2.05, 3.63)$	$5.44 \pm 2.87 (3.82, 7.07)$	-2.60
	Rt. Eye (12)	$3.29 \pm 1.50 (2.44, 4.14)$	$4.58 \pm 1.21 (3.89, 5.26)$	-1.29
	Lt. eye (12)	$8.28 \pm 16.10 (-0.83, 17.39)$	$10.15 \pm 15.15 (1.58, 18.72)$	-1.87
	Mandible(12)	$1.96 \pm 1.72 (0.98, 2.93)$	$4.28 \pm 3.05 (2.56, 6.00)$	-2.32
Breast	Heart (17)	$6.43 \pm 5.29 (3.91, 8.94)$	$18.13 \pm 5.42 (15.56, 20.71)$	-11.70
	Rt. Lung(17)	$3.34 \pm 2.14 (2.29, 4.39)$	$6.53 \pm 3.20 (4.96, 8.10)$	-3.19
	Lt. Lung(17)	$2.45 \pm 0.76 (2.07, 2.82)$	$3.05 \pm 0.57 (2.77, 3.33)$	-0.60
Abdom	Liver (4)	$3.75 \pm 1.40 (2.38, 5.12)$	$18.46 \pm 16.92 (1.88, 35.04)$	-14.71

{19}------------------------------------------------

en	Rt. Kidney(4)	$3.88 \pm 2.06$ (1.86, 5.90)	$6.61 \pm 2.83$ (3.84, 9.38)	-2.73
	Lt. kidney(4)	$3.17 \pm 0.97$ (2.21, 4.12)	$5.86 \pm 2.60$ (3.31, 8.40)	-2.69
Pelvis	Bladder (15)	$14.83 \pm 30.69$ (-1.24, 30.91)	$38.59 \pm 24.31$ (25.85, 51.33)	-23.76
	Rt. Femurhead (14)	$12.42 \pm 11.32$ (6.27, 18.57)	$36.54 \pm 15.01$ (28.38, 44.70)	-24.12
	Lt. Femurhead (14)	$12.94 \pm 12.92$ (5.62, 20.25)	$41.20 \pm 6.61$ (37.46, 44.94)	-28.26

● Table 25. DSC for each oragan. By standard kernel

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (4)	0.97 ± 0.01 (0.96, 0.98)	0.96 ± 0.00 (0.96, 0.97)	0.01
	Rt. Eye (4)	0.67 ± 0.11 (0.57, 0.77)	0.79 ± 0.03 (0.76, 0.81)	-0.12
	Lt. eye (4)	0.62 ± 0.13 (0.49, 0.74)	0.76 ± 0.04 (0.73, 0.80)	-0.14
	Mandible (4)	0.92 ± 0.04 (0.88, 0.96)	0.82 ± 0.03 (0.79, 0.85)	0.10
Breast	Heart (6)	0.92 ± 0.05 (0.88, 0.96)	0.70 ± 0.07 (0.64, 0.76)	0.22
	Rt. Lung (6)	0.99 ± 0.00 (0.98, 0.99)	0.96 ± 0.01 (0.95, 0.97)	0.03
	Lt. Lung (6)	0.96 ± 0.05 (0.92, 1.00)	0.95 ± 0.03 (0.92, 0.98)	0.01
Abdomen	Liver (1)	0.97	0.85	0.12
	Rt. Kidney (1)	0.91	0.50	0.41
	Lt. kidney (1)	0.89	0.88	0.01
Pelvis	Bladder (4)	0.73 ± 0.36 (0.38, 1.09)	0.59 ± 0.22 (0.37, 0.81)	0.14
	Rt. Femur head (4)	0.84 ± 0.14 (0.70, 0.99)	0.56 ± 0.07 (0.49, 0.63)	0.28
	Lt. Femur head (4)	0.81 ± 0.17 (0.64, 0.98)	0.53 ± 0.11 (0.43, 0.63)	0.28

● Table 26. 95% HD (mm) for each oragan. By standard kernel

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (4)	2.82 ± 0.63 (2.21, 3.44)	3.96 ± 0.54 (3.43, 4.48)	-1.14
	Rt. Eye (4)	5.48 ± 1.25 (4.26, 6.70)	5.06 ± 1.62 (3.47, 6.65)	0.42
	Lt. eye (4)	5.77 ± 1.19 (4.60, 6.94)	7.67 ± 5.05 (2.72, 12.62)	1.90
	Mandible (4)	1.90 ± 0.83 (1.09, 2.71)	5.14 ± 3.19 (2.01, 8.26)	-3.24
Breast	Heart (6)	5.93 ± 2.43 (3.99, 7.87)	19.18 ± 6.49 (13.99, 24.38)	-13.25
	Rt. Lung (6)	1.91 ± 0.78 (1.29, 2.53)	7.94 ± 2.82 (5.68, 10.20)	-6.03
	Lt. Lung (6)	14.70 ± 30.79 (-9.94,39.34)	11.38 ± 12.80 (1.14, 21.63)	3.32
Abdomen	Liver (1)	3.27	32.82	-29.55
	Rt. Kidney (1)	3.27	5.88	-2.61
	Lt. kidney (1)	3.27	6.55	-3.28
Pelvis	Bladder (4)	10.49 ± 10.06 (0.63, 20.36)	31.33 ± 33.16 (-1.17, 63.83)	-20.84
	Rt. Femur head (4)	11.72 ± 10.67 (1.26, 22.18)	36.28 ± 10.56 (25.93, 46.62)	-24.56
	Lt. Femur head (4)	23.28 ± 24.30 (-0.54,47.10)	46.11 ± 12.11 (34.24, 57.98)	-22.83

● Table 27. DSC for each oragan. By medium kernel

Part	Organ	AVIEW	Predicate device	Difference
Head&	Brain (4)	0.97 ± 0.01 (0.97, 0.98)	0.96 ± 0.00 (0.96, 0.97)	0.01

{20}------------------------------------------------

Neck	Rt. Eye (4)	$0.85 \pm 0.05 (0.80, 0.90)$	$0.77 \pm 0.05 (0.72, 0.82)$	0.08
	Lt. eye (4)	$0.78 \pm 0.08 (0.71, 0.86)$	$0.77 \pm 0.05 (0.72, 0.82)$	0.01
	Mandible (4)	$0.91 \pm 0.04 (0.87, 0.94)$	$0.81 \pm 0.13 (0.68, 0.94)$	0.10
Breast	Heart (9)	$0.94 \pm 0.02 (0.93, 0.96)$	$0.75 \pm 0.10 (0.69, 0.82)$	0.19
	Rt. Lung (9)	$0.97 \pm 0.01 (0.96, 0.98)$	$0.95 \pm 0.02 (0.94, 0.97)$	0.02
	Lt. Lung (9)	$0.96 \pm 0.02 (0.95, 0.97)$	$0.95 \pm 0.02 (0.94, 0.97)$	0.01
Abdomen	Liver (16)	$0.96 \pm 0.01 (0.96, 0.97)$	$0.86 \pm 0.06 (0.84, 0.89)$	0.10
en	Rt. Kidney(16)	$0.91 \pm 0.02 (0.90, 0.92)$	$0.77 \pm 0.12 (0.72, 0.83)$	0.14
	Lt. kidney(16)	$0.91 \pm 0.03 (0.89, 0.92)$	$0.78 \pm 0.08 (0.74, 0.82)$	0.13
Pelvis	Bladder (17)	$0.90 \pm 0.07 (0.87, 0.93)$	$0.55 \pm 0.27 (0.42, 0.67)$	0.35
	Rt. Femurhead (19)	$0.90 \pm 0.06 (0.87, 0.93)$	$0.56 \pm 0.10 (0.51, 0.61)$	0.34
	Lt. Femurhead (19)	$0.89 \pm 0.09 (0.85, 0.93)$	$0.53 \pm 0.13 (0.47, 0.58)$	0.36

● Table 28. 95% HD (mm) for each oragan. By medium kernel

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (4)	28.16 ± 51.23 (-22.04,78.36)	3.28 ± 0.45 (2.84, 3.72)	24.88
	Rt. Eye (4)	2.77 ± 0.37 (2.42, 3.13)	4.75 ± 1.50 (3.29, 6.22)	-1.98
	Lt. eye (4)	3.26 ± 0.53 (2.74, 3.78)	5.30 ± 2.18 (3.16, 7.44)	-2.04
	Mandible (4)	1.91 ± 0.51 (1.42, 2.41)	5.04 ± 4.11 (1.01, 9.08)	-3.13
Breast	Heart (9)	5.92 ± 2.97 (3.98, 7.86)	20.17 ± 3.52 (17.86, 22.47)	-14.25
Abdomen	Rt. Lung (9)	2.73 ± 0.61 (2.33, 3.13)	7.30 ± 2.63 (5.58, 9.02)	-4.57
	Lt. Lung (9)	2.97 ± 0.26 (2.80, 3.14)	3.63 ± 1.25 (2.81, 4.45)	-0.66
	Liver (16)	9.10 ± 15.19 (1.66, 16.55)	29.04 ± 14.54 (21.92, 36.16)	-19.94
Abdomen	Rt. Kidney (16)	8.40 ± 11.42 (2.81, 14.00)	15.54 ± 9.83 (10.73, 20.36)	-7.14
	Lt. kidney (16)	5.47 ± 3.29 (3.86, 7.08)	18.94 ± 10.02 (14.03, 23.85)	-13.47
	Pelvis	Bladder (17)	7.04 ± 9.22 (2.65, 11.42)	23.99 ± 17.93 (15.71, 32.27)
Rt. Femur head (19)		8.01 ± 6.47 (5.10, 10.92)	50.42 ± 39.59 (32.13, 38.71)	-42.41
Lt. Femur head (19)		8.57 ± 7.05 (5.40, 11.74)	41.98 ± 9.27 (37.7, 46.27)	-33.41

. Table 29. DSC for each oragan. By sharp kernel

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (5)	0.97 ± 0.01 (0.96, 0.98)	0.96 ± 0.01 (0.96, 0.97)	0.01
	Rt. Eye (5)	0.77 ± 0.07 (0.70, 0.83)	0.87 ± 0.04 (0.84, 0.91)	-0.10
	Lt. eye (5)	0.71 ± 0.07 (0.65, 0.77)	0.85 ± 0.05 (0.81, 0.90)	-0.14
	Mandible (5)	0.88 ± 0.06 (0.83, 0.93)	0.80 ± 0.07 (0.74, 0.86)	0.08
Breast	Heart	N/A	N/A	N/A
	Rt. Lung	N/A	N/A	N/A
	Lt. Lung	N/A	N/A	N/A
Abdomen	Liver (5)	0.95 ± 0.02 (0.93, 0.96)	0.91 ± 0.06 (0.86, 0.96)	0.04
	Rt. Kidney (5)	0.87 ± 0.03 (0.84, 0.90)	0.69 ± 0.32 (0.40, 0.97)	0.18
	Lt. kidney (5)	0.86 ± 0.07 (0.79, 0.92)	0.76 ± 0.21 (0.58, 0.95)	0.10
Pelvis	Bladder	N/A	N/A	N/A
	Rt. Femur head	N/A	N/A	N/A
	Lt. Femur	N/A	N/A	N/A

{21}------------------------------------------------

	head
--	------	--	--	--

Table 30. 95% HD (mm) for each oragan. By sharp kernel ●

Part	Organ	AVIEW	Predicate device	Difference
Head&Neck	Brain (5)	3.00 ± 0.42 (2.64, 3.37)	4.20 ± 0.87 (3.44, 4.96)	-1.20
	Rt. Eye (5)	3.90 ± 1.24 (2.81, 4.99)	3.05 ± 0.68 (2.45, 3.65)	0.85
	Lt. eye (5)	4.83 ± 1.50 (3.52, 6.14)	3.97 ± 2.85 (1.47, 6.47)	-0.86
	Mandible (5)	2.30 ± 0.41 (1.94, 2.66)	101.61 ± 207.65 (-80.40,283.61)	-99.31
Breast	Heart	N/A	N/A
	Rt. Lung	N/A	N/A
	Lt. Lung	N/A	N/A
Abdomen	Liver (5)	4.52 ± 1.97 (2.79, 6.25)	13.74 ± 12.22 (3.03, 24.45)	-9.22
	Rt. Kidney (5)	4.92 ± 1.69 (3.44, 6.40)	19.86 ± 24.04 (-1.21, 40.93)	-14.94
	Lt. kidney (5)	7.06 ± 8.03 (0.02. 14.20)	12.32 ± 12.74 (1.16, 23.48)	-5.26
Pelvis	Bladder	N/A	N/A
	Rt. Femur head	N/A	N/A
	Lt. Femur head	N/A	N/A

• There are organs that aren' available in a certain range or vendor which the value was input as N/A

◆ Number of samples for each analysis

each part	Head & Neck	Breast	Abdomen	Pelvis	Total
N	25	32	26	27	120
Each part by organs	Head & Neck	Breast	Abdomen	Pelvis	Total
N	100	94	78	109	120
Each vendor	SIEMENS	GE	PHILIPS	TOSHIBA	Total
N	48	25	21	26	120
each slice thickness (mm)	≥1, ≤2	>2, ≤3	>3, ≤4	>4, ≤5	Total
N	18	70	20	12	120
Each kernel	SOFT	STANDARD	MEDIUM	SHARP	Total
N	47	15	48	20	120

Table 31.

10 CONCLUSIONS

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 as safe and as effective as the predicate. Therefore, it is our opinion that the AVIEW RT ACS 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).