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VIRTUOSO is a software-based planning system used to create treatment plans for radiation therapy with high-energetic phontons. It is used for patients which are selected for a precise radiation therapeutical treatment according to medical diagnosis. It may be used only by radiation therapeutical experts under medical supervision in rooms which are suitable for the operation of computers.

The VIRTUOSO Stereotaxic Planning Software is a software-based planning system intended for the creation of treatment plans for radiation therapy with high-onergetic phontons.

The provided documentation for VIRTUOSO Stereotaxic Planning Software (K991706) is very limited and primarily focuses on establishing substantial equivalence to a predicate device (STP treatment planning software K892425D) rather than detailing a specific study with acceptance criteria and performance metrics.

Based only on the provided text, the device's acceptance is based on its substantial equivalence to a previously marketed device, due to it not raising "any new safety and efficacy concerns." There is no detailed study described in the provided text that outlines specific acceptance criteria, performance metrics, or a rigorous validation against a ground truth dataset with expert input.

Therefore, many of the requested details about a specific performance study cannot be answered from the provided document.

Here's a breakdown of what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance:

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

• Not explicitly stated. The document does not describe a performance study with a test set. The basis for equivalence is the lack of new safety/efficacy concerns compared to a predicate, not a direct performance measurement on a patient dataset.

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

• Not explicitly stated. No test set or ground truth establishment process is described in the provided document for this device.

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

• Not applicable/Not explicitly stated. The document does not describe a performance study that would involve adjudication.

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:

• No. The document does not mention an MRMC study or any comparison of human readers with or without AI assistance. This device is described as a "planning software," implying direct use by experts rather than an AI assistance tool for human interpretation.

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

• Not explicitly stated as a formal study. The device is a "planning software," which by definition is an algorithm used by experts. Its performance is implicitly tied to its function for experts, but a formal "standalone" performance study of the algorithm independent of human use/review is not described.

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

• Not explicitly stated. No specific ground truth methodology is mentioned as part of a performance study for this device.

8. The sample size for the training set:

• Not applicable/Not explicitly stated. The document does not indicate that this device utilizes machine learning or requires a training set in the modern sense. It is described as planning software, implying rule-based or calculational processes rather than AI learning from data.

9. How the ground truth for the training set was established:

• Not applicable/Not explicitly stated. As there is no mention of a training set, the establishment of ground truth for such a set is also not discussed.

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