The OARtrac® System with patient specific, reusable up to five times, pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron 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. The system is indicated for use with electron energy when adhered to the skin with or without a bolus, and for photon energy when adhered to the skin with a minimum 3mm bolus or inserted into the rectum for measurements at the rectal wall during cancer treatment via a specifically designed OARtrac® endorectal balloon device.

Device Description

The OARtrac® System with patient specific, reusable up to five times, pre-calibrated PSD sensors is intended for use in photon and electron radiation therapy to monitor and validate radiation dose during External Beam Therapy and HDR Brachytherapy to the surface of the skin or the rectal wall. 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 the 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 is a 510(k) Summary of Safety and Effectiveness for the OARtrac® System. It outlines the device's indications for use, its technical characteristics, and how it compares to a predicate device to demonstrate substantial equivalence.

Based on the information provided, here's a breakdown of the acceptance criteria and the study (non-clinical performance data) that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the OARtrac® System are primarily based on demonstrating substantial equivalence to its predicate device (RadiaDyne OARtrac® System with Patient Specific Reusable PSD Sensors, K162954) and meeting relevant safety and performance standards. While the text doesn't explicitly list "acceptance criteria" as a separate table, the "Dose Accuracy" row in Table 1 functions as a key performance criterion, with other general and specific tests confirming safety and effectiveness.

Here's a table derived from the provided information:

Acceptance Criterion (Implicit)	Reported Device Performance/Met Standard
Dose Accuracy	Photon and Electron based therapies: ±5% (2 sigma) HDR based therapies: ±6% (2 sigma)
Overall Design & Specifications	Meets all requirements (confirmed through testing)
Sterilization	Meets requirements (same test protocols as predicate)
Biocompatibility	Meets requirements (tested per ISO 10993-1, Parts 5, 10, and 11)
Packaging	Meets requirements (same test protocols as predicate)
Shelf-Life	Meets requirements (tested per ASTM F1090-07)
Electrical Safety	Meets requirements (tested per IEC 60601-1)
EMC (Electromagnetic Compatibility)	Meets requirements (tested per IEC 60601-1-2)
Software Verification & Validation	Meets requirements (per IEC 62304)
Bioburden	Meets requirements (per ISO 11137-1)
Cleaning and Disinfection	Meets requirements (per AAMI TIR 12 and AAMI TIR 30)
Device Risk Analysis	Per ISO 14971
Dose Range Verification Testing	Performed and met criteria (details not specified)
Electron-based Radiation Testing	Performed and met criteria (details not specified, crucial for new indication)
Endorectal Balloon Verification Testing	Performed and met criteria (details not specified)
Compatibility with Predicate's Standards	The proposed device was subjected to the same test protocols and standard validation studies as the predicate device (K162954), which were previously accepted by FDA. Meets criteria under the same national and international test standards as the predicate device. Performance data demonstrated substantial equivalence in performance and fundamental technology, and is as safe and effective.

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

The document explicitly states: "10. Clinical and Animal Performance Data - Not Conducted" (Page 6).
This means there was no human or animal test set/data in the traditional sense for this 510(k) submission. The data provenance is therefore entirely from non-clinical (laboratory/bench) testing, which includes validation against standards and previous predicate device data. The data provenance would be from the manufacturer (RadiaDyne) through their internal testing and third-party lab certifications for standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since no clinical or animal performance data was collected, there was no expert adjudication for a ground truth derived from clinical cases. The "ground truth" for the non-clinical tests would have been established by the engineering specifications and the established standards (e.g., IEC, ISO, ASTM) against which the device performance was measured. These standards were developed and validated by relevant expert bodies in the field.

4. Adjudication Method for the Test Set

As no clinical test set was used, there was no adjudication method applied to clinical data. The evaluation was based on compliance with pre-defined engineering and safety standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was done. The document explicitly states "Clinical and Animal Performance Data - Not Conducted." The purpose of this submission was to demonstrate substantial equivalence through non-clinical data, not to show improvement over human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a radiation dose verification system, not an AI/algorithm for diagnosis or image interpretation. While it contains software, its core function is to measure physical radiation dose. Therefore, the concept of "standalone algorithm only performance" as typically applied to AI/ML devices for medical image analysis does not directly apply in this context. The device's performance was evaluated based on the accuracy of its dose measurements. The software processes these measurements, but it's not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's performance evaluation was primarily physical measurements against established radiation dosimetry standards and validated test procedures. This is analogous to physical/engineering ground truth rather than clinical ground truth (like pathology, expert consensus, or outcomes data). For example, a known dose from a calibrated radiation source served as the "ground truth" for the device's dose accuracy measurements.

8. The Sample Size for the Training Set

Since this is not an AI/ML device that requires a training set in the typical sense of machine learning algorithms for pattern recognition (e.g., image classification), the concept of a "training set" is not applicable. The device's calibration and design would rely on physical principles and potentially pre-calibrated sensors, but not a data-driven training set like an AI model.

9. How the Ground Truth for the Training Set Was Established

As there is no training set in the AI/ML context, this question is not applicable. The "ground truth" for the device's development and calibration would be derived from the fundamental physics of radiation detection and dosimetry, using highly calibrated and traceable radiation sources and measurement standards.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

RadiaDyne, LLC % Ms. Carmelina Allis Attorney The Allis Law Firm, PLLC 2437 Bay Area Blvd.. #30 HOUSTON TX 77058

March 22, 2019

Re: K182395

Trade/Device Name: OARtrac® System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: NZT Dated: February 21, 2019 Received: February 25, 2019

Dear Ms. Allis:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and

Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara

For

Thalia Mills, 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) K182395

Device Name OARtrac® System

Indications for Use (Describe)

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

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510(k) Summary of Safety and Effectiveness

OARtrac® System

Submission Sponsor

RadiaDyne, LLC 10801 Hammerly Blvd Suite 220 Houston, Texas 77043 Phone: 281.759.9600 Fax: 281.759.9609 Contact: John Isham, Founder & CEO

2. Submission Correspondent

Carmelina G. Allis The Allis Law Firm, PLLC 2437 Bay Area Blvd., #30 Houston, TX 77058 Phone: 281-819-0216 Email: CAllis@TheAllisLawFirm.com

3. Date Prepared

August 22, 2018

4. Device Identification

Trade/Proprietary Name:	OARtrac® System
Common/Usual Name:	Radiation dose verification system
Regulation Name:	Medical charged-particle radiation therapy system
Regulation Number:	21 C.F.R. § 892.5050
Product Code:	NZT
Regulatory Class:	II
Classification Panel:	Radiology

5. Legally Marketed Predicate Device(s)

Radiadyne OARtrac® System with Patient Specific Reusable PSD Sensors, K162954

6. Device Description

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but only provides dose data which a trained Radiation Oncologist can decipher and use to adjust a patient's treatment plan accordingly.

7. Indication for Use Statement

8. Substantial Equivalence Discussion

RadiaDyne has chosen its own OARtrac® System with Patient Specific Reusable PSD Sensors (K162954), cleared under Product Code NZT and 21 C.F.R. § 892.5050 as the predicate device for its OARtrac® System.

The following table compares the OARtrac® System to the predicate device. As shown below, the subject device is substantially equivalent to the predicate device with respect to intended use, technological characteristics and principles of operation.

Device Trade Names:	OARtrac® System	OARtrac® System with Patient Specific Reusable PSD Sensors
510(k):	Pending	K162954
Product Code:	NZT	NZT
Regulation:	§892.5050	§892.5050
Class:	II	II
Indications for Use:	The OARtrac® System with patient specific, reusable up to five times, pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron 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. The system is indicated for use with electron energy when adhered to the skin with or without a bolus, and for photon energy when	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

	adhered to the skin with a minimum	prostatic interface via a specifically
	3mm bolus or inserted into the	designed endorectal
	rectum for measurements at the	balloon device.
	rectal wall during cancer treatment
	via a specifically designed
	OARtrac® endorectal balloon
	device.
Mode of Operation:	Plastic scintillation detectors (PSD)	Plastic scintillation detectors (PSD)
	allow for dose verification of the	allow for dose verification of the
	patient's radiation treatment	patient's radiation treatment
	procedures at the point of location.	procedures at the point of location.
PSD Sensors:	Simplex 0.5mm PSD	Simplex Sensor Cable
	Simplex 1mm PSD	Duplex Unbundled Sensors
		Duplex Bundled Sensors
Material:	PSD sensors are made from	PSD sensors are made from
	polystyrene	polystyrene
Scintillating	1, 1	1, 2, 2
Fiber:
Fiducial Marker:	1, 1	1, 2, 1
Implantable:	No	No
Body Location:	The surface of the skin or inside of a	The surface of the skin or inside of a
	Radiadyne OARtrac rectal balloon.	Radiadyne OARtrac rectal balloon.
Sterile:	No	No
Single Use:	No, reusable up to five times	No, reusable up to five times
Hard Wired:	Yes, fiber optic cable	Yes, fiber optic cable
Pre-Calibrated:	Yes (Linac)	Yes (Cobalt-60)
System Software:	Yes	Yes
Energy Range:	6-18 MV Photon Dose	1-20 MV Photon Dose
	12 MeV Electron Dose
Dose Range:	2 cGy – 1 kGy	90 Gy maximum
	(Assumes minimum dose rate of 2
	cGy/s)
Dose Per Fraction:	200 Gy/use (up to 5 uses)	1-2000 cGy @ dose rates of 1 cGy/s
	1 kGy (single use)	and above
	(Assumes minimum dose rate of 2cGy/s)
Time to Read	1 millisecond	20 seconds
Dosimeter:
Dose	Photon and Electron based therapies:	±6% @95% confidence interval.
Accuracy:	±5% (2 sigma)
	HDR based therapies: ±6 (2 sigma)

Table 1

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9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of the OARtrac® System and in showing substantial equivalence to the predicate device, RadiaDyne completed several tests. Like the predicate device, the OARtrac® System meets all the

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requirements for overall design, sterilization, biocompatibility, packaging, shelf-life, electrical safety and EMC, which confirms that the output meets the design inputs and specifications for the device. The proposed device was subjected to the same test protocols and standard validation studies as the predicate device, which were previously accepted by FDA under K162954.

The OARtrac® System meets criteria under the same national and international test standards as the predicate device. Performance data submitted in support of the OARtrac® System demonstrate that the device is substantially equivalent to the predicate device in performance and fundamental technology and is as safe and effective as the predicate device.

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
Bioburden per ISO 11137-1
Cleaning and disinfection per AAMI TIR 12 and AAMI TIR 30
Package Shelf-Life per ASTM F1090-07
. Device Risk Analysis per ISO 14971
Dose Range Verification Testing
Electron-based Radiation Testing
Endorectal Balloon Verification Testing

10. Clinical and Animal Performance Data - Not Conducted

The OARtrac System does not introduce new intended uses, modes, features, or technologies relative to the predicate device that would require evaluation through clinical or animal testing. These types of devices, including the predicate device, have been on the market for many years with proven safety and effectiveness for their intended use. The non-clinical testing detailed in this submission is sufficient to demonstrate that the OARtrac® System is as safe and effective as the predicate device in support of a substantial equivalence determination.

11. Statement of Substantial Equivalence

In conclusion, the tests conducted, as well as all verification and validation activities, demonstrate that the design specifications and technological characteristics of the OARtrac® System meet applicable requirements and standards for the safety and effectiveness of the device for its intended use. The intended use and fundamental technology are the same between the subject and predicate devices. There are some differences in the indications for use and technological characteristics between the predicate and subject devices, but those differences allow for the subject device to have additional use capabilities during electron-based radiation treatments. The testing and validation activities conducted demonstrate that any differences between the devices do not raise new or different questions of safety or effectiveness as compared to the predicate device. Therefore, the OARtrac® System is substantially equivalent to 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.