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Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data.

Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.

Mobius3D is a software product used within a radiation therapy clinic for quality assurance and treatment plan verification. It is important to note that while Mobius3D operates in the field of radiation therapy, it is neither a radiation delivery device (e.g. a linear accelerator), nor is it a treatment planning system (TPS). Mobius3D cannot design or transmit instructions to a delivery device, nor does it control any other medical device. Mobius3D is an analysis tool meant solely for quality assurance (QA) purposes when used by trained medical professionals. Being a software-only QA tool, Mobius3D never comes into contact with patients.

Mobius3D performs dose calculation verifications for radiation treatment plans by doing an independent calculation of radiation dose. Radiation dose is initially calculated by a treatment planning system (TPS), which is a software tool that develops a detailed set of instructions (i.e. a plan) for another system (e.g. a linear accelerator) to deliver radiation to a patient. The dose calculation performed by Mobius3D uses a proprietary collapsed cone convolution superposition (CCCS) algorithm.

Mobius3D also performs dose delivery quality assurance for radiation treatment plans by using the measured data recorded in a linear accelerator's delivery log files to calculate a delivered dose. This is presented to the end user in a software component of Mobius3D called MobiusFX. The MobiusFX component is available to users through licensing as an add-on to the core Mobius3D software features.

This document largely focuses on the regulatory approval (510(k) clearance) of Mobius3D. While it describes the device's function and intended use, it does not provide detailed information about the specific acceptance criteria, the study design, or the performance outcomes that would typically be found in a clinical or validation study report.

Therefore, I cannot provide a complete answer to your request based on the provided text. The requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training sets is not present in this 510(k) summary and FDA letter.

Here's what I can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the document. The document mentions "detailed technological characteristics and indications for use presented within the full set of submitted documentation for this 510(k) application support the claim that Mobius3D is substantially equivalent to the predicate devices." This implies that performance criteria were likely benchmarked against predicate devices, but the specific numerical targets are not here.
• Reported Device Performance: Not explicitly stated in the document with specific metrics or values (e.g., accuracy, precision). The document states that Mobius3D "performs dose calculation verifications for radiation treatment plans by doing an independent calculation of radiation dose" and "performs dose delivery quality assurance... by using the measured data." This describes its function, not its quantified performance against acceptance criteria.

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

• Sample Size (Test Set): Not mentioned.
• Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective).

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

• Not mentioned, as the document does not describe the establishment of ground truth for a test set in the context of device performance validation.

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

• Not mentioned.

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 mentioned. This device is described as a QA tool for radiation therapy, an "analysis tool meant solely for quality assurance (QA) purposes." It is not described as a device that directly assists human readers in interpreting images or making a diagnosis in a way that an MRMC study would typically evaluate for AI image analysis tools.

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

• The device itself is an "algorithm only" software for independent dose calculation and QA. Its performance is inherently "standalone" in its primary function of calculating dose. However, the results of its calculation are "presented to the end user" and used by "trained medical professionals." The document does not provide a specific "standalone performance study" report with metrics like accuracy or precision of its dose calculations, compared to a gold standard. It only describes what it does.

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

• Not explicitly mentioned. For a dose calculation system, ground truth would typically refer to highly accurate dosimetry measurements or a gold-standard calculation method. The document only states it performs an "independent calculation of radiation dose" using a "proprietary collapsed cone convolution superposition (CCCS) algorithm."

8. The 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 text from the 510(k) summary and FDA clearance letter focuses on the regulatory aspects, device description, and indications for use. It lacks the technical and scientific details about validation studies, acceptance criteria, and performance results that your request pertains to. Such information would typically be found in a separate validation report or technical documentation submitted as part of the 510(k) application, but not usually in the public summary or clearance letter itself.

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