The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.

The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for:

contouring
image manipulation
simulation
image fusion
plan optimization
QA and plan review

Device Description

Monaco is a radiation treatment planning system that first received FDA clearance in 2007 (K071938). The modified system received clearance in 2009, when Volumetric Modulated Arc Therapy (VMAT) planning capability was added (K091179). The Monaco system accepts patient diagnostic imaging data and "source" dosimetry data from a linear accelerator. The system then permits the user to display and define (contour) the target volume to be treated and critical structures which must not receive above a certain level of radiation on these diagnostic images.

Based on the prescribed dose, the user, a Dosimetrist or Medical Physicist, can create multiple treatment scenarios involving the number, position(s) and energy of radiation beams and the use of a multileaf collimator (MLC) between the source of radiation and the patient to shape the beam. The Monaco system then produces a display of radiation dose distribution within the patient, indicating doses to the target volume and surrounding structures. The "best" plan satisfying the prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volumes.

AI/ML Overview

The Monaco RTP System is a radiation treatment planning system. Here's a breakdown of its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided summary does not explicitly list distinct, quantifiable acceptance criteria with corresponding performance metrics in a readily extractable table format for dose calculation or planning accuracy. Instead, it states that verification tests were "written and executed to ensure that the system is working as designed" and that "Pass/fail requirements and results of this testing can be found in section 18 of this submission." However, Section 18 is not included in the provided text.

Based on the available information, the general performance criteria can be inferred as:

Acceptance Criteria (Inferred from intended use and testing descriptions)	Reported Device Performance
Accurate dose calculation for photon treatment plans	"Algorithm testing was performed to compare calculated against measured doses to ensure dose calculation accuracy." The system "successfully passed verification testing."
Capability for contouring	Yes
Capability for image manipulation	Yes
Capability for simulation	Yes (CT Simulation)
Capability for image fusion	Yes
Capability for plan optimization	Yes
Capability for QA and plan review	Yes
Support for Dynamic Conformal capability	Yes, as a new feature of the Monaco RTP System. The system supports dynamic delivery methods.
Overall system functionality as designed	"Verification tests were written and executed to ensure that the system is working as designed... Monaco successfully passed verification testing." The product was "deemed fit for clinical use."

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

The summary states that "Clinical trials were not performed as part of the development of this product." Instead, "Algorithm testing was performed to compare calculated against measured doses," and "clinically oriented validation test cases were written and executed in-house by CMS customer support personnel."

Therefore:

Test Set Sample Size: Not specified in terms of number of patient cases. The testing involved "algorithm testing" (comparing calculated vs. measured doses) and an unspecified number of "clinically oriented validation test cases."
Data Provenance: Not explicitly stated regarding origin (e.g., country). However, the testing was "in-house" by the manufacturer (Computerized Medical Systems, Inc., USA). This implies the data used for the algorithm and validation tests would be internally generated or sourced. The context suggests it was not patient data from clinical settings.
Retrospective/Prospective: The testing appears to be retrospective in the sense that it did not involve prospective human subjects but rather validation against pre-existing data (measured doses) or simulated/representative cases for the "clinically oriented validation test cases."

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

Number of Experts: Not explicitly stated. The "clinically oriented validation test cases" were "written and executed in-house by CMS customer support personnel."
Qualifications of Experts: The personnel were "CMS customer support personnel." While they handled "clinically oriented" test cases, their specific clinical qualifications (e.g., medical physicist, dosimetrist, or specific years of experience) are not provided. The summary also notes that plans are "reviewed and approved by qualified clinicians" in a clinical setting, but this refers to post-approval clinical use, not the ground truth establishment for the premarket testing.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing ground truth for the test set. Since the testing involved "algorithm testing" comparing calculated against measured doses, and "clinically oriented validation test cases" executed in-house, it is unlikely a multi-expert adjudication method was employed in the traditional sense. The "ground truth" for algorithmic accuracy would be established by the physical measurements, and for validation cases, by adherence to predefined clinical expectations or specifications.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The device is a radiation treatment planning system, not an AI-assisted diagnostic tool for human readers. Its primary function is to calculate dose and aid in plan creation, not to improve human reader performance in interpreting images or making diagnoses.

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

Yes, a form of standalone performance assessment was done. "Algorithm testing was performed to compare calculated against measured doses to ensure dose calculation accuracy." This directly evaluates the algorithm's output (calculated dose) against an objective standard (measured dose) without a human-in-the-loop decision-making process. The "clinically oriented validation test cases" also assessed the system's ability to produce acceptable plans based on defined criteria.

7. The Type of Ground Truth Used

For Algorithm Testing: The ground truth was measured doses. The summary states "Algorithm testing was performed to compare calculated against measured doses." This implies physical measurements were used as the gold standard.
For "Clinically Oriented Validation Test Cases": The ground truth was based on predefined clinical expectations/specifications or internal standards established by the CMS customer support personnel who wrote and executed these cases.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. The Monaco system is a radiation treatment planning system that calculates dose and optimizes plans based on established physics models and algorithms. It does not appear to be a machine learning model that requires a distinct "training set" in the common understanding of AI devices. Its development would involve calibration, verification, and validation, rather than a training process on a large dataset of patient images or outcomes.

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

Since a "training set" in the context of machine learning is not mentioned or implied for this device, the method for establishing its ground truth is not applicable/not provided. The system's foundational accuracy would stem from its underlying physical models and their calibration, which would involve experimental data and established physics principles, rather than a labeled training dataset.

Summary

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JUN 2 4 2011

K110730

June 14, 2011

Monaco RTP System Premarket Notification (510(k)) Summary of Safety and Effectiveness

INTRODUCTION

This document summarizes the safety and effectiveness information contained within this Premarket Notification. The Summary of Safety and Effectiveness contains no confidential or trade secret information and is intended for full public disclosure and distribution.

PREMARKET NOTIFICATION INFORMATION

1. Product Information:
- a. Product Trade Name
- b. Release Version Number
1. Classification Information:
- a. Classification Name
- b. Common/Usual Name
- Product Classification c.
- d. Product Code
- e. Reference
- f. Review Panel
1. Establishment Information:
- a. Submitter
- b. Submitter Address
- c. Establishment Number
- d. Contact
- e. Contact Phone
- Contact Fax f.

Monaco RTP System DCAT feature added in rel. 3.0.0

Medical charged-particle radiation therapy system Radiation Treatment Planning System Class II MUJ

21 CFR 892.5050 Radiology

Computerized Medical Systems, Inc. 13723 Riverport Dr. , Suite 100 Maryland Heights, MO 63043 1937649 Kathryn Stinson, RA Specialist 314-993-0003 314-993-1175

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PREDICATE DEVICE INFORMATION

The Monaco RTP System with dynamic conformal (DCAT) functionality is substantially equivalent to the following devices that the FDA has cleared for distribution and are currently being actively marketed in the United States.

1. Monaco RTP System Computerized Medical Systems, Inc. K091179
1. ERGO++RTP System Computerized Medical Systems, Inc. K080601
1. Eclipse Treatment Planning System Varian Medical Systems K102011

MONACO INTENDED USE

The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for:

. contouring
. image manipulation
simulation .
image fusion .
. plan optimization
QA and plan review .

DESCRIPTION OF THE PRODUCT

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from a linear accelerator. The system then permits the user to display and define (contour) the target volume to be treated and critical structures which must not receive above a certain level of radiation on these diagnostic images.

LEVEL OF CONCERN

Item 4b of Table 1 in the FDA Guidance document entitled, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices asks, "Does the Software Device control the delivery of potentially harmful energy that could result in death or serious injury, such as radiation treatment systems ... " Monaco does not directly control the linear accelerator that delivers the radiation. Once completed, plans are reviewed and approved by qualified clinicians and may be subject to quality assurance practices before treatment actually takes place. There is no automatic link between the Monaco software and the linear accelerator. However, should a flaw in the treatment plan escape the notice of the qualified professionals using the Monaco system, serious injurv or death could result. Therefore, we believe Monaco to be of major level of concern.

SUMMARY OF CLINICAL TESTING

Clinical trials were not performed as part of the development of this product. Clinical testing on patients is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Algorithm testing was performed to compare calculated against measured doses to ensure dose calculation accuracy. In addition, clinically oriented validation test cases were written and executed in-house by CMS customer support personnel. The product was deemed fit for clinical use.

SUMMARY OF NON-CLINICAL TESTING

Verification tests were written and executed to ensure that the system is working as designed. Pass/fail requirements and results of this testing can be found in section 18 of this submission. Monaco successfully passed verification testing.

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SUBSTANTIAL EQUIVALENCE COMPARISON

Table 5-1 compares Monaco with Dynamic Conformal capability to its predicate devices. A more detailed discussion of substantial equivalence is contained in Section 12 of this submission.

ﺃ

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	Monaco w/DCATFunctionality	Monaco (w/VMAT)(K091179)	ERGO++(K080601)	Eclipse TPS(K102011)
Intended Use and Indications for Use
Contouring	Yes	Yes	Yes	Yes
Dose Calculation	Yes	Yes	Yes	Yes
Plan Optimization	Yes	Yes	Yes	Yes
Image Manipulation & Fusion	Yes	Yes	Yes	Yes
CT Simulation	Yes	Yes	No	Yes
QA/Plan Review	Yes	Yes	Yes	Yes
Brachytherapy	No	No	No	No
Statement specifies that system is for IMRT only	No	No	No	No
Basic System: Technological Characteristics
Dose Calculation Algorithms	Monte Carlo (photon) &Pencil Beam (optimization only)	Monte Carlo (photon) & PencilBeam (optimization only)	Pencil Beam	Pencil Beam, Electron Monte Carlo,Convolution Superposition
Local Biological Measure Optimization	Yes	Yes	No	Yes
MLC Support	Yes	Yes	Yes	Yes
Support of Other Treatment Aids	No	No	Yes	Yes
Support for Dynamic Delivery Methods	Yes	Yes	Yes	Yes
Operating System	Windows	Windows	Linux	Windows
DICOM RT Support	Yes	Yes	Yes	Yes
Modalities Supported: Full RTP Workflow	Photon Only	Photon Only	Photon Only	Electron, Photon, Proton
Modalities Supported: Partial Workflow*	Electron, Photon, Proton	Electron, Photon, Proton	N/A	Electron, Photon, Proton
New Features: Technological Characteristics
Includes Dynamic Conformal Capability	Yes	Yes	Yes	Yes
Stereotactic Localization	No	No	Yes	Yes
Support for Cone-Based Stereotactic	No	No	Yes	Yes

able 5-1: Substantial Equivlaence to Predicate Device:

A partal world include only the finctions of Monaco that are shared with Focal, such as ontention, and plan review. Clinicans who use only the Focal
finctions within Monaco

5-5

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Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

JUN 2 4 2011

Ms. Kathryn Stinson Regulatory Affairs Specialist Elekta, Inc., CMS Software 13723 Riverport Drive, Suite 100 MARYLAND HEIGHTS MO 63043

Re: K110730

Trade/Device Name: Monaco RTP System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: May 10, 2011 Received: May 12, 2011

Dear Ms. Stinson:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in. Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vito Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/ReportalProblem/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/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known): K110730

Device Name: Monaco RTP System

Indication for Use:

The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for:

contouring
image manipulation
simulation
image fusion
plan optimization
QA and plan review

Prescription Use (21 CFR Part 801 Subpart D And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, OIVI

Mary Stottle

Division of Badiologic Office of In Vitro

510K K116736

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.