Model 1218028 Dose Calculator computes a dose volume for a user-specified treatment delivery device based on user-provided three dimensional volumetric imaging information (e.g., computed tomography) and beam intensity values. Both the imaging data and beam intensity values are specified in DICOM-RT format. The beam model for the specified treatment delivery device is provided with the software. The output of the SDC is a DICOM RT dose volume.

The Dose Calculator is for use with external beam photon radiation therapy calculations. Charged particle radiotherapy calculations (including electron, proton, and heavy ion therapy) are not indicated for use with this product.

The Dose Calculator software application is considered to be a software module that may be used by several Sun Nuclear Corporation products and/or 300 party applications.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Model 1218028 Dose Calculator." It does not contain the detailed study information typically found in a clinical trial report or a comprehensive validation study. The document primarily focuses on establishing substantial equivalence to a predicate device.

Therefore, many of the requested categories cannot be fully answered with the information available.

Here's an attempt to extract what is present and indicate what is missing:

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

The document states: "Test results of the modified device have demonstrated that the device performs within its design specifications and equivalently to the predicate device." However, specific acceptance criteria or quantitative performance metrics are not provided in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "appropriate bench testing methods" but does not specify the sample size of the test set, the provenance of the data, or whether it was retrospective or prospective.

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 and is unlikely to be relevant for this type of device (a dose calculator) where "ground truth" would likely be established through physical measurements or established theoretical models, not expert consensus on images.

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

Adjudication methods are typically used for subjective assessments by experts. Since the device calculates dose volumes, and the "ground truth" establishment is not explicitly described, this information is not provided and likely not applicable in the traditional sense.

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 does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a dose calculator, not an AI-assisted diagnostic tool that would typically involve human readers.

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

The document describes the device as "a software product intended to compute a radiotherapy dose volume." This inherently implies a standalone performance of the algorithm in its primary function, as it computes the dose volume based on inputs. The statement "Test results of the modified device have demonstrated that the device performs within its design specifications" suggests standalone testing, but explicit details of "standalone performance" metrics are not provided.

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

The document does not explicitly state the type of "ground truth" used. For a dose calculator, the ground truth would likely be derived from:

Physical measurements: Using phantoms and dosimeters to measure actual dose distribution.
Established reference calculations/models: Comparing the device's output to results from validated and widely accepted dose calculation algorithms or commercial treatment planning systems.
Theoretical physics principles: Ensuring calculations adhere to fundamental physics.

Given the context of "bench testing," it's highly probable that physical measurements or comparisons to established reference systems were used, but this is not explicitly stated.

8. The sample size for the training set

The document does not mention a training set sample size. This type of device, which computes dose volumes based on physical models and inputs, is generally not "trained" on a dataset in the way a machine learning algorithm for image recognition would be. Its "knowledge" is embedded in its beam model and calculation algorithms.

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

As there is no mention of a traditional "training set" for machine learning, this information is not applicable/provided. The "ground truth" for the device's underlying models (like beam models) would be established through extensive calibration and measurement using dosimetric equipment and physical phantoms, but this process is not detailed here.

Summary

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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.

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

May 20, 2015

Sun Nuclear Corporation % Mr. James Luker Regulatory Affairs Manager 3275 Suntree Boulevard MELBOURNE FL 32940

Re: K150848

Trade/Device Name: Model 1218028 Dose Calculator Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 13, 2015 Received: March 31, 2015

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. 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 (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 O'Hara

For

Robert Ochs, Ph.D. Acting 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): _ K150848

Device Name: Model 1218028 Dose Calculator

Indications for Use:

The Sun Nuclear Dose Calculator is a software product intended to compute a radiotherapy dose volume.

Prescription 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 (OIR)

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

K150848 510(k)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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

Section 5 - 510(k) Summary

Provided in accordance with 21 CFR 807.92 (c)

1 General Provisions

Date Prepared:

March 12, 2015

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:

James Luker JamesLuker@sunnuclear.com

Ph: 321-259-6862 extension 2428

Classification Name:

Accelerator, Linear, Medical

Common Name:

Secondary check QA software

Proprietary Names:

Model 1218028 Dose Calculator

Establishment Registration Number:

1038814

Classification:

Regulation Number: 21 CFR 892.5050 Name: Accelerator, Linear, Medical Product code: IYE

Class II

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Predicate Device(s):

Model Name:	Mobius 3D
Common Name:	Secondary check QA software
510(k) #	K140660
Manufacturer:	Mobius Medical Systems, LP
Submitted:	May 05, 2014

To our knowledge, this predicate has not been subject to a designrelated recall.

2 Description and Use:

The Dose Calculator software application is considered to be a software module that may be used by several Sun Nuclear Corporation products and/or 300 party applications.

3 Intended Use Statement:

The Sun Nuclear Dose Calculator is a software product intended to compute a radiotherapy dose volume.

ব Technological Characteristics

The primary technological characteristics of the Model 1218028 Dose Calculator are the usage of three dimensional volumetric imaging information and beam intensity values in DICOM-RT format to compute a dose volume (also in DICOM-RT format). The technological characteristics are believed to be substantially equivalent to the predicate device.

5 Performance Data and Comparison with Predicate

Model 1218028 Dose Calculator has been tested using appropriate bench testing methods. Test results of the modified device have demonstrated that the device performs within its design specifications and equivalently to the predicate device.

6 Summarv

Model 1218028 Dose Calculator is believed to be substantially equivalent to the predicate Mobius 3D device due to the similarities in function, technology, and performance. The intended use, performance testing, safety and effectiveness reviews demonstrate that Model 1218028 Dose Calculator is as safe, as effective, and performs as well as the predicate device.

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.