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Oncentra is a radiation therapy 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.

Oncentra Brachy 4.4 is a radiation therapy 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.

Oncentra Brachy 4.4 is a brachytherapy treatment planning only version of the Oncentra treatment planning system (Oncentra 4.2- K121448) and does not include Oncentra external beam treatment planning capabilities. Oncentra Brachy 4.4 includes all Oncentra software that is required for brachytherapy treatment planning which includes

• 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.
• 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.
• Brachy Planning Module: The Brachy Planning (BP) module handles execution of Brachytherapy dose calculations. The software allows reconstruction of the implant from external images, identification of the radioactive sources, optimization methods, displayed dose distributions and output of treatment times.
• 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 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.
• Collapsed Cone Algorithm (ACE): Is a model based dose calculation that has been implemented in accordance with the AAPM TG-186 recommendations for brachytherapy uniformity. This algorithm takes into account the effects of tissue heterogeneities (normal tissue, air and bone), shields and applicators within finite patient dimensions.

The provided document is a 510(k) summary for a medical device (Oncentra Brachy 4.4), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and a comprehensive study report in the way a clinical trial might. It describes non-clinical and clinical "testing" at a high level.

Here's an attempt to extract and present the information based on the typical requirements for acceptance criteria and study descriptions, interpreting "testing" as "study" where appropriate:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a tabular format as one would expect from a rigorous clinical study. The "acceptance criteria" are implied by the summary statements regarding verification, validation, and clinical agreement.

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

• Test Set Sample Size: Not explicitly stated. The document refers to "test cases for each requirement, identified risk, clinical scenarios and usability issues" for non-clinical testing and "All sites" for clinical testing. No specific number of cases or patients is provided for either.
• Data Provenance: The document does not specify the country of origin for any data. Given that Nucletron B.V. is based in The Netherlands, it is possible some data could originate from there, but this is not confirmed. The nature of the studies (retrospective or prospective) is not explicitly stated. The "clinical scenarios" could imply retrospective data or simulated prospective cases.

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

• Number of Experts: Not specified. The document mentions "All sites were in agreement," implying multiple clinical sites and potentially multiple clinicians/experts, but no specific number or roles are provided.
• Qualifications of Experts: Not specified beyond the implication that they would be "qualified medical personnel" as mentioned in the "Indications for Use" for reviewing and approving treatment plans. There is no mention of their specific experience (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

Not specified. The statement "All sites were in agreement" suggests a consensus was reached, but the process (e.g., 2+1, 3+1, none) is not detailed.

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

• Was it done? No. The document does not describe a comparative effectiveness study involving human readers with and without AI (or in this case, the new calculation algorithm). The study focuses on verifying the software's functionality and alignment with clinical requirements and user expectations.
• Effect size of human readers with AI vs. without AI assistance: Not applicable, as no such study was performed or reported. The device itself is a planning software, not an AI assistance tool for human reading in the typical sense. The "AI" aspect here refers to the advanced dose calculation algorithm (ACE), not an interpretative AI.

6. Standalone (Algorithm Only) Performance Study

• Was it done? Yes, implicitly for the dose calculation algorithm. The document states, "A collapsed cone algorithm has been implemented to meet the AAPM TG 186 recommendations for brachytherapy uniformity; ACE (Advanced Dose calculation Engine) accounts for tissue heterogeneities, backscatter, attenuation, shielding and provides the user with a comparison of AAPM TG-43 and AAPM TG-186 based calculations." This suggests the algorithm's performance was evaluated against the AAPM TG 186 recommendations, which are a standard for standalone dose calculation accuracy. The non-clinical verification and validation would have assessed the algorithm's output independently.

7. Type of Ground Truth Used

• Non-clinical testing: Likely based on simulated data, phantom data, and known input-output relationships for software function verification and dose calculation accuracy based on physics principles and established standards (like AAPM TG 186).
• Clinical testing: "Clinical requirements and user expectations" likely imply a subjective assessment of the reasonableness and utility of the treatment plans generated by the software when applied to real or realistic patient cases, with "agreement" among sites/experts serving as a form of expert consensus or validation against clinical practice. It doesn't appear to be based on pathology, or long-term patient outcomes data.

8. Sample Size for the Training Set

Not applicable. This device is a treatment planning software that implements a specific dose calculation algorithm (ACE/AAPM TG 186). It is not described as a machine learning or AI-driven diagnostic system that typically requires a "training set" in the context of supervised learning. The algorithm is based on established physics models.

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

Not applicable, as there is no mention of a training set for a machine learning model. The algorithm's "ground truth" would be the underlying physics principles and the AAPM TG 186 recommendations it was designed to adhere to.

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