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The Navigus Unibody Fiducial Marker System is intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging.

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The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Navigus Unibody Fiducial Marker System." This type of letter confirms that the device is "substantially equivalent" to a legally marketed predicate device, meaning it has similar indications for use and technological characteristics and is considered as safe and effective.

However, a 510(k) clearance does not typically include the detailed acceptance criteria or the specific study results proving those criteria were met in the way a clinical trial report or a comprehensive technical document would. The FDA letter is a regulatory approval document, not a scientific publication of study findings.

Therefore,Based on the provided document, the following information cannot be extracted:

• A table of acceptance criteria and the reported device performance: The letter states the device is "substantially equivalent" but does not define specific performance metrics or acceptance criteria, nor does it report the device's performance against them.
• Sample size used for the test set and the data provenance: No information about a test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) is provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The document does not mention any ground truth establishment for a test set or the involvement of experts for this purpose.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: No information is available regarding an adjudication method.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: The device is a physical "Fiducial Marker System," not an AI-powered diagnostic or assistive tool, so an MRMC study related to AI assistance is not applicable and not mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: As this is a physical medical device, not an algorithm, a standalone performance study in this context is not relevant and not mentioned.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No information about ground truth is provided.
• The sample size for the training set: There is no mention of a training set as this is not an AI/machine learning device.
• How the ground truth for the training set was established: Not applicable, as there's no training set mentioned.

The document's primary purpose is to grant regulatory clearance by establishing substantial equivalence to a predicate device, not to detail specific performance studies or their methodologies.

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