The OARtrac® System with patient specific, reusable, pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body, and indicated for use when adhered to the skin with a bolus, or inserted into the rectum to measure the rectal prostatic interface via a specifically designed endorectal balloon device.

Device Description

The OARtrac® System with patient specific, reusable, pre-calibrated PSD sensors is intended for use in photon radiation therapy to monitor and validate radiation dose during External Beam Therapy and HDR Brachytherapy to the surface of the skin or the rectal prostatic interface. This dose verification information obtained during the treatment is then used to compare with the planned dose that the Radiation Oncologists expect to provide to their patient. The OARtrac® System itself does not stop the radiation treatment to the patient, or change the radiation delivery, but only provides dose data which a trained Radiation Oncologist can decipher and use to adjust a patient's treatment plan accordingly.

AI/ML Overview

The provided text does not contain information about an Artificial Intelligence (AI) device or a study proving its performance against acceptance criteria in the context of AI. The document is a 510(k) premarket notification for a medical device called the "OARtrac® System with Patient Specific Reusable PSD Sensors," which is a radiation dose verification system.

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through non-clinical performance data related to material, electrical safety, EMC, software, package shelf-life, risk analysis, dose range verification, and importantly, cleaning and disinfection validation for reusability.

Therefore, I cannot provide the requested information regarding AI device acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies, as these concepts are not addressed in the provided text.

Specifically:

A table of acceptance criteria and the reported device performance: The document lists "Key Performance Specifications/Characteristics" for the device, which includes:
- Photon Energy Based Therapies: Energy Range .37-18 MeV
- Dose Rate Range: 1.3-17.3 cGy/s
- Dose Range: 27-1200 cGy
- Dose Accuracy: +/-6%, 2 σ
  It states that the subject device meets these requirements, and that "all the testing" was passed. However, it does not provide detailed performance results in a table format comparing acceptance criteria to reported performance for each specific test item in the same way an AI model's performance metrics (e.g., sensitivity, specificity, accuracy) would be presented against pre-defined thresholds. The key focus of this submission is on the reusability validation.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a non-AI device. The testing described is primarily laboratory-based non-clinical performance validation (e.g., electrical safety, EMC, cleaning/disinfection validation). Specific sample sizes for these types of engineering tests are not detailed in this summary.
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): Not applicable. "Ground truth" in the context of expert consensus is relevant for AI diagnostic or prognostic devices. For this device, "ground truth" would relate to verifiable physical measurements in a laboratory setting for dose accuracy, cleaning efficacy, etc. The document does not specify experts for establishing such ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a non-AI device's non-clinical performance testing.
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: Not applicable, as this is not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests mentioned, the "ground truth" would be established by standard engineering and scientific methodologies (e.g., calibrated reference instruments for dose measurement, laboratory testing protocols for cleaning/disinfection efficacy, an accredited laboratory for biocompatibility).
The sample size for the training set: Not applicable, as this is not an AI device and thus has no training set in that context.
How the ground truth for the training set was established: Not applicable, as this is not an AI device.

Summary

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

June 1, 2017

RadiaDyne, LLC % Mr. Stuart Goldman Senior Consultant Emergo Group 2500 Bee Cave Road, Bldg. 1, Suite 300 AUSTIN TX 78746

Re: K162954

Trade/Device Name: OARtrac® System with Patient Specific Reusable PSD Sensors Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: NZT Dated: May 3, 2017 Received: May 8, 2017

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 of medical devicerelated 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/ResourcesforYou/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.

Michael D. O'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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Indications for Use

510(k) Number (if known) K162954

Device Name

OARtrac® System with Patient Specific Reusable PSD Sensors

Indications for Use (Describe)

The OARtrac® System with patient specific, reusable, pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon radiation therapy as an adjunct to treatment planning measurement and validation of radiation dose received by the patient to the targeted area of their body, and indicated to the skin with a bolus, or inserted into the rectum to measure the rectal prostatic interface via a specifically designed endorectal balloon device.

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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Section 5 – 510(k) Summary

OARtrac® System with Patient Specific Reusable PSD Sensors

K162954

1. Submission Sponsor

RadiaDyne, LLC

10801 Hammerly Blvd.

Suite 220

Houston, TX 77043

USA

Phone number: (281) 759-9600

Contact: John Isham

Title: President & CEO

2. Submission Correspondent

Emergo Global Consulting, LLC

2500 Bee Cave Road, Bldg. 1, Suite 300

Austin, TX 78746

Office Phone: (512) 327-9997

Contact: Stuart R. Goldman, Senior Consultant, RA

Email: project.management@emergogroup.com

3. Date Prepared

May 29, 2017

4. Device Identification

Trade/Proprietary Name:	OARtrac® System with Patient Specific Reusable PSD Sensors
Common/Usual Name:	Radiation Dose Verification System
Classification Name:	Medical charged-particle radiation therapy system

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Regulation Number:	892.5050
Product Code:	NZT (dosimeter, ionizing radiation, implanted)
Device Class:	Class II
Classification Panel:	Radiology

5. Legally Marketed Predicate Devices

OARtrac® System with Skin Sensors (K150719)

OARtrac® System (K141154)

6. Device Description

7. Indication for Use Statement

8. Substantial Equivalence Discussion

RadiaDyne has chosen its OARtrac® System (K141154) that was cleared for use at the prostatic rectal interface, and their OARtrac® System with Skin Sensors (K150719) that was cleared for use on the surface of the patient's skin as the predicate devices for its OARtrac® System with Patient Specific Reusable PSD Sensors that is the subject of this 510(k) submission. The following table compares the subject device against the two referenced predicate devices with respect to intended use, indications for use, technology and performance testing between them, thus demonstrating the basis for determination of substantial equivalence between these three devices.

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Device	RadiaDyne		Similarities/Differences
Trade Name:	OARtrac® Systemwith Patient Specific Reusable PSD Sensors	OARtrac® Systemwith SkinSensors	OARtrac® System	-
510(k):	Pending	K150719	K141154	-
Product Code:	NZT	NZT	NZTPCT	Same
Regulation:	§892.5050	§892.5050	§892.5050§892.5720	Same
Class:	II	II	II	Same
Intended Use:	The OARtrac® System with patientspecific, reusable, pre-calibrated PSDsensors is intended for use in photonradiation therapy to monitor and validateradiation dose during External BeamTherapy and HDR Brachytherapy to thesurface of the skin or the rectal prostaticinterface.	The OARtrac®System withSkin Sensors isintended foruse in photonbeamradiationtherapy tomonitor andverifyradiationtreatmentdose at theentrance tothe skin.	TheOARtrac®System isintendedfor use inphotonbeamradiationtherapy tomonitorand verifyradiationtreatmentdose to thesurrounding organs atrisk,specificallytheprostaticrectalinterface,duringprostateexternalbeamradiationtreatment.	The subject andpredicate devices act asa radiation doseverification system, tothe prostatic rectalinterface, and the skinof the patient, thathave been exposed toradiation treatment.
Indications forUse:	The OARtrac® System with patientspecific, reusable, pre-calibrated PSDsensors are intended for use during cancertreatments to measure photon radiationtherapy as an adjunct to treatmentplanning permitting measurement andvalidation of radiation dose received bythe patient to the targeted area of theirbody, and indicated for use when adhered	The OARtrac®System pre-calibrated skinsensors arespecificallyindicated foruse duringcancertreatments to	TheOARtrac®System isspecificallyindicatedfor maleprostatecancertreatment	The subject device hasexpanded indicationswhere the OARtrac®System PSD sensors arenow reusable up to fivetimes in total on thesame patient.
	the rectum to measure the rectal prostatic	photon beam	photon
	interface via a specifically designed	therapy as an	beam
endorectal balloon device.		adjunct to	therapy as
		treatment	an adjunct
		planning	to
		permitting	treatment
		measurement	planning
		of radiation	permitting
		dose received	measurem
		on the surface	ent of in-
		of the skin.	vivo
		OARtrac®	radiation
		System pre-	dose
		calibrated skin	received on
		sensors are	the
		indicated for	anterior
		use when	surface of a
		adhered to the
		surface of the	modified
			prostate
		skin using	Endorectal
		medical grade	Balloon
		adhesive and	(ERB)
		with a medical	device to
		grade bolus	monitor
		buildup placed	and verify
		directly on top	the
		of the sensor.	surroundin
			g organs at
			risk,
			specifically
			the
			prostatic
			rectal
			interface.
Material:	Plastic scintillation detectors (PSD) aremade from polyurethane.	Plasticscintillation	Plasticscintillation	Same
		detectors	detectors
		(PSD) are	(PSD) are
		made from	made from
		polyurethane.	polyuretha
			ne.
Implantable:		No	No	Same
Body Location:	NoProstatic rectal interface and the skin of	Skin	Placed in	Same
	the patient.	contacting.	rectum;

			inserted
			insideprostate

			Endorectalballoon.
Sterile:	No	No	No	Same
Single Use:	No	Yes	Yes	The PSD sensors used
				with the subject device
				can be reused up to five

Table 5-1 – Comparison of Characteristics

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				times.
PSD SensorsCleaned andDisinfected	Yes	No	No	The PSD sensors usedwith the subject devicehave been validated(cleaning anddisinfecting) for up tofive times.
KeyPerformanceSpecifications/Characteristicsof the Device	Photon Energy Based Therapies Energy Range .37-18 MeV Dose Rate Range 1.3-17.3 cGy/s Dose Range 27-1200 cGy Dose Accuracy +/-6%, 2 $ σ $				Same	Same	Same
Biocompatibility Testing perISO 10993-1	Yes	Yes	Yes	Same
ElectricalSafety Testingper IEC 60601-1	Yes	Yes	Yes	Same
EMC Testingper IEC 60601-1-2	Yes	Yes	Yes	Same

9. Non-Clinical Performance Data

As part of demonstrating the safety and effectiveness of the OARtrac® System with Patient Specific Reusable PSD Sensors and in showing substantial equivalence to the predicate devices that are the subject of this 510(k) submission, RadiaDyne completed a number of tests. The subject device meets all the requirements for overall design, biocompatibility, package shelf-life, electrical safety, EMC, cleaning and disinfection, which confirms that the output meets the design inputs and specifications for the device, and passed all the testing in accordance with national 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
Cleaning validation to demonstrate reusability per AAMI 12 and 30
. Disinfection validation to demonstrate reusability per AAMI 12 and 30

10. Clinical Performance Data

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There was no human clinical testing required to support the OARtrac® System with Patient Specific Reusable PSD Sensors as the original OARtrac® System predicate devices cleared under K141154 and K150719 were not subjected to any human clinical studies. The purpose of the testing presented in this 510(k) submission by RadiaDyne was to demonstrate that its PSD sensors can be effectively cleaned and disinfected so that they can be used up to five times on the same patient. The non-clinical testing detailed in this submission supports the substantial equivalence of the predicate devices.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics, and that can be demonstrated that the subject device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device. The OARtrac® System with Patient Specific Reusable PSD Sensors, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices, the OARtrac® System (K141154), and the OARtrac® System with Skin Sensors (K150719).

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.