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Intended Use: The Navigus Passive Probe is intended to be used in conjunction with the Navigus family of trajectory guides and the Medtronic StealthStation® Treatment Guidance System for patient registration and navigation. The device is provided sterile and for single use.

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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them. The document is primarily a 510(k) clearance letter from the FDA for the 'Navigus Passive Probe', indicating that the device has been found substantially equivalent to a legally marketed predicate device.

Specifically, the text is missing information regarding:

1. A table of acceptance criteria and reported device performance: This information is typically found in a summary of safety and effectiveness, which is not part of this clearance letter.
2. Sample size used for the test set and data provenance: No details about a test set or its origin are present.
3. Number and qualifications of experts: No mention of experts or ground truth establishment.
4. Adjudication method: Not discussed in the document.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No information about such a study or effect sizes is provided.
6. Standalone performance: No details about the algorithm's performance without human intervention.
7. Type of ground truth used: The document does not describe the ground truth for any study.
8. Sample size for the training set: Not mentioned.
9. How ground truth for the training set was established: Not mentioned.

The document only states the device's intended use and that it received 510(k) clearance. To find the information you're looking for, you would typically need to consult the 510(k) summary submitted by the manufacturer to the FDA, which often includes more detailed safety and effectiveness data.

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