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. 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. .

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, the ability to plan multileaf collimator (MLC) shapes, and verify and record treatment setup and delivery.

This Premarket Notification addresses the addition of the "Evaluate" module, which calculates and displays dose volume histograms (DVHs) for the purpose of review and evaluation of radiation treatment plans.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the MOSAIQ Oncology Information System:

It's important to note that this document is a 510(k) Premarket Notification summary for software, specifically an Oncology Information System (MOSAIQ). Such notifications primarily focus on demonstrating substantial equivalence to a predicate device and usually involve software verification and validation, not clinical trials in the sense of demonstrating diagnostic accuracy or efficacy in a patient population. Therefore, many of the typical acceptance criteria and study components you'd expect for an AI/algorithm-based diagnostic device will not be present.

Based solely on the provided text, many of the requested categories (especially those related to clinical performance, ground truth, and expert evaluation) are not applicable or not reported as they would be for a typical AI diagnostic device.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative performance-based acceptance criteria for a "device" in the sense of an AI algorithm producing a measurement or diagnosis. Instead, the "device" is an information system, and its acceptance criteria are implicitly tied to the successful completion of non-clinical verification and validation testing, ensuring it functions as designed and meets safety requirements.

Acceptance Criteria Category	Description from Document (or N/A)	Reported Device Performance
Functional Requirements	The system successfully performs its stated functions, including assembling patient charts, managing treatment plans, calculating dosages (for medical oncology, 18+ patients only), importing/viewing/managing images, comparing radiation plans, designing leaf plans, verifying treatment machine settings against planned values, alerting users to mismatches, viewing reference images for setup, and recording delivered radiation values. (Implicit, based on "DESCRIPTION OF THE PRODUCT" and "Indications for Use"). Specific to this submission: The "Evaluate" module calculates and displays dose volume histograms (DVHs) for review and evaluation of radiation treatment plans.	"MOSAIQ passed testing and was deemed safe and effective for its intended use." (Implies all functions operate as intended and meet requirements). The "Evaluate" module was added, implying it passed its specific verification.
Safety Requirements	The system safely manages workflows without causing harm. Specifically, for the record and verify function (major level of concern), it detects potential mismatches between planned and actual machine settings and alerts the user. Risks are mitigated. (Implicit, based on "LEVEL OF CONCERN," "SUMMARY OF NON-CLINICAL TESTING").	"tests to ensure that risk mitigations function as intended" were executed and passed. "MOSAIQ passed testing and was deemed safe and effective for its intended use."
System Reliability/Stability	The software operates consistently and without critical failures. (Implicit in general software testing).	Over 100 test procedures executed, including exploratory, new functionality, risk mitigation, and regression tests, without indicating failures that prevented acceptance.
Performance (e.g., speed)	Not explicitly stated in terms of quantitative operational performance metrics (e.g., specific response times).	N/A (Not reported or not a specific focus for this type of submission).
Accuracy (e.g., calculation)	Not explicitly stated with quantitative targets. For medical oncology dosage, it "calculates applicable medication dosages." For radiation treatment plan verification, it "reads actual settings...compares these settings with predefined values. If a mismatch occurs...the system warns the user." The "Evaluate" module "calculates and displays dose volume histograms (DVHs)." (Implicit: these calculations are accurate).	The system passed testing, implying that calculations and comparisons function correctly as designed.
Usability	Not explicitly detailed in the provided summary (though generally part of software development).	N/A (Not reported).
Substantial Equivalence	The device is substantially equivalent to predicate devices (MOSAIQ K120067 and Mobile MIM K112930) in intended use, safety, and effectiveness.	The FDA reviewed the 510(k) and determined the device is substantially equivalent, noting concurrence by the Division of Radiological Health.

Study Details: MOSAIQ Oncology Information System

This submission focuses on software validation rather than a clinical study evaluating diagnostic performance.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Description: "Bench testing was performed... using simulated clinical workflows and ad hoc testing where appropriate, with actual patient data."
- Sample Size: Not specified for the "actual patient data" used within the bench testing. The total number of test procedures was "Over 100."
- Data Provenance: "actual patient data" implies retrospective, but no country of origin is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications: Not specified. For software verification and validation, "ground truth" would typically be defined by engineering specifications, expected outputs, and clinical input from subject matter experts (e.g., oncologists, physicists, dosimetrists) who validate the functional correctness of the system rather than establishing a diagnostic truth for patient cases.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this was not a human reader study requiring adjudication of interpretations. The "adjudication" would be through verifying test procedure results against expected outcomes defined during the software development lifecycle.
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 done. The document explicitly states: "Clinical trials were not performed as part of the development of this product." and "Clinical testing on patients is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device."
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The non-clinical testing was focused on the software's ability to perform its functions independently ("algorithm only") under simulated conditions, but the device's intended use is with a human in the loop, as an information system for workflow management and to warn users. The testing verified the software's functional correctness.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this type of software would be based on:
  - Functional Specifications/Requirements: The software must perform according to its design documents.
  - Clinical Domain Knowledge: Accuracy of calculations (e.g., dosage, DVHs) and correctness of comparisons (e.g., planned vs. actual machine settings) would be validated against established medical/physics principles and expected clinical outcomes.
  - Expected Outputs: For test cases, the correct output (e.g., a specific DVH curve, a warning message for a mismatch) would be predefined and compared to the software's actual output.
The sample size for the training set:
- No "training set" in the context of machine learning was mentioned or indicated. This is a rule-based/deterministic software system, not an AI/ML-based system that requires training data.
How the ground truth for the training set was established:
- Not applicable, as there was no machine learning training set mentioned.

Summary

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KI 23230

DEC 1 2 2012

October 12, 2012

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 2.50
2.	Classification Information:
	a.	Classification Namesystem	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. MOSAIQ is substantially equivalent to these products in intended use and safety and effectiveness.

1. MOSAIQ Oncology Information System IMPAC Medical Systems, Inc. K120067
1. Mobile MIM MIM Software Inc. K112930

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 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. MOSAIO® 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. .

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

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 MOSAIO 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.

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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 exploratory tests, 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. Pass/fail criteria for this testing effort was equivalent to past testing efforts for the previous versions of MOSAIQ. MOSAIQ passed testing and was deemed safe and effective for its intended use.

5-4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure with three stylized wing shapes.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 12, 2012

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

Re: K123230

Trade/Device Name: MOSAIQ Oncology Informaiton System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 12, 2012 Received: November 6, 2012

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 device-related adverse evénts) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

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

Sincerely vours,

Janine MAMorris -S

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): K123230

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. 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. .

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
AND/OR
Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Janine M. Morris -S 2012.12.11 14:38:44 -05'00' /

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K123230 510(k)

Page 1 of

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.