Sensus TPS Workstation is a software system intended for treatment planning and analysis of intraoperative radiation therapy administered with the Sensus IORT System, a device suitable for intraoperative radiotherapy.

The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs.

The intended users of Sensus TPS Workstation shall be clinically qualified radiation therapy staff trained in using the system.

Device Description

The Sensus TPS Workstation is a multi-functional, integrated software suite that forms a comprehensive electronic oncology management system for radiation oncology facilities. For radiation oncology users, the TPS Workstation provides image-enabled electronic patient charting and record management. For radiation oncology users, it also includes the ability to import and export radiation treatment plan information, beam geometry planning, treatment plan review, and verification and record treatment setup and delivery. The Sensus Healthcare TPS Workstation is dedicated for use with the Sensus Healthcare IORT System only. The software is not a general-use product compatible with other IORT systems.

AI/ML Overview

The Sensus TPS Workstation is a software system intended for treatment planning and analysis of intraoperative radiation therapy administered with the Sensus IORT System. The software has undergone design verification and validation testing to ensure it functions according to its design parameters and meets safety and performance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the acceptance criteria in terms of the successful completion of various verification and validation tests. The reported device performance is that the device passed all these tests.

Acceptance Criteria (Test Protocol Name)	Reported Device Performance (Results)
TPS Software Verification Validation Test Plan (6-2-7380-0000)	Pass
TPS Software System Integration Testing (6-2-7381-0000)	Pass
Static Analysis Report Summary (6-2-7390-0000)	Pass
Unit Testing Report Summary (6-2-7391-0000)	Pass
Comparison of the measured dose and the dose calculated by the radiation treatment planning system (SEN18940_RPT)	Proved accurate and consistent beam/dose output
IEC 62304 (Medical device software – Software life cycle processes)	Compliance
ISO 14971 (Medical devices -- Application of risk management to medical devices)	Compliance
FDA Guidance for Management of Cybersecurity in Medical Devices	Compliance

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

The document does not explicitly state the sample size (e.g., number of patient cases or specific test data points) used for each listed test protocol. It mentions "several test treatment plans" were generated for the treatment plan-to-beam generation fidelity testing, but no specific number is provided.

The data provenance is not explicitly mentioned as country of origin; however, the testing was performed internally by Sensus Healthcare as part of their design and development process for regulatory submission. The testing appears to be based on an internal bench testing paradigm rather than patient data.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. The "ground truth" for the performance testing appears to be based on established engineering benchmarks, system requirements, and the expected output of a radiation treatment planning system, rather than expert clinical interpretation of patient data. For the "Comparison of the measured dose and the dose calculated by the radiation treatment planning system," the truth was against "measured dose."

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The tests appear to be pass/fail based on predetermined criteria outlined in the test protocols and system requirements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned in the provided document. The study focuses on the standalone performance and safety of the Sensus TPS Workstation itself and its equivalence to a predicate device, rather than the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The described "Non-Clinical Performance Testing" and "Non-clinical Safety Tests" are essentially standalone evaluations of the Sensus TPS Workstation software. The system functionality, dose calculation engine, and various software modules were tested to ensure they performed according to their specifications and produced accurate and consistent results independently. The "treatment plan-to-beam generation fidelity testing" directly evaluates the algorithm's output against actual physical measurements.

7. Type of Ground Truth Used

The ground truth used for testing includes:

System Requirements Specifications (SRS): The tests were executed to ensure the system functioned "in accordance with its design parameters" and passed "all of the requirements determined in the testing procedures."
Measured Dose and Beam Output: For the treatment plan-to-beam generation fidelity testing, the "ground truth" was established by measuring the actual beam output and yield from the Sensus IORT System's x-ray source and comparing it with the computational engine output and results.
Predicate Device Performance: Performance testing demonstrated that the Sensus TPS Workstation "provided the same technical capabilities as the predicate device," implying the predicate device's established performance served as a benchmark for equivalence.

8. Sample Size for the Training Set

The document does not mention a training set, as this device is a treatment planning software system, not a machine learning or AI model that typically requires a training set in the conventional sense. The "pre-calculated Monte Carlo simulations" for the Sensus IORT System described under "Calculation for photons" could be considered analogous to a foundational data set used by the algorithm, but it's not a "training set" in the context of supervised learning for image analysis, for example.

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

As noted above, there is no mention of a traditional "training set" for a machine learning model. For the pre-calculated Monte Carlo simulations (which could be seen as foundational data), the document states: "A set of Monte Carlo simulations has been performed to predict the dose distribution produced by each operating point of the Sensus IORT device with high accuracy." This implies that the ground truth for these simulations would be based on established physics principles and validated simulation methods, likely compared against physical measurements of dose distribution for the IORT system, though the specific validation of the Monte Carlo simulations themselves is not detailed here.

Summary

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Image /page/0/Picture/0 description: The image contains 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.

Sensus Healthcare, Inc. Nicolas Soro QA/RA Manager 851 Broken Sound Parkway NW Suite 215 Boca Raton, Florida 33487

February 21, 2019

Re: K182665

Trade/Device Name: Sensus TPS Workstation Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: January 17, 2019 Received: January 22, 2019

Dear Nicolas Soro:

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 Mav 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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

Robert A. 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) K182665

Device Name Sensus TPS Workstation

Indications for Use (Describe)

The intended users of Sensus TPS Workstation shall be clinically qualified radiation therapy staff trained in using the system.

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

[As Required by 21 CFR 807.92(c)]

Submitter's Name & Address:	Sensus Healthcare851 Broken Sound Parkway NWSuite 215Boca Raton, FL 33487
Contact Person:	Kal Fishman, COOTelephone (561) 922-5808Fax (561) 948-2071kal@sensushealthcare.com)
Date Summary Prepared:	January 16, 2019
Device Name:	Trade/Proprietary Name – Sensus TPS Workstation
	Common/Usual Name – Treatment Planning Station
	Classification Name – Medically Charged-ParticleRadiation Therapy
Predicate Device:	Radiance V4 (K171885)
Reference Device:	N/A

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Device Description:

Indications for Use:

The intended user of Sensus TPS Workstation shall be clinically qualified radiation therapy personnel trained in using the system.

Prescriptive Statement

Caution: Federal law restricts this device to sale by or on the order of a physician.

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Technological Characteristics/Principles of Operation - System Architecture

From a system architecture standpoint, the basis for the functionality of TPS Workstation is as follows.

Architectural Design

The complete functionality of the TPS Workstation is achieved by partitioning the responsibilities of the system and assigning them to subsystems. The following diagram depicts the subsystems and their inter-relationships.

Image /page/5/Figure/4 description: The image shows a block diagram of the TPS components. The components include the user, graphical user interface, medical images engine, dose calculation engine, routing server, and sensus robotic IORT system. The graphical user interface is connected to the user, medical images engine, dose calculation engine, and routing server. The medical images engine, dose calculation engine, and routing server are connected to the TPS components.

The following modules are the subsystems associated with the TPS Workstation.

Graphical User Interface

The software that is used to create the GUI is in the form of an iOS application running

on an iPad Pro. The responsibilities of this subsystem are:

Communicate with the routing server to access the DB; ●
List the required medical records to do the treatment planning: ●
Provide graphical representation of the radiation source target; o
Request medical images from MIE; ●
Request dose calculations from DCE; ●

510(k) Summary (Sensus Healthcare - TPS Workstation)

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o Provide multi planar medical viewer for the generated isodose;
Provide graphical tools for contouring;
Present 3D reconstruction of selected isosurfaces; and ●
Send treatment plan to the IORT system.

Dose Calculation Engine

The software that is used to create the DCE is in the form of daemon running on PC. It was designed to work on both Linux and Windows OS. The responsibilities of this subsystem are:

Receive requests from the GUI; o
o Perform volumetric dose distribution calculations; and
o Provide calculated data to the GUI.

Medical Images Engine

The software that is used to create the MIE is in the form of daemon running on PC. It was designed to work on both Linux and Windows OS. The responsibilities of this subsystem are:

o Receive requests from the GUI:
Perform interpolation on the medical image; and ●
. Provide medical image to the GUI.

Routing Server

The software that is used to create the Routing Server is in the form of node.js web service running on a PC. The responsibility of this subsystem is to provide an interface to access the DB of the IORT system.

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Non-Clinical Performance Testing:

The Sensus TPS Workstation has undergone thorough design verification and validation testing in accordance with the test protocols listed in Table 1 below. Verification and validation tests were written based on the full system requirements specifications and executed to ensure that the system was functioning in accordance with its design parameters.

The TPS Workstation underwent code Static Analysis and Cyclomatic Complexity, Unit Testing, and System Integration Testing. The software passed all of the requirements determined in the testing procedures.

Performance testing consisted of bench testing that has demonstrated that the performance of the TPS Workstation provided the same technical capabilities as the predicate device. Performance testing was executed to validate the operational characteristics associated with the TPS Workstation as defined in the System Requirements Specification (SRS). The TPS Workstation passed all performance testing, and premised on the test results, supports Sensus Healthcare's claims of system performance and equivalency.

Non-clinical Safetv Tests:

The TPS Workstation verification and validation testing included various safety testing to ensure the device fulfilled all of the System Requirements Specifications. These V&V tests included test cases such as: locking down treatment plans to prevent unauthorized/erroneous modifications, approval and disapproval of treatment plans, user authentication and access level control, data integrity and management, and proper communication between the TPS Workstation and the Sensus IORT System.

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The TPS Workstation was developed in accordance with IEC 62304 Medical device software – Software life cycle processes to ensure proper design and development to all aspects of patient, operator, and device safety. A hazards analysis, risk assessment, and cybersecurity risk assessment were performed to ISO 14971 and FDA Guidance for Management of Cybersecurity in Medical Devices to identify and mitigate any potential causes that may be introduced that lead to a hazard.

The TPS Workstation underwent a comprehensive treatment plan-to-beam generation fidelity testing, which included the generation of several test treatment plans, benchmarking those treatment plans' output yield and results with the DCE's computational engine output and results, and then uploading those test treatment plans to the Sensus IORT System and measuring the actual beam output and yield from the system's x-ray source. The test results gathered proved that the TPS Workstation's performance and treatment plans generation yield accurate and consistent beam output and dose output, which further demonstrates its safety and clinical efficacy.

The TPS Workstation passed all safety testing, and premised on the test results, supports Sensus Healthcare's claims of system safety and efficacy.

Test Standards Employed

Table 1 delineates the testing standards employed by Sensus Healthcare during the design and development of the TPS Workstation.

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Document/Protocol	Name
ISO 62304	Medical device software – Software life cycle processes
ISO 14971	Medical devices -- Application of risk management to medical devices
6-2-7380-0000	TPS Software Verification Validation Test Plan
6-2-7381-0000	TPS Software System Integration Testing
6-2-7390-0000	Static Analysis Report Summary
6-2-7391-0000	Unit Testing Report Summary
SEN18940_RPT	Comparison of the measured dose and the dose calculated by the radiation treatment planning system

Table 1 Test Standards & Protocols Employed

Test Results

Table 2 delineates the test results obtained as a result of executing each test protocol.

Table 2 Test Results

Document/Protocol	Date Testing Performed	Results(Pass/Fail)
6-2-7380-0000	1/16/2019	Pass
6-2-7381-0000	1/16/2019	Pass
6-2-7390-0000	1/16/2019	Pass
6-2-7391-0000	1/16/2019	Pass

Substantial Equivalence Conclusion Statement

The Sensus TPS Workstation has the same intended use as the predicate device. Any technological changes to the device do not raise new questions of safety or effectiveness. Performance testing, along with verification activities demonstrate that the Sensus Healthcare TPS Workstation is as safe and effective, and performs as well as the predicate device. Therefore, the Sensus Healthcare TPS Workstation can be considered substantially equivalent to the predicate device.

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Attributes	SensusTPS Workstation(K182665)	Radiance V4(K171885)	Discussion
Manufacturer	Sensus Healthcare	GMV SolucionesGlobales Internet S.A.U.	---
Classification	21 CFR 892.5050	21 CFR 892.5050	Equivalent
Product Code	MUJ	MUJ	Equivalent
Indications for Use	Sensus TPS Workstationis a software systemintended for treatmentplanning and analysis ofintraoperative radiationtherapy administered withthe Sensus IORT System,a device suitable forintraoperativeradiotherapy.The treatment plansprovide treatment unit set-upparameters andestimates of dosedistributions expectedduring the proposedtreatment, and may beused to administertreatments after reviewand approval by theintended user. The systemfunctionality can beconfigured based on userneeds.The intended users ofSensus TPS Workstationshall be clinicallyqualified radiation therapystaff trained in using thesystem.	Radiance V4 is a softwaresystem intended fortreatment planning andanalysis of intraoperativeradiation therapyadministered with devicessuitable for intraoperativeradiotherapy.The treatment plansprovide treatment unit set-upparameters andestimates of dosedistributions expectedduring the proposedtreatment, and may beused to administertreatments after reviewand approval by theintended user. The systemfunctionality can beconfigured based on userneeds. The intended usersof Radiance V4 shall beclinically qualifiedradiation therapy stafftrained in using thesystem.	Equivalent
System Design	Software only	Software only	Equivalent
Calculation for electrons	N/A	Dose distributionscomputedusing a three dimensionaldoseengine.Pencil Beam computationandMonte Carlo Computationforelectrons	Although the predicate iscompatible with bothIORT and IOERT devices,the Sensus Healthcare TPSWorkstation is onlycompatible with the SensusIORT device, and so doesnot support calculations forelectrons.
Calculation for photons	Use of pre-calculatedMonte Carlo simulationsfor the Sensus IORTSystem	Dose Painting (Planningcalculation interpolationof PDDmeasurements) andHybrid Monte Carlocomputationfor INTRABEAM.	A set of Monte Carlosimulations has beenperformed to predict thedose distribution producedby each operating point ofthe Sensus IORT devicewith high accuracy. Thesepre-calculated dose
Attributes	SensusTPS Workstation(K182665)	Radiance V4(K171885)	Discussion
Input	Externally acquiredpatient medical imagesand user input. Calibrationfiles and beam modelingmeasurements for SensusIORT System	Externally acquiredpatient medical imagesand user input.Calibration files and beammodeling measurementsfor INTRABEAM	Equivalent
Output	Treatment plans withcorresponding dosedistributions	Treatment plans withcorresponding dosedistributions	Equivalent
Plan review and approval	Allows electronicapproval of treatmentplans by trained andauthorized staff	Allows electronicapproval of treatmentplans by trained andauthorized staff	Equivalent
Dose calculationalgorithm confirmation	Algorithms confirmed fora widevariety of fieldgeometries,treatment units, treatmentsetupsand patient positions,includingdifferent dose gridresolutionsettings.	Algorithms confirmed fora widevariety of fieldgeometries,treatment units, treatmentsetupsand patient positions,includingdifferent dose gridresolutionsettings.	Equivalent
Beam modeling tool	Beam modeling of thetreatmentunit based on relativemeasurements and outputfactors.	Beam modeling of thetreatmentunit based on relativemeasurements and outputfactors.	Equivalent
distributions are used bythe Sensus Healthcare TPSWorkstation to calculatethe combination ofoperating points that mostclosely matches the targettreatment dose distribution.This calculation isperformed using a globaloptimization algorithm.

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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.