MOSAIO® 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. 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. MOSAIO® 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 stereotactic localization to calculate set-up coordinates for treatments. .

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

MOSAIQ is a multi-functional, integrated software suite that forms a comprehensive electronic oncology management system for medical and radiation oncology facilities. For both medical and radiation oncology users, MOSAIQ provides image-enabled electronic patient charting and record management as well as medical transcription and billing functionality. For radiation oncology users, it also includes the ability to import and export radiation treatment plan information, stereotactic localization, treatment plan review, the ability to plan multileaf collimator (MLC) shapes, and verify and record treatment setup and delivery.

This Premarket Notification addresses the addition of the Locate module for Radiation Oncology, which adds stereotactic localization capability to MOSAIQ.

AI/ML Overview

The provided document is a 510(k) premarket notification for the MOSAIQ Oncology Information System. It describes the device's intended use, functionalities, and a comparison with predicate devices to establish substantial equivalence. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving device performance against those criteria.

Here's a breakdown of what can and cannot be extracted from the document:

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

The document does not explicitly state quantitative acceptance criteria in a table format with corresponding quantitative performance metrics for the MOSAIQ Oncology Information System. Instead, it describes a summary of non-clinical testing where "Verification tests were written and executed to ensure that the system is working as designed. Over 100 test procedures were executed, including tests to verify requirements for new product functionality were met, tests to ensure that risk mitigations function as intended, and regression tests to ensure continued safety and effectiveness of existing functionality. Pass/fail criteria for this testing effort was similar to past testing efforts for the previous versions of MOSAIQ. MOSAIQ passed testing and was deemed safe and effective for its intended use."

While it confirms tests were performed and passed, specific numerical acceptance criteria (e.g., accuracy percentages, error rates, time limits) and the detailed study results meeting those criteria are not provided. The "reported device performance" is a qualitative statement of "passed testing and was deemed safe and effective."

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, "Bench testing was performed...using simulated clinical workflows and ad hoc testing where appropriate, with actual patient data."

Sample Size for Test Set: The exact number of patient data samples used for testing is not specified. It mentions "actual patient data," but not how many cases or the size of this dataset.
Data Provenance: The country of origin for the "actual patient data" is not specified. It does not indicate whether the data was retrospective or prospective, though the term "simulated clinical workflows" often implies a retrospective or synthetic approach.

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)

This information is not provided in the document. The document refers to "actual patient data" and "simulated clinical workflows," but it does not describe the process of establishing ground truth for this data, nor does it mention the involvement or qualifications of experts.

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

This information is not provided in the document. There is no mention of any adjudication process for the test results or the ground truth.

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

The document states, "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."
Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with or without AI assistance was not performed. The device, an Oncology Information System, is not an AI-assisted diagnostic tool in the sense of image interpretation where MRMC studies are typically applicable.

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

The document describes "Verification tests were written and executed to ensure that the system is working as designed." These tests would inherently represent a form of standalone testing of the software's functionality against its requirements.
However, the device is designed to interface with human users ("alerting the user," "warns the user") and is an "Oncology Information System" that "supports information flow among healthcare facility personnel." This implies a human-in-the-loop system where the software provides information and alerts, but human clinicians make final decisions. While individual sub-functions of the software (e.g., dose calculation, mismatch detection) would have been tested in a standalone manner, the overall system is not purely "algorithm only" without human interaction in its intended use.

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

The document uses "actual patient data" in its bench testing but does not specify the type of ground truth established for this data (e.g., whether it was based on pathology, expert consensus, or clinical outcomes). The testing focused on verifying the system's design and functionality rather than diagnostic accuracy against a specific ground truth. For instance, for the "mismatch" warning function, the ground truth would be whether a mismatch truly existed between planned and actual settings, rather than a clinical outcome.

8. The sample size for the training set

This information is not applicable or not provided. The MOSAIQ Oncology Information System, as described, appears to be a rule-based software system for managing workflows and information in oncology, rather than a machine learning or AI system that requires a "training set" in the conventional sense. The document does not mention any machine learning components that would necessitate training data.

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

This information is not applicable or not provided as there is no mention of a "training set" or machine learning models.

In summary, the provided document focuses on establishing substantial equivalence for an Oncology Information System based on its functionalities and comparison with predicate devices, rather than detailed performance metrics against specific acceptance criteria relevant to diagnostic or AI algorithms. The "study" referenced is a series of "verification tests" performed internally, without the rigorous quantifiable metrics often associated with AI/ML device evaluations.

Summary

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

September 5, 2014

IMPAC Medical Systems, Inc. % Kathryn Stinson Regulatory Affairs Specialist 100 Mathilda Place, 5th Floor SUNNYVALE, CA 94086

Re: K141572

Trade/Device Name: MOSAIO Oncology Information System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 12, 2014 Received: June 18, 2014

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael O'Harafor

Janine M. Morris 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): K141572

Device Name: MOSAIQ Oncology Information System

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 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. MOSAIO® 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 stereotactic localization to calculate set-up coordinates for treatments. .

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

Prescription Use X(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use ______(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

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June 3, 2014

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

INTRODUCTION

This document summarizes the safety and effectiveness information contained within the MOSAIQ Oncology Information 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

1. Product Information:
a. Product Trade Name	MOSAIQ
b. Release Version Number	Release 2.60
2. Classification Information:
a. Classification Name system	Medical charged-particle radiation therapy
b. Common/Usual Name	Oncology Information System
c. Product Classification	Class II
d. Product Code	IYE
e. Reference	21 CFR 892.5050
f. Review Panel	Radiology
3. Establishment Information:
a. Submitter	IMPAC Medical Systems, Inc.
b. Submitter Address	100 Mathilda Place, 5th FloorSunnyvale, CA 94086
c. Establishment Number	2950347
d. Contact	Kathryn Stinson, RA Specialist
e. Contact Phone	314-993-0003
f. Contact Fax	314-993-0075

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PREDICATE DEVICE INFORMATION

The MOSAIQ Oncology Information System is substantially equivalent to the following devices that the Food and Drug Administration (FDA) has cleared for distribution and are currently being actively marketed in the United States. MOSAIO is substantially equivalent to these products in intended use and safety and effectiveness.

1. MOSAIQ Oncology Information System IMPAC Medical Systems, Inc. K123230
1. ERGO++ RTP System IMPAC Medical Systems, Inc. K080601

MOSAIQ INTENDED USE/INDICATIONS FOR USE

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 MOSAIO® 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 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 stereotactic localization to calculate set-up coordinates for treatments. .

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

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DESCRIPTION OF THE PRODUCT

This Premarket Notification addresses the addition of the Locate module for Radiation Oncology, which adds stereotactic localization capability to MOSAIQ.

LEVEL OF CONCERN

The FDA guidance document entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005, Table 1, item 4b states, "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 verify function within MOSAIQ does not directly control the machine that delivers the radiation. However, it does interface with the linear accelerator and is responsible for detecting potential mismatches between planned and actual machine settings and alerting the user. Thus, it is a major level of concern function.

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. Bench testing was performed, as described in Section 16.8. using simulated clinical workflows and ad hoc testing where appropriate, with actual patient data. 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. Over 100 test procedures were executed, including tests to verify requirements for new product functionality were met, tests to ensure that risk mitigations function as intended, and regression tests to ensure continued safety and effectiveness of existing functionality. Pass/fail criteria for this testing effort was similar to past testing efforts for

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the previous versions of MOSAIQ. MOSAIQ passed testing and was deemed safe and effective for its intended use.

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Table 11-1: Substantial Equivalence to LegallyMarketed Products	MOSAIQwith Locate(new)	MOSAIQ(Previous)K123230	ERGO++ RTPSystemK080601
Ability to define leaf plans for use with radiotherapytreatment machines equipped with multileaf collimator	Yes	Yes	Yes
Ability to import, view, annotate, manipulate, enhance,manage and archive images	Yes	Yes	Yes
Allows users to create, view, and edit geometricinformation associated with treatment field definitions,including the MLC accessory.	Yes	Yes	Yes
Checks radiation treatment plans against treatmentmachine constraints, provides the capability to notifyclinicians of actions that need to take place prior totreatment, displays reference images for setup purposes,and facilitates treatment machine setup according topredefined settings.	Yes	Yes	No
Verification against imported radiation treatment plans	Yes	Yes	No
Recording of actual delivered treatment values	Yes	Yes	No
Record-only interfaces for appropriate treatmentmachines	Yes	Yes	No
Integrated electronic patient charting functionality	Yes	Yes	No
Administrative functions for practice management (e.g.,scheduling, billing)	Yes	Yes	No
Medical oncology management including care plans,calculation of medication dosage & dose deliverytracking	Yes	Yes	No
Security features to enable customer HIPAAcompliance	Yes	Yes	Yes
DICOM connectivity with compatible systems	Yes	Yes	Yes
Software runs on Windows operating system	Yes	Yes	No (Linux)
Dose Volume Histogram (DVH) creation and display	Yes	Yes	Yes
Displays DVH Statistics	Yes	Yes	Yes
Comparison of multiple radiation treatment plans	Yes	Yes	Yes
Radiation treatment plan summation and subtraction	Yes	Yes	Yes
Includes ability to evaluate brachytherapy & externalbeam radiation treatment plans	Yes	Yes	External BeamOnly
Isodose & beam display	Yes	Yes	Yes
Supports frame-based stereotactic localization	Yes	No	Yes
Supports frameless stereotactic localization	No	No	No
Support for angiographic images	No	No	Yes
Radiation treatment plan optimization & dosecalculation	No	No	Yes
Image contouring functionality	No	No	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.