MOSAIQ® is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy are prescribed.

Users can configure MOSAIQ® for Medical Oncology use, Radiation Oncology use, or the two together. It lets users:

· Assemble electronic patient charts and treatment plans, order diagnostic tests, and prescribe medications.
· Generate and keep medication formulary lists and calculate applicable medication dosages for medical oncology.
· Import, view, annotate, adjust, enhance, manage and archive images.
· Compare radiation treatment plans and evaluate dose coverage.
· Design leaf plans for operation with radiotherapy treatment machines that have multileaf collimators.
· Make sure radiation treatment plans imported from treatment planning systems agree with treatment machine constraints. MOSAIQ® reads actual settings from the treatment machine communication interface. It compares these settings with predefined values. If a mismatch occurs between the planned values and the actual machine settings, the system warns the user.
· View reference images to setup treatment. MOSAIQ® refers to predefined settings to help treatment machine setup, and communicates patient and machine setup instructions.
· Record actual delivered radiation values in an electronic chart to track treatment.
· Use stereotactic localization to calculate set-up coordinates for treatments.
· Observation of Intrafractional motion with real time image overlay.

MOSAIQ® is not intended for use in diagnosis. Medical oncology dose calculation functions are designed for use with patients 18 years or older only.

Device Description

The MOSAIQ Oncology Information System (OIS) is an image-enabled electronic medical record system. It manages clinical and administrative workflows within oncology departments and facilities efficient patient care. It can be configured for Medical Oncology, or both.

The Medical Oncology (MO) configuration is a medical oncology charting solution that includes customizable regimens (Care Plans) that automate chemotherapy orders for labs, procedures, and appointment views are used for reviewing treatment administration, documents, assessment and lab data. Users can enter medications and druglallergy interactions. MOSAIQ also performs standard calculations such as Body Sufface Area Under the Curve (AUC). The Medical Administration Record (MAR) supports all information related to chemotherapy and blood product administration, clinical trial study drugs, dose amounts, infusion time, multiple sites of administration, etc. MOSAQ's Medical Oncology functions are . It is labeled accordingly and calculates all doses accordingly.

The Radiation Oncology configuration is also a charting solution with computerized physician order entry (CPOE) capability, along with added features for image management, patient setup and record, plan import, review, and approval, stereotactic localization, and pretreatment checks. MOSAQ's Radiation Can be used to support a wide variety of treatment modalities including INRT. IGRT, particle therapy, and stereotactic radiotherapy. It can import and store treatment plans from TPS systems via DICOM import DICOM RT import.

AI/ML Overview

The provided document, a 510(k) Premarket Notification for the Elekta MOSAIQ Oncology Information System, states that clinical trials were not performed as part of this product's submission. Instead, it indicates that "Validation testing involved simulated clinical workflows" and that "Non-clinical testing was written and executed to ensure that the system is working as designed."

Therefore, based on the provided text, the device did not undergo a study involving human subjects or a multi-reader multi-case (MRMC) comparative effectiveness study to prove it meets specific acceptance criteria related to its performance in a clinical setting with human readers. The document explicitly states:

No clinical trials: "Clinical trials were not performed as part of this product. Clinical testing on patients is not advantageous in demonstrating substantial equivalence or safety and effective can be performed such that no human subjects are exposed to risk." (Page 6)
Validation through simulated workflows and non-clinical testing: "Validation testing involved simulated clinical workflows, described in section 16.8. The product was deemed fit for clinical use. Non-clinical testing was written and executed to ensure that the system is working as designed use executed, including tests to verify requirements for new product functionality, tests to ensure that instion as intended, and regression tests to ensure continued safety and existing functionality. MOSAIQ passed testing and was deemed safe and effective for its intended use." (Page 6)

Given this, it's not possible to provide the requested information regarding:

Acceptance Criteria Table and Reported Device Performance (Table 1): The document does not describe specific quantitative acceptance criteria or clinical performance metrics for the device that would be typically found in a clinical study report (e.g., sensitivity, specificity, accuracy). Its validation focused on functional correctness against design specifications.
Sample size and data provenance for test set: No test set of clinical cases is described.
Number of experts and qualifications for ground truth: No experts were used for establishing clinical ground truth for a test set.
Adjudication method for test set: Not applicable as there was no clinical test set.
MRMC comparative effectiveness study: Explicitly stated as not performed.
Standalone performance: While internal non-clinical testing was done, the document doesn't provide performance metrics in the way an AI algorithm's standalone performance might be reported (e.g., AUC, F1 score).
Type of ground truth: The "ground truth" for the non-clinical and simulated workflow testing would be the predefined system requirements and expected outputs, rather than expert consensus, pathology, or outcomes data from real patients.
Sample size for training set: No training set for an AI/ML model is mentioned, as the device is described as an "Oncology Information System" and not an AI-driven diagnostic or assistive tool in the context of this submission.
How ground truth for training set was established: Not applicable.

Summary of Device Validation as per the Document:

The provided document indicates that the device's safety and effectiveness were demonstrated through:

Substantial Equivalence: Comparison to legally marketed predicate devices (MOSAIQ K141572) and a reference device (The ViewRay (MRIdian) Linac System K162393) based on intended use and technological characteristics (detailed in tables on Pages 8-9).
Non-Clinical Testing: Verification tests to ensure the system works as designed, including:
- Verification of new product functionality requirements.
- Ensuring installation as intended.
- Regression tests for continued safety and existing functionality.
Simulated Clinical Workflows: Validation testing performed using simulated clinical scenarios, without human subjects.

This approach is common for information systems and record-keeping devices where the primary function is workflow management, data integration, and safety checks, rather than direct diagnostic interpretation or image analysis using AI. The "level of concern" for the software was identified as "major" due to its interface with linear accelerators and responsibility for detecting mismatches, which could lead to serious injury if it failed. Therefore, the non-clinical and simulated testing would have rigorously focused on these critical safety functions.

Summary

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December 4, 2018

Elekta, Inc % Ms. Faiza Ahmed Regulatory Affairs Specialist 100 Mathilda Place 5th Floor SUNNYVALE CA 94086 US

Re: K183034

Trade/Device Name: MOSAIQ Oncology Information System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: October 30, 2018 Received: November 1, 2018

Dear Ms. Ahmed:

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

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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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183034

Device Name MOSAIQ Oncology Information System

Indications for Use (Describe)

Users can configure MOSAIQ® for Medical Oncology use, Radiation Oncology use, or the two together. It lets users:

· Assemble electronic patient charts and treatment plans, order diagnostic tests, and prescribe medications.
· Generate and keep medication formulary lists and calculate applicable medication dosages for medical oncology.
· Import, view, annotate, adjust, enhance, manage and archive images.
· Compare radiation treatment plans and evaluate dose coverage.
· Design leaf plans for operation with radiotherapy treatment machines that have multileaf collimators.
· Make sure radiation treatment plans imported from treatment planning systems agree with treatment machine

constraints. MOSAIQ® reads actual settings from the treatment machine communication interface. It compares these settings with predefined values. If a mismatch occurs between the planned values and the actual machine settings, the system warns the user.

· View reference images to setup treatment. MOSAIQ® refers to predefined settings to help treatment machine setup, and communicates patient and machine setup instructions.
· Record actual delivered radiation values in an electronic chart to track treatment.
· Use stereotactic localization to calculate set-up coordinates for treatments.
· Observation of Intrafractional motion with real time image overlay.

MOSAIQ® is not intended for use in diagnosis. Medical oncology dose calculation functions are designed for use with patients 18 years or older only.

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)

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October 30, 2018

MOSAIQ Oncology Information System Premarket Notification (510(k)) Summary of Safety and Effectiveness

INTRODUCTION

This document summarizes the safety and effectiveness information within the MOSAIQ Oncology Information System 510(k). The Summary of Safety and Effectiveness contains of 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
- c. Product Classification
- d. Product Code
- e. Reference
- f. Review Panel

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

IYE
MOSAIQ

Release 2.65

21 CFR 892.5050
Radiology

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Establishment Information: 3.

a.	Submitter	Elekta, Inc.
b.	Submitter Address	100 Mathilda Place 5th FloorSunnyvale CA 94086
c.	Establishment Number	2950347
d.	Contact	Faiza Ahmed, RA Specialist
e.	Contact Phone	408-830-8920
f.	Contact Fax	208-830-8003
g.	Contact	Faiza Ahmed, RA Specialist
h.	Contact Phone	408-830-8920
i.	Contact Fax	408-830-8003

PREDICATE DEVICE INFORMATION

The MOSAIQ Oncology Informaiton System is substantially equivalent to the Food and Drug Administration (FDA) has cleared for distribution and is currently being actively marketed in the United States. MOSAIQ is substantially equivalers in intended use and safety and effectiveness.

MOSAIQ Oncology Information System IMPAC Medical Systems, Inc. K141572

REFERENCE DEVICE INFORMATION

The MOSAIQ Oncology Information is using the following device to demonstrate intended use and technical similarities. The Food and Drug Administration (FDA) has cleared the reference device for distribution and is currently being actively marketed in the United States.

The ViewRay (MRIdian) Linac System ViewRay Incorporated

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K162393

MOSAIQ INTENDED USE/INDICATIONS FOR USE

Users can configure MOSAIQ® for Medical Oncology use, Radiation Oncology use, or the two together. It lets users:

Assemble electronic patient charts and treatment plans, order diagnostic tests, and prescribe medications.
Generate and keep medication formulary lists and calculate medication dosages for medical oncology. ●
Import, view, annotate, adjust, enhance, manage and archive images,
Compare radiation treatment plans and evaluate dose coverage. ●
Design leaf plans for operation with radiotherapy treatment machines that have multileaf collimators. ●
Make sure radiation treatment planning systems agree with treatment machine constraints. MOSAIQ® ● reads actual settings from the treatment machine communication interface. It compares these settings with predefined values. If a mismatch occurs between the actual machine settings, the system warns the user.
. View reference images to setup treatment. MOSAQ® refers to predelined settings to help treatment machine setup, and communicates patient and machine setup instructions.
Record actual delivered radiation values in an electronic chart to track treatment. ●
Use stereotactic localization to calculate set-up coordinates for treatments. ●
Observation of Intrafractional motion with real time image overlay. ●

MOSAQ® is not intended for use in diagnosis dose calculation functions are designed for use with patients 18 years or older only.

OVERVIEW OF MOSAIQ

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LEVEL OF CONCERN

ltem 4b of Table 1 in the FDA Guidance document entitled, "Guidance for the Content of 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... " The record and vithin MOSAQ does not directly control the machine that delivers the radiation. However, it does interface with the linear accelerator and is responsible for detecting potential mismatchine settings and alerting the user. A failure in MOSAIQ can result, thus, we believe it is a major level of concern.

SUMMARY OF CLINICAL TESTING

Clinical trials were not performed as part of this product. Clinical testing on patients is not advantageous in demonstrating substantial equivalence or safety and effective can be performed such that no human subjects are exposed to risk. Validation testing involved simulated clinical workflows, described in section 16.8. The product was deemed fit for clinical use.

SUMMARY OF NON-CLINICAL TESTING

Ventification tests were written and executed to ensure that the system is working as designed use executed, including tests to verify requirements for new product functionality, tests to ensure that instion as intended, and regression tests to ensure continued safety and existing functionality. MOSAQ passed testing and was deemed safe and effective for its intended use.

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Substantial Equivalence to Legally Marketed Products	MOSAIQ with newfeatures	PredicateDeviceMOSAIQ(K141572)	Reference DeviceThe ViewRay (MRIdian)Linac System(K162393)
Intended Use Comparison
Ability to define leaf plans for use with radiotherapy treatment machinesequipped with multileaf collimator	Yes	Yes	Yes
Ability to import, view, annotate, manipulate, enhance, manage andarchive images	Yes	Yes	Yes
Allows users to create, view, and edit geometric information associatedwith treatment field definitions, including the MLC accessory.	Yes	Yes	Yes
Checks radiation treatment plans against treatment machine constraints,provides the capability to notify clinicians of actions that need to take placeprior to treatment, displays reference images for setup purposes, andfacilitates treatment machine setup according to predefined settings.	Yes	Yes	Yes
Verification against imported radiation treatment plans	Yes	Yes	Yes
Recording of actual delivered treatment values	Yes	Yes	Yes
Record-only interfaces for appropriate treatment machines	Yes	Yes	N/A - not a standalone V&Rsystem
Integrated electronic patient charting functionality	Yes	Yes	N/A - not a standalonecharting system
Administrative functions for practice management (e.g., scheduling, billing)	Yes	Yes	No
Medical oncology management including care plans, calculation ofmedication dosage & dose delivery tracking	Yes	Yes	No
Dose Volume Histogram (DVH) Statistics creation and display	Yes	Yes	Yes
Intrafractional motion with real time image overlay	Yes	No	Yes
Technological Characteristics Comparison				Comparison of multiple radiation treatment plans	Yes	Yes	Yes	Radiation treatment plan summation and subtraction	Yes	Yes	Yes	Includes ability to evaluate brachytherapy & external beam radiationtreatment plans	Yes	Yes	No
Technological Characteristics Comparison
Comparison of multiple radiation treatment plans	Yes	Yes	Yes
Radiation treatment plan summation and subtraction	Yes	Yes	Yes
Includes ability to evaluate brachytherapy & external beam radiationtreatment plans	Yes	Yes	No

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Isodose & beam display	Yes	Yes	Yes
Supports frame-based stereotactic localization	Yes	Yes	No
Contouring, optimization and dose calculation.	No	No	Yes
Support for IMRT	Yes	Yes	Yes
Support for IGRT	Yes	Yes	Yes
Support for adaptive therapy	Yes	No	Yes
Patient positioning using volumetric images	Yes	Yes	Yes
Motion management within the MR-Linac environment includes continuousstream of MR images during treatment, refreshing multiple times persecond.	Yes	No	Yes
Motion management within the MR-Linac environment includes automaticgating in response to patient motion	No	No	Yes
Integrated software & treatment delivery hardware:Radiation software for image guidance and linear accelerator to deliverradiation therapy	MOSAIQ is aseparate,standalone softwaredevice, with imageguidance functiondesigned for usewith the MR Linacand testedaccordingly.	N/A	K162393 addresses bothtreatment hardware andsoftware.
Security features to enable customer HIPAA compliance	Yes	Yes	Yes
DICOM connectivity with compatible systems	Yes	Yes	Yes
Software runs on Windows operating system	Yes	Yes	Yes

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.