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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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