Model 1177 MapCHECK 2 is a two-dimensional (2D) radiotherapy beam dosimetry QA system intended for the measurement of radiation dose distributions for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS).

ArcCHECK, Model 1220 is a three-dimensional (3D) radiotherapy beam dosimetry QA system intended for the measurement of radiation dose distributions for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS).

Device Description

The Model 1177 MapCHECK 2 and Model 1220 ArcCHECK devices are diode detector arrays that allow the user to perform radiation therapy delivery quality assurance (QA) and dosimetry.

The MapCHECK 2 is a two-dimensional detector array intended to measure radiation dose distribution. The 1527 diode detectors are embedded in polymethyl methacrylate (PMMA) phantom in an array size of 32 cm, with a detector spacing of 7.07 mm and a weight of 7.1 kg. With the provided software installed on the user's computer and connected to the MapCHECK 2 with an 8 pin DIN power/data conduit cable, the software provides the ability for the user to perform QA analysis of a patient's radiation therapy plan prior to treatment.

The ArcCHECK is a three-dimensional cylindrical detector array designed for coherent measurement geometry during rotational treatment delivery. The 1386 diode detectors are embedded in a PMMA phantom on a cylindrical geometric surface with an array size of 21 cm diameter x 21 cm length, with a detector spacing of 10 mm and a weight of 16 kg. This cylindrical array allows for dosimetry measurements to be made from all gantry angles as the therapy beam rotates about the diode array. With the provided software installed on the user's computer and connected to the ArcCHECK with an 8 pin DIN power/data conduit cable, the software provides the ability for the user to perform QA analysis of a patient's radiation therapy plan prior to treatment.

Both MapCHECK 2 and ArcCHECK use the same software application that includes functions for array and dose calibration; measurement and display of the spatial distribution of the dose resulting from delivery of a radiation treatment plan; saving the measurement; importing the treatment planning system (TPS) calculated dose distribution; comparing the measured and planned dose distributions using the analysis methods of gamma or dose difference and distance to agreement (DTA) with user specified analysis criteria; and a report of this analysis that includes percent pass rates.

AI/ML Overview

The provided document describes the Sun Nuclear MapCHECK 2 and ArcCHECK devices, which are radiation therapy dosimetry quality assurance (QA) systems. However, it does not explicitly state quantitative acceptance criteria or a detailed study proving the device meets those criteria.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (RIT113 Film Analysis System, K935928) based on intended use, performance testing, safety, and effectiveness.

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific quantitative acceptance criteria (e.g., pass rates for gamma analysis, dose difference thresholds) are provided in the document. The performance is described qualitatively as having "correlation with the actual treatment plan" and "good correlation" when compared to film dosimetry devices.

Acceptance Criteria (Implied)	Reported Device Performance
Correlation with actual treatment plan	"results were found to have correlation with the actual treatment plan"
Correlation with film dosimetry	"results had good correlation"
Compliance with design specifications	"perform within their design specifications"
Electrical safety and EMC standards	"compliance with relevant electrical safety and EMC standards"

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

Sample Size: Not explicitly stated. The document mentions "known patient treatment plan outputs" and "tests were also performed to compare the results... with film dosimetry devices." This suggests a test set was used, but its size is not quantified.
Data Provenance: The tests were conducted in "non-clinical and clinical settings," but no specific country of origin is mentioned. It discusses "patient treatment plan outputs," implying patient-specific data, but it's unclear if this refers to retrospective clinical data or simulated patient plans. The design suggests these are phantom-based measurements against planned data, not direct measurements on patients.

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 "ground truth" for the device's comparison is the "simulated dose distribution... as calculated by the treatment planning system (TPS)" and "film dosimetry devices." This implies the "ground truth" is derived from computational models and established dosimetry methods rather than expert human interpretation of image data.

4. Adjudication Method for the Test Set:

Not applicable/Not provided. The testing described involves comparing a measured dose distribution from the device to a calculated dose distribution from a TPS or a measured distribution from a film dosimetry device. This is an objective, quantitative comparison (e.g., gamma analysis, dose difference, DTA) rather than a subjective human adjudication process.

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. This document describes a device for objective dose measurement and QA in radiation therapy, not an AI-assisted diagnostic tool that would involve human readers or interpretation of complex medical images. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device and was not performed.

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

This device essentially operates in a "standalone" manner in terms of its measurement capabilities. It measures the radiation dose distribution, and its software then provides quantitative comparisons (e.g., gamma analysis, dose difference). The output (pass rates, dose maps) is then presented to a human user for review and decision-making. The core measurement and comparison functionality within the software can be considered an "algorithm only" performance, as it objectively compares two dose distributions based on predefined criteria. The human's role is to define the comparison criteria (e.g., gamma parameters) and interpret the results, but the device's primary function is the automated measurement and comparison.

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

The ground truth used for performance evaluation is primarily:
- Treatment Planning System (TPS) calculated dose distributions: The device's measurements are compared against the expected dose distributions generated by the TPS.
- Film dosimetry results: Comparisons were also made against measurements from established film dosimetry devices, which themselves serve as a reference for dose distribution measurement.

8. The sample size for the training set:

Not applicable/Not provided. The MapCHECK 2 and ArcCHECK are hardware devices with associated software for measurement and analysis, not machine learning or AI algorithms that require a "training set" for model development.

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

Not applicable/Not provided. As stated above, these devices do not involve machine learning and therefore do not have a "training set" in the conventional sense.

Summary

{0}------------------------------------------------

K131466

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, uppercase letters. Below "SUN NUCLEAR" is the word "corporation" in a smaller, non-bold font. The logo is simple and professional, conveying a sense of reliability and expertise.

Your Most Valuable QA & Dosimetry Tools

Section 6 - 510(k) Summary

Provided in accordance with 21 CFR 807.92 (c)

General Provisions 1

Date Prepared:

May 17, 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 jkapatoes@sunnuclear.com

Classification Name:

Accelerator, Linear, Medical

Common Name:

Dosimetric Quality Assurance for Patient Specific Radiation Treatment

Proprietary Names:

Model 1177 MapCHECK 2 Model 1220 ArcCHECK

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) # Ka35928 Manufacturer: Radiation Imaging Technology Dec 7, 1993 Submitted:

AUG 20 2013

{1}------------------------------------------------

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.

2 Description and Use:

The Model 1177 MapCHECK 2 and Model 1220 ArcCHECK devices are diode detector arrays that allow the user to perform radiation therapy delivery quality assurance (QA) and dosimetrv.

3 Intended Use Statements:

Sun Nuclear Corporation (SNC) Model 1177 MapCHECK 2 and Model 1220 ArcCHECK have the following intended use:

Model 1220 ArcCHECK is a three-dimensional (3D) radiotherapy beam dosimetry QA system intended for the measurement of radiation dose distributions for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS).

4 Technological Characteristics

The primary technological characteristic of the MapCHECK 2 and the ArcCHECK is the high spatial resolution of the diode detector with an array size and a detector density that enables measurement of dose distributions that have high dose gradients found in radiotherapy deliveries. The spatial resolution of the diode detector is 0.8 mm x 0.8 mm, resulting in very little dose volume averaging over the high dose gradient regions in the plan.

The MapCHECK 2 serves as a 2D phantom with the array of detectors located on a 2D surface embedded at a radiological depth of 2 g/cm². The ArcCHECK serves as a 3D

{2}------------------------------------------------

Image /page/2/Picture/0 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, uppercase letters. Below that, the word "corporation" is written in a smaller, lowercase font. The logo is simple and professional, conveying a sense of reliability and expertise.

phantom with the detectors located on a 3D cylindrical surface embedded at a radiological depth of 3 g/cm².

The predicate device utilizes silver halide film for its radiation detector, which also provides a high spatial resolution and a large area (25 cm x 30 cm) 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 from a radiation therapy 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

The MapCHECK 2 and the ArcCHECK have been tested in non-clinical and clinical settings, and it was shown that these devices perform within their design specifications. Tests that compare known patient treatment plan outputs with that measured by these devices have been conducted; the results were found to have correlation with the actual treatment plan.

Tests were also performed to compare the results of the MapCHECK 2 and the ArcCHECK with film dosimetry devices. It was determined that the results had good correlation.

Performance testing also indicated compliance with relevant electrical safety and EMC standards.

6 Summary

The Model 1177 MapCHECK 2 and the Model 1220 ArcCHECK are deemed substantially equivalent to the predicate device. The intended use, performance testing, safety and effectiveness reviews demonstrate that these devices are as safe, as effective, and perform as well or better than the predicate device. The minor technological differences between the MapCHECK 2, the ArcCHECK and the predicate do not raise new types of safety or effectiveness questions.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling human figures or waves, stacked vertically.

Public Health Service

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

August 20, 2013

JEFF KAPATOES PRODUCT MANAGER SUN NUCLEAR CORPORATION 3275 SUNTREE BLVD. MELBOURNE FL 32940

Re: K131466

Trade/Device Name: MapCheck 2, ArcCheck Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 18, 2013 Received: July 19, 2013

Dear Dr. 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 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 (sec 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 (Scctions 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

Page 2-Dr. Kapatoes

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/Resourcesfor You/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 vours,

Sammy H. Presto

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

510(k) Number (if known): K131466

Device Name:Model 1177 MapCHECK2 and Model 1220 ArcCHECK

Indications for Use:

Perscription 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)

Flaminghi. Meroe

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

510(k)_k131466

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.