Model 1216 Quality Reports is a multi-functional information and data management software application intended to be used by trained clinicians who are familiar with radiation therapy, such as medical physicists, medical dosimetrists, and radiation oncologists.

Model 1216 Quality Reports receives DICOM data from Treatment Planning Systems (TPS) which are capable of providing such data. The data may include images, radiation therapy (RT) objects such as RT Plan, RT Structure Set and RT Dose. The user may also capture data through manual input.

The application allows the user to:

Create reports and charts which may be sent to the institution's Electronic . Medical Record (EMR) system.
Measure quality with standardized metrics that are based on the institution's ● chosen standards.
Capture information from the clinical team during pre-treatment planning. ●
Establish benchmark and progress data to demonstrate continuous improvement.
Audit the Dose Volume Histogram (DVH) from the TPS.
. Facilitate quantitative review of the estimated dose via a single DVH metric.
Customize and save a library of non-dosimetric plan parameters and compare ● them against user defined constraints.
. Track plan quality scores over time to assess performance and provide the basis for measuring continual improvement.

AI/ML Overview

This document is a 510(k) premarket notification for the Model 1216 Quality Reports by Sun Nuclear Corporation. The information provided outlines the device's intended use and technical specifications, comparing it to predicate devices. However, it explicitly states that no clinical trials were performed for this device, and testing was limited to bench testing using simulated clinical workflows.

Therefore, it is not possible to provide acceptance criteria and a study proving the device meets those criteria based on the provided text, as such a study was not conducted. The document states:

"As with the predicate device, no clinical trials were performed for Model 1216 Quality Reports. Testing was limited to Bench testing using simulated clinical workflows." (Page 5)

Without clinical data or a formal study demonstrating performance against specific acceptance criteria, the detailed information requested below cannot be extracted from this document.

However, I can extract information related to the testing that was performed and the general claims made:

1. A table of acceptance criteria and the reported device performance
No specific acceptance criteria for clinical performance are provided in the document, nor is there reported clinical device performance, as no clinical trials were conducted. The document mentions:

"Verification tests were written and executed to ensure that the system was working as designed."
"Pass/fail criteria were used to verify requirements and to ensure that risk mitigations functioned as intended."
"Regression tests were performed."

This indicates internal verification and validation testing, but not performance against clinical acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
As no clinical trials were performed, there is no "test set" in the context of patient data. Testing was done with "simulated clinical workflows," meaning synthetic or representative data, but the sample size (number of cases or types of simulations) and data provenance (country, retrospective/prospective) are not specified.

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)
Not applicable, as no clinical test set with externally established ground truth was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used that would require adjudication.

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 study was performed. The device is a "multi-functional information and data management software application" for quality assessment, not an AI-assisted diagnostic tool for human readers in the traditional sense of improving interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device functions as a standalone software, but its performance was assessed through "bench testing using simulated clinical workflows" rather than a formal standalone clinical performance study using patient data and ground truth. The document states it is "intended to be used by trained clinicians who are familiar with radiation therapy, such as medical physicists, medical dosimetrists, and radiation oncologists," indicating human-in-the-loop operation for the overall process, even if the software itself runs independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the internal "verification tests" and "simulated clinical workflows," the ground truth would typically be defined by the expected behavior or output of the software according to its design specifications. It would not involve expert consensus, pathology, or outcomes data from real patients.

8. The sample size for the training set
Not applicable. The document does not describe an AI/machine learning model that requires a training set. This is a software application for data management and quality assessment, not a learning algorithm.

9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned or implied.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

December 5, 2014

Sun Nuclear Corporation % Mr. James Luker Regulatory Affairs Consultant 2640 Nobility Avenue MELBOURNE FL 32934

Re: K142142

Trade/Device Name: Ouality Reports, Model 1216 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: November 5, 2014 Received: November 10, 2014

Dear Mr. Luker:

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 events) (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 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/Resourcesfor You/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 D. O'Hara
for

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) K142142

Device Name Model 1216 Quality Reports

Indications for Use (Describe)

Model 1216 Quality Reports is intended for quality assessment of radiotherapy treatment plans and the radiotherapy treatment planning process.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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."

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Image /page/3/Picture/0 description: The image shows the logo for Sun Nuclear Corporation. The logo features a blue square with a yellow sun inside on the left. To the right of the square, the words "SUN NUCLEAR" are written in blue, with the word "corporation" written in a smaller font below.

Section 5 - 510(k) Summary

Provided in accordance with 21 CFR 807.92 (c)

1 General Provisions

Date Prepared:

August 2, 2014

Submitted by:

Sun Nuclear Corporation 3275 Suntree Blvd. Melbourne, FL 32940 Ph: 321-259-6862 Fax: 321-259-7979 Web: www.sunnuclear.com

Contact Person:

Jonathan Lee jonathanlee@sunnuclear.com

Ph: 321-259-6862 extension 423

Classification Name:

21 CFR § 892.5050 IYE Medical charged-particle radiation therapy system Class II

Common Name:

Oncology Information system

Proprietary Names:

Model 1216 Quality Reports

Establishment Registration Number:

1038814

Classification:

Regulation Number: 21 CFR 892.5050 Name: Medical charged-particle radiation therapy system, dosimetric quality control system Product code: IYE

Predicate Device(s):

Model Name:	MOSAIQ Release 2.50
Common Name:	Oncology Information System
510(k) #	K123230
Manufacturer:	IMPAC Medical Systems, Inc.
Submitted:	November 6, 2012

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Model Name: MOSAIQ Release 2.40 Oncology Information System Common Name: 510(k) # K120067 Manufacturer: IMPAC Medical Systems, Inc. Submitted: January 9, 2012

2 Description and Use:

The application allows the user to:

Create reports and charts which may be sent to the institution's Electronic . Medical Record (EMR) system.
Measure quality with standardized metrics that are based on the institution's ● chosen standards.
Capture information from the clinical team during pre-treatment planning. ●
Establish benchmark and progress data to demonstrate continuous improvement.
Audit the Dose Volume Histogram (DVH) from the TPS.
. Facilitate quantitative review of the estimated dose via a single DVH metric.
Customize and save a library of non-dosimetric plan parameters and compare ● them against user defined constraints.
. Track plan quality scores over time to assess performance and provide the basis for measuring continual improvement.

3 Intended Use Statement:

Model 1216 Quality Reports is intended for quality assessment of radiotherapy treatment plans and the radiotherapy treatment planning process.

ব Technological Characteristics

As with the predicate devices, Model 1216 Quality Reports software runs on a standard PC running a Windows Operating System (OS). The complexity of DICOM data and the sheer data volume in images and DICOM RT objects (notably RT Structure Sets and RT Doses) demands high performance computer processing and memory. The software holds all vital data in memory during each analysis and report generation session to ensure high performance to optimize the user experience, and thus there are special requirements for the machine(s) on which the software is installed.

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System Recommendations

. Operating Systems Supported: Windows 7 (32- or 64-bit), Windows 8 (32- or 64bit), and Windows Server 2008, 2008 R2, and 2012
I CPU: 2.4+ GHz
l CPU: Multi-core processor (4+ cores, 8+ threads)
l Hard drive space: Software components fully installed require only ~20 MB, but storage requirements for voluminous patient data and archives are much larger but will vary clinic-to-clinic. A minimum of 900 GB hard drive is suggested with larger drives for DICIOM archives.
Memory (RAM): 2+ GB x number of cores (e.g. 8+ GB for 4 cores)
. Display Resolution: 1920 x 1080 screen resolution, 24- or 32-bit color depth.

5 Performance Data and Comparison with Predicate

As with the predicate device, no clinical trials were performed for Model 1216 Quality Reports. Testing was limited to Bench testing using simulated clinical workflows.

Verification tests were written and executed to ensure that the system was working as designed. Pass/fail criteria were used to verify requirements and to ensure that risk mitigations functioned as intended. Regression tests were performed.

6 Summary

Model 1216 Quality Reports is deemed substantially equivalent to the predicate devices due to the similarities in function, technology, and performance. The intended use, performance testing, safety and effectiveness reviews demonstrate that Quality Reports is as safe, as effective, and performs as well as the predicate device. The minor technological differences between Model 1216 Quality Reports and the predicate devices do not raise new types of safety or effectiveness questions.

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.