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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 Benzylpenicillin in the range of 0.016 - 256 ug/ml or 0.002 - 32 ug/ml with streptococci other than S. pneumoniae.

Previously cleared applications include non-fastidious Gram positive aerobic bacteria, S. pneumoniae and anaerobic bacteria.

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The provided text is a 510(k) clearance letter from the FDA for the Etest® Benzylpenicillin device. It does not contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory responsibilities. While it mentions "Indications For Use" (page 2), which indirectly relates to what the device is intended to do, it doesn't provide the quantitative performance metrics or study details you're requesting.

Therefore, I cannot extract the information required to populate the table or answer the specific questions about the study from the provided document. The document confirms the device's clearance for marketing, but not the underlying study details.

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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 Enterocccus 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 µg/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation. This Etest 510(k) application is for MIC determination of Benzylpenicillin in the range of 0.016 - 256 µg/ml or 0.002 - 32 µg/ml with non-fastidious Gram positive aerobic bacteria, S. pneumoniae, streptococci other than S. pneumoniae, N. gonorrhoeae and anaerobic bacteria.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the Etest® Benzylpenicillin device. It acknowledges that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed acceptance criteria and study information typically found in a device submission.

Specifically, the document does not provide any of the following information:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information about a standalone (algorithm only) performance study.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

The document primarily focuses on regulatory approval based on substantial equivalence to existing predicate devices. It states the indications for use and classification information. To obtain the requested study details, one would typically need access to the full 510(k) submission, which is not included here.

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