PerFRACTION allows for the comparison of the cumulative exit image(s) for one treatment fraction to the cumulative exit image(s) for another treatment fraction, thus providing a consistency check on the delivery of the treatment fraction.

Device Description

PerFRACTION™ is a device that includes software installed on standard, modern computing hardware (provided with the software) that allows clinicians to perform quality assurance for each fraction of a radiotherapy treatment plan. PerFRACTION compares the beam-exit measurement data from a treatment fraction to data from a prior baseline fraction. This comparison allows for the detection of errors that may occur with the delivery system such as the multi-leaf collimator, accelerator, and collimating jaws.

AI/ML Overview

The FDA 510(k) summary for the PerFRACTION (Model 1215) device provides limited information regarding specific acceptance criteria and detailed study designs. However, based on the provided text, here's what can be extracted and inferred:

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

The document does not explicitly state a table of acceptance criteria with numerical targets. Instead, it broadly states: "PerFRACTION™ has been tested in non-clinical and clinical settings, and it has been shown that this device performs within its design specifications."

It further elaborates on the types of errors the device was tested to detect:

Errors in the collimation jaws
Errors in multileaf collimator leaves
Errors in accelerator output
Errors in gantry rotation of the treatment delivery device

The performance claim is: "Based on the results of this performance testing when evaluated against published data for the predicate, Model 1215 PerFRACTION is as safe, as effective, and performs as well or better than the predicate device."

Inferred Acceptance Criteria (based on the description):
The device is expected to reliably detect errors in the delivery of radiation therapy treatment, specifically those related to collimation jaws, MLCs, accelerator output, and gantry rotation, to a degree comparable to or better than the predicate device.

Reported Device Performance:
The device "performs within its design specifications" and is "as safe, as effective, and performs as well or better than the predicate device" in detecting the specified errors.

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

The document does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that the device was "tested in non-clinical and clinical settings."

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

This information is not provided in the document.

4. Adjudication method for the test set

This information is not provided in the document.

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 an MRMC study or any assessment of human reader improvement with or without AI assistance. The device is described as software that performs a consistency check, implying a standalone analysis rather than an assistive tool for human interpretation.

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

Yes, based on the description, a standalone performance assessment was done. The device "compares the beam-exit measurement data from a treatment fraction to data from a prior baseline fraction," and this comparison "allows for the detection of errors." This implies the algorithm (PerFRACTION) performs the detection independently.

7. The type of ground truth used

The document does not explicitly state the type of ground truth used. However, given that the device detects "errors that can occur in the delivery of a patient's radiation therapy treatment" and was tested when "exposed to errors," it strongly suggests that the ground truth was based on known, induced errors or simulated errors in a controlled environment, likely confirmed by physical measurements or pre-defined error scenarios. It could also potentially involve comparison against highly precise reference measurements or other established QA methods.

8. The sample size for the training set

The document does not mention a "training set" or its sample size. This suggests that the device might not be based on a machine learning model that requires explicit training data in the typical sense. It seems to be a rule-based or algorithmic comparison system.

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

As no training set is explicitly mentioned, this information is not provided.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three intertwined snakes and a staff.

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

September 26, 2014

Sun Nuclear Corporation % Mr. Jeff Kapatoes Sr. Director Product Management 3275 Suntree Boulevard MELBOURNE FL 32940

Re: K141800

Trade/Device Name: PerFRACTION (Model 1215) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 30, 2014 Received: July 3, 2014

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 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.

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

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. 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

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

Indications for Use Form

510(k) Number (if known):

Device Name: Model 1215 PerFRACTION

Indications for Use:

PerFRACTION is intended to allow for the detection of errors that can occur in the delivery of a patient's radiation therapy treatment.

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)

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

K141800 510(k)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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

Image /page/3/Picture/1 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. To the right of the image is the company name, "SUN NUCLEAR" in large blue letters, with "corporation" in smaller blue letters below.

510(k) Summary K141800

Provided in accordance with 21 CFR 807.92 (c)

1 General Provisions

Date Prepared:

June 30, 2014

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

Common Name:

Quality Assurance for Patient Radiation Treatment

Trade Names:

Model 1215 PerFRACTION™

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

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

Image /page/4/Picture/1 description: The image is a logo for Sun Nuclear Corporation. The logo features a blue square with a yellow circle inside of it on the left side. The words "SUN NUCLEAR" are in large blue letters, and the word "corporation" is in smaller blue letters below it.

2 Description:

3 Intended Use Statement:

Model 1215 PerFRACTION is intended to allow for the detection of errors that can occur in the delivery of a patient's radiation therapy treatment.

ব Technological Characteristics

PerFRACTION™ utilizes the output from the electronic portal imaging device (EPID) that is part of the treatment delivery device to perform a consistency check between fractions, while the predicate uses an array of ionization chambers. The EPID confers the advantage of having very high density detectors (0.4 mm spacing or less) while the predicate offers the use of ionization chambers. The latter item is not viewed as significant as PerFRACTION performs a consistency check fraction and does not convert EPID signal to dose.

5 Performance Data

PerFRACTION™ has been tested in non-clinical and clinical settings, and it has been shown that this device performs within its design specifications. Performance testing involved assessment of the device when exposed to errors in the collimation jaws, multileaf collimator leaves, accelerator output, and gantry rotation of the treatment delivery device. Based on the results of this performance testing when evaluated against published data for the predicate, Model 1215 PerFRACTION is as safe, as effective, and performs as well or better than 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.