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Mobius3D software is used for quality assurance, treatment plan verification, and patient alignment and anatomy analysis 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. Patient alignment and anatomy analysis is based on read-in treatment planning images (such as computed tomography) and read-in daily treatment images (such as registered cone beam computed tomography).

Mobius3D is not a treatment planning system. It is to be used only 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.

It appears there's a misunderstanding based on the provided document. The request asks for acceptance criteria and a study that proves the device meets those criteria, including specifics like sample sizes, expert qualifications, and ground truth establishment.

However, the provided FDA 510(k) clearance letter for Mobius3D (4.1) does not contain the detailed performance study results that would prove the device meets specific acceptance criteria.

The 510(k) summary (pages 5-7) primarily discusses:

• Device Description and Intended Use: What Mobius3D is and what it's used for (QA, treatment plan verification, patient alignment).
• Comparison to Predicate Device: How Mobius3D 4.1 differs from 4.0.
• Summary of Performance Testing (Non-Clinical):
  • Mentions software verification and validation, including unit, integration, and end-to-end testing.
  • Highlights MLC Modelling Accuracy testing comparing different Mobius3D versions, measurements, and a Treatment Planning System (Eclipse TPS 16.1).
  • States that "studies and reviews have been performed to assess the accuracy of newly introduced features and modifications" for Rapid Arc Dynamic Support and MLC Tongue and Groove Modelling.
  • Notes conformance to cybersecurity and interoperability requirements.
  • Crucially, it explicitly states: "No animal studies or clinical tests have been included in this pre-market submission." This means there isn't a human-in-the-loop study or a study directly demonstrating clinical performance against ground truth in a clinical setting.
• Use of Consensus Standards: A list of standards the device's design and evaluation conform to.
• Determination of Substantial Equivalence: Varian's conclusion that the device is substantially equivalent to the predicate.

Therefore, many of the specific details requested (Table of acceptance criteria, sample sizes for test sets, number/qualifications of experts for ground truth, adjudication methods, MRMC study, standalone performance, type of ground truth, training set sample size/ground truth establishment) are NOT present in this 510(k) clearance letter.

The letter focuses on the regulatory submission process and the FDA's determination of substantial equivalence based on the provided non-clinical testing and comparison to a predicate device. It doesn't typically include the full, detailed study reports with precise performance metrics and ground truth methodologies. Such details would typically be found in the more extensive technical documentation submitted by the manufacturer to the FDA, but they are summarized at a high level in the public 510(k) summary.

In summary, based only on the provided text, I cannot provide the detailed information requested regarding the specific acceptance criteria and the study that proves the device meets those criteria in the format you've requested. The document indicates non-clinical software testing and accuracy assessments were performed but does not provide the specific metrics or study design details for clinical performance proof.

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