HDRplus is a Brachytherapy Treatment Planning System used by medical professionals. HDRplus is used for the creation of treatment plans for remote afterloader based HDR and PDR brachytherapy. HDRplus will calculate a proposed treatment course based on imported clinical images and other user entered data. HDRplus also supports the evaluation of clinical images in calculating the local and global doses to organs at risk and target volumes. HDRplus especially supports the Multisource and Gynesource Brachytherapy Remote Controlled Afterloading Devices from Eckert & Ziegler BEGIB GnbH.

Device Description

HDRplus is a software package which runs on a Windows - based PC and is used by medical professionals to create a radiation therapy plan based on imported medical images and the input entered by the operator. The software offers tools to enhance imported images and offers contouring of the planned target volume and organs at risk. The isotopes used in the calculations match those which are normally used in High Dose Rate (HDR) and Pulsed Dose Rate (PDR) remote afterloaders. The main use of HDRplus is to calculate the required dwell times at the predetermined dwell positions in a uniform way so that the Planning Target Volume (PTV) is treated with the prescribed dose while sparing the Organs At Risk (OAR). HDRplus can reconstruct one or more applicators. Based on the contoured target volume and the prescription dose, HDRplus will calculate the optimal dose distribution for the turnor volume. Evaluation tools are available to qualify the proposed treatment. The therapy planning is then transferred from the HDRplus software to the brachytherapy afterloader radiation device. The HDRplus software is intended to be used with the Multisource and GyneSource Brachytherapy Remote Controlled Afterloading Devices from Eckert & Ziegler BEBIG GmbH.

The HDRplus System comprises subjoined listed subsystems:

Personal Computer . It executes the HDRplus software.
Monitor . To visualise the treatment planning process.
Keyboard . To enter treatment data.
Mouse . To select objects on the screen

The PC is used to execute the HDRplus software and runs under Windows XP Professional or Windows 7. The hard disk stores patient data and the built in DVD-RW is used for making backup of the Patient Data. The PC can be connected to the hospital network to import Patient Image Data.

Accessory: Film Scanner
The Film Scanner allows the user to scan in an X-Ray image to present it on the screen to visualise the implant.

Accessory: Printer
The Printer allows for hard copy of the patients treatment plan and other stored data.

Accessory: Pen Tablet
The Pen Tablet acts as an alternative replacement for the mouse enabling the user to outline more accurately and faster a contour on the monitor.

Accessory: Touch Panel
The Touch Panel acts as an alternative replacement for the user to outline more accurately and faster a contour on the monitor.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called HDRplus, a Brachytherapy Treatment Planning System. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for specific performance metrics is not available in the provided text.

The document discusses the device's intended use, technological characteristics, and comparison to a predicate device, concluding that it is substantially equivalent. However, it does not detail a study designed to explicitly test and report on acceptance criteria for device accuracy or clinical performance.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Not Available. The document does not provide a table of acceptance criteria or specific, quantifiable performance metrics for the HDRplus treatment planning system. The focus is on substantial equivalence to a predicate device, implying that its performance is expected to be comparable, but no direct performance data or acceptance targets are listed.

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

Not Available. The document does not mention any specific test sets, sample sizes, or data provenance from a study evaluating the HDRplus system against acceptance criteria.

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)

Not Available. Since no specific test set or ground truth establishment process is described for performance evaluation, information about experts is not provided.

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

Not Available. No adjudication method is mentioned as there is no description of a formal test set evaluation process.

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

Not Applicable / Not Available. The HDRplus is a treatment planning system, not an AI-assisted diagnostic tool for human readers in the traditional sense of an MRMC study. It aids in calculating optimal dose distribution. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not described or relevant for this type of device based on the provided information.

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

Partially Applicable / Not Explicitly Detailed as a "Study": The device, HDRplus, is a software package that "calculates a proposed treatment course" and "calculates the optimal dose distribution." This implies a "standalone" algorithmic function. However, the document does not present this as a separate "study" with specific performance metrics and acceptance criteria for "algorithm-only performance." It's integrated into the description of the device's function. The system is intended to be used by "medical professionals," indicating human oversight and input.

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

Not Available. No specific ground truth type is mentioned for validating the device's performance against acceptance criteria. The calculations performed by the device are based on "imported clinical images and other user entered data," and it "evaluates clinical images in calculating the local and global doses." The accuracy of these calculations would likely be verified against established physics models and clinical standards, but the document does not detail how this was done for a formal "ground truth" study.

8. The sample size for the training set

Not Applicable / Not Available. The HDRplus device is described as a software package for calculating radiation therapy plans. There is no mention of machine learning or AI models that would require a "training set" in the context of deep learning. It's a deterministic calculation system based on physics models and user input.

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

Not Applicable / Not Available. As there's no mention of a training set for machine learning, this question is not applicable.

In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the HDRplus Brachytherapy Treatment Planning System to an existing legally marketed device. This type of submission typically relies on comparing intended use, technological characteristics, and safety/effectiveness profiles rather than presenting a detailed study with explicit acceptance criteria and performance data for the new device. Therefore, the document does not contain the specific experimental data and statistical analyses requested.

Summary

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510(k) Summary as required by 21 CFR 807.92 6

Submitter of 510(k) 6.1

510(k) owner's name	:	Eckert & Ziegler BEBIG GmbH
address	:	Robert-Rössle-Strasse 10
	:	13125 Berlin
	:	Germany
phone	:	+49 30 941084130
fax	:	+49 30 941084112
name of contactperson	:	Hub van de Bergh
e-mail	:	hubvandebergh@gmail.com
date the summary was prepared	:	August 10, 2012

6.2 Device: HDRplus

name of the device / trade or proprietary name: HDRplus common or usual name: Brachytherapy Treatment Planning System classification name: . Remote controlled radionuclide applicator system (per 21 CFR section 892.5700 Product code MUJ)

Legally Marketed Device(s) 6.3

HDRplus can be shown to be substantial equivalent to the legally marketed predicate device cited in the table below.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Device1		------------------------------------------------------------------------------------------------------------------------------------------------------------------------------A 66. J. B. B.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------oviniar-----------------.	.	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------17004 1

6.4 Description of the Device

HDRplus 6.4.1

The software offers tools to enhance imported images and offers contouring of the planned target volume and organs at risk. The isotopes used in the calculations match those which are normally used in High Dose Rate (HDR) and Pulsed Dose Rate (PDR) remote afterloaders. The main use of HDRplus is to calculate the required dwell times at the predetermined

dwell positions in a uniform way so that the Planning Target Volume (PTV) is treated with the prescribed dose while sparing the Organs At Risk (OAR).

HDRplus can reconstruct one or more applicators. Based on the contoured target volume and the prescription dose, HDRplus will calculate the optimal dose distribution for the turnor volume. Evaluation tools are available to qualify the proposed treatment. The therapy planning is then transferred from the HDRplus software to the brachytherapy afterloader radiation device. The HDRplus software is intended to be used with the Multisource and GyneSource Brachytherapy Remote Controlled Afterloading Devices from Eckert & Ziegler BEBIG GmbH.

Eckert & Ziegler BEBIG GmbH

HDRplus 510(k) PMN Section 6: 510(k) Summary

Robert-Rössle-Straße 10 13125 Berlin Germany

Phone : +49 30 941084130 +49 30 941084112 Fax e-mail : info@bebig.eu

Doc ID 0011-0001 | Rev 01 | Date Nov 12, 2012 | page 14 / 45

APR 0 4 2013

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Image /page/1/Picture/0 description: The image shows the logo for Eckert & Ziegler. The logo consists of a black oval shape with horizontal lines above and below it, followed by the text "Eckert & Ziegler" in a sans-serif font. The text is in black and appears to be slightly bolded.

The HDRplus System comprises subjoined listed subsystems:

Personal Computer . It executes the HDRplus software.
Monitor . To visualise the treatment planning process.
Keyboard . To enter treatment data.
Mouse . To select objects on the screen

Accessory: Film Scanner 6.4.2

The Film Scanner allows the user to scan in an X-Ray image to present it on the screen to visualise the implant.

6.4.3 Accessory: Printer

The Printer allows for hard copy of the patients treatment plan and other stored data.

6.4.4 Accessory: Pen Tablet

The Pen Tablet acts as an alternative replacement for the mouse enabling the user to outline more accurately and faster a contour on the monitor.

Accessory: Touch Panel 6.4.5

The Touch Panel acts as an alternative replacement for the user to outline more accurately and faster a contour on the monitor.

Intended use of the Device 6.5

The HDRplus is used for the creation of treatment plans for High Dose Rate and Pulsed Dose Rate remote afterloader based brachytherapy. HDRplus will calculate a proposed treatment course based on imported clinical images and other user entered data. HDRpius also supports the evaluation of clinical images in calculating the local and global doses.

Technological characteristics of device compared to the 6.6 predicate device

The HDRplus Brachytherapy Treatment Planning System has the same technological characteristics as the legally marketed predicate device listed above which is cleared under 510(k) #K091145.

The HDRplus technology is based on a computer system, a monitor for data visualisation, keyboard and mouse for data entry. Optionally a frame grabber may be used with HDRplus for capturing video images.

Substantial Equivalence 6.7

From the discussion in previous paragraphs it can be concluded that the HDRplus Brachytherapy Treatment Planning System has the same technological characteristics compared to the legally marketed predicate device indicated in section 6.3.

The differences between HDRplus and predicate devices do not concern the basic principle of operation nor does it adversely affect the safety or effectiveness of the device.

The intended use of HDRplus and predicate device are the same.

The conclusion is that HDRplus is substantial equivalent to the legally marketed predicate device.

Eckert & Ziegler BEBIG GmbH

HDRplus 510(k) PMN Section 6: 510(k) Summary

Robert-Rössle-Straße 10 13125 Berlin Germany

Phone : +49:30 941084130 +49 30 941084112 Fax e-mail : info@bebig.eu

Doc ID 0011-0001 | Rev 01 | Date Nov 12, 2012 | page 15 / 45

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

April 4, 2013

Hub van de Bergh Consultant ECKERT & ZIEGLER BEBIG GMBH C/O TRACEABILITY OA & RA SERVICES MUURZWALUW 30, 3905 RZ VEENENDAAL NETHERLANDS

Re: K123263

Trade/Device Name: HDRplus & Add in prostate Module for HDRplus Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: MUJ Dated: March 15, 2013 Received: March 20, 2013

Dear Mr. van de Bergh:

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 (reporting of medical device-related 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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Page 2-Mr. Bergh

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,

MichaFDA Hara

for

Janine M. Morris, M.S. 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): K123263

Device Name:_________________ HDRplus

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Mishra EOA Hara

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health .

510(k) K123263

Page 1 of 1

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.