Model 1220-MR ArcCHECK-MR is a three dimensional diode sensor used for ionizing radiation measurement for radiotherapy quality assurance. The cylindrical diode array is embedded in a cylindrical plastic phantom that allows for dosimetry measurements to be made from all gantry angles as the therapy beam rotates about the diode array.

The provided GUI 'SNC Patient' software application installed on the user's computer and connected to the Model 1220-MR ArcCHECK-MR by an 8 pin DIN cable and is unchanged from the K142617 predicate device.

This submission introduces Model 1220-MR ArcCHECK-MR. This model is equivalent in form and function to the cleared Model 1220, but has been verified as an MR-conditional product.

AI/ML Overview

The provided document is a 510(k) summary for the ArcCHECK-MR device, which is an ionizing radiation measurement device for radiotherapy quality assurance. It focuses on demonstrating substantial equivalence to a predicate device (ArcCHECK) rather than providing detailed acceptance criteria and a comprehensive study report for the device's performance.

Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test and training sets, data provenance, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text.

However, I can extract the following based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in a table format. Instead, it states that "Test results of the modified device have demonstrated that the device performs within its design specifications and equivalently to the predicate K142617 Model 1220 ArcCHECK device."

The primary change to the device is its MR-conditional status, achieved through material changes (stainless steel hardware instead of carbon steel). The equivalence is based on the subject device performing "as well as" the predicate.

Acceptance Criteria (Inferred from equivalence claim)	Reported Device Performance (Inferred from equivalence claim)
Performs within design specifications.	Test results demonstrated the device performs within its design specifications.
Performs equivalently to the predicate K142617 Model 1220 ArcCHECK device.	Performed equivalently to the predicate K142617 Model 1220 ArcCHECK device.
Is as safe, as effective, and performs as well as the K142617 predicate device.	Demonstrated to be as safe, as effective, and performs as well as the K142617 predicate device.
MR-Conditional status.	Designed and tested for conditional use in an MR environment.

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

The document states that the device was "tested using appropriate bench testing methods." However, it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This is typically detailed in a full test report, not a 510(k) summary.

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

The document does not provide information regarding experts used to establish ground truth or their qualifications. The testing appears to be primarily bench testing for functionality and MR compatibility, not a clinical study involving human interpretation.

4. Adjudication method for the test set

The document does not provide information regarding an adjudication method. This is not typically relevant for bench testing of a radiation measurement device.

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 or mentioned. The device is a "three-dimensional (3D) ionizing radiation measurement device" for quality assurance, not an AI-powered diagnostic tool for human readers.

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

The device itself is a measurement tool; its performance is inherently "standalone" in the sense that it collects radiation data. The "SNC Patient" software processes this data. The document states that "Test results of the modified device have demonstrated that the device performs within its design specifications and equivalently to the predicate..." indicating standalone performance testing was conducted, but details of this standalone testing (metrics, full results) are not provided.

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

For a radiation measurement device, the "ground truth" would likely be based on established physics principles and validated reference dosimetry measurements from calibrated instruments or computational models. The document does not explicitly state the type of ground truth but implies it through "bench testing methods" and comparison to a predicate device's established performance.

8. The sample size for the training set

The device is a hardware measurement device with associated software. It does not appear to be an AI/machine learning model that requires a "training set" in the conventional sense. The "SNC Patient" software is described as "unchanged from the K142617 predicate device," suggesting its algorithms are already developed and validated.

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

As there is no indication of an AI/machine learning training set, this information is not applicable/provided.

Summary

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Image /page/0/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 three overlapping human profiles or faces, depicted in a dark color.

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

May 13, 2016

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

Re: K160057

Trade/Device Name: ArcCHECK-MR Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 15, 2016 Received: April 19, 2016

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.'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration
Indications for Use	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below

510(k) Number (if known)	K160057
Device Name	Model 1220-MR ArcCHECK-MR
Indications for Use (Describe)	Model 1220-MR ArcCHECK-MR is a three-dimensional (3D) ionizing radiation measurement device intended for radiotherapy quality assurance.

Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

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information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)	Page 1 of 1
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Image /page/3/Picture/0 description: The image contains the logo for Sun Nuclear Corporation. The logo consists of a blue square with rounded corners on the left side, inside of which is a yellow circle with several horizontal lines. To the right of the square is the text "SUN NUCLEAR" in blue, with the word "corporation" underneath it in a smaller font size, also in blue.

510(k) Summary

Provided in accordance with 21 CFR 807.92 (c)

1 General Provisions

Date Prepared:

March 25, 2016

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

Common Name:
Dosimetric Quality Assurance for Patient Specific Radiation Treatment

Proprietary Names:

Model 1220-MR ArcCHECK-MR

Establishment Registration Number:

1038814

Classification:

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

Class II

Predicate Device(s):

Model Name:	Model 1220 ArcCHECK
Common Name:	Dosimetric Quality Assurance for Patient SpecificRadiation Treatment
510(k) #	K142617 (primary predicate), K131466
Manufacturer:	Sun Nuclear Corporation.
Submitted:	September 16, 2014, May 21, 2013

The predicate devices have not been subject to a design-related recall.

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2 Description and Use:

This submission introduces Model 1220-MR ArcCHECK-MR. This model is equivalent in form and function to the cleared Model 1220, but has been verified as an MR-conditional product.

3 Intended Use Statement:

Model 1220-MR ArcCHECK-MR is a three-dimensional (3D) ionizing radiation measurement device intended for radiotherapy quality assurance.

ব Technological Characteristics

The following table provides a comparison between Model 1220-MR ArcCHECK-MR and the predicate Model 1220 ArcCHECK device.

1220-MR ArcCHECK MR (subject device)	1220 ArcCHECK (predicate device)	Comparison
The primary technologicalcharacteristics of model 1220-MRArcCHECK-MR is the high spatialresolution of the diode detector withan array size and a detector densitythat enables measurement of dosedistributions that have high dosegradients found in radiotherapydeliveries.	The primary technologicalcharacteristics of model 1220ArcCHECK is the high spatial resolutionof the diode detector with an array sizeand a detector density that enablesmeasurement of dose distributions thathave high dose gradients found inradiotherapy deliveries.	Both the subject device andpredicate device have the sameprimary technologicalcharacteristics.
Model 1220-MR ArcCHECK-MR is anMR Conditional device.	Model 1220 ArcCHECK is an MRunsafe device.	The subject device has beendesigned and tested for conditionaluse in an MR environment. Eachmodel will be labeled appropriatelyfor its use environment.
Model 1220-MR ArcCHECK-MRserves as a 3D Phantom.	Model 1220 ArcCHECK serves as a 3DPhantom	Both the subject device andpredicate device serve as 3DPhantoms
Hardware/software platform-	Hardware/software platform-	Both the subject device and
Industry Standard personal computerhardware and Windows basedsoftware	Industry Standard personal computerhardware and Windows based software	predicate device use IndustryStandard personal computerhardware and Windows basedsoftware
Materials	Materials	The subject device utilizes
PMMA cylinder with printed circuitboards. Use of stainless steelhardware.	PMMA cylinder with printed circuitboards. Use of some carbon steelhardware.	Stainless steel in an attempt tominimize the potential magneticattraction properties

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5 Performance Data and Comparison with Predicate

Model 1220-MR ArcCHECK-MR 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 K142617 Model 1220 ArcCHECK device.

6 Summary

Model 1220-MR ArcCHECK-MR is believed to be substantially equivalent to the predicate ArcCHECK device due to the similarities in function, technology, and performance. The intended use, performance testing, safety and effectiveness reviews demonstrate that Model 1220-MR ArcCHECK-MR is as safe, as effective, and performs as well as the K142617 predicate device. The changes to the predicate device described within this submission are not thought to 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.