VariSeed 7.1 is a software application for planning and evaluating brachytherapy procedures for the treatment of prostate cancer that can be modeled according to AAPM TG-43. It facilitates pre-operative planning and post-operative evaluation as well as intra-operative planning and evaluation.

Device Description

VariSeed 7.1 is a computer based software application for planning and evaluating prostate brachytherapy procedures. The application runs on standard Intel PCs under Microsoft Window® 32-bit operating systems. The application interfaces with video sources, printers, network sources, as well as DICOM and other image and data sources.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Summary for a medical device called VariSeed 7.1. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study of acceptance criteria and device performance in the way a clinical trial or a performance study for a novel device would.

Therefore, the information required to fully answer your request (especially regarding detailed acceptance criteria, sample sizes, expert qualifications, and specific performance metrics like those in MRMC studies) is not present in the provided text. The document primarily describes the device, its intended use, and its technological characteristics compared to predicate devices.

However, I can extract the available information and point out what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated as quantifiable acceptance criteria with thresholds. The document relies on demonstrating "substantial equivalence" to predicate devices (VariSeed 7.0 and BrachyVision 6.0) by matching their functionality and adhering to specific industry standards.
Reported Device Performance: No specific performance metrics (e.g., accuracy, sensitivity, specificity, or quantitative error rates) are reported in the text. The device performance is implicitly considered acceptable if it matches the functionalities and adheres to the standards of the predicate devices.

Feature/Characteristic	Acceptance Criteria (Implicit from Predicate Devices)	Reported Device Performance (VariSeed 7.1)
Intended Use	Planning and evaluation of brachytherapy procedures for prostate cancer.	Broadened to include HDR image acquisition. Substantially equivalent to predicate devices.
Work Flows	Offline, real-time, and nomogram planning with/without ultrasound images.	All matched with predicate devices.
HDR Image Acquisition	Utility for acquiring images and inputting pre-plan artifacts (present in BrachyVision).	Added; uses existing VariSeed 7.0 capabilities. Export to DICOM RT.
Dose Calculation Standard	AAPM TG-43 support for Anisotropy Constant and Factor.	All matched with predicate devices.
Anisotropy Function	Support for Anisotropy Function (present in BrachyVision).	Added; clinicians have option to represent dose distributions per TG-43 standard.
Real-time Isodose Calc.	Real-time calculation and display of isodoses over patient anatomy.	Matched with predicate devices.
Automatic Source Decay	Automatic source decay calculation.	Matched with predicate devices.
Industry Conformance	Conforms to AAPM TG-43 - Dosimetry of interstitial brachytherapy sources.	Matched with predicate devices.
DICOM Export	Image and structure data export to DICOM (VariSeed 7.0), Plan export (BrachyVision).	Image, structure, and plan data export to DICOM.
Level of Concern	Moderate (implicit from predicate devices' classification and function).	Moderate. Not intended for diagnostics or control of plan delivery.

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

Sample Size for Test Set: Not mentioned or applicable in this type of submission. Performance testing data relevant to specific sample sizes is not provided.
Data Provenance: Not mentioned.

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

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

Adjudication Method: Not mentioned. This type of submission would typically involve verification and validation testing against known physics models or established clinical results, rather than expert adjudication of "ground truth" on a test set as might be done for diagnostic AI.

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

MRMC Study: No, an MRMC study was not done or reported. This device is a treatment planning software, not a diagnostic AI system intended to assist human readers in interpreting medical images.
Effect Size: Not applicable as no MRMC study was conducted.

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

Standalone Performance: The document does not describe standalone performance in the typical sense of an algorithm making decisions. The software is the algorithm, performing calculations (like dose distribution) based on user input. The "performance" is implicitly tied to its adherence to standards like AAPM TG-43 and its ability to replicate the functionality of predicate devices. There wouldn't be a separate "standalone" study from its core function. It's a tool for planning, not an autonomous agent.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this device's functionality would likely be based on:
- Physics Models/Standards: Conformance to AAPM TG-43 dosimetry standards for dose calculation.
- Predicate Device Functionality: The functions and outputs of the previously cleared VariSeed 7.0 and BrachyVision 6.0 are the primary "ground truth" for demonstrating substantial equivalence.
- User Requirements/Specifications: The software was developed to meet defined clinical needs for brachytherapy planning.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is not a machine learning device that relies on a "training set" in the common sense. It's a rule-based software application for calculations and data management.

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

Ground Truth for Training Set: Not applicable, as there is no training set in the machine learning context. The "ground truth" for its development would be the established physics principles and clinical requirements for brachytherapy planning.

Summary

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K$\phi$3$\phi$534

Premarket Notification [510K] Summary as required by 21 CFR 807.92

Date Summary was prepared:

February 14, 2003

Submitter's Name:

Varian Medical Systems 3100 Hansen Way E-110 Palo Alto, CA 94304

Contact Person:

Linda S. Nash Corporate Director, Regulatory Affairs and Quality Assurance Phone (650) 424-6990 FAX (650) 842-5040 E-mail lind.nash@varian.om

Device Name:

VariSeed 7.1

Classification Name:

Source, Brachytherapy, Radionuclide

Predicate Device:

VariSeed 7.0 (K982821), BrachyVision 6.0 (K992762)

Product Description:

VariSeed 7.1 is a computer based software application for planning and evaluating prostate brachytherapy procedures.

Hardware Platform and Operating System

The application runs on standard Intel PCs under Microsoft Window® 32-bit operating systems.

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Peripherals and Accessories

The application interfaces with video sources, printers, network sources, as well as DICOM and other image and data sources.

Software Features

1. Image Acquisition/Import: The ability to acquire patient data from which a plan or evaluation is constructed
1. Structure Contouring: The ability to define patient structures within the image space.
1. Source Placement & Dosimetry: The ability to plan source placement within the image space and to calculate the resulting dosimetry.
1. 2D and 3D visualization: The ability to visualize the resulting dose profile and structure in 2D and 3D.
1. Reporting: The ability to produce hard and soft copy reports to facilitate the delivery of the plan, to document the plan and to document the post-procedure evaluation.
1. Brachy Source Specification: The ability for the expert user to modify the profile of seed source specifications and device specifications.
1. Database functions: The ability to manage the patient data in the application database including archiving, deleting and restoring data.
1. Licensing: The ability to license the system by application function and interface.
1. Interface: The ability to interface with other planning systems.

Application Development

The application was developed for 32-bit Microsoft Windows® operating system using Microsoft Visual C++.

Intended Use:

VariSeed 7.1 is a software application used for planning and evaluation of brachytherapy procedures.

Technological Characteristics:

The VariSeed 7.1 treatment planning system is substantially equivalent to the brachytherapy functions of the Varian Medical Systems, Inc. VariSeed 7.0 (K982821) and Varian Medical System, Inc. Brachy Vision 6.0 (K992762) treatment planning systems.

The table below compares the feature sets of the three devices. The new software features for VariSeed 7.1 are in bold, all other VariSeed features are supported in a currently approved product.

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The intended use and indications for use of VariSeed 7.1 have been broadened to account for HDR image acquisition functionality. The intent of this functionality is more clearly stated below.

VariSeed 7.1 is substantially equivalent to the two predicate devices offering functionality for planning and evaluating brachytherapy procedures for the treatment of prostate cancer that can be modeled according to AAPM TG-43.

Significant functionality improvements to VariSeed 7.1 include anisotropy function and a utility for acquiring images and inputting pre-plan artifacts for high dose rate (HDR) brachytherapy planning. Each is available in the predicate BrachyVision device. With the addition of anisotropy function as a dose calculation method clinicians can have the option of representing dose distributions according to another model supported by the TG-43 standard. The HDR capture utility uses existing capabilities in the VariSeed 7.0 device to provide a simplified interface for acquiring ultrasound images and inputting pre-plan artifacts that can be exported according to the DICOM RT standard. The level of concern for VariSeed 7.1 is moderate. VariSeed 7.1 is not intended for diagnostic purposes nor will it control the delivery of the plan. Plan implementation will continue to be performed manually.

VariSeed 7.0(Predicate)	BrachyVision(Predicate)	VariSeed 7.1(New)
	Work Flows
Off-line planning with or withoutultrasound images	Off-line planning with or withoutultrasound images	Off-line planning with or withoutultrasound images
Real-time planning using imagesacquired from ultrasound	Real-time planning using imagesacquired from ultrasound	Real-time planning using imagesacquired from ultrasound
Nomogram planning	Nomogram planning	Nomogram planning
	HDR Image Acquisition utility	HDR Image Acquisition utility-The HDR capture utility usesexisting capabilities in the VariSeed7.0 device to provide a simplifiedinterface for acquiring ultrasoundimages and inputting pre-planartifacts that can be exportedaccording to the DICOM RTstandard.
	Calculation
AAPM TG-43 Support for AnisotropyConstant	AAPM TG-43 Support for AnisotropyConstant	AAPM TG-43 Support for AnisotropyConstant
AAPM TG-43 Support for AnistropyFactor	AAPM TG-43 Support for AnistropyFactor	AAPM TG-43 Support for AnistropyFactor
	AAPM TG-43 Support for AnisotropyFunction	AAPM TG-43 Support forAnisotropy Function-With the addition of anisotropyfunction as a dose calculationmethod clinicians can have theoption of representing dosedistributions according to another
		model supported by the TG-43standard.
Real-time calculation of isodoses anddisplay over patient anatomy asisodose lines.	Real-time calculation of isodoses anddisplay over patient anatomy asisodose lines.	Real-time calculation of isodoses anddisplay over patient anatomy asisodose lines.
Automatic source decay	Automatic source decay	Automatic source decay
Industry Conformance
Conforms to AAPM TG-43 - Dosimetryof interstitial brachytherapy sources	Conforms to AAPM TG-43 - Dosimetryof interstitial brachytherapy sources	Conforms to AAPM TG-43 - Dosimetryof interstitial brachytherapy sources
General
Independent of the radiation deliverysystem	Independent of the radiation deliverysystem	Independent of the radiation deliverysystem
Hardcopy reports of all views	Hardcopy reports of all views	Hardcopy reports of all views
Planning support for all solid sourcedelivery systems - line, seed, andseed train	Planning support for all solid sourcedelivery systems - line, seed, andseed train	Planning support for all solid sourcedelivery systems - line, seed, andseed train
User defined dose points	User defined dose points	User defined dose points
Manual structuring	Manual structuring	Manual structuring
Manual source localization	Manual source localization	Manual source localization
Window level tools	Window level tools	Window level tools
Multiple plan variations	Multiple plan variations	Multiple plan variations
Ultrasound import from DICOM	Ultrasound import from DICOM	Ultrasound import from DICOM
Included source management utilities	Included source management utilities	Included source management utilities
Included patient management utilities	Included patient management utilities	Included patient management utilities
Automated prostate contouring.	Automated prostate contouring.	Automated prostate contouring.
Contour editing	Contour editing	Contour editing
Contour interpolation	Contour interpolation	Contour interpolation
Contour margining	Contour margining	Contour margining
Point and line landmarks.	Reference points and lines	Point and line landmarks.
Source location export	Plan export	Source location export
Volume editing	Volume editing	Volume editing
Image and structure data export toDICOM	Image and structure data export toDICOM	Image, structure, and plan data exportto DICOM
Dosimetric quality alerts	Unacceptable dose values are flaggedin the Plan Organizer.	Dosimetric quality alerts
Image set co-registration	Image set co-registration	Image set co-registration

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes and a flowing tail.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 21 2003

Ms. Linda S. Nash Corporate Director, Regulatory Affairs and Ouality Assurance Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038

Re: K030534

Trade/Device Name: VariSeed 7.1 Regulation Number: 21 CFR §892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: February 14, 2003 Received: February 20, 2003

Dear Ms. Nash:

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.

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); 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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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on vour responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy Cbrogdon

Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

(if known): K$\phi$3$\phi$534

510(k) Number (if known):

Device Name: VariSeed 7.1

Indications for use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Usef OR (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Nancy C Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030534

Regulation Number and Section

§ 892.5730 Radionuclide brachytherapy source.

(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.