EVTOOL software module provides the ability to compare and evaluate the radiation dose delivery to the tumor volume and surrounding organs from generated dose volume histograms and radiobiological values. It expands the DMLC IV-ERGO system, which is a combination of a radiation collimator with multiple tungsten leaves that move during delivery of radiation therapy and a computer based treatment planning and control system.

Device Description

EVTOOL is a software module that has been designed to expand the features and functions of the DMLC IV- ERGO treatment planning software. The software runs on a silicon graphics workstation and Irix operating system. EVTOOL software is used for comparing and evaluating radiation therapy treatment plans from a quantitative and radiobiological point of view. The software displays one or more stored plans for comparison and analysis. It can display the dose volume histograms of the various plans and organ dose statistics (mean, modal, maximum and minimum dose). It allows the user to input radiobiological corrections in order to enhance the evaluation of the treatment plan. It also optimizes the dose prescription by displaying reference dose and number of treatment fractions. EVTOOL is fully integrated into the ERGO treatment planning environment in order to easily exchange information from the patients' database. The patient information is selected and automatically loaded into the EVTOOL software. From the patient database the user can select one or multiple treatment plans to display and calculate the dose statistics, including dose volume histograms and radiobiological models. The analytical information is displayed in 4 windows with a zoom capability. These windows can display the overall plan and individual organs of interest. EVTOOL provides options for incorporating radiobiological corrections to assist the physician in determining the optimal dose prescription and fractionation based on TCP (Tumor Control Probability), NTCP (Normal Tissue Complication Probability) and UTCP (Uncomplicated Tumor Control Probability) values. This software is a useful tool in evaluating the entire volumetric treatment plan, it is not used to directly treat the patient. It provides the physician with a tool to compare various plan versions side by side in order to determine the most appropriate treatment plan to be used with the DMLC IV equipment. The display of the treatment plans within EVTOOL provides a permanent record and effective control on the actual dose delivered to the patient.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the EVTOOL software. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study with performance metrics. Therefore, many of the requested details about acceptance criteria and study design are not present in this document.

Here's an attempt to answer the questions based only on the provided text, noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific quantitative "acceptance criteria" or report "device performance" in terms of clinical outcomes or diagnostic accuracy. The core of this 510(k) is to demonstrate substantial equivalence to a predicate device for its intended use as a radiation therapy planning assessment tool.

Acceptance Criteria Category	Acceptance Criteria (Not explicitly stated as such, but inferred from the document's purpose)	Reported Device Performance (No explicit performance metrics in this document)
Intended Use	The device should function as a tool to compare and evaluate radiation therapy treatment plans from a quantitative and radiobiological perspective, displaying dose volume histograms and organ dose statistics, and allowing for radiobiological corrections.	The EVTOOL software is used for comparing and evaluating radiation therapy treatment plans... It can display the dose volume histograms of the various plans and organ dose statistics... It allows the user to input radiobiological corrections...
Safety and Effectiveness	The device should be substantially equivalent in safety and effectiveness to the predicate device (3D Line DMLC IV-ERGO, K001163), enhancing functionality without introducing new safety/effectiveness concerns.	The EVTOOL software is substantially equivalent to the predicate devices. It enhances the functionality of the defined predicate device to provide evaluation tools for radiation therapy treatment planning.
Integration	The device should be fully integrated into the ERGO treatment planning environment for easy information exchange.	EVTOOL is fully integrated into the ERGO treatment planning environment in order to easily exchange information from the patients' database.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This document does not describe a clinical performance study with a test set of patient data to evaluate device performance against ground truth. It describes a software module.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The document does not detail a study involving expert-established ground truth.

4. Adjudication method for the test set

This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study is mentioned or implied in this document. The EVTOOL is described as a tool to assist physicians in evaluating treatment plans, not necessarily as an AI system designed to improve human reader performance in a diagnostic sense in this context.

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

No standalone performance study is mentioned. The device is a "software module" that "provides the physician with a tool to compare various plan versions." It's explicitly stated, "it is not used to directly treat the patient."

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

Not applicable. The document does not describe a study requiring ground truth for performance evaluation. The "ground truth" for this type of software would typically be the accuracy of its calculations and displays based on established physics and radiobiology models, which would be validated through software testing processes, not clinical studies with patient outcomes.

8. The sample size for the training set

Not applicable. This document describes a software module for radiation therapy planning evaluation, not a machine learning or AI algorithm that requires a training set.

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

Not applicable.

Summary

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01353.5

Premarket Notification 3D Line: EVTOOL Date : 20 October 2001

JAN 1 8 2002

Image /page/0/Picture/3 description: The image shows a logo with the text "3D LINE". The "3D" is stylized to appear three-dimensional, with shading and depth. The word "LINE" is written below "3D" in a simpler, blocky font. The overall design has a slightly pixelated or low-resolution appearance.

Date: October 20, 2001

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

3D Line USA 2807 Old Court Rd Baltimore MD 21208 Phone: 410-580-1730 Fax: 410-580-1732

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by section 807.92(c)

Submitter of 510(k) a.

Company name:	3D Line USA
Registration #	9041925
Address:	2807 Old Court RoadBaltimore, MD 21208
Contact Person:	Karen RigamontiPresident
Phone:	410-580-1730
Fax:	410-580-1732

b. Device Name:

Trade/Proprietary Name:	EVTOOL
Common/Usual Name:	Radiation Therapy Planning System
Classification Name:	Accelerator, Linear, Medical, Accessory21 CFR 892.5050 Class II.

C. Legally Marketed Predicate Device(s)

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

Manufacturer	Device	510(k) #
3D Line	DMLC IV-ERGO	K001163

Description d.

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Premarket Notification 3D Line: EVTOOL Date : 20 October 2001

EVTOOL software is used for comparing and evaluating radiation therapy treatment plans from a quantitative and radiobiological point of view. The software displays one or more stored plans for comparison and analysis. It can display the dose volume histograms of the various plans and organ dose statistics (mean, modal, maximum and minimum dose). It allows the user to input radiobiological corrections in order to enhance the evaluation of the treatment plan. It also optimizes the dose prescription by displaying reference dose and number of treatment fractions.

EVTOOL is fully integrated into the ERGO treatment planning environment in order to easily exchange information from the patients' database. The patient information is selected and automatically loaded into the EVTOOL software. From the patient database the user can select one or multiple treatment plans to display and calculate the dose statistics, including dose volume histograms and radiobiological models. The analytical information is displayed in 4 windows with a zoom capability. These windows can display the overall plan and individual organs of interest. EVTOOL provides options for incorporating radiobiological corrections to assist the physician in determining the optimal dose prescription and fractionation based on TCP (Tumor Control Probability), NTCP (Normal Tissue Complication Probability) and UTCP (Uncomplicated Tumor Control Probability) values.

This software is a useful tool in evaluating the entire volumetric treatment plan, it is not used to directly treat the patient. It provides the physician with a tool to compare various plan versions side by side in order to determine the most appropriate treatment plan to be used with the DMLC IV equipment. The display of the treatment plans within EVTOOL provides a permanent record and effective control on the actual dose delivered to the patient.

Intended use e.

Summary of technological considerations f.

The EVTOOL software is substantially equivalent to the predicate devices. It enhances the functionality of the defined predicate device to provide evaluation tools for radiation therapy treatment planning.

Karen Rigamonti

Name: Karen Rigamonti, MD, MBA, M.P.H. Title President 3D Line USA. Inc. Baltimore, MD

10/18/01

Date

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and three lines representing its legs.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2002

Karen Rigamonti, M.D. President 3D Line USA, Inc. 2807 Old Court Road BALTIMORE MD 21208 Re: K013535

Trade/Device Name: EVTOOL Model V 1.0 Accessory to RTP System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II

Product Code: 90 MUJ Dated: October 20, 2001 Received: October 23, 2001

Dear Dr. Rigamonti:

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 11 you 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 your 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 C. Brogdon

Nancy 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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Premarket Notification 3D Line: EVTOOL Date : 20 October 2001

Image /page/4/Picture/1 description: The image shows a logo with the text "3D LINE" in a stylized, three-dimensional design. The "3D" is stacked on top of the word "LINE", with the "3" and "D" forming a single, connected shape. The letters have a textured appearance, giving them a sense of depth and dimension. The overall design is simple yet modern, suggesting a focus on technology or innovation.

October 20, 2001

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

3D Line USA

2807 Old Court Rd Baltimore MD 21208 Phone: 410-580-1730 Fax: 410-580-1732

Statement of Intended Use

Device Name:

EVTOOL

Intended use

Prescription use

The EVTOOL is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and certified medical professional.

Karen Rigamonti

10/18/01

Date

Name: Karen Rigamonti, MD, MBA, M.P.H. Title: President > 3D Line USA, Inc. Baltimore, MD

Nancy C Broadon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013535

Prescription Use

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.