The Prelude Planning Software for the electron beam IORT treatment can be used for any malignant and benign tumor. For Prelude no limitation is given to the patient population. Local/Regional recommendations or guidelines may indicate patient who will benefit from IORT more than from other treatment modalities.

In general, since Prelude is tailored for the planning with the Mobetron®, it can be used for IORT treatment planning, if a patient is prescribed to be treated with the Mobetron®.

Device Description

The Prelude software supports the IORT treatment workflow. Prelude Dosimetric measurement data of the radiation device can be displayed by selecting the machine parameters. Upon that information the user can easily plan the treatment and the software calculate the required parameters for the IORT devices.

For quality assurance the machines parameters can be recorded and visualized.

For the calculation of the output factors or the monitor units either the IAEA or AAPM protocol is followed.

The software is intended to be used by medical professionals in the area of radiation therapy.

The main purpose is to plan the technical parameters required to perform an electron beam IORT to treat both malignant and benign tumors

AI/ML Overview

This document describes the MedCom GmbH Prelude planning software, K180308, for electron beam Intraoperative Radiation Therapy (IORT) treatment planning.

1. A table of acceptance criteria and the reported device performance

The provided text does not contain a specific table of acceptance criteria with corresponding device performance metrics in the format typically used for AI/ML device submissions (e.g., sensitivity, specificity, AUC, FROC analysis). Instead, the document focuses on general software safety, effectiveness, and usability assessments, emphasizing that the software meets its intended use and is safe and effective.

The performance details are described qualitatively rather than quantitatively against specific acceptance criteria. Key performance aspects reported include:

Acceptance Criteria (Inferred)	Reported Device Performance
Software Functionality and Intended Use	Confirmed that the Prelude System meets its intended use. Provides expected parameters for simulated treatment data.
Usability	User could successfully create a treatment plan, defining all necessary treatment parameters (beam energy, applicator diameter, prescribed dose, etc.). Clearly understandable where to enter parameters and their impact on dose distribution. Workflow requires crucial parameters before calculation and approval.
Treatment Plan Approval and Storage	Complete treatment plan successfully approved by user (with sufficient rights) and saved into the database. User able to review and confirm all treatment parameters by verifying the report and accessing the plan from the database.
Radiation Dose Distribution Visualization	Fast dose distribution visualization with energy mixing. Based on measured beam data. Note: does not account for tissue inhomogeneities.
Quality Assurance (QA) Management	Integration of patient and treatment data into one platform/database facilitates data analysis and reporting. QA management features allow streamlining workflow and tracking equipment performance.
Safety and Risk Management	Tested software does not create any new risk. Safe and usable in clinical environment. All identified risks reduced to acceptable level. Overall residual risk acceptable. Probability of serious injury evaluated as "improbable." No issues detected that would prevent clinical use. Considered risks from similar devices.
Effectiveness (Comparative to Existing Procedures/Tools)	The software improves efficiency of the IORT procedure by integrating various treatment planning and QA tools. Clinical evaluation shows the system is effective and comparable to existing procedures. State of the art like other tools on the market.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document states that "Clinical patient data was simulated." It does not specify a numerical sample size for this simulated data.
Data Provenance: The data used for testing was "dosimetric measurement data from a Mobetron® device" and "simulated" clinical patient data. The country of origin for the simulated data or the Mobetron® device's data is not explicitly mentioned, but MedCom GmbH is located in Germany. The study appears to be a retrospective analysis of simulated data and device performance.

3. 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)

The concept of "ground truth" as typically defined for AI/ML diagnostic devices (e.g., truth established by pathology or expert consensus on a test set) is not directly applicable here in the same way. The device is a planning software, not a diagnostic one.

Instead, the "truth" or correctness of the outputs was assessed through:

Comparison to "expected parameters" for the simulated input data.
Usability testing with "users" and "Mobetron users and other experts in that field" who provided feedback.
Risk assessment team included "application specialists and a medical expert besides the development team and quality managers with risk management experience." Specific numbers and detailed qualifications of these individuals are not provided, beyond stating they were "medical expert" and "experts in that field."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No formal adjudication method (like 2+1 or 3+1 for resolving disagreements among multiple readers) is described for a test set in the context of diagnostic decision-making. The testing involved verification that the software produced "expected parameters" for simulated data and that users could successfully create plans and approve them, and that the software assisted in optimizing the treatment delivery.

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 multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is mentioned. The software is a planning tool, not an AI diagnostic assistant. Its purpose is to support medical professionals in radiation therapy by assisting in treatment planning and QA, not to be a diagnostic aid that would typically involve an MRMC study.

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

The evaluation described is intrinsically "human-in-the-loop" as Prelude is a planning software intended to be used by medical professionals. The software assists in calculations and visualizations, but the user defines parameters, approves plans, and interprets outputs. The testing included assessing user interaction and ability to create and approve plans.

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

The "ground truth" for evaluating this planning software was based on:

Expected parameters: For the simulated clinical patient data, the software's calculated output parameters were compared against "expected parameters" for a treatment.
Usability Feedback/Expert Opinion: Evaluation of whether users could successfully create treatment plans, define parameters, and whether the workflow was understandable. This suggests expert review of the software's functionality and output.
Established Radiation Therapy Protocols: The software follows IAEA or AAPM protocols for calculation methods, implying adherence to recognized standards.

8. The sample size for the training set

The document does not describe the use of machine learning models requiring a distinct "training set." Prelude is a treatment planning software that performs calculations based on measured dosimetric data and established physical principles (IAEA/AAPM protocols), rather than a system trained on a large dataset of patient images or outcomes. Therefore, the concept of a "training set" in the context of AI/ML is not applicable here.

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

As there is no mention of a training set for machine learning, the question of how its ground truth was established is not applicable. The software's calculations leverage "dosimetric measurement data of the radiation device," which serves as input to its algorithms based on physics principles, not as training data for a learning model.

Summary

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March 27, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

MedCom GmbH % Mr. Johannes Messow Quality Manager Dolivostrasse 11 Darmstadt, Hessen 64293 GERMANY

Re: K180308

Trade/Device Name: Prelude Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ, LHO Dated: January 29, 2018 Received: February 2, 2018

Dear Mr. Messow:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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.

For comprehensive regulatory information about medical devices and radiation-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 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) K180308

Device Name Prelude

Indications for Use (Describe)

In general, since Prelude is tailored for the planning with the Mobetron®, it can be used for IORT treatment planning, if a patient is prescribed to be treated with the Mobetron®.

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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III. 510(k) Summary of Safety and Effectiveness

A. Submitter

Name:	MedCom GmbH
Address:	Dolivostr. 11Darmstadt, HE 64293Germany
Establishment Reg.:	3006579682
Telephone:	+49 (6151) 95147-285
Fax:	+49 (6151) 95147-20
Contact:	Mr. Johannes Messowjmessow@medcom-online.de
Date:	Jan 29, 2018

B. Device

Trade Name:	Prelude
Common name:	IntraOp Prelude
Classification:	Regulatory Class:	II
	Product Code:	MUJ
	Classification Name:	System, Planning,Radiation TherapyTreatment
	CFR Section:	892.5050
	Panel:	Radiology

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C. Predicate Devices

Device trade name:	Radiance
510(k) number:	K171885
Company name:	GMV
Classification Number:	892.5050
Classification:	Class 2
Product code:	MUJ
Device trade name:	Track-it
510(k) number:	510(K) Exempt
Company name:	PTW-FREIBURG
Classification Number:	892.1940
Classification:	Class I
Product code:	LHO

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D. Reason for Submission

New device application

E. Standards

ISO 14971:2007, Medical devices - Application of risk management to medical devices. (General I (QS/RM))
IEC 62304:2006/AMD1:2015, Medical Device Software - Software Life Cycle Processes. (Software/Informatics)
IEC 62083:2009 - Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems

F. Description

software supports the IORT treatment workflow. Prelude Dosimetric measurement data of the radiation device can be displayed by selecting the machine parameters. Upon that information the user can easily plan the treatment and the software calculate the required parameters for the IORT devices.

For quality assurance the machines parameters can be recorded and visualized.

For the calculation of the output factors or the monitor units either the IAEA or AAPM protocol is followed.

The software is intended to be used by medical professionals in the area of radiation therapy.

The main purpose is to plan the technical parameters required to perform an electron beam IORT to treat both malignant and benign tumors

Examples of compatible devices are:

Device	Type	510(k) / registration number
Planning System,QA software	GMV Radiance	K171885
	PTW – Track It	510(k) Exempt

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Image /page/6/Figure/2 description: The image shows a system overview diagram for Medcom Prelude. The diagram includes components such as the Medcom Prelude Installer, Windows Registry, Operating System, Medcom Prelude, and Medcom Database. It also shows actors like an Administrator and Medical Staff interacting with the system, as well as hardware components like a printer, touchscreen, and hospital database.

The Prelude software is developed in Microsoft Visual Studio in programming language C. As main architectonical style is a module concept. Each module consists of a standard and predefined set of function for data initialization, parameter-file handling, UI creation and handling.

The Prelude Database Server is written in C/C++ using Microsoft Foundation Classes (MFC) and an SQLite database.

For details of the Software Architecture refer to: 003_MC.5078.TDC.0001.System_Architecture

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Image /page/7/Figure/2 description: The image shows a diagram of the Medcom Prelude architecture. The diagram includes components such as Kernel, Planning, Treatment, Invivo, QA, Settings, Database (Client), FileIO, Sub, UITools, Medcom Prelude Database, Hospital Database, Database Files, IntraOp Mobetron, Harddrive, Printer, and Touchscreen. The diagram also shows the connections between these components, as well as the interfaces between them.

Figure 1: Architecture Overview

Figure 1 shows an overview of the program and it´s modules. The blue line marks the MedCom Products (Prelude and its Database Server) and their interaction with internal/external devices.

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G. Intended Use

The Prelude software supports intra-operative radiation therapy workflows with intra-operative radiation devices like IntraOp® Mobetron®

It assists to find product specific machine parameters for treatment and can send those proposals to the intra-operative radiation device.

The machine parameters are not intended to be used for direct control for the radiation device.

Dose distribution visualizations are based on measured beam data and tissue inhomogeneities are not taken into account, the resulting dose distribution for anatomic locations in close proximity to bone and lung (or other tissue of high or low density) may differ from the presented visualization.

Machine Output Quality can be visualized and recorded over time for quality assurance.

The use of Prelude is restricted to medical professionals of radiation therapy.

H. Indications for Use

The Prelude Planning Software for the electron beam IORT treatment can be used for any malignant and benign tumor.

For Prelude no limitation is given to the patient population. Local/Regional recommendations or guidelines may indicate patient who will benefit from IORT more than from other treatment modalities.

In general, since Prelude is tailored for the planning with the Mobetron®, it can be used for IORT treatment planning, if a patient is prescribed to be treated with the Mobetron®.

Prelude is a prescription device.

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1. Technological Comparison to Predicate Devices

The device Prelude is substantially equivalent to the following predicate devices:

K171885	GMV Radiance
510(k) Exempt	PTW Track It

The predicate device Radiance (GMV) has similar main functionalities and characteristics as Prelude for the planning part of an IORT treatment.

Both devices provide a visualization of the dose distributions in the treatment field. Both systems are based on measured dosimetric characteristic of the beam. Monitor Units calculation in both systems is based on Percentage Depth Dose curve along central axes of the beam.

Those are the core functions of both systems and they are similar.

Prelude, unlike Radiance, does not use 3D patient data (e.g. CT scans) so performed calculations are based on homogenous medium (i.e. water) and material heterogeneities are not taken into account. Since. IORT intends to treat mainly soft tissue (which, from the radiation perspective, is equivalent to water) water-based calculation of dose distribution and MUs provides very good approximation of clinical situation and the planning can be done faster.

Anyhow in an IORT treatment room, there is often no possibility to acquire CT scans during the treatment. Thus, planning on pre-operative images, like it is done with Radiance, is also an approximation of the treatment region during the surgery. This dissimilarity in the functionality of both systems should be considered insignificant.

The predicate device Track-It® (PTW) and Prelude are adequately similar concerning management of Quality Assurance of Electron Beam devices and analyzing QA results recorded over time. Both devices enable detailed tracking of QA measurements in order to analyze trends occurring in the machine functionality. The devices can be adapted to common QA protocols for medical accelerators (e.g. AAPM guidelines or IAEA protocols). QA sessions can be recorded offline and synchronized once a server connection is reestablished. It is possible to track data of multiple devices separately. Prelude and Track-It® have a client/server architecture with a server-side database that can be queried with custom filter conditions.

Prelude does not support multiple types of medical accelerator and currently only supports data tracking for electron beams, which are generated by the Mobetron® Prelude is not customizable to the same extent as the general-purpose QA data tracking tool Track-It®. These dissimilarities between Prelude and Track-It® are insignificant since Prelude is tailored and intended only for the use in combination with the Mobetron® accelerator. Hence, limitations in beam energies and accelerator types pose no limitations of safety, performance and effectiveness but are intended design decisions.

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J. Non-clinical Performance Data

Non-clinical verification and validation software tests were conducted to confirm that the Prelude System meets its intended use and is safe and effective.

Tests have been performed with dosimetric measurement data from a Mobetron® device. Clinical patient data was simulated and achieved results led to expected parameters for a treatment of the simulated input data.

Usability testing showed, that the user could successfully create a treatment plan. defining all necessary treatment parameters (beam energy, applicator diameter, prescribed dose, etc.). It was absolutely understandable and clear for the user, where to enter each parameter and how these parameters impact the dose distribution visualized by the software. The workflow offered by the software requires all crucial parameters to be entered before the Monitor Units can be calculated and the treatment plan can be approved.

The complete treatment plan was successfully approved by the user (with sufficient rights) and saved into the database. User was able review and confirm all treatment parameters by verifying the report created by the software and by accessing the plan from the database.

Based on extensive testing, briefly summarized above, one can conclude that all the usability goals were met. Tested software does not create any new risk to the intraoperative radiotherapy procedure performed with the Mobetron®. It is safe and usable in the clinical environment.

The tested software is safe and useful in the process of Intraoperative Radiotherapy. Based on performed tests and feedback provided by Mobetron users and other experts in that field, the IORT treatment delivery could be optimized due to fast dose distribution visualization with energy mixing.

Integration of all patient and treatment data into one software platform and one central database makes the data analysis and reporting very convenient and efficient. What is more. Quality Assurance management features allow streamlining workflow and tracking equipment performance.

It might be concluded that the software improves efficiency of IORT procedure by integrating various treatment planning and QA tools into a single, intuitive platform.

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K. Conclusion

Based on the information provided in this Premarket Notification MedCom concludes that Prelude system is as safe and effective and substantially equivalent to the predicate devices described herein.

The risk analysis shows that the product is safe and the risk/benefit ratio is acceptable.

Risks identified with similar MedCom devices and similar marketed devices of other manufacturers were considered and included in the risk assessment of Prelude. For an effective identification, estimation and evaluation of risks, the risk assessment team included application specialists and a medical expert besides the development team and quality managers with risk management experience.

All identified risks were reduced by appropriate risk control measures to an acceptable level, also including risks which were evaluated as acceptable before any measures. The overall residual risk is acceptable. According to the intended use of Prelude, the users are medical professionals and familiar with IORT treatments and have sufficient knowledge in that respective area. The overall probability of serious injury was therefore evaluated as "improbable".

The Clinical Evaluation shows that the system is effective and comparable to existing procedures.

No issues have been detected that would prevent Prelude to be used in the clinical environment. Data has been collected through literature search which indicates that Prelude is state of the art like other tools currently on the market and thus a focused clinical evaluation appears sufficient.

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.