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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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