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The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel.

The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel. The system is intended for use by qualified medical personnel in radiotherapy clinics, suitably trained by Nucletron staff (or other competent people) in using the system. The Oncentra system should be configured locally and maintained by radiation physicists. It is a requirement that the person responsible for the local configuration has been suitably trained in configuring and maintaining the system. Oncentra 4.2 uses externally acquired medical images and user input. The Oncentra 4.2 software is based on a modular client/server design, with the treatment planning functions divided into "Activities".

This document describes the Oncentra 4.2 radiation treatment planning software. However, the provided text does not contain sufficiently detailed information about "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the format requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Oncentra MasterPlan 3.1, K081281) for regulatory purposes. It mentions "dosimetric validation" for brachytherapy and external beam calculations, which are relevant to performance, but it does not specify quantitative acceptance criteria or a formal study design that would typically be expected for a detailed evaluation of device performance against specific targets.

Here's an analysis based on the available information, highlighting what is and is not present:

Missing Information:
The document does not provide:

• A table of quantitative acceptance criteria with corresponding device performance metrics.
• Sample sizes for a dedicated test set.
• Data provenance for a test set (country of origin, retrospective/prospective).
• Number of experts or their qualifications for establishing ground truth for a test set.
• Adjudication method for a test set.
• Any information about a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
• Details about a standalone (algorithm only) performance study against specific, pre-defined metrics.
• The sample size for a training set (as this is not an AI/ML device in the modern sense, but rather a treatment planning software).
• How the ground truth for a training set was established.

Information on "Acceptance Criteria" and "Study" (based on interpretation of "Dosimetric Validation"):

The closest the document comes to describing an "acceptance criterion" and a "study" is in sections 5.1 and 5.2 regarding Dosimetric Validation.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a "test set" in the context of a formal study with specific case counts. The validation refers to comparisons (with other software, phantom measurements, and published data).
• Data Provenance: Not specified for a particular test set. The validation is internal ("evaluated by the physics team").

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

• Experts: "Evaluated by the physics team." Specific number and qualifications are not detailed beyond "physics team."
• Qualifications: Not specified.

4. Adjudication method for the test set:

• Not 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 MRMC comparative effectiveness study was done as this is a radiation treatment planning software, not an AI diagnostic aid for human readers. The document predates widespread discussion of "human readers improve with AI."

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

• The "dosimetric validation" described for both brachytherapy and external beam calculations focuses on the algorithms' output (dose calculations). This can be considered a standalone assessment of the algorithms' accuracy in generating dose distributions. However, it's not presented as a standalone study against a defined ground truth in the way a modern AI/ML device might be evaluated for a specific diagnostic task. It's more of a verification of calculation consistency and agreement with established methods.

7. The type of ground truth used:

• Brachytherapy: Comparisons were made against:
  • Results from the Plato version 14.3.5 planning system (another dose calculation algorithm).
  • Phantom measurements (physical validation data).
  • Data published in the TG-43 report (consensus-based physics model for brachytherapy dose calculations).
• External Beam: Comparisons were made against results from earlier versions of Oncentra (verifying consistency, implying the previous version's calculations served as a reference).

8. The sample size for the training set:

• This is not an AI/ML device in the context of machine learning training data. Therefore, a "training set" in that sense is not applicable or discussed. The software is based on physics models and algorithms, not data-driven machine learning.

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

• Not applicable for the reasons stated above.

In summary, the provided document offers a high-level overview of dosimetric validation performed to support the substantial equivalence claim for Oncentra 4.2. It emphasizes consistency with prior versions and established methods, rather than presenting a detailed performance study against explicit quantitative acceptance criteria for a novel AI/ML device.

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MUV 4.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy.

MUV 4.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy. The intended user is a medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy.

The software requires beam data for individual treatment plans to be imported through the DICOM RT Plan format. The parameters associated with the treatment delivery on the accelerator can not be edited within the software, although parameters related to the calculation inside the patient/phantom, such as the coordinates and depths of the calculation points, are open for editing.

The software is validated for broad megavoltage photon beams in the range from 4 up to 30 MV and broad electron beams from 4 to 30 MeV, delivered by standard medical linear accelerators (linacs).

The software runs on a Windows XP, windows Vista and windows 7 systems (32 bit)

This document, K103515, describes the 510(k) premarket notification for the EQUAL Dose 4.0, a quality assurance (QA) tool for independent verification of dose calculations in external beam radiation therapy.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria in terms of numerical thresholds (e.g., accuracy percentages, deviation limits) for the EQUAL Dose 4.0 software.

However, the document describes the software's validation, which implies its performance meets certain expectations:

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It mentions "beam data for individual treatment plans" can be imported but doesn't detail the origin or quantity of this data for validation.

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications. It states the intended user is a "medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy," which suggests expert involvement might be assumed in practice, but no formal ground truth establishment process is detailed.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This is an independent verification tool for dose calculations, not a diagnostic imaging device typically evaluated with MRMC studies for human reader performance improvement.

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

The provided information suggests that the validation described is for the standalone (algorithm only) performance of the EQUAL Dose 4.0. It's a "QA tool intended for independent verification of the dose calculations." The "intended user is a medical physicist," implying that the medical physicist uses the tool, but the validation described is of the software's calculation capabilities itself rather than human-AI combined performance. The validation addresses the accuracy of the software's internal calculations and algorithms (Pencil Beam, Gaussian Pencil Beam) against known physical principles and expected outcomes for radiation beams.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. However, given it's a dose calculation verification tool, the ground truth would typically be established by:

• Established physics principles and analytical models: The algorithms (Pencil Beam, Gaussian Pencil Beam) are based on fundamental physics.
• Measurements from phantoms: Often, dose calculations are validated against actual dose measurements in phantoms using ionization chambers, films, or other dosimeters.
• Comparison to other validated treatment planning systems: Although this device is for verification, sometimes initial validation involves comparing its output to highly accurate reference systems.

The text's statement "The software is validated for broad megavoltage photon beams... and broad electron beams..." implies a comparison against established physical reality for these beam types.

8. Sample Size for the Training Set

The document does not specify a sample size for the training set. For a physics-based dose calculation software, a traditional "training set" as understood in machine learning might not be applicable in the same way. Instead, the "training" phase would involve the development and internal testing of the algorithms to ensure they correctly implement the physical models.

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

Similar to point 8, the concept of a "training set" for ground truth establishment might not directly apply. If any "training" data were used during development (e.g., to fine-tune model parameters), the ground truth for that would likely be based on:

• Known physical properties of radiation beams and materials.
• Experimental data from linear accelerators and phantoms.

In summary, the provided submission focuses on the technical specifications and intended use of the EQUAL Dose 4.0 as a verification tool based on established physics algorithms, rather than detailing extensive clinical study results for acceptance criteria, sample sizes, or ground truth establishment in the way typically seen for diagnostic AI models. The validation mentioned is more akin to demonstrating the accurate implementation of known physical models within the software.

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Oncentra Simulation is an accessory to a radiation therapy simulation system which is intended to prepare patients for radiation therapy. The Simulator emulates the geometrical positions of radiation therapy treatment machines. Using conventional radiographic and fluorographic system, patients are positioned, filmed and marked to prepare them for treatment.

Oncentra Simulation 2.3 is a revision of the image handling software of the Simulix Evolution. This software has been adapted such that images can be acquired and processed from an Image Intensifier such as used on the Nucletron Radiotherapy simulators Simulix MC, Simulix HP and Simulix HQ. This makes it a replacement for the predicate device DTI (K954055). The PC based simulator workstation comes with functionality to support simulation procedures: Image acquisition, Image display, Image enhancement and multiple views, Database and DICOM Import / Export functionality, Simulator controls. The modification to the previously cleared device K033470 is: Added support for Image Intensifiers. The software runs on a PC on a Windows XP platform.

This 510(k) submission for Oncentra Simulation 2.3 is a special 510(k) for a software revision and focuses on demonstrating substantial equivalence to a predicate device (Simulix Evolution, K033470). It does not contain the detailed study information typically found in an original 510(k) or PMA submission regarding acceptance criteria, performance studies, or ground truth establishment.

Here's an analysis based on the provided text, highlighting what is not available in this document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating that the revised software, Oncentra Simulation 2.3, performs its intended functions (image acquisition, display, enhancement, database functionality, simulator controls, and support for Image Intensifiers) adequately and is substantially equivalent to the predicate device.

The "performance" described is functional equivalence, not diagnostic accuracy. The key performance aspect mentioned is "Added support for Image Intensifiers." This is a functional addition, and its 'performance' is implicitly met if the system successfully interfaces with and processes images from Image Intensifiers as intended.

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

Not specified. This document describes a software revision and its functional equivalence to a predicate device. It does not detail a study involving a test set of patient data with specific sample sizes. The evaluation would have been more about verifying the software's functionality and compatibility rather than analyzing a clinical dataset.

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

Not applicable/Not specified. Since there's no mention of a clinical test set requiring ground truth for diagnostic accuracy, there's no information on experts or their qualifications.

4. Adjudication Method for the Test Set:

Not applicable/Not specified. As there is no clinical test set described, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study is not mentioned or implied by the document. The submission focuses on substantial equivalence based on technological considerations and functional performance, not a comparative effectiveness study involving human readers.

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

Not applicable/Not specified. The device is a simulation system, an accessory to radiation therapy. It's an imaging and planning tool used by humans, not an AI algorithm making independent diagnostic decisions. The "algorithm" in this context refers to the software's functional logic, not a standalone diagnostic AI.

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

Not applicable/Not specified. As no clinical performance study involving diagnostic accuracy is described, no ground truth types are mentioned. The ground truth for a software revision like this would likely be engineering specifications and functional testing results.

8. The sample size for the training set:

Not applicable/Not specified. This is a software revision, not a machine learning model that requires a training set in the conventional sense. The "training" for the software would involve development, testing against specifications, and verification/validation activities.

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

Not applicable/Not specified. Again, this is not a machine learning context. The "ground truth" for software development typically refers to design specifications, requirements, and expected functional behavior, which are verified through various software testing methodologies.

In summary:

This 510(k) submission pertains to a software revision for a radiation therapy simulation system. It demonstrates substantial equivalence primarily by showing that the updated software (Oncentra Simulation 2.3) has the same intended use and similar technological characteristics to a legally marketed predicate device, with the key modification being "Added support for Image Intensifiers." The document does not contain information about clinical performance studies, diagnostic accuracy metrics, test/training sets, or expert evaluations in the context of ground truth establishment. Such detailed clinical performance data is typically found in submissions for novel devices or devices with significant changes affecting clinical outcomes, not usually for a functional software update like this one.

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The intended use of the device is gynecological brachytherapy procedures for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.

The Interstitial Ring CT/MR Applicator Set is based on the Ring CT/MR Applicator Set enhanced with the addition of nine guiding holes in the ring tube (seven holes for part number 110.130). These guide holes allow placement of guiding tubes through which Proguide needles (K060349) can be inserted into the tumor. The addition of interstitial needles makes it possible to achieve asymmetric alteration of the dose distribution. The needles are inserted perpendicular to the ring and are parallel to the tandem. The applicator is fully CT/MR compatible. The device is composed of polymers, to eliminate distortion on CT or MR imaging. Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available.

The device is similar to the legally marketed predicate device Vienna Ring CT/MR Applicator Set. The difference between this device and the Vienna Ring CT/MR Applicator Set is that this device allows the use of Proguide needles instead of the titanium needles used with the Vienna Ring CT/MR Applicator Set

The Utrecht Interstitial Fletcher CT/MR Applicator Set is based on the legally marketed predicate device Standard CT/MR Applicator Set enhanced with five similar guiding holes in each ovoid as the guiding holes in the ring of the Interstitial Ring CT/MR Applicator Set. These guiding holes allow placement of guiding tubes through which Proguide needles (K060349) can be inserted into the tumor. The addition of interstitial needles makes it possible to achieve asymmetric alteration of the dose distribution. The needles are inserted perpendicular to the ovoids. The applicator is fully CT/MR compatible. The device is composed of polymers, to eliminate distortion on CT or MR imaging. Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available.

The MR line markers are optional devices that can make the channels of the Nucletron CT/MR applicators visible using magnetic resonance imaging. The markers consist of a thin Teflon tube that can be filled with an appropriate fluid that is clearly visible on magnetic resonance images.

The tubes are inserted before imaging in the channels of the CT-MR applicator and are removed before the treatment of the patient.

The devices are used as accessories to the Nucletron microSelectron Afterloaders

This document is a 510(k) summary for a medical device (Nucletron's Interstitial Ring CT/MR Applicator Set & Utrecht Interstitial Fletcher CT/MR Applicator Set) seeking clearance. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment for a standalone or comparative effectiveness study is not available in the provided text.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in a structured table as it would be for a performance study. The core "acceptance criteria" for this submission is demonstrating substantial equivalence to a legally marketed predicate device. The "performance" described relates to the features and intended use of the new device being similar to the predicate.

   • Acceptance Criteria (Implicit for 510(k) Special): Substantial equivalence to the predicate devices (Ring CT/MR Applicator Set and Standard CT/MR Applicator set, K983341) regarding:

     • Intended Use (Gynecological brachytherapy for cancer treatment of cervix and endometrium, with optional interstitial brachytherapy).
     • Technological Characteristics (Polymer construction for CT/MR compatibility, similar design with added guiding holes for interstitial needles).
     • Safety and Effectiveness (Not explicitly stated in detail, but inferred by substantial equivalence).

   • Reported Device Performance (Implicit):

     • Allows placement of guiding tubes for Proguide needles.
     • Enables asymmetric alteration of dose distribution.
     • Fully CT/MR compatible due to polymer composition, eliminating distortion.
     • MR line markers can make channels visible on MR images.
     • Functions as an accessory to Nucletron microSelectron Afterloaders.

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

   • Not applicable (N/A). This document describes a medical device seeking 510(k) clearance based on substantial equivalence, not a performance study involving a test set of data or patient samples. The "data" here refers to the device's design specifications and comparison to a predicate.

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

   • Not applicable (N/A). No test set or ground truth derived from experts is detailed in this 510(k) summary.

4. Adjudication Method for the Test Set:

   • Not applicable (N/A). No test set or adjudication process is detailed in this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. This document does not describe an MRMC comparative effectiveness study to assess human reader improvement with or without AI assistance. This is a traditional 510(k) submission for a physical medical device (applicator set), not an AI/software device.

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

   • No. This is not an AI/algorithm-based device. No standalone performance study for an algorithm is described.

7. The Type of Ground Truth Used:

   • Not applicable (N/A). The concept of "ground truth" as typically used in performance studies (e.g., pathology, outcomes data) does not apply directly to this 510(k) submission. The "ground" for comparison is the predicate device's established safety and effectiveness.

8. The Sample Size for the Training Set:

   • Not applicable (N/A). This is not an AI/machine learning device that requires training data.

9. How the Ground Truth for the Training Set was Established:

   • Not applicable (N/A). As above, this is not an AI/machine learning device.

In summary, the provided document is a regulatory submission for device clearance, not a study report detailing performance against specific acceptance criteria in the manner one might expect for a diagnostic or AI-driven device. The focus is on demonstrating that the new applicator set is "substantially equivalent" to existing, cleared devices.

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The Oncentra RT Viewer is intended to be used for review and evaluation of DICOM based patient data by qualified specialists. It is used to load and display data generated by different DICOM modalities including, but not limited to: RT Image, RT Structure Set, RT Plan, RT Dose, CT, CR, MR, and PET.

It provides the user with a wide range of tools to compile, compare, and manipulate views and images. It enables super-positioning of geometrically related DICOM data.

RT Viewer provides tools for analysis of single and summed plans, and for comparison of several alternative plans. All image series and all RT objects (Structure Set, Plans, RT Images and Dose) in the study can be displayed and explored.

RT Viewer is principally a read-only activity and produces no new data or modifications to the data for the study and the plan(s).

Single Plan Evaluation

• Display of plan dose in original, reconstructed planar and 3D images.
• Display of dose as a sequence of objects,
• Inspection and comparison of individual objects for a plan in a study.
• Display of DVH in individual and total mode to view contributions from total plan or individual beams.
• Display of DVH statistics.

Plan Comparison

• Side-by-side display of a plan for selected plans in a study, shown as a sequence of objects.
• Comparison of DVH and dose statistics for plans in a study.

Plan Summation

• Summation of dose distributions for plans and display of summed dose.
• Display of DVH in individual and total mode to view contributions from summed or individual plans.

The software runs on a Windows XP or VISTA platform.

The provided text is a 510(k) summary for the Nucletron Oncentra RT Viewer 1.0. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, specific studies conducted to prove device performance, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.

Therefore, I cannot populate the table or answer the questions as requested based on the given input.

The document primarily focuses on establishing substantial equivalence to a predicate device (Oncentra MasterPlan 3.1) and obtaining clearance from the FDA for marketing, rather than detailing a specific performance study with acceptance criteria. The statement "$510(k) Summary of Safety and Effectiveness Information$" suggests that the primary method of demonstrating safety and effectiveness for this type of device (a viewer/display system) is through comparison to an already cleared predicate, rather than extensive new clinical efficacy studies.

To address your request, I would need a different type of document, such as a validation study report or a more detailed technical file for the device, which would typically describe specific performance tests and their results against predefined acceptance criteria.

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The Vienna Ring CT/MR Applicator is intended for use with Nucletron remote afterloading equipment for gynaecological brachytherapy procedures.

The Vienna Ring CT/MR Applicator is based on the Ring CT/MR Applicator set enhanced with the addition of nine guide holes in the ring tube (seven holes for part number 189.699). These guide holes allow placement of interstitial titanium needles using the ring tube as a needle template while still maintaining the treatment on the dose distribution. The addition of interstitial needles makes it possible to achieve asymmetric dose distributions around the ring and are parallel to the tandem. The applicator is fully CT/MR compatible. Its design uses composite fiber tubing, to eliminate distortion on CT or MR imaging. Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available. The Titanium Needles are fully CT/MR compatible and can be used in order to have minimal artifacts on the acquired images.

This document is a 510(k) premarket notification for a medical device (Vienna Ring CT/MR Applicator). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, study design, or performance metrics that would be used to "prove the device meets the acceptance criteria."

The 510(k) submission process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on presenting raw performance data or clinical study results in the same way a PMA or de novo submission might.

Therefore, I cannot fulfill your request for the tables and information about study design, sample sizes, ground truth establishment, or expert adjudication, as this information is not present in the provided text.

The document mainly includes:

• Device Identification: Name, classification, and manufacturing information.
• Predicate Device: Identification of the legally marketed device to which the new device claims substantial equivalence.
• Description of Modifications: Details how the new device differs from the predicate.
• Intended Use Statement: Clarifies the medical purpose of the device.
• FDA Clearance Letter: Official communication from the FDA confirming clearance.

To answer your request, a document detailing the verification and validation testing for this device would be needed.

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The Oncentra MasterPlan system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel.

The Oncentra MasterPlan 3.1 system is radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments affer review and approval by qualified medical personnel.

Oncentra MasterPlan 3.1uses externally acquired medical images and user input. The Oncentra MasterPlan 3.1software is based on a modular client/server design, with the treatment planning functions divided into "Activities".

Oncentra MasterPlan 3.1 contains the following Activities:

Anatomy Module: .
The Anatomy Modeling (AM) module is an advanced contouring package for defining structures (ROIs) related to the patient anatomy and target volumes for treatment planning, The AM allows the user to create and edit image registration between image series so that image fusion tools can be utilized.

· Beam Module
The Beam Modelling (BM) module handles specification of the beam shapes and other manipulation of the treatment plan.

Connectivity Module: .
The Connectivity Module (CM) module handles all forms of DICOM data input to the Oncentra Brachy system from external sources, and data output from the system to external sources.

Dose Module .
The Dose Modelling (DM) module handles execution of External Beam dose calculations.

Optimizer Module .
The Oncentra Optimizer (OM) module handles execution of treatment plan optimization. This activity will result in an optimized treatment plan for which the final dose calculation must be performed by DM.

Brachy Planning Module .
The Brachy Planning (BP) module handles execution of Brachytherapy dose calculations.

Evaluation Module: .
The Evaluation Module (EM) handles the necessary tools for evaluating one treatment plan that has a calculated Dose result. EM supports the same tools as BM but in a read-only mode. Tools that are not read-only like new/delete beams, field shaping, edit MLC, apply/remove wedges, etc. are not supported in EM.

Evaluator Module .
The Oncentra Evaluator (EVAL) handles the necessary tools for evaluating and comparing multiple treatment plans and dose summation of two or more plans for a selected case. The user may also select a candidate plan and approve the plan for treatment. The EVAL is a read-only activity with the exception of the plan approval function.

· Volume Rendering
The Volume Rendering (VR) module handles visualization of plans and their corresponding dose in 3D. No plan related data is modified in this module.

In addition, various system utilities are available.

The software runs on a Windows XP platform.

The provided text is a 510(k) summary for the Oncentra MasterPlan 3.1 radiation treatment planning system. It describes the device, its intended use, and its substantial equivalence to previously cleared devices. However, this document does not contain information about specific acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested table or answer the questions related to a study's methodology, sample sizes, expert ground truth, adjudication, or MRMC comparative effectiveness. The document primarily focuses on establishing substantial equivalence to predicate devices, a regulatory pathway that often relies on demonstrating similar performance characteristics rather than presenting new clinical study data against defined acceptance criteria.

Information that could be extracted and is relevant, but doesn't fully address your request:

• Device Name: Oncentra MasterPlan 3.1
• Common Name: Radiation Therapy Planning System
• Intended Use: "The Oncentra MasterPlan system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel."
• Regulatory Class: Class II (21 CFR 892.5050)
• Predicate Devices:
  • Nucletron BV, OTP 1 (K031349)
  • Nucletron B.V., Рl ATTO (K983343)

Missing Information (and why it's missing based on the provided text):

1. Table of acceptance criteria and reported device performance: Not present. The document focuses on "substantial equivalence" to predicate devices, implying similar performance is expected, but doesn't define or report against specific, quantified acceptance criteria for the new device.
2. Sample size used for the test set and data provenance: No test set is described or referenced.
3. Number of experts used to establish the ground truth for the test set and qualifications: No test set or ground truth establishment is described.
4. Adjudication method: Not applicable as no test set or ground truth establishment is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
6. Standalone (algorithm only) performance: Not explicitly discussed. The device is a "treatment planning software" used by medical personnel, suggesting it's part of a human-in-the-loop process, but no standalone performance metrics are provided.
7. Type of ground truth used: Not applicable as no test set or ground truth establishment is described.
8. Sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

In summary, the provided document is a regulatory submission focused on substantial equivalence rather than a detailed report of a performance study against specific acceptance criteria.

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Titanium needles are intended for interstitial Brachytherapy procedures involving Nucletron mHDR remote afterloading equipment.

The Titanium Needle Set as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, mHDR and is intended for interstitial Brachytherapy procedures.

Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available. More and more brachytherapy treatments are carried out where CT and MR based imaging is used for volume and target delineation. The Titanium Needles are fully CT/MR compatible and can be used in order to have minimal artefacts on the acquired images.

The Titanium Needle is inserted into the treatment area, using standard interstitional insertion techniques. CT markers are inserted into the Titanium Needles for visualisation. Radiographic images are obtained to determine the precise location within the body. This information is then used for Brachytherapy treatment planning purposes.

The Titanium Needle Set is used as an accessory to the Nucletron microSelectron remote afterloaders.

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for device performance. Therefore, many of the requested elements for a study proving acceptance criteria will not be present in this document.

Here's an analysis of the provided text in relation to your request:

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

The provided document (K080871) is a 510(k) summary for "Titanium Needle Sets." In a 510(k) submission for this type of device, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device, particularly for devices like interstitial needles which are accessories to a larger system. Performance is generally assessed through design specifications, material compatibility, and intended use alignment rather than through new clinical outcome studies with predefined statistical acceptance criteria typical of novel therapies or diagnostics.

The document states:

• "The Titanium Needle Set as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, mHDR and is intended for interstitial Brachytherapy procedures."
• "The Titanium Needles are fully CT/MR compatible and can be used in order to have minimal artefacts on the acquired images."
• "The modified device has the same intended use as the legally marketed predicate device cited."
• "The Titanium Needle Set is substantially equivalent to the cleared predicate device, Interstitial Needle Set, 510(k)#: K953946."

Based on the available text, specific quantitative acceptance criteria and reported device performance metrics (e.g., sensitivity, specificity, accuracy, or a specific range of artifact reduction) are not detailed. The "performance" is implicitly demonstrated through the claim of CT/MR compatibility with minimal artifacts and the overall substantial equivalence to the predicate.

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

This document does not describe a clinical study with a "test set" in the context of diagnostic or interventional performance. The "test" in this submission would likely refer to engineering verification and validation testing (e.g., material compatibility, dimensional accuracy, sterilization efficacy, imaging compatibility) rather than a clinical trial. Therefore, sample sizes for a clinical test set are not applicable here.

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 applicable, as no clinical "test set" requiring ground truth established by experts is described for this type of 510(k) submission.

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

Not applicable, as no clinical "test set" requiring adjudication for ground truth 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

Not applicable. This device is an interstitial needle for brachytherapy, not an AI-powered diagnostic or decision support tool.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable, as no clinical "test set" requiring ground truth is described. For a device like this, the "ground truth" would relate to its physical properties and performance (e.g., actual dimensions matching specifications, material composition, artifact presence in imaging under controlled conditions).

8. The sample size for the training set

Not applicable. This document is not describing a machine learning or AI algorithm development.

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

Not applicable. This document is not describing a machine learning or AI algorithm development.

In summary:

The provided 510(k) document is for a medical device accessory (Titanium Needle Set) and aims to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission typically relies on comparing design, materials, and intended use, along with non-clinical performance data (e.g., imaging compatibility, mechanical robustness, biocompatibility), rather than extensive human-in-the-loop clinical studies with statistical acceptance criteria. Therefore, most of your requested information related to comprehensive clinical study design and performance metrics is not present in this regulatory submission.

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Oncentra GYN 1.0 is a software application intended for Brachytherapy Treatment Planning, for the treatment of cancer, ie. intercavitary, interstitial, intraluminal, involving radioactive sources.

Oncentra GYN is a "real time" treatment planning system for brachytherapy especially meant for the treatment of gynaecological cancers. Direct 3D imaging of the treatment area gives the physician the possibility to update the planning of the dwell positions of the radioactive source in the target volume of the patient. The program provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution, e.g. dose volume histograms, dose verification points and dose profiles. The software program provides the physician with anatomical and dosimetric information, to determine the positioning and loading of the radioactive sources, prior to radiation treatment. The software is an adaptation of the software of the predicate device to make the software more suitable for the use with gynaecological cancers. The following features have been added for this: Support for applicators and needles (instead of only needles), 3D MRI, CT and ultra sound image import (instead of only ultra sound), Support of multiple target volumes (instead of only one), Optimisation algorithms more suitable for gynaecological treatments. The modified device is an accessory to a brachytherapy afterloader. The program consists of two modules: Treatment planning Software: Oncentra GYN, Database: Smoothbase. The software runs on a Windows XP platform on the same hardware as Swift 2.0.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance), or training set information for a specific device.

The document is a 510(k) summary for a medical device called "Oncentra GYN," which is a treatment planning system for brachytherapy. It describes the device, its intended use, and its substantial equivalence to a predicate device (SWIFT 2.0). However, it focuses on regulatory submission details and does not include clinical study data or performance metrics.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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EQUAL Dose 1.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy, prior to the clinical treatment start. The intended user is a medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy.

MUV 1.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy, prior to the clinical treatment start. The intended user is a medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy.

The software requires beam data for individual treatment plans to be imported through the DICOM RT Plan format. The parameters associated with the treatment delivery on the accelerator can not be edited within the software, although parameters reliated to the calculation inside the patient/phantom, such as the coordinates and depths of the calculation points, are open for editing.

The software is validated for broad megavoltage photon beams in the range from 4 up to 30 MV, delivered by standard medical linear accelerators (linacs),

The software runs on a Windows XP platform.

The provided text describes a 510(k) premarket notification for the "Nucletron EQUAL Dose 1.0" device, a Radiation Therapy Verification Tool. However, the document does not contain specific information regarding acceptance criteria, a detailed study proving device performance against those criteria, or the methodology used for establishing ground truth or expert involvement.

The document primarily focuses on:

• Substantial equivalence to a predicate device (MDS Nordion DCM1.0).
• Description and intended use of EQUAL Dose 1.0 as a Quality Assurance (QA) tool for verifying dose calculations in external beam therapy.
• Administrative details of the 510(k) submission and FDA's clearance letter.

Therefore, I cannot provide the requested table or detailed study information based on the given text. The text explicitly states that EQUAL Dose 1.0 is "merely a verification tool" and validates it for "broad megavoltage photon beams in the range from 4 up to 30 MV". This implies that its "performance" would likely be assessed by how accurately its dose calculations compare to accepted physics models and/or measurements, but the document does not provide the acceptance criteria for these comparisons or the study results.

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