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 and/or chemotherapy are prescribed. Users can configure MOSAIQ® for Medical Oncology use, Radiation Oncology use, or the two together. Medical oncology dose calculations are designed to support both adult and pediatric patients. 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 multi-leaf 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.
· Monitor Intrafractional motion with real time image overlay.

MOSAIQ® is not intended for use in diagnosis.

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 facilitates efficient patient care. It can be configured for Medical Oncology, Radiation 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 appointments. Configurable flowsheet views are used for reviewing treatment administration, documents, assessment and lab data. Users can enter medications and screen for drug/drug and drug/allergy interactions. MOSAIQ also performs standard calculations such as Body Surface Area (BSA) and 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 administration, etc.

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 positioning, verify and record, plan import, review, and approval, stereotactic localization, and pretreatment checks. MOSAIQ's Radiation Oncology functionality can be used to support a wide variety of treatment modalities including Intensity Modulated Radio Therapy (IMRT), Image Guided Radio Therapy (IGRT), particle therapy, and stereotactic radiotherapy. It can import and store treatment plans from Therapy Planning Systems (TPS) via DICOM import/DICOM RT import.

In addition to these, the current version of MOSAIQ introduces the following modifications for radiation oncology:

· Anatomic Position Monitoring (APM) with Manual interrupt (also referred to as True Tracking as it 'tracks' in 3D and enables the system to gate using the 3D position of the anatomy's motion)
· APM with Anatomic Tolerance Check (ATC)
· Adaptive Therapy with optional Baseline Shift (BLS) Recoverv
· Care Rules for motion management.

These modifications are not contained solely within MOSAIQ, as the full clinical benefit is achieved with interoperability of Unity, Monaco RTP, and MOSAIQ OIS.

AI/ML Overview

The provided text is a 510(k) summary for the MODAIQ® Oncology Information System. Based on this document, the following information can be extracted regarding acceptance criteria and supporting studies:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of quantitative acceptance criteria and corresponding reported device performance metrics in the format typically seen for diagnostic or AI-driven systems (e.g., sensitivity, specificity, AUC).

Instead, the "acceptance criteria" are implied to be conformance with various standards and successful completion of design verification and performance testing. The "reported device performance" is essentially a statement that the device met these criteria through testing.

Therefore, a table of stated acceptance criteria and reported performance would look like this, based on the narrative:

Acceptance Criterion (Implicit)	Reported Device Performance
Conformance with FDA's Quality System Regulation (21 CFR §820.30)	Design verification and performance testing carried out in accordance.
Conformance with ISO 13485 Quality Management System Requirements	Design verification and performance testing carried out in accordance.
Conformance with ISO 14971 Risk Management Requirements	Design verification and performance testing carried out in accordance.
Conformance with IEC 62304 Software Life-Cycle Processes	Design verification and performance testing carried out in accordance.
Conformance with FDA guidance for major level of concern software (Class C per IEC 62304)	Software verification testing conducted and documented.
Conformance with ISO 14971 (Risk Management)	Satisfied.
Conformance with IEC 62304 (Software Life-Cycle)	Satisfied.
Conformance with ISO 62083 (Safety of Radiotherapy Planning Systems)	Satisfied.
Conformance with IEC 61217 (Radiotherapy Equipment - Coordinates, Movements and Scales)	Satisfied.
Conformance with IEC 62274 (Safety of Radiotherapy Record and Verify Systems)	Satisfied.
Conformance with AAMI RT2:2017 (Radiation Therapy Readiness Check)	Satisfied.
Conformance with IEC 62366-1 (Usability Engineering for Medical Devices)	Satisfied.
Conformance with ISO 15223 (Symbols for Medical Devices)	Satisfied.
Meeting established safety and performance criteria	Demonstrated through verification and validation.
Being substantially equivalent to the predicate device	Determined through non-clinical testing.

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

The document states: "No animal or clinical tests were performed to establish substantial equivalence with the predicate device." This indicates that no test set involving patient data was used for performance evaluation in the context of clinical outcomes or diagnostic accuracy. The testing was non-clinical.

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)

Since no clinical or animal tests were performed, there was no need for experts to establish ground truth for a test set in the conventional sense of clinical performance studies. The "ground truth" for the non-clinical testing would have been established by engineering specifications, design requirements, and standard compliance.

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

As no clinical test set was used for performance evaluation that would require human expert adjudication of results, no adjudication method was employed.

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 MRMC comparative effectiveness study was conducted. The device is an Oncology Information System and not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases with or without AI assistance.

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

The document describes "Design verification and performance testing" and "Software verification testing." These are standalone evaluations of the device's functionality and adherence to technical specifications and regulatory standards. However, it's not a standalone clinical performance study as would be seen for a diagnostic algorithm. The device's modifications for "Anatomic Position Monitoring" and "Adaptive Therapy" are explicitly mentioned to involve "interoperability of Unity, Monaco RTP, and MOSAIQ OIS," implying a system-level performance rather than a single algorithm's standalone clinical performance.

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

For the non-clinical testing performed, the ground truth was based on:

Design and risk management requirements: The device's functions were tested against pre-defined specifications.
Recognized consensus standards: Compliance with standards like ISO 14971, IEC 62304, ISO 62083, etc., served as the "ground truth" for its safety and essential performance.
Predicate device characteristics: Substantial equivalence was established by demonstrating that the new device's characteristics and performance align with or don't adversely deviate from the predicate device (MOSAIQ OIS, K203172).

8. The sample size for the training set

The document does not mention any "training set." This type of testing is for an updated version of an existing Oncology Information System, focusing on functional verification and regulatory compliance, not machine learning model training.

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

As no training set is mentioned or implied, this question is not applicable.

Summary

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

February 23, 2023

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

Elekta Solutions AB % Melinda Smith Director, Regulatory Affairs & Quality - Americas Elekta, Inc. 400 Perimeter Center Terrace NE Suite 50 ATLANTA GA 30346

Re: K223229

Trade/Device Name: MOSAIO® 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: January 26, 2023 Received: January 27, 2023

Dear Melinda Smith:

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

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

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Lora D. Weidner. The signature was created on February 23, 2023 at 14:33:58 -05'00'.

Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known)

K223229

Device Name

MOSAIQ® Oncology Information System

Indications for Use (Describe)

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. Medical oncology dose calculations are designed to support both adult and pediatric patients. 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 multi-leaf 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.
· Monitor Intrafractional motion with real time image overlay.

MOSAIQ® is not intended for use in diagnosis.

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

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}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Elekta. The logo consists of a circular graphic to the left of the word "Elekta". The graphic is a circle with three smaller circles inside of it.

TRADITIONAL 510(K) SUMMARY (21 CFR § 807.92)

-SUBMITTER

Contact:

Elekta Solutions AB Kungstensgatan 18 Box 7593 Stockholm, SE SE10393

Melinda Smith, MS, RAC, CBA Melinda.Smith@elekta.com

Establishment Registration #: 510(k) Number: Date Prepared:

3015232217 K223229 7 December 2022

DEVICE II.

Trade Name:	MOSAIQ Oncology Information System
Product Classification:	Class II
Common Name:	Radiation charged-particle radiation system
Regulation Number:	21 CFR § 892.5050
Regulation Description:	Medical charged-particle radiation therapy system
Product Code:	IYE

lll. PREDICATE DEVICE

Predicate Device: MOSAIQ OIS (K203172)

IV. DEVICE DESCRIPTION

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

Image /page/4/Picture/0 description: The image shows the logo for Elekta, a company that specializes in precision radiation medicine. The logo features a stylized teal-colored circle with three smaller circles inside, followed by the company name "Elekta" in a sans-serif font, also in teal. The overall design is clean and modern, reflecting the company's focus on innovation and technology in the healthcare industry.

In addition to these, the current version of MOSAIQ introduces the following modifications for radiation oncology:

· Anatomic Position Monitoring (APM) with Manual interrupt (also referred to as True Tracking as it 'tracks' in 3D and enables the system to gate using the 3D position of the anatomy's motion)
· APM with Anatomic Tolerance Check (ATC)
· Adaptive Therapy with optional Baseline Shift (BLS) Recoverv
· Care Rules for motion management.

These modifications are not contained solely within MOSAIQ, as the full clinical benefit is achieved with interoperability of Unity, Monaco RTP, and MOSAIQ OIS.

V. INTENDED USE / INDICATIONS FOR USE

· 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 multileat collimators.
· Make sure radiation treatment plans imported from treatment planning systems agree with treatment machine constraints.

MOSAIQ® reads actual settings from the treatment machine through the 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 stereotacticlocalization to calculate set-up coordinates for treatments.
· Monitor intrafractional motion with real time image overlay.

MOSAIQ is not intended for use in diagnosis.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE

MOSAIQ® Oncology Information System version 3.2 is an updated version of the predicate device and has identical intended use and technological characteristics (identical designs, principles of operation, and use environments) as well as the same indications for use as the predicate device cleared per K203172.

The similarities and differences in key device characteristics and performance specifications of the current and predicate MOSAIQ configuration are noted in the table below. Through adequate verification, validation and usability evaluations. Elekta has concluded that the differences do not impact the substantial equivalence with the predicate device.

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

Image /page/5/Picture/0 description: The image shows the logo for Elekta. The logo consists of a circular graphic to the left of the word "Elekta". The graphic is a circle with three smaller circles inside of it. The word "Elekta" is written in a sans-serif font.

Technological Characteristics Comparison		MOSAIQ(Subject Device)	MOSAIQ(K203172)
Administrative Features– MDDS (non-medical)Features	Practice management features – billing,scheduling, scheduling, billing, managementreporting and data analysis	✓	✓
Medical oncologymanagement	Includes plan of care management, calculation ofmedication dosage, and dose delivery tracking	✓	✓
Radiation OncologyManagement	Ability to add a radiation prescription, importradiation therapy treatment plans, machine setupincludingpatient positioning, treatment calendarmanagement, cumulative dose tracking andeChart Check feature for weekly chart check.Review of treatment plans through Evaluatefeature.	✓	✓
Imaging Functionality	Ability to import, view, annotate, manipulate,enhance, manage and archive images	✓	✓
Record and Verify-Sequencer	Verifies radiation treatment plans againsttreatment machine constraints, provides thecapability to notify clinicians of actions that needto take place prior to treatment, displaysreference images for setup purposes, andfacilitates treatment machine setup according topredefined settings. Recording of actual treatmentvalues and interfaces with treatment machines.	✓	✓
MLC Fit	Design leaf plans for operation with radiotherapytreatment machines that have multi-leafcollimators.	✓	✓
Modality support	Supports IMRT, IGRT, particle therapy,stereotactic radiotherapy and MR-Linactreatments	✓	✓
MotionManagement inTreatmentSessionManager	Motion monitoring with manual interrupt	✓	✓
	Anatomical Position Monitoring (APM) withmanual interrupt	✓	X
	APM with ATC (Anatomical Tolerance Check)	✓	X
	Adaptive Therapy with optional BLS (BaselineShift) Recovery	✓	X
StereotacticLocalization	Stereotactic localization through MOSAIQLOCATE feature allows clinicians to visualize thetarget on patient images, perform imagecalibration, and calculate stereotactic coordinates.	✓	✓
DICOM Connectivity	DICOM connectivity with compatible systems	✓	✓
Operating System	Windows operating systemSupport for Windows 10	✓	✓

SUMMARY OF PERFORMACE TESTING (NON-CLINICAL) VII.

Design verification and performance testing were carried out in accordance with design controls of FDA's Quality System Regulation (21 CFR §820.30), applicable ISO 13485 Quality Management System requirements, ISO 14971 risk management requirements, IEC 62304 requirements for software life-cycle processes.

Non-clinical testing was performed to evaluate device performance and functionality against design and risk management requirements at sub-system, integration and system levels. Software verification testing was conducted and documented in accordance with

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

Image /page/6/Picture/0 description: The image shows the logo for Elekta. The logo consists of a circular graphic to the left of the word "Elekta". The circular graphic is made up of a larger circle with three smaller circles inside of it. The word "Elekta" is written in a sans-serif font.

FDA guidance 1 for devices that pose a major level of concern (Class C per IEC 62304).

Basic safety and essential performance have been satisfied through conformance with device-specific recognized consensus standards, as well as the general and collateral safety and essential performance standards for medical devices listed below.

Standard No.	Standard Title
ISO 14971	Medical Devices – Application of risk management to medical devices
IEC 62304	Medical device software - Software life-cycle processes
ISO 62083	Medical electrical equipment - Requirements for the safety of radiotherapytreatment planning systems
IEC 61217	Radiotherapy equipment - Coordinates, movements and scales
IEC 62274	Medical electrical equipment - Safety of radiotherapy record and verify systems
AAMI RT2:2017	Radiation therapy readiness check
IEC 62366-1	Medical devices - Application of usability engineering to medical devices
ISO 15223	Medical devices -Symbols to be used with medical devices, labeling and informationto be supplied - Part 1: General requirements

VIII. SUMMARY OF PERFORMACE TESTING (CLINICAL)

No animal or clinical tests were performed to establish substantial equivalence with the predicate device. The performance data demonstrate that MOSAIQ is as safe and effective and performs as well as the predicate device.

IX. SUBSTANTIAL EQUIVALENCE CONCLUSION

MOSAIQ is substantially equivalent (SE) to the predicate device, MOSAIQ (K203172). The intended use and indications for use are identical to the predicate device and the principles of operation remain unchanged.

The technological characteristics are substantially equivalent to the predicate device; the additional motion management strategies do not affect the fundamental scientific technology or raise different questions of safety or effectiveness of the device.

The device safety and performance have been addressed by non-clinical testing in conformance with pre-determined performance criteria, FDA guidance, and recognized consensus standards.

The results of verification and validation as well as conformance to relevant safety standards demonstrate that MOSAIQ meets the established safety and performance criteria and is substantially equivalent to the predicate device.

1 Content of Premarket Submissions for Software Contained in Medical Devices – Guidance for Industry and Food and Drug Administration Staff, May 2005

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.