Virtual simulation with VSS is intended to be used to prepare geometric and anatomical data relating to a proposed radiation therapy treatment prior to dosimetry planning on a treatment planning system. Complex 3D volumes and field geometries can be visualised for plan preparation.

When connected to a Nucletron Simulix radiation therapy simulator, the simulation of the planned treatment fields can be aided by automated set-up on the Simulix simulator. Adjustments made on the Simulix can be reviewed on the virtual simulation system screen. A direct comparison of the CT-based treatment plan with the actual set-up on the Simulix, prior to patient treatment, can be made to verify the geometric beam parameters and set-up conditions.

Device Description

VSS virtual simulation described in this submission is a software package for the virtual simulation of radiation therapy plans. VSS is installed and runs on a PLATO radiation therapy treatment planning system workstation.

Nucletron's VSS provides the virtual simulation capabilities required to define anatomical volumes and geometric treatment beams for radiation therapy treatment simulation. The 3D patient model is based on CT images and is displayed in single or multiple image windows. Treatment beams are simulated using surface rendering and digitally reconstructed radiographs.

The system uses CT images either from a DICOM 3 compatible scanner or from the PLATO treatment planning system patient database. Previously defined anatomical structures and beams can be read from the PLATO patient database. All anatomical structures and beams can be stored in the PLATO patient database or sent to a DICOM RT compatible system.

When connected to a Nucletron Simulix radiation therapy simulator, VSS allows the planned beam parameters to be downloaded directly to the Simulator for automatic set-up. The user can initiate the real-time transfer of actual simulator position to update the field parameters on VSS. VSS can be used to display the live image intensifier image, viewed on the same screen as the beam's eye view and planar image(s). A direct comparison of the CT-based treatment plan with the actual set-up on the Simulix, prior to patient treatment, can be made to verify the geometric beam parameters and set-up conditions.

AI/ML Overview

The provided text is a 510(k) summary for the Nucletron VSS (Virtual Simulation System), dated February 11, 1998. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than detailing a specific study with acceptance criteria and performance metrics in the way a clinical trial report would.

Therefore, much of the requested information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training) is not present in the provided document.

However, I can extract the relevant information that is available and indicate where information is missing.

Acceptance Criteria and Study for Nucletron VSS (Virtual Simulation System)

The provided document, a 510(k) Pre-Market Notification, aims to demonstrate substantial equivalence to legally marketed predicate devices for regulatory clearance. It does not present a formal clinical study with specific acceptance criteria and performance metrics in the manner typically seen for new diagnostic or therapeutic devices. Instead, the "acceptance criteria" here implicitly refer to the FDA's requirement for demonstrating substantial equivalence for design, intended use, and technological characteristics to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Criterion	Predicate Devices	Nucletron VSS (Reported Performance)
Intended Use	Radiation therapy virtual simulation system for preparing geometric/anatomical data prior to dosimetry planning.	"Virtual simulation with VSS is intended to be used to prepare geometric and anatomical data relating to a proposed radiation therapy treatment prior to dosimetry planning on a treatment planning system. Complex 3D volumes and field geometries can be visualised for plan preparation." When connected to a Nucletron Simulix, it aids automated set-up on the simulator, allows review of adjustments, and enables direct comparison of CT-based plan with actual set-up to verify geometric beam parameters.
Technological Characteristics	Allows use of CT images for anatomical volumes and simulation of treatment beams.	"The VSS is substantially equivalent to the predicate devices. It allows the use of CT images for the definition of anatomical volumes and the simulation treatment beams." Uses CT images (DICOM 3 compatible or PLATO database). Displays 3D patient model, simulates treatment beams using surface rendering and digitally reconstructed radiographs. Stores anatomical structures and beams in PLATO database or sends to DICOM RT. Can download planned beam parameters to Simulix for automatic set-up, transfer real-time simulator position, and display live image intensifier image for comparison.
Safety and Effectiveness	Legally marketed and deemed safe and effective by prior FDA clearance for similar devices.	Assumed to be safe and effective due to substantial equivalence to predicate devices, subject to general controls provisions of the Act (annual registration, listing, GMP, labeling, prohibitions against misbranding and adulteration).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not explicitly stated. The document is a 510(k) summary, which focuses on substantial equivalence rather than a detailed clinical validation study with a specific test set. It describes the device's functionalities but does not report on how those functionalities were tested on a specific dataset or patient cohort.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not stated. As there is no described test set or study validating performance against a ground truth, this information is not provided. The comparison is against predicate devices and general standards for similar technology.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not stated.

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

No. This document describes a "Virtual Simulation System" for radiation therapy planning, not an AI-assisted diagnostic or assistive device that would typically involve an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not stated. While the VSS is a software package, the context of its use is "human-in-the-loop" for radiation therapy planning. The document does not describe a standalone performance evaluation in the context of comparing automated output to a gold standard without human intervention.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable/Not stated. There is no described study in this document that establishes a "ground truth" for evaluating the VSS's performance in the way clinical studies do. The ground for approval is substantial equivalence to existing devices.

8. The sample size for the training set

Not applicable/Not stated. The document describes a software system for virtual simulation, not a machine learning or AI model that relies on a specific training set of data.

9. How the ground truth for the training set was established

Not applicable/Not stated.

Summary

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Nucletron VSS Date : 11, February 1998

Image /page/0/Picture/1 description: The image shows the word "Nucletron" in bold, black letters. To the left of the word is a logo of a circle with two smaller circles inside of it, all enclosed in a square. Below the logo and word is the text "MAY 6 1998".

Department of Health and Human Services Center of Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section

NUCLETRON B.V.

Waardgelder 1 3905 TH Veenendaal 3900 AX Veenendaal P.O.Box 930 The Netherlands Phone +31 318 557133 +31 318 550485 Fax

K980629

TBN MKT VSS 510k

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by section 807.92(c)

Submitter of 510(k) a.

Company name: Registration # Address:

Nucletron Corporation 1121753 7080 Columbia Gateway Drive Columbia, MD 21046-2133

Contact Person:

Ralph E. Shuping Regulatory Affairs Manager 410-312-4100 Phone:. 410-312-4197 Fax:

Device Name: b.

VSS, Virtual Simulation System Trade/Proprietary Name: Common/Usual Name: Radiation therapy virtual simulation system Radiation Therapy Simulation System, Classification Name: 21 CFR 892.5840 Class II.

Legally Marketed Predicate Device(s) C.

Our Device is substantially equivalent to the legally marketed predicate devices cited in the table below.

Manufacturer	Device	510(k) #
Picker International	ACQSIM	K923851
GE Medical Systems	Advantage Sim	K951830
Nucletron	PLATO	K964206

Appendix 5, page 2

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Description d.

Intended use e.

Summary of technological considerations し

The VSS is substantially equivalent to the predicate devices. It allows the use of CT images for the definition of anatomical volumes and the simulation treatment beams.

7 J. St

11 Feb. 1998

Date

Name: T.J. Bateman Product Manager Title Nucletron bv Veenendaal Netherlands

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, representing medicine and healing. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 6 1998

Ralph E. Shuping. Sc.D. Regulatory Affairs Manager Nucletron Corporation 7080 Columbia Gateway Drive Columbia, MD 21046-2133

Re:

K980629 VSS Virtual Simulation System Dated: February 17, 1998 Received: February 18, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Mr. Shuping:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmadsmam.html".

Sincerely yours,

Kiliai Yi

Lillian Yin, Ph.D Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of indications for use

510(k) Number (if known):

Device Name: VSS Virtual Simulation System

Indications for Use: Virtual simulation with VSS is intended to be used to prepare geometric and anatomical data relating to a proposed radiation therapy treatment prior to dosimetry planning on a treatment planning system. Complex 3D volumes and field geometries can be visualised for plan preparation.

x980629

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over the Counter Use

David C. Beynon
(Division Sign-Off)

(Optional Format 1-2-96)

(Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological Devi 510(k) Number

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.