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BeamDose is a software for the following purposes in radiotherapy:

• absolute dose measurements as field class dosemeter (according to IEC 60731)
• monitor calibration
• positioning of detectors in PTW water phantoms

The software enables the user of a BEAMSCAN, TANDEM, TANDEM XDR, UNIDOS E, UNIDOS webline, UNIDOS Tango, UNIDOS Romeo or MULTIDOS electrometer to operate the electrometer as a therapy dosemeter in accordance with IEC 60731.

The software establishes the communication with the electrometer, provides calibration and correction factors for various detectors and displays the measurement results.

Additionally, the software enables the positioning of a measuring detector in the desired measuring depth with a motorized PTW water phantom.

The measured absolute dose values must not be used directly in radiation therapy. They have to be checked for plausibility by qualified personnel.

The software must be used only by qualified personnel, usually the medical physicist responsible for the radiotherapy system or an authorized person.

The software measures with BEAMSCAN, TANDEM, TANDEM XDR, UNIDOS E, UNIDOS webline, UNIDOS Tango, UNIDOS Romeo, and MULTIDOS and calculates absolute dose values.

The software controls the positioning of detectors in BEAMSCAN, MP3, MP2, and MP1 water phantoms.

The software comprises the readout of the detector data from a data base (Detector Library) with calibration factors and other detector parameters.

The software corrects measurement data according to temperature and atmospheric pressure and with user correction factor.

The software supports RS232 and TCP/IP interfaces to read out measurement data from the electrometers and to operate the water phantoms.

The provided text describes the BeamDose software, its intended use, and its performance relative to a predicate device, DoseView 3D, in the context of a 510(k) premarket notification. The document states that the BeamDose software was tested to evaluate and verify that it meets the required performance specifications which are defined in the product standard IEC 60731:2011 (Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy).

Here's a breakdown of the requested information based on the provided text:

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

The acceptance criteria for the BeamDose software are primarily derived from the product standard IEC 60731:2011. The reported device performance is presented as fulfilling these criteria when used with specific electrometers (BEAMSCAN, TANDEM, TANDEM XDR).

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VERIQA is a software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.

VERIQA software is a tool for evaluation and data management of digital images and treatment plan information. It supports the medical imaging modalities CT, MR, PET according to the ACR/NEMA DICOM 3.0 standard and other modalities. VERIQA supports the following applications:

• a) Receiving, transmitting, storing, display, and processing of medical images and DICOM objects.
• b) Creating, displaying and printing of reports containing medical images.
• c) Image registration, fusion display, and review of medical images for treatment evaluation and treatment planning.
• d) Localization and definition of structures such as tumors and normal tissue in medical image sets.
• e) Creation, transfer, and modification of contours and dose distributions such as quantitative analysis, aiding adaptive radiation therapy, transferring contours and dose distributions to radiation treatment planning systems, and archiving contours and dose distributions for patient follow-up and management.
• f) Secondary Monte Carlo dose calculation for patient specific quality assurance.

VERIQA must not be used while a patient is present. VERIQA must not be used for treatment planning.

Software for viewing and analyzing of DICOM and DICOM RT data as well as for contouring of these data for radiation therapy. All the relevant data, including image data sets and treatment plans, can be imported into VERIQA. The software enables interactive viewing of these data in 2D/3D/4D and evaluation of the treatment plans with secondary Monte Carlo 3D dose calculation. The user can register images and process RT Dose, RT Plan, and RT Structure objects. Results can be saved in the DICOM RT format for use by other systems for radiation treatment planning purposes.

The provided text describes the VERIQA device, its intended use, and a comparison with predicate devices. However, it does not contain detailed information about specific acceptance criteria or a study that specifically proves the device meets those criteria with numerical performance data. It generally states that "Software verification and validation testing results were conducted and submitted according to appropriate bench testing methods" and "It was demonstrated that VERIQA fulfils the design specification and its intended use, and that it is equivalent to the predicate devices."

Therefore, I cannot fully complete all sections of your request based solely on the provided text. I will fill in what can be inferred or explicitly stated.

Here's the breakdown of the acceptance criteria and study information based on the provided text:

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

The document does not explicitly state numerical acceptance criteria or reported device performance metrics from a formal study. The "Device Comparison Table" on pages 5-6 lists technological characteristics and functionalities, indicating whether VERIQA and its predicates possess them ("Yes" or "No"), but not quantitative performance.

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

This information is not provided in the document. The text only vaguely states "Software verification and validation testing results were conducted and submitted according to appropriate bench testing methods."

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)

This information is not provided in the document.

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

This information is not provided in the document.

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

This information is not provided in the document. The device description does not imply AI assistance for human readers in the context of improving their performance, but rather offers secondary calculations and visualization tools for medical physicists and other professionals.

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

The document implies standalone performance for the Monte Carlo dose calculation ("Secondary Monte Carlo dose calculation and evaluation for patient specific quality assurance") and other automated features like "Automated processing of secondary checks" and "Automatic notification". However, specific details or results of such standalone performance are not provided, beyond the functional confirmation of their presence.

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

This information is not provided in the document. For radiation therapy QA software, ground truth for dose calculation is typically established against established physics models, phantom measurements, or other validated dose calculation systems. However, the specific method is not detailed here.

8. The sample size for the training set

This information is not provided in the document. The document describes VERIQA as software for display, evaluation, and digital processing, rather than a machine learning/AI model that typically undergoes explicit "training"; thus, a traditional "training set" might not be applicable in the same way.

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

As with point 8, this information is not provided and may not be applicable in a traditional sense for this type of software.

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The BEAMSCAN MR system is used preferably in combined MRI-radiation therapy systems with static magnetic fields of up to 1.5T and is intended to collect beam data in water under the aspect of machine QA for the following purposes:

• acceptance testing and/or commissioning of a combined MRI-radiation therapy system
• measurements after repair or replacement of major treatment unit components of a combined MRI-Radiation therapy system
• beam data analysis according to international therapy dosimetry protocols
• acquisition, formatting and transfer of basic data to treatment planning systems
• periodic QA procedures, e.g. constancy check
• high precision data acquisition for scientific research (not a medical device indication)

The BEAMSCAN MR system is comprised of a PMMA tank with a moving mechanism and radiation detectors. Further main components are a carriage with built-in electrometer, control unit and control interface. The carriage includes a water reservoir. The whole system is controlled by software for data display and processing.

Here's a breakdown of the acceptance criteria and the study information for the BEAMSCAN MR device, based on the provided FDA 510(k) summary:

The document focuses on demonstrating substantial equivalence to a predicate device (BEAMSCAN water phantom system, K161807) and adapting the system for use in combined MRI-radiation therapy systems with static magnetic fields up to 1.5T. Therefore, the "acceptance criteria" largely revolve around meeting relevant safety and performance standards for this new environment, and the "study" involves verification and validation testing to confirm these aspects.

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

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

The document does not specify a distinct "test set" with a number of cases in the traditional sense of a clinical study. The performance evaluation is based on:

• Bench and Non-clinical Testing: These are laboratory-based tests. The "sample size" would relate to the number of measurements taken or the number of units tested. This information is not provided beyond stating that verification and validation were performed.
• Clinical Workflow Validation: This was conducted "with qualified medical physicists and experienced PTW staff." There is no specific number of "cases" or "patients" as the device is for QA and not used with patients. The provenance is internal to the manufacturer (PTW staff) and likely conducted at their facilities or collaborator sites.

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)

No "ground truth" established by external experts in the way typical for AI/diagnostic devices. The "validation of the clinical workflow" was performed by:

• "qualified medical physicists"
• "experienced PTW staff"

The specific number of these individuals or their detailed qualifications (e.g., years of experience) are not provided. Given the nature of a QA device, the "ground truth" for its performance accuracy would be derived from physical dosimetry standards and established protocols, rather than expert interpretation of patient data.

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

No adjudication method is mentioned as there isn't a traditional "test set" requiring expert consensus on findings. The performance evaluation relies on objective measurements against engineering specifications and relevant industry standards.

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, an MRMC comparative effectiveness study was not done. This device is a quality assurance tool for radiation therapy systems, not a diagnostic imaging device that assists human readers. Therefore, the concept of "human readers improving with AI assistance" is not applicable here.

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

The BEAMSCAN MR is a hardware system with integrated software for data display and processing. It performs "standalone" measurements of beam characteristics. There isn't a human-in-the-loop diagnostic process for the device itself; rather, humans (medical physicists) operate the device to perform QA. The software itself contains "no new functions" and was previously cleared. The focus is on the hardware's performance in an MR environment.

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

The "ground truth" for the device's performance is based on:

• Physical Dosimetry Standards: Compliance with standards like IEC 60731:2016 for radiotherapy dose measurements.
• Engineering Specifications: The device's ability to accurately measure parameters like detector positioning, reproducibility, and mechanical alignment against its design inputs.
• Regulatory Standards: Adherence to electrical safety (IEC 61010-1:2010), EMC (IEC 60601-1-2:2014), and MR safety (ASTM F2052-15) standards.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of this device because it is a measurement tool, not a diagnostic or prognostic one.

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of machine learning, as this device primarily relies on physics principles and engineering. The "software contains no new functions" and was previously cleared. Therefore, any development data for the original software would have been part of the predicate device's clearance.

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

Not applicable as there is no mention of a "training set" for machine learning purposes for this device. The software's ground truth (i.e., its correct functionality) would have been established through traditional software verification and validation, ensuring it correctly implements the algorithms for data acquisition, processing, and display as specified by physics principles and dosimetry protocols.

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The OCTAVIUS System is intended to collect beam data for patient plan verification of a treatment planning system (TPS) and under the aspect of machine QA for the following purposes:

• IMRT patient plan verification
• periodic QA procedures, e.e. constancy checks
• beam data analysis according to international therapy dosimetry protocols
• measurements after repair or replacement of major treatment unit components

The OCTAVIUS System is comprised of a two-dimensional ion chamber based detector array, uniformly arranged as a matrix and a separate detector interface for data acquisition. The detector array can be placed either in a static cubic or octagonal phantom or in a linear rotational phantom. For the measurement of moving radiation sources (e.g. the rotating gantry of a LINAC), the rotational phantom rotates synchronously with the gantry. An inclinometer, fixed to the gantry, delivers the gantry angle values which are used to align the rotating detector to the gantry. The whole system is controlled with software for data display and processing.

The provided text describes the OCTAVIUS System, a device for dosimetry measurements in radiotherapy, and its FDA 510(k) premarket notification. However, it does not contain a detailed study with specific acceptance criteria and reported device performance metrics in a tabular format, nor does it detail a multi-reader multi-case (MRMC) comparative effectiveness study, ground truth establishment methods for training or test sets, or standalone algorithm performance.

Therefore, much of the requested information cannot be extracted directly from this document. Based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states, "The FDA has not published any performance standards for this product," meaning specific quantitative acceptance criteria set by the FDA are not provided in this document. The document primarily focuses on verifying that the device "fulfills the design specification and its intended use."

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text. The testing seems to be internal verification and validation of the device's functionality rather than a clinical study with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not specified. The "ground truth" for this device appears to be its internal design specifications and the expected physical measurement outcomes, rather than expert-labeled data for an AI algorithm.

4. Adjudication method for the test set:

• Not applicable as no expert-based ground truth establishment or adjudication method is described.

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, an MRMC comparative effectiveness study is not mentioned. The OCTAVIUS System is a dosimetry measurement device, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images.

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

• The document implies that the device's software was tested in isolation ("software verification and validation testing results were conducted and submitted"). The device itself is a measurement system, and its "performance" is its ability to accurately collect beam data. It's not an AI algorithm in the traditional sense that operates autonomously on diagnostic data or has a "human-in-the-loop" for interpretation.

7. The type of ground truth used:

• The implicit "ground truth" for the OCTAVIUS System's performance would be the physical reality of radiation dose distributions and the design specifications of the device for measuring these distributions accurately. The verification and validation process likely involved comparing the device's measurements against known or highly calibrated standards.

8. The sample size for the training set:

• Not applicable. The OCTAVIUS System is a physical measurement device, not an AI system that undergoes "training" on a data set.

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

• Not applicable for the same reason as above.

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