Model 1212 3DVH is a radiotherapy dose delivery quality assurance (QA) software application intended to estimate the dosimetric impacts of the deviations and imperfections of a treatment delivery device. and its accessories, on the 3D patient dose volume as defined by a treatment planning system (TPS). These dosimetric impacts are based upon QA measurement of the radiation dose distributions that are delivered to a phantom.

Device Description

The Sun Nuclear 3DVH product, model 1212, is a software application that creates an estimated patient dose distribution using data measured during delivery of the treatment plan to certain 2D or 3D detector arrays and the planning patient dose volume computed by the treatment planning system (TPS) as inputs. The patented 3DVH dose algorithm (US patent #7,945,022) uses the measured data to make perturbations to the TPS patient dose volume to produce the estimated patient dose volume. From a comparison of the 3DVH result to the TPS 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

The provided text describes a 510(k) summary for the Sun Nuclear Model 1212 3DVH device, a radiotherapy dose delivery quality assurance (QA) software application. However, the document does not explicitly state specific acceptance criteria or provide a detailed study proving the device meets acceptance criteria. It contains general statements about performance testing but lacks the quantitative details required to answer your request fully.

Based on the information available:

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

The document does not explicitly list quantitative acceptance criteria (e.g., specific thresholds for accuracy, precision, or agreement metrics). It only states: "3DVH has been tested in non-clinical and clinical settings, and it has been shown that this device performs within its design specifications and industry-specific guidelines. Performance testing included extensive benchmarking of the dose calculation algorithm (its individual components and as an integrated whole). Performance testing also included confirmation of the computed dose volume histogram data and comparison tools such as dose different, distance-to-agreement, and gamma index analysis. Based on the results of this performance testing, Model 1212 3DVH is as safe, as effective, and performs as well or better than the predicate device."

Without specific numerical criteria or results, a table cannot be constructed.

2. Sample size used for the test set and the data provenance:

The document states: "3DVH has been tested in non-clinical and clinical settings". However, it does not provide any details about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not mention the use of experts or the establishment of ground truth for a test set in the context of device performance testing. The intended use specifies that a "qualified clinician makes the decision whether the TDD along with its accessories... is capable of delivering the treatment as prescribed," but this refers to the ultimate clinical decision-making, not the evaluation of the device's algorithmic performance against a ground truth during testing.

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

Since there is no mention of experts establishing a ground truth for a test set, there is no information about an adjudication method.

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 describes the 3DVH as a "software application that creates an estimated patient dose distribution" and "intended to estimate the dosimetric impacts." It does not describe an MRMC comparative effectiveness study involving human readers or any assessment of human improvement with or without AI assistance. The device's function is to provide an estimated dose volume, which a clinician then uses for decision-making, but its performance is evaluated on its accuracy in generating that estimate, not on how it changes human interpretation in a comparative effectiveness study.

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

The performance testing described primarily evaluates the algorithm itself. The text states: "Performance testing included extensive benchmarking of the dose calculation algorithm (its individual components and as an integrated whole)." This strongly implies that standalone (algorithm only) performance was assessed.

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

The document implies that the ground truth for evaluating the dose calculation algorithm would be physical dose measurements or highly accurate simulated dose distributions that the algorithm aims to match. It mentions the "use of DICOM input data" and that the algorithm uses "measured data to make perturbations to the TPS patient dose volume." The goal is to produce an "estimated patient dose volume." Therefore, the ground truth would likely be external reference dose datasets or actual physical measurements.

8. The sample size for the training set:

The document does not provide any information regarding a training set size.

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

Since there is no mention of a training set, there is no information on how its ground truth was established.

Summary

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K13/862

Image /page/0/Picture/1 description: The image shows the logo for Sun Nuclear Corporation. The logo consists of a stylized image of a circle with horizontal lines inside it, followed by the words "SUN NUCLEAR" in large, bold letters. Below that, the word "corporation" is written in smaller letters.

Your Most Valuable QA & Dosimetry Tools

Section 6 - 510(k) Summary

Provided in accordance with 21 CFR 807.92 (c)

1 General Provisions

Date Prepared:

June 21, 2013

Submitted by:

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

AUG 2 1 2013

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 1212 3DVH

Establishment Registration Number:

1038814

Classification:

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

Predicate Device:

Model Name:	Compass
Common Name:	Accelerator, linear, medical
510(k) #	K072374
Manufacturer:	Scanditronix Wellhdfer GmbH
Cleared:	Dec 7, 2007

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Image /page/1/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 entire logo is in black and white.

2 Description:

ന Intended Use Statement:

Sun Nuclear Corporation (SNC) Model 1212 3DVH has the following intended use:

Model 1212 3DVH is a radiotherapy dose delivery quality assurance (QA) software application intended to estimate the dosimetric impacts of the deviations and imperfections of a treatment delivery device, and its accessories, on the 3D patient dose volume as defined by a treatment planning system (TPS). These dosimetric impacts are based upon QA measurement of the radiation dose distributions that are delivered to a phantom.

While the exact wording of this Intended Use and that for the predicate are not identical, the intended uses are substantively the same with one exception: Compass claims input from "online or offline measurements". "Online" use implies with the patient present during patient treatment. Model 3DVH is only intended with input from "offline" measurements, i.e without the patient present. This difference is not critical to the intended diagnostic use of the device since 3DVH is intended for quality assurance performed without the patient present, typically done before treatment commences. The difference does not affect the safety and effectiveness of the device when used as labeled because 3DVH is only intended to be used with input acquired offline. Use of online measurements would constitute a different intended use and thus a different product.

ব Technological Characteristics

Model 1212 3DVH shares both similar and different technological characteristics. Similar characteristics include the use DICOM input data from third party treatments systems and analysis tools such as dose volume histogram (DVH) display, color-wash dose display for multiple anatomical planes, and structure-based dose statistics. A different technological characteristic is the algorithm used to produce the estimated patient dose volume.

5 Performance Data

3DVH has been tested in non-clinical and clinical settings, and it has been shown that this device performs within its design specifications and industry-specific quidelines. Performance testing included extensive benchmarking of the dose calculation algorithm (its individual components and as an integrated whole). Performance testing also included confirmation of the computed dose volume histogram data and comparison tools such as dose different, distance-to-agreement, and gamma index analysis. Based on the results of this performance testing, Model 1212 3DVH is as safe, as effective, and performs as well or better than the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, which is a symbol often associated with healthcare.

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

August 21. 2013

Sun Nuclear Corporation % Jeff Kapatoes. Ph.D. Product Manager 3275 Suntree Blvd. MELBOURNE FL 32940

Re: K131862

Trade/Device Name: Model 1212 3DVH Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 21, 2013 Received: June 27, 2013

Dear Dr. Kapatoes:

We have reviewed vour 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. Isting 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

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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 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/McdicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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.

Jamingh. Mense

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): K131862

Device Name: Model 1212 3DVH

Indications for Use:

Intended Use:

Perseription Use X (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (21 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 (OJR)

Jaming M. Mense

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

510(k)

Page 1 of 1

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.