Model 1214 EPIDose is a radiotherapy beam QA software application intended for twodimensional (2D) electronic portal imaging device (EPID) image conversion to a phantom dose distribution for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS).

EPIDose is indicated for radiotherapy beam QA of radiotherapy treatment plans delivered on any treatment delivery device with an EPID that outputs DICOM-compliant images.

Device Description

Sun Nuclear EPIDose product, model 1214, is a software application that converts electronic portal imaging device (EPID) image data -acquired by a third party treatment delivery device (TDD)- to a dose distribution which can subsequently be compared with the planned dose distribution for radiation therapy quality assurance purposes. From this companson of the EPIDose result to the planned dose, a qualified clinician makes the decision whether the TDD along with its accessories (including the treatment planning system, or TPS) is capable of delivering the treatment as prescribed.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Sun Nuclear Corporation Model 1214 EPIDose, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Minimum Pass Rate using Gamma Analysis)	Reported Device Performance (Achieved Pass Rates)
68% (with 3.5% dose difference and 3.5 mm DTA)	Above 94%

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: "various clinical and non-clinical cases" were used. A specific number is not provided.
Data Provenance: The data was generated through "measurements internally performed as well as through reference." The country of origin is not specified, but the submission is from Sun Nuclear Corporation in Melbourne, FL, USA.
Retrospective/Prospective: Not explicitly stated, but "internally performed measurements" suggest prospective testing specific to the device's development and validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The comparison was primarily made against film results, implying that previous film dosimetry protocols served as the reference, rather than independent expert consensus per se for each case.

4. Adjudication Method for the Test Set:

This information is not applicable/provided in the context of this study. The performance was assessed by comparing EPIDose results directly against film results using gamma analysis, not through a human adjudication process to establish ground truth for each case.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a MRMC comparative effectiveness study was not done. The study compares the device's output to film dosimetry, not improvements in human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, this was a standalone performance study. The EPIDose software converts EPID images to a dose distribution, which is then compared to planned dose distributions. The study focuses on the accuracy of this conversion performed by the algorithm itself, independently of human interpretation during the comparison (though a "qualified clinician makes the decision" based on the comparison, this study validates the conversion part).

7. The Type of Ground Truth Used:

The ground truth used was film dosimetry (film results). The EPIDose results were compared to dose distributions derived from film, which is a widely accepted method for radiation therapy dosimetry.

8. The Sample Size for the Training Set:

The document does not provide information on the sample size used for the training set.

9. How the Ground Truth for the Training Set Was Established:

The document does not provide information on how ground truth was established for a training set. Given that the device's "significant technological characteristic" is a "patented method for image to dose conversion," it's likely that fundamental physics principles and established dosimetry methods (potentially including film or other reference dosimeters) were used in its development and calibration, rather than a distinct "training set" with independently established ground truth in the machine learning sense. The performance study described seems to be a validation study against an existing reference standard (film).

Summary

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K131704.

Image /page/0/Picture/1 description: The image shows the logo for Sun Nuclear Corporation. The logo consists of a stylized sun symbol on the left, followed by the words "SUN NUCLEAR" in bold, sans-serif font on the top line. Below that, the word "corporation" is written in a smaller, sans-serif font. The sun symbol is a black circle with several horizontal white lines inside, partially obscured by a black shape on the right side.

Your Most Valuable QA & Dosimetry Tools

510(k) Summary

Provided in accordance with 21 CFR 807.92 (c)

1 General Provisions

Date Prepared:

June 7, 2013

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:

Jeff Kapatoes jeffkapatoes@sunnuclear.com

Classification Name:

Accelerator, Linear, Medical

Common Name:
Dosimetric Quality Assurance for Patient Specific Radiation Treatment

Proprietary Names:

Model 1214 EPIDose

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:

Model Name:	RIT113 Film Analysis System
Common Name:	Film Scanning System
510(k) #	K935928
Manufacturer:	Radiation Imaging Technology
Submitted:	Dec 7, 1993

AUG 0 5 2013

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Image /page/1/Picture/0 description: The image shows the logo for Sun Nuclear Corporation. The logo consists of a black square with a stylized sun inside, followed by the words "SUN NUCLEAR" in bold, sans-serif font. Below that, the word "corporation" is written in a smaller, sans-serif font.

2 Description and Use:

3 Intended Use Statement:

Sun Nuclear Corporation (SNC) Model 1214 EPIDose has the following intended use:

EPIDose is indicated for radiotherapy beam QA of radiotherapy treatment plans delivered on any treatment delivery device with an EPID that outputs DICOM-compliant images.

Apart from format and lanquage refinement, the intended use statements are substantively the same for EPIDose and the predicate device.

ব Technological Characteristics

The significant technological characteristic of EPIDose is the patented method for image to dose conversion, where the image is created by an amorphous silicon (a-Si) array produced in a third-party EPID (US Patent # 8, 130,905, March 6, 2012, "Dosimetry System and Method for Radiation Therapy"). The information density and spatial resolution of the dose distribution are comparable to that of film, while the durability, repeatability and accuracy are comparable to that of the dosimetric diode array.

The predicate device utilizes film for its radiation detector, which also provides a high spatial resolution and a large area that enables measurement of dose distributions that have high dose gradients found in radiotherapy deliveries. The film must be used in conjunction with a known phantom to simulate the correct radiologic characteristics. When this film is exposed to radiation theraov beam and then developed, the result is that the film exhibits an increased optical density. When a film is exposed by a patient radiation therapy treatment plan, this optical density can then be converted to a dose distribution as would be delivered by that radiation therapy treatment.

5 Performance Data and Comparison with Predicate

EPIDose performance was verified using measurements internally performed as well as through reference. EPIDose and film results were compared for various clinical and non-clinical cases. For effective comparison of the data sets, gamma analysis was applied using a minimal pass rate of 68% with a 3.5% dose difference and 3.5 mm distance-to-agreement (DTA) tolerance, as recommended by report number 83 of the International Commission on Radiation Units and Measurements (ICRU). The pass rates for all cases were above 94%, greatly exceeding the recommended ICRU level. Given gamma analysis is a currently accepted scientific method for comparing two radiotherapy data sets and given the high level of agreement between EPIDose and film results, it is concluded that these results support a substantial equivalence determination with the predicate device.

6 Summary

The Model 1214 EPIDose intended use, performance testing, safety and effectiveness reviews demonstrate that this device is as effective, and performs as well or better than the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

August 5, 2013

Sun Nuclear Corporation % Jeff Kapatoes 3275 Suntree Blvd. MELBOURNE, FL 32940

Re: K131704

Trade/Device Name: Model 1214 EPIDose Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: June 7, 2013 Received: June 11, 2013

Dear Mr. Kapatoes:

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 10 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 docs 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.

Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The eagle is positioned to the right of a circular arrangement of text that reads "THE DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".

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Page 2 - Mr. Kapatoes

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 sct 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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 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 Form

510(k) Number (if known): K131704

Device Name: Model 1214 EPIDose

Indications for Use:

EPIDose is indicated for radiotherapy beam QA of radiotherapy treatment plans delivered on any treatment delivery device with an EPID that outputs DICOM-compliant images.

Prescription Usc X (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (2) CFR 801 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)

Michael D. O'Hara

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

K131704 210(k)

Page I 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.