The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron 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), again when Dynamic Conformal Arc planning was added (K110730), and electron planning, support for stereotactic cones, and SUV calculation were added (K132971). Specialty image creation was added in 2015 (K151233), and adaptive planning and dose calculation in the presence of a magnetic field (e.g., MR-Linac) was added in 2018 (K183037). A 510(k) was filed in 2017 for the addition of carbon ion planning. The 510(k) was withdrawn because there was no hardware cleared for the US market capable of delivering carbon ion plans. Monaco's carbon ion planning functionality remains licensed off and inaccessible to US users.

The Monaco system accepts patient 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 beam modifier (MLC, block, etc.) 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 clinican prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volumes.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Monaco RTP System based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Functional/Technological)	Reported Device Performance (Monaco with new features)
Contouring	Yes
Dose Calculation	Yes
Plan Optimization	Yes
Image Manipulation & Fusion	Yes
CT Simulation	Yes
QA/Plan Review	Yes
Dose Calculation Algorithms	Monte Carlo (electron & photon), Collapsed Cone (photon), Pencil Beam (optimization only), GPUMCD for MR-linac
Calculates dose for MR-Linac (including magnetic field, coils & cryostat)	Yes
Adaptive therapy features	Yes
Calculation and display of standardized uptake value	Yes
Local Biological Measure Optimization	Yes
Support for various treatment aids	Yes
Support for Dynamic Delivery Methods	Yes
Operating System	Windows
DICOM RT Support	Yes
Modalities Supported: Full RTP workflow (Photon, Electron)	Photon, Electron
Modalities Supported: Partial workflow (Photon, Electron, Proton)	Photon, Electron, Proton
Support for brachytherapy	No
Interoperable with OIS system	Yes, including support for prescribed relative offset (PRO)
Beam modeling	Beam modeling is performed by Elekta personnel. New standardized beam models are provided for some Elekta linac energy options, and absolute dose calibration will be performed by users.
Conformity to pre-defined pass/fail criteria (equivalent to K183037)	Confirmed. The product was deemed substantially equivalent and fit for clinical use.
Functionality as designed, including new features, risk mitigations, and existing features	Verified by over 600 test procedures.

Study Information:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of cases or patients. The validation testing involved "simulated clinical workflows using actual patient data, such as patient images."
- Data Provenance: "Actual patient data, such as patient images." The country of origin is not specified, but the context of an FDA submission implies a focus on data relevant to the U.S. market, though not exclusively. The study was retrospective in the sense that it used pre-existing "actual patient data."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The adjudication of ground truth for the test set is not explicitly detailed.
Adjudication method for the test set:
- The document states that plans are "reviewed and approved by qualified clinicians and may be subject to quality assurance practices before treatment actually takes place." However, for the specific test set used in validation, the adjudication method (e.g., 2+1, 3+1 consensus) is not explicitly described. The testing involved "pre-defined pass/fail criteria" that were "equivalent to that of the predicate, K183037."
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:
- A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The device is a treatment planning system, not an AI-assisted diagnostic tool for human readers in the traditional sense discussed in MRMC studies.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the primary validation was effectively a standalone performance evaluation of the software. The document states: "Verification tests were written and executed to ensure that the system is working as designed. Over 600 test procedures were executed, including tests to verify requirements for new product functionality, tests to ensure that risk mitigations function as intended, and regression tests to ensure continued safety and effectiveness of existing functionality." This describes an algorithm-only evaluation against predefined criteria.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the test set verification was based on pre-defined pass/fail criteria and ensuring the system's calculations and functionality matched expectations established by the predicate device (K183037) and internal Elekta requirements. It also relied on "simulated clinical workflows using actual patient data" to ensure the system produced expected dose distributions and plan outputs. It is not framed as comparing to pathology or long-term outcomes data, but rather the accurate computation and display of dose distributions as per established physics and clinical planning principles.
The sample size for the training set:
- The document does not specify a distinct "training set" for the Monaco RTP System. As a radiation treatment planning system, it relies on physics models and algorithms rather than machine learning models that typically require a training set in the AI sense. The development likely involved extensive testing and calibration against known physics principles and clinical data, which is distinct from a machine learning training set.
How the ground truth for the training set was established:
- Since a distinct "training set" in the machine learning context is not mentioned, the concept of establishing ground truth for it is not applicable based on the provided text. The accuracy of the system is established through rigorous verification against physics models, calculations, and clinical expectations, rather than learning from a labeled training dataset.

Summary

{0}------------------------------------------------

March 29, 2019

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Elekta, Inc. % Ms. Kathryn Stinson Principal Regulatory Affairs Engineer 13723 Riverport Drive, Suite 100 MARYLAND HEIGHTS MO 63043

Re: K190178

Trade/Device Name: Monaco RTP System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: January 30, 2019 Received: February 1, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination. product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

{1}------------------------------------------------

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara
For

Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K190178

Device Name Monaco RTP System

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

January 30, 2019

therapy

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

K190178

INTRODUCTION

Product Information:

This document summarizes the safety and effectiveness information contained within the Monaco RTP System 510(k). 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

Product Trade Name Monaco a. Release Version Number Release 5.50 ﻒ 2. Classification Information: a. Classification Name Medical charged-particle radiation system b. Common/Usual Name Radiation Treatment Planning System Product Classification Class II C. d. Product Code MUJ 21 CFR 892.5050 Reference e. f. Review Panel Radiology 3. Establishment Information: a. Submitter
b. Submitter Address

Elekta, Inc. 13723 Riverport Dr., Suite 100 Maryland Heights, MO 63043

C. Establishment Number
d. Contact
Contact Phone e.
f. Contact Fax

1937649 Kathryn Stinson, Principal RA Engineer 314-993-0003 314-812-4496

{4}------------------------------------------------

PREDICATE DEVICE INFORMATION

The Monaco RTP System with new features is substantially equivalent to the previously cleared Monaco RTP System (K183037), which is actively marketed in the United States. The updated Monaco is substantially equivalent in intended use and safety and effectiveness.

MONACO INTENDED USE/INDICATIONS 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

DESCRIPTION OF THE PRODUCT

{5}------------------------------------------------

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 injury 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 demonstration substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Validation testing involved simulated clinical workflows using actual patient data, such as patient images, described in section 20. Pre-defined pass/fail criteria were also equivalent to that of the predicate, K183037. The product was deemed substantially equivalent and fit for clinical use.

SUMMARY OF NON-CLINICAL TESTING

Verification tests were written and executed to ensure that the system is working as designed. Over 600 test procedures were executed, including tests to verify requirements for new product functionality, tests to ensure that risk mitigations function as intended, and regression tests to ensure continued safety and effectiveness of existing functionality. Verification testing was performed according to the FDA Quality System Requlation (21 CFR §820). ISO 13485 Quality Management System standard, IEC 62304 Software Life Cycle standard, and ISO 14971 Risk Management Standard, as was the predicate version, K183037. Quality System procedures goverening the testing process, including pre-defined pass/fail criteria, were equivalent to procedures used in the testing of the previous Monaco version cleared under K183037. Conformity to the same passifall criteria as the predicated that Monaco 5.50 was substantially equivalent in safety and effectiveness. Monaco 5.50 was deemed safe and effective for its intended use.

{6}------------------------------------------------

	Monaco with new features	Monaco (K183037)
Intended Use and Indications for Use
Contouring	Yes	Yes
Dose Calculation	Yes	Yes
Plan Optimization	Yes	Yes
Image Manipulation & Fusion	Yes	Yes
CT Simulation	Yes	Yes
QA/Plan Review	Yes	Yes
Technological Characteristics
Dose Calculation Algorithms	Monte Carlo (electron & photon), Collapsed Cone (photon), Pencil Beam (optimization only), GPUMCD for MR-linac	Monte Carlo (electron & photon), Collapsed Cone (photon), Pencil Beam (optimization only), GPUMCD for MR-linac
Calculates dose for MR-Linac (including magnetic field, coils & cryostat)	Yes	Yes
Adaptive therapy features	Yes	Yes
Calculation and display of standardized uptake value	Yes	Yes
Local Biological Measure Optimization	Yes	Yes
Support for various treatment aids	Yes	Yes
Support for Dynamic Delivery Methods	Yes	Yes
Operating System	Windows	Windows
DICOM RT Support	Yes	Yes
Modalities Supported: Full RTP workflow*	Photon, Electron	Photon, Electron
Modalities Supported: Partial workflow*	Photon, Electron, Proton	Photon, Electron, Proton
Support for brachytherapy	No	No
Interoperable with OIS system	Yes, including support for prescribed relative offset (PRO)	Yes
Beam modeling	Beam modeling is performed by Elekta personnel. New standardized beam models are provided for some Elekta linac energy options, and absolute dose calibration will be performed by users in such cases.	Beam modeling is performed by Elekta personnel

*It is possible to configure Monaco for limted functionality such as image fusion, contouring and simulation, not including IMRT optimization or dose calculation. Customers can purchase a "simulation package" that does not include the ability to optimize or calculate dose.

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.