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Brachytherapy planning with Oncentra manual Low Dose Rate Treatment Planning is intended for use with brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal including bronchial and surface applicator treatments, involving manually loaded radioactive sources. The software program provides the physician with anatomical and dosimetric information to determine the positioning and loading of the radioactive sources prior to inserting. The software also provides the treatment time and dose distribution for the specific loading. Form this information the patient can be treated with radioactive sources.

Oncentra manual Low Dose Rate Brachytherapy v1.0 is a software package designed for treatment planning of manually loaded low dose rate radioactive sources. This software runs on an Oncentra radiation therapy treatment planning system workstation. Oncentra manual Low Dose Rate Brachytherapy v1.0 is capable of reconstructing the brachytherapy implant from radiographic images or the specification of coordinates, defining the location of the radioactive sources within the implant, and identifying a reference point, e.g. software program calculates the treatment data which includes dose distributions and treatment/implantation time. The brachytherapy treatment planning session allows the physician to evaluate the implant prior to insertion of the low dose radioactive sources, e.g. tubes, wires, in order to determine the most optimal dose distribution within the treatment volume. Once the physician approves the treatment plan the implant is manually loaded with radioactive sources. The program provides a variety of plan evaluation tools to assist in the assessment of the implant quality, e.g. dose volume histogram, dose verification to defined points, dose profiles within the implant, etc. This software program is for manually loaded low dose radioactive sources and does not interface with an external treatment machine, software programs or control units; it strictly provides hard copy output related to the dose distribution, total treatment time, and other treatment related information.

Here's the analysis of the provided text regarding the acceptance criteria and study for the Nucletron Oncentra mLDR v1.0 device:

Acceptance Criteria and Device Performance

Study Information

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

   • The document mentions "Comparison testing was performed," but it does not specify a sample size for the test set.
   • Data provenance is not mentioned. It's unclear if the data was retrospective or prospective, or its country of origin.

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

   • The document does not provide any information about experts used or their qualifications for establishing ground truth specifically for the comparison testing.

3. Adjudication method for the test set:

   • The document does not describe an adjudication method.

4. 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. The study described is a non-clinical comparison between the new device and a predicate device, focusing on "treatment planning output." The concept of "human readers improving with AI vs. without AI assistance" is not relevant here as the device is a treatment planning system, not an AI diagnostic tool that assists human readers in interpreting images.

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

   • Yes, a standalone comparison was essentially done. The "Comparison testing" was between the Oncentra manual Low Dose Rate Treatment Planning software and the predicate device's software output. This is an evaluation of the algorithm's output (treatment planning data) in isolation, rather than in the context of human interaction or clinical outcomes derived from that interaction.

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

   • The ground truth for the comparison testing was essentially the output of the legally marketed predicate device (PLATO Brachytherapy, K983343). The new device's output was compared to this established and previously cleared device to demonstrate "substantial equivalence."

7. The sample size for the training set:

   • The document does not mention a training set sample size. This is likely because the device is a treatment planning system based on established physics and algorithms, rather than a machine learning model that requires a "training set" in the traditional sense. The development would have involved software engineering and validation against known physical models and clinical requirements, rather than a data-driven training approach.

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

   • As no training set is mentioned in the context of machine learning, this question is not applicable. The "ground truth" for the device's functionality would be derived from fundamental physics of radiation dosimetry and brachytherapy principles, inherent in the design and validation of such a system. The predicate device's performance serves as the benchmark for equivalence.

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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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In a radiation therapy department, a course of patient treatment is prescribed by a written directive from a radiation oncologist. Certain parameters from this directive are used by the medical dosimetrist and/or medical physicist along with x-rays or CT scans where applicable to plan a course of treatment. Typically a radiation treatment planning system is used to properly define the precise location and dose distribution for the radiation therapy. As part of the planning process monitor unit settings and dose to a volume or specific anatomical points will be generated.

The MuCheck - Monitor Unit/Dose validation Software verifies the monitor unit or dose calculated by the primary treatment planning system. MuCheck can also be used to calculate the monitor or dose for simple plans that do not require the use of the primary treatment planning system.

The intended use of the MuCheck software has been extended by the addition of an optional module called BrachyCheck. Brachycheck is used to verify brachytherapy procedures(implants using radioactive sources) performed by a brachytherapy treatment planning system. As part of the planning process, dwell positions will be generated and dose contributions from these dwell positions to specified anatomical points will be calculated.

The BrachyCheck module (device under review) verifies the dose calculated to the specified points by the primary treatment planning system. It serves as quality assurance as part of good treatment protocol to have a second means to verify the accuracy of the primary calculation.

The BrachyCheck Dose Validation module is an optional software module that is part of the MuCheck software. MuCheck is designed to operate on a personal computer in a Windows environment. It has been designed to operate either in a stand alone mode independent of any brachytherapy treatment planning system or to import plans from a brachytherapy treatment planning system. It does not connect to or control any radiation hardware device. BrachyCheck performs dose calculations to verify the dose calculated by the primary radiation brachytherapy treatment planning system.

The provided text describes the MuCheck - Monitor Unit/Dose Validation Program, with a specific focus on the BrachyCheck Dose Validation module. The information provided outlines the regulatory submission for premarket notification (510(k)) and details about its intended use and a summary of safety and effectiveness.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific sample size for a "test set" in the context of typical clinical study reporting. The evaluation appears to be based on non-clinical tests comparing BrachyCheck's calculations to those of a brachytherapy treatment planning system or hand calculations.

• Test Set Size: Not explicitly stated as a number of cases or plans. It refers to "tests" that were "conducted using a brachytherapy treatment planning system or hand calculations and BrachyCheck."
• Data Provenance: The data used for these non-clinical tests would be internally generated or from established brachytherapy treatment planning systems and hand calculations. The origin is not specified as a country, and it is inherently retrospective in the sense that it evaluates the device against existing calculation methods rather than collecting new patient data.

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

The ground truth for the non-clinical tests appears to have been established by:

• "A brachytherapy treatment planning system": These are established systems used in clinical practice, which serve as a de facto "expert" in terms of established calculation methods.
• "Hand calculations": These would be performed by qualified medical physicists or dosimetrists. The document mentions "The staff at Oncology Data Systems includes a certified medical dosimetrist with over 34 years of clinical experience." While not explicitly stated that this individual established the ground truth for every test case, their expertise underpins the company's capabilities and the validity of hand calculations.
• Number of Experts: Not explicitly stated for specific test cases. It implies reliance on output from existing validated systems and potentially multiple dosimetrists/physicists for hand calculations.
• Qualifications: For hand calculations, the internal expertise includes a "certified medical dosimetrist with over 34 years of clinical experience."

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1). The "tests results all matched very closely" implies a direct comparison rather than an adjudicated consensus.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Summary of Clinical Testing: Clinical testing was not required to demonstrate substantial equivalence or safety and effectiveness." The evaluation was based on non-clinical tests. Therefore, no effect size of human readers improving with AI vs. without AI assistance is applicable or reported.

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

Yes, a standalone (algorithm only) performance evaluation was done. The BrachyCheck module is a software tool that performs calculations and verifies doses. The non-clinical tests directly compare its computational output to existing systems or hand calculations. It functions as a "standalone mode independent of any brachytherapy treatment planning system" for its verification task. The results reported ("test results all matched very closely") refer to the algorithm's performance in this standalone capacity.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical tests was based on:

• Established gold standard calculations: Output from a "primary radiation brachytherapy treatment planning system."
• Expert hand calculations: Performed by qualified personnel (e.g., certified medical dosimetrist).

This implicitly represents a form of expert consensus or established methodologies rather than pathology or outcomes data.

8. The Sample Size for the Training Set

The document does not mention a training set or machine learning components. BrachyCheck appears to be a deterministic software system that performs dose calculations based on established physics algorithms, not a machine learning model that requires training data.

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

Since no training set is mentioned (as the device is not described as involving machine learning), this question is not applicable to the provided information.

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Real Time HDR is a software application for Brachytherapy Treatment Planning, for the treatment of cancer, i.e. intercavitary, interstitial, intraluminal, involving radioactive sources.

Real Time HDR (RT HDR) is a "real time" treatment planning system for brachytherapy especially meant for treatment of cancer in the prostate. Direct 3D Ultrasound imaging of the treatment gives the physician the possibility to update the planning of the dwell positions of the source in the prostate of the patient. The program provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution, i.e. dose volume histograms, dose verification points and dose profiles. The software program provides the physician wih anatomical and dosimetric information, to determine the positioning and loading of the radioactive sources, prior to radiation treatment. The program also provides the treatment time and dose distribution for the specified loading. From this the information the patient can be treated with the dwell positions of the source. Modifications to SPOT previously cleared K992303, have been made to add functionality for: - o Post Planning , ----- - . Auto activation dwell positions The Ultrasound acquisitation has been changed form longitidinal to transversal. The Post Planning functionality has been derived from Plato BPS K983343. The Dicom 3 Import/Export has been derived from Plato External Beam K964206. Real Time HDR (RT HDR) is an accessory to the microSelectron-HDR (V2). The program constists of two modules: - Treatment Planning Software: Real Time HDR ● - Database: Smoothbase ● The software runs on a Windows 2000 platform.

The provided document is a Special 510(k) submission for the Nucletron Real Time HDR system, an accessory to a radiotherapy device. It focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria, a specific study proving device performance against acceptance criteria, or most of the other detailed study-related information requested.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted, and why:

Information NOT available in the document:

• 1. A table of acceptance criteria and the reported device performance: The document describes the device modifications and its intended use, but it does not specify any quantitative performance metrics or acceptance criteria for those metrics.
• 2. Sample sized used for the test set and the data provenance: There is no mention of a "test set" in the context of device performance evaluation, nor any sample size or data origin.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set or ground truth establishment is described.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 a treatment planning system, not an AI-assisted diagnostic tool for human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes a software system that assists physicians; it does not present a standalone algorithm being evaluated.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: There is no mention of a "training set" as this is not an AI/ML device in the modern sense that would typically involve supervised learning with a training set.
• 9. How the ground truth for the training set was established: Not applicable.

Information that CAN be extracted or inferred:

Description of the Device and its Purpose (from the "study" context):

The "study" in this context is the Special 510(k) submission itself, which aims to demonstrate that a modified medical device ("Real Time HDR") is "substantially equivalent" to a previously cleared predicate device ("SPOT - Sonographic Planning of Oncology Treatments," K992303). The "proof" is the FDA's clearance letter (K022739), stating that the device is substantially equivalent for its stated indications for use.

The document highlights modifications made to the predicate device:

• Added "Post Planning" functionality (derived from Plato BPS K983343).
• Added "Auto activation dwell positions."
• Changed Ultrasound acquisition from longitudinal to transversal.
• Added Dicom 3 Import/Export (derived from Plato External Beam K964206).

The intended use is stated as: "Real Time HDR is intended for use with Brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal, involving afterloading radioactive sources."

The device is a "real time" treatment planning system for brachytherapy, specifically for prostate cancer. It uses 3D Ultrasound imaging to update dwell positions, provides plan evaluation tools (dose volume histograms, dose verification points, dose profiles), and supplies anatomical and dosimetric information for source positioning and loading.

Conclusion:

The provided text is a regulatory submission for device clearance based on substantial equivalence, not a clinical or performance study evaluating specific acceptance criteria with detailed statistical results. Therefore, most of the requested information regarding "acceptance criteria" and "study results" is not present in this document.

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SPOT PRO is a software application for Brachytherapy Treatment Planning, for the treatment of cancer, i.e. intercavitary, interstitial, intraluminal, involving radioactive sources.

SPOT PRO is a "real time" treatment planning system for brachytherapy especially meant for treatment of cancer in the prostate. Direct 3D Ultrasound imaging of the treatment gives the physician the possibility to update the planning of the radioactive seeds implant in the prostate of the patient. The software program provides the physician wih anatomical and dosimetric information, to determine the positioning and loading of the radioactive sources, prior to insertion. The software program provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution, i.e. dose volume histograms, dose verification points and dose profiles. The software program also provides the treatment time and dose distribution for the specified loading. From this the information the patient can be treated with radioactive sources. Modifications to SPOT previously cleared K992303, have been made to add functionality for: . Post Planning functionality . Auto activation dwell positions . Auto contouring . Usage of CT / MR images acquired by Dicom 3 Import/Export . The Post Planning functionality has been derived from Plato BPS K983343. The Dicom 3 Import/Export has been derived from Plato External Beam K964206. The software runs on a Windows NT platform.

The provided text describes a Special 510(k) for the Nucletron SPOT PRO device, a "real-time" treatment planning system for brachytherapy. However, the document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding performance metrics, sample sizes, ground truth establishment, or expert involvement in a study.

The document primarily focuses on:

• Identification of the device: Nucletron SPOT PRO, a radiation therapy planning system.
• Purpose: For brachytherapy treatment planning, especially for prostate cancer, assisting physicians in determining the positioning and loading of radioactive sources.
• Modifications: Post Planning functionality, Auto activation dwell positions, Auto contouring, and DICOM 3 Import/Export capabilities.
• Intended Use: Same as the predicate device (SPOT, K992303).
• Substantial Equivalence: To the predicate device and other Nucletron software (Plato BPS K983343 and Plato External Beam K964206).
• Regulatory information: Classification, product codes, and the FDA's clearance letter.

Therefore, I cannot provide the requested information in the table or answer the specific questions about acceptance criteria and study details because this information is not present in the provided text. The document is a regulatory submission for substantial equivalence rather than a detailed performance study report.

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