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Tigecycline is indicated for Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and by modified procedures Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pnemoniae.

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The provided text is related to a 510(k) premarket notification for a medical device: "Tigecycline Antimicrobial Susceptibility Test Disc." This document is a clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies. It is a regulatory clearance document, not a scientific study report.

Therefore, I cannot provide the requested information from the given text.

To be clear:

• A table of acceptance criteria and the reported device performance: Not available in the provided text.
• Sample sized used for the test set and the data provenance: Not available.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
• Adjudication method for the test set: Not available.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not available.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available (this device is a physical test disc, not an algorithm).
• The type of ground truth used: Not available.
• The sample size for the training set: Not available (training set would not be applicable in the typical sense for this device).
• How the ground truth for the training set was established: Not available.

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