Search Results

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.

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.

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.

Ask a specific question about this device