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For in vitro diagnostic use:

Etest is a quantitative technique for the determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, Pneumococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.

This application is for MIC determination of Chloramphenicol in the range of 0.016 - 256 µg/ml with streptococci other than S. pneumoniae.

Previously cleared applications include H. influenzae and S. pneumoniae.

The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.

This document is a FDA 510(k) clearance letter for the Etest® Chloramphenicol, indicating it's a device for in vitro diagnostic use to determine antimicrobial susceptibility. The letter itself does not contain the detailed acceptance criteria or the study that proves the device meets them. This information would typically be found in the 510(k) submission itself, which is not provided in this extract.

Therefore,Based on the provided document, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study details
6. Standalone performance details
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document is an FDA clearance letter confirming "substantial equivalence" of the Etest® Chloramphenicol to a legally marketed predicate device, allowing it to be marketed. It states the indications for use as:

"For in vitro diagnostic use: Etest is a quantitative technique for the determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, Pneumococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation. This application is for MIC determination of Chloramphenicol in the range of 0.016 - 256 µg/ml with streptococci other than S. pneumoniae. Previously cleared applications include H. influenzae and S. pneumoniae."

To answer your questions, the actual 510(k) submission document, which describes the studies performed to demonstrate substantial equivalence, would be required. This letter only summarizes the FDA's decision based on that submission.

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