Smart Segmentation Knowledge Based Contouring provides a combined atlas and model based approach for automated and manual segmentation of structures including target volumes and organs at risk to support the radiation therapy treatment planning process.

Device Description

The Smart Segmentation Knowledge Based Contouring was most recently cleared as the Varian Smart Segmentation Knowledge Based Contouring, K133227.

Smart Segmentation - Knowledge Based Contouring is a software only product that provides a combined atlas and model based approach to automated segmentation of structures together with tools for manual contouring or editing of structures. A library of already contoured expert cases is provided which is searchable by anatomy, staging, or free text. Users also have the ability to add or modify expert cases to suit their clinical needs. Expert cases are registered to the target image and selected structures propagated. SmartSegmentation Knowledge Based Contouring supports inter and intra user consistency in contouring. This product also provides an anatomy atlas which gives examples of delineated organs for the whole upper body, as well as anatomy images and functional description for selectable structures.

AI/ML Overview

The provided text does not include a detailed study that proves the device meets specific acceptance criteria with quantifiable metrics. It primarily states that "Verification and Validation testing demonstrate that the product met defined user needs and defined design input requirements."

However, based on the information provided, we can infer some aspects and construct a response that highlights what is present and points out what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. It generally states that the device "met defined user needs and defined design input requirements" and "perform at least as well as the predicate device."
Without a detailed performance study, specific numerical acceptance criteria and reported device performance cannot be extracted.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Validation testing was performed on a production equivalent device, under clinically representative conditions by qualified personnel." However, it does not specify:

The sample size used for the test set.
The data provenance (e.g., country of origin, retrospective or prospective nature of the data).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide this information. It states that "a library of already contoured expert cases is provided" and that users can "add or modify expert cases to suit their clinical needs." However, this refers to the creation and customization of the atlas, not the establishment of ground truth for a structured validation test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for establishing ground truth for a test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human reader improvement with AI assistance. The device is described as "a combined atlas and model based approach for automated and manual segmentation... to support the radiation therapy treatment planning process," implying it assists, but no study on the impact of this assistance on human readers is provided.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document states that "Smart Segmentation - Knowledge Based Contouring is a software only product that provides a combined atlas and model based approach to automated and manual segmentation of structures." It implies the device can perform automated segmentation. However, it does not present a standalone performance study with specific metrics that would quantify its performance without human intervention or interaction. It focuses on the combined approach and support for the planning process.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document refers to an "expert case library" which contains "already contoured expert cases." This implies the ground truth for an internal atlas/model is likely based on expert contours. However, for any formal validation or test set, the specific method for establishing ground truth is not detailed.

8. The Sample Size for the Training Set

The document refers to an "expert case library" that serves as the basis for the atlas and model. It allows users to "add or modify expert cases." However, it does not specify the sample size used for the original training/creation of the underlying atlas and model. It only mentions: "New expert cases for Nasopharynx, Tonsil, Base of Tongue, Hypopharynx, Larynx" for the updated version.

9. How the Ground Truth for the Training Set Was Established

The ground truth for the "expert case library" is established by "already contoured expert cases." This suggests that expert delineation/contouring was the method. The document states that users can also "add or modify expert cases," allowing for clinical customization of this "ground truth." However, the specific process, number of experts, or adjudication for the original expert cases used for model training is not detailed.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 5, 2014

Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94303

Re: K141248

Trade/Device Name: Smart Segmentation - Knowledge Based Contouring Regulation Number: 21CFR 892.5050 Regulation Name: Medical charged particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: July 22, 2014 Received: July 23, 2014

Dear Mr. Coronado:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara
for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Page 3- Mr. Peter Coronado

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Indications for Use

510(k) Number (if known): K141248

Device Name: Smart Segmentation Knowledge Based Contouring

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K141248

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Image /page/4/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a serif font, with a stylized "I" that resembles a person with their arms raised. Below the word "VARIAN" are the words "medical systems" in a smaller, sans-serif font. The logo is black and white.

Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Fel +1 650 493 4000 www.varian.com

May 7, 2014 Summary 510(k)

The information below is provided for the Smart Segmentation Knowledge Based Contouring, following the format of 21 CFR 807.92.

1. 510(k) Owner: Varian Medical Systems 3100 Hansen Way, M/S C 260 Palo Alto, CA 94304 Contact Name: Peter J. Coronado - Director, Regulatory Affairs Phone: 650/424.6320 Fax: 650/646.9200 E-mail: submissions.support@varian.com

2. Name of the Device:Trade/Proprietary Names:	Smart Segmentation Knowledge Based ContouringSmart Segmentation – Knowledge Based Contouring
Common Name:	Smart Segmentation Knowledge Based Contouring
Classification Name:	Medical Charged Particle Radiation Therapy System21 CFR §892.5050Class IIProduct Code MUJ

1. Predicate Devices: Smart Segmentation Knowledge Based Contouring K133227
1. Description of the Device:

The Smart Segmentation Knowledge Based Contouring was most recently cleared as the Varian Smart Segmentation Knowledge Based Contouring, K133227.

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1. Reason for Submission Changes in Device:
  Changes in SS-KBC have prompted a new submission. Semi-automatic segmentation of lung tumors and sorting of expert cases based on similarity of image are changes new to Smart Segmentation Knowledge Based Contouring.

New Features Table
Segmentation Tools
New Lung tumor segmentation tool
Calypso beacon detection tool allows automated detection and Segmentation of implanted Calypso beacons.
Expert case Browser
Expert Case browser has been redesigned to allow retrieving Expert Cases based on similarity to clinical case.
It is easier to select a segmentation algorithm used to contour a structure.
Expert case library
New expert cases for Nasopharynx, Tonsil, Base of Tongue, Hypopharynx, Larynx.
Controlled Structure Terminology
SS-KBC contains a structure dictionary. The use of the structure dictionary allows identifying a structure by assigning a standardize label. The assigned label is uniquely matched to computer readable code, enabling effective data mining and exchange of knowledge models between systems using different naming schemes.
The structure creation in SS-KBC starts with a label search. The selected ID populates the structure ID, color and type. The structure ID can be edited and serves as custom structure name which will be displayed through the system (including the Expert Case Library). The default structure IDs can be changed in the RT Administration workspace. In order to ensure interoperability between systems which do not implement structure codes and labels, it is recommended to maintain the default IDs.

1. Intended Use Statement
  Smart Segmentation - Knowledge Based Contouring provides a combined atlas and model based approach for automated and manual segmentation of structures including target volumes and organs at risk to support the radiation therapy treatment planning process.

7. Indications for Use Statement

SmartSegmentation Knowledge BasedContouring provides acombined atlas and model based approach for automated and manual segmentation of structures includingtarget volumes and organs at risk to support the radiation therapy treatment planning process.

1. Substantial Equivalence
  Compared with the predicate devices, the Smart Segmentation Knowledge Based Contouring (K133227), the basic operation and technological characteristics are the same. Operational

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differences are described in the Instructions for Use for the SS-KBC 13.5. Also, the Intended Use and Indications for Use are unchanged.

The new features table lists the new features of Smart Segmentation Knowledge Based Contouring, as compared to the predicate device. The features of the predicate device are many while there are only a few added. Therefore Varian concludes the modified device, the Smart Segmentation Knowledge Based Contouring, is substantially equivalent to the predicate device, the Smart Segmentation Knowledge Based Contouring (K133227).

1. Summary of Non-Clinical Testing
  Verification testing was performed to demonstrate that the performance and functionality of the new and existing features met the design input requirements.

Regression testing was performed to verify the integrity of any changes. Validation testing was performed on a production equivalent device, under clinically representative conditions by qualified personnel.

10. Conclusions from Non-Clinical testing

Results from Verification and Validation testing demonstrate that the product met defined user needs and defined design input requirements. Varian therefore considers Smart Segmentation Knowledge Based Contouring to be safe and effective and to perform at least as well as the predicate device.

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.