The OARtrac® System pre-calibrated skin sensors are specifically indicated for use during cancer treatments to measure photon beam therapy as an adjunct to treatment planning permitting measurement of radiation dose received on the surface of the skin. OARtrac® System pre-calibrated skin sensors are indicated for use when adhered to the skin using medical grade adhesive and with a medical grade bolus buildup placed directly on top of the sensor.

Device Description

The OARtrac® System with Skin Sensors provides Radiation Oncologists with near real-time, multi-point radiation-dose information obtained from two (2) Radiatrac® Plastic Scintillating Detectors (PSD) located on the surface of the patient's skin to monitor dose photon based radiation therapy for cancer treatment. This information allows the physician to monitor the dose at the skin surface, compare the actual dose relative to the planned dose, and provides graphs and dose information for the current treatment as well as a log of the dose from five previous treatments. The actual verification of the dose radiation is accomplished by the other main components of the OARtrac® System, those being the Clinical Detector Unit (CDU) with its Charged Coupled Device (CCD) camera and the system's own proprietary dose management software.

AI/ML Overview

The provided document, a 510(k) summary for the OARtrac® System with Skin Sensors, focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for a standalone device. The device is a radiation dose verification system that measures photon beam therapy on the surface of the skin.

Here's an analysis based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in the format typically used for a standalone effectiveness study. Instead, it relies on demonstrating equivalence to a predicate device through various non-clinical tests.

However, based on the description of performance testing, we can infer some implied acceptance criteria and reported "performance" in the context of equivalence:

Acceptance Criteria (Implied)	Reported Device Performance
Overall design requirements met	Passed all testing in accordance with national and international standards
Biocompatibility	Passed Biocompatibility Testing per ISO 10993-1 (Parts 5, 10 and 11)
Package Shelf life	Passed Package Shelf-Life per ASTM F1980-07
Electrical safety	Passed Electrical Safety per IEC 60601-1
EMC (Electromagnetic Compatibility)	Passed EMC per IEC 60601-1-2
Software Verification and Validation	Passed Software Verifications and Validation per IEC 62304
Device Risk Analysis	Passed Device Risk Analysis per ISO 14971
Dose Range Verification	Results acceptable to current clinical standards when simulating treatments from a standard LINAC machine and the Accuray CyberKnife system.
Accuracy compared to predicate device (K141154)	Accurate to that within the established accuracy of the original OARtrac® System cleared under K141154.
Ship Testing Calibration	Passed Ship Testing Calibration

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

Sample Size for Test Set: The document does not specify a "test set" in the context of a dataset of patient images or outcomes for evaluating an AI algorithm. The testing described is primarily non-clinical, involving laboratory-based simulations and physical testing of the device. Therefore, a sample size of "patients" or "cases" is not applicable in this context.
Data Provenance: Not applicable. The testing is described as being performed in a laboratory setting, simulating radiation treatments.

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

Not applicable. The device measures radiation dose, and its accuracy is assessed against established physical standards and the performance of a predicate device, not through expert consensus on medical images or diagnoses.

4. Adjudication method for the test set

Not applicable, as there is no test set requiring expert adjudication for ground truth.

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 done. This device is a measurement tool for radiation dose, not an AI-assisted diagnostic or assistive tool for human readers.

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

The document does not describe the device as containing an "algorithm" in the AI sense. It is a measurement system. The "standalone" performance was assessed through non-clinical laboratory testing to verify its measurement capabilities. The performance referred to is the device itself performing its measurement function.

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

The "ground truth" for the non-clinical performance data appears to be:

Physical standards and engineering specifications: For aspects like biocompatibility, electrical safety, EMC, software verification, risk analysis, and package shelf-life, the ground truth is adherence to established national and international standards (e.g., ISO, IEC, ASTM).
Established accuracy of the predicate device: For dose range verification, the ground truth is the established accuracy of the original OARtrac® System (K141154) and "current clinical standards" for simulating treatments from LINAC and CyberKnife machines.

8. The sample size for the training set

Not applicable. This device is not described as utilizing machine learning or AI that requires a "training set."

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

Not applicable, as there is no training set for the device's functionality.

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 features a stylized depiction of a human figure, represented by three curved lines that resemble a person in profile. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern.

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

June 16, 2015

RadiaDyne, LLC % Mr. Stuart Goldman Senior Consultant Emergo Group 816 Congress Avenue, Suite 1400 AUSTIN TX 78701

Re: K150719

Trade/Device Name: OARtrac® System with Skin Sensors Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged Particle Radiation Therapy System Regulatory Class: II Product Code: NZT Dated: March 18, 2015 Received: March 19, 2015

Dear Mr. Goldman:

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 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

510(k) Number (if known)

K150719

Device Name OARtrac® System with Skin Sensors

Indications for Use (Describe)

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)

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510(k) Summary

for

OARtrac® System with Skin Sensors

1. Submission Sponsor

RadiaDyne, LLC 2313 W. Sam Houston Pkwy N Suite 107 Houston Texas, 77043, USA Phone: 281.759.9600 Fax: 281.759.9609 Contact: John Isham, President & CEO

2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701, USA Office Phone: 512.327.9997 Fax: 512.327.9998 Contact: Stuart R. Goldman, Senior Consultant, RA/QA Email: project.management@emergogroup.com

3. Date Prepared

March 18, 2015

4. Device Identification

Trade/Proprietary Name:	OARtrac® System with Skin Sensors
Common/Usual Name:	Dose radiation verification
Classification Name:	dosimeter, ionizing radiation, implanted
Classification Regulation:	892.5050
Product Code:	NZT
Device Class:	Class II
Classification Panel:	Radiology

5. Legally Marketed Predicate Device

RadiaDyne, LLC OARtrac® System (K141154)

6. Device Description

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graphs and dose information for the current treatment as well as a log of the dose from five previous treatments. The actual verification of the dose radiation is accomplished by the other main components of the OARtrac® System, those being the Clinical Detector Unit (CDU) with its Charged Coupled Device (CCD) camera and the system's own proprietary dose management software.

7. Indication for Use Statement

The OARtrac® System pre-calibrated skin sensors are specifically indicated for use during cancer treatments to measure photon beam therapy as an adjunct to treatment planning permitting measurement of radiation dose received on the surface of the skin. OARtrac® System pre-calibrated skin sensors are indicated for use when adhered to the surface of the skin using medical grade adhesive and with a medical grade bolus buildup placed directly on top of the sensor.

8. Substantial Equivalence Discussion

RadiaDyne has chosen its own OARtrac® System as the predicate device which was previously cleared under K141154, and indicated for male prostate cancer treatment to measure photon beam therapy as an adjunct to treatment planning permitting measurement of in-vivo radiation dose received at the protatic rectal interface. The following table compares the OARtrac® System with Skin Sensors to the original OARtrac® System with respect to intended use, indications for use, and performance testing between the subject and predicate device, thus demonstrating the basis for determination of substantial equivalence between the two devices.

Device	RadiaDyne	Similarities/Differences
Trade Name:	OARtrac® System with Skin Sensors	OARtrac® System	-
510(k):	Pending	K141154	-
Product Code:	NZT	NZT + PCT	The OARtrac® System with SkinSensors is based on the sametechnology of the originalOARtrac® System.
Regulation:	§892.5050	§892.5050§892.5720	The subject and predicatedevice act as a radiation doseverification system.
Class:	II	II	Same
Intended Use:	The OARtrac® System withSkin Sensors is intended foruse in photon beamradiation therapy to monitorand verify radiationtreatment dose at the	The OARtrac® System isintended for use in photonbeam radiation therapy tomonitor and verify radiationtreatment dose to thesurrounding organs at risk,	The subject and predicatedevice act as a radiation doseverification system.
		rectal interface, duringprostate external beamradiation treatment.
Indications forUse:	The OARtrac® System pre-calibrated skin sensors arespecifically indicated for useduring cancer treatments tomeasure photon beamtherapy as an adjunct totreatment planningpermitting measurement ofradiation dose received onthe surface of the skin.OARtrac® System pre-calibrated skin sensors areindicated for use whenadhered to the surface ofthe skin using medical gradeadhesive and with a medicalgrade bolus buildup placeddirectly on top of thesensor.	The OARtrac® System isspecifically indicated formale prostate cancertreatment to measurephoton beam therapy as anadjunct to treatmentplanning permittingmeasurement of in-vivoradiation dose received onthe anterior surface of amodified prostateEndorectal Balloon (ERB)device to monitor and verifythe surrounding organs atrisk, specifically the protaticrectal interface.	The OARtrac® System with SkinSensors is indicated forplacement on the surface of theskin, while the OARtrac® Systemis specifically indicated forplacement near the prostate.
Material:	Plastic scintillation detectors(PSD) are made frompolyurethane.	Plastic scintillation detectors(PSD) are made frompolyurethane.	Same
Implantable:	No	No	Same
Body Location:	Skin contacting	Placed in rectum	The OARtrac® System with SkinSensors makes skin contact,while the OARtrac® Systemmakes contact with the protaticrectal interface.
Sterile:	No	No	Same
Single Use:	Yes	Yes	Same
BiocompatibilityTesting per ISO10993-1	Yes	Yes	Same
Electrical SafetyTesting per IEC60601-1	Yes	Yes	Same
EMC Testing perIEC 60601-1-2	Yes	Yes	Same

Table 1 - OARtrac® System with Skin Sensors vs. OARtrac® System

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9. Non-Clinical Performance Data

As part of demonstrating the safety and effectiveness of the OARtrac® System with Skin Sensors and in showing substantial equivalence to the predicate device that is the subject of this 510(k) submission, RadiaDyne completed a number of tests. The OARtrac® System with Skin Sensors meets all the requirements for overall design, biocompatibility, package shelf

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life, electrical safety and EMC, which confirms that the output meets the design inputs and specifications for the device.

The OARtrac® System with Skin Sensors passed all the testing in accordance with national and international standards shown below to support substantial equivalence of the subject device to the predicate device for which substantial equivalence is being claimed.

Biocompatibility Testing per ISO 10993-1 (Parts 5, 10 and 11)
Electrical Safety per IEC 60601-1
. EMC per IEC 60601-1-2
Software Verifications and Validation per IEC 62304
. Package Shelf-Life per ASTM F1980-07
. Device Risk Analysis per ISO 14971
. Dose Range Verification Testing
Ship Testing Calibration

10. Clinical Performance Data

There was no human clinical testing required to support the OARtrac® System with Skin Sensors as the original OARtrac® System was not subjected to any human clinical studies. The non-clinical testing detailed in this submission supports the substantial equivalence of the OARtrac® System with Skin Sensors to the predicate device. The purpose of this testing was to verify that the OARtrac® System skin sensors with Radiatrac® PSD detectors provide results that are acceptable to current clinical standards when simulating treatments from a standard LINAC machine and the Accuray CyberKnife system. RadiaDyne showed that using the Radiatrac® PSD to take measurements at the surface of the skin is accurate to that within the established accuracy of the original OARtrac® System cleared under K141154.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared device, or has the same intended use and different technological characteristics, but it can be demonstrated that the new device is substantially equivalent to the predicate device, and that the new device does not raise any questions regarding its safety and effectiveness when compared to the predicate device.

The OARtrac® System with Skin Sensors functions as a radiation does verification system when the patient receives their radiation treatment to the targeted area of their body applied at the surface of their skin. Therefore, based on the substantial equivalence analysis described above, the OARtrac® System with Skin Sensors, as designed, developed and manufactured for RadiaDyne, is determined to be substantially equivalent to the company's original OARtrac® System (K141154).

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.