The LANDAUER® microSTAR®ii Medical Dosimetry System provides an accurate, reliable and easy-to-use dosimeter and reader intended for use in measuring dose on-phantom or on-patient in medical dosimetry applications, such as radiotherapy and diagnostic radiology. When used to measure patient dose, the system is used to provide a secondary verification of radiation dose as a means of Quality Control for the primary dose calculation method. The output of the microSTAR®ii system is not used to adjust the dose to the patient.

Device Description

The LANDAUER® microSTARii Medical Dosimetry System consists of the following components to provide secondary verification of dose from various radiotherapy and diagnostic imaging devices: Dosimeter (nanoDot) to record radiation during radiation exposure. Reading device (microSTARii Reader) for reading the radiation dose recorded by the dosimeter. microSTARii Software Application, a simple software tool that the user interacts with for radiation dose calculation, dose reporting, managing and storing data. 2D barcode scanner. Calibration Dosimeter Set (nanoDots) for QC/Calibration.

AI/ML Overview

The provided text is a 510(k) summary for the microSTARii Medical Dosimetry System. It is an application for a medical device that measures radiation dose, not an AI/ML device that requires typical acceptance criteria and validation studies as outlined in the prompt.

Therefore, many of the requested details about acceptance criteria, study methodologies (like data provenance, expert ground truth, MRMC studies, standalone performance, training sets, etc.), which are standard for AI/ML device submissions, are not applicable to this document. This document describes a physical dosimetry system (hardware and software) used for quality control in medical dosimetry, not an AI algorithm that makes diagnostic or prognostic predictions.

Specifically, the document states:

"No mandatory performance standards have been established for this device (Section 514 of the Act)."
"Clinical testing was not necessary to support substantial equivalence of the proposed device to the predicate device."

This indicates that the validation approach focuses on non-clinical performance (bench testing, software testing, EMC) to demonstrate substantial equivalence to a predicate, rather than human-in-the-loop or standalone AI performance.

Given this, I cannot extract the information required by the prompt regarding acceptance criteria and study methodologies as they relate to an AI/ML device. The acceptance criteria and study described are for a traditional medical device's performance, safety, and effectiveness.

Summary

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December 27, 2019

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Landauer % Mr. Matt Ennis Quality Manager 2 Science Road GLENWOOD IL 60425

Re: K192196

Trade/Device Name: microSTARii Medical Dosimetry System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: October 8, 2019 Received: October 16, 2019

Dear Mr. Ennis:

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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)

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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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192196

Device Name microSTARii Medical Dosimetry System

Indications for Use (Describe)

The LANDAUER® microSTAR®ii Medical Dosimetry System provides an accurate, reliable and easy-to-use dosimeter and reader intended for use in measuring dose on-phantom or on-patient in medical dosimetry applications, such as radiotherapy and diagnostic radiology. When used to measure patient is used to provide a secondary verification of radiation dose as a means of Quality Control for the primary dose calculation method. The output of the microSTAR®ii system is not used to adjust the dose to the patient.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submission Date: August 5, 2019

Submitter Information:

Submitted By:	Moe Khosravi, RegulatoryAffairs & Quality DirectorFluke Biomedical6920 Seaway Blvd.Everett, WA 98203Phone: (425) 238-1137Email: moe.khosravi@flukebiomedical.com
Secondary Contact:	Robin MartinRegulatory Affairs ConsultantKinetic Compliance Solutions, LLCEmail: robinmartin@kineticcompliance.com
Device Information:
Trade Name:	microSTAR®ii Medical Dosimetry System
Common Name:	Dosimetry System
Classification Name:	21 CFR 892.5050 Medical Charged-particle radiation therapysystem
Device Classification:	Class II
Product Code:	IYE
Predicate Device(s):	Portable Dosimeter, K092285Best Medical Canada, Ltd.Class II,Product Code IYE21 CFR 892.5050 Medical Charged-particle radiation therapysystem
Device Description:	The LANDAUER® microSTARii Medical Dosimetry System

	Dosimeter (nanoDot) to record radiation during radiation exposure. Reading device (microSTARii Reader) for reading the radiation dose recorded by the dosimeter. microSTARii Software Application, a simple software tool that the user interacts with for radiation dose calculation, dose reporting, managing and storing data. 2D barcode scanner. Calibration Dosimeter Set (nanoDots) for QC/Calibration.
Indications for Use:	The LANDAUER® microSTAR®ii Medical Dosimetry System provides an accurate, reliable and easy-to-use dosimeter and reader intended for use in measuring dose on-phantom or on-patient in medical dosimetry applications, such as radiotherapy and diagnostic radiology. When used to measure patient dose, the system is used to provide a secondary verification of radiation dose as a means of Quality Control for the primary dose calculation method. The output of the microSTAR®ii system is not used to adjust the dose to the patient.
Comparison to Predicate:	Though the indications for use are slightly different from the predicate, the intended use remains the same between the proposed device and predicate device (capturing and displaying radiation dose) and the proposed differences in indications are for clarity and do not have impact on safety or effectiveness. The microSTARii system utilizes OSL (optically-stimulated luminescence) dosimeters whereas the predicate utilizes MOSFET (Si-based metal-oxide-semiconductor field-effect transistor) dosimeters.The proposed device employs the same fundamental scientific technology and these technological differences do not raise different questions of safety or effectiveness.
Performance Testing:Non-Clinical:	No mandatory performance standards have been established for this device (Section 514 of the Act). The following testing was conducted to support the substantial equivalence of the proposed device to the predicate: Software testing was conducted to verify performance in accordance with FDA's guidance document entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." FDA's guidance entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”
• Electromagnetic Compatibility (IEC 61326-1:2012)• Performance (Bench) Testing, including:• Burn in / Intrinsic measurement• Light leakage• Repeatability Testing: Moving / Stationary• Calibration Factor• Linearity-QC Accuracy• LLD-Strong / LLD-Weak
Clinical: Clinical testing was not necessary to support substantial equivalence of the proposed device to the predicate device.
Conclusion: The above testing supports that the proposed device is as safe, effective and performs as well or better than the legally marketed predicate in its intended use. Therefore, the proposed device is substantially equivalent to the predicate.

m consists of the following components to provide secondary verification of dose from various radiotherapy and diagnostic imaging devices:

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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.