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Thermo Scientific Oxoid Antimicrobial Susceptibility Test Discs are used in the semi quantitative agar diffusion test method for in vitro susceptibility testing.

The Thermo Scientific Oxoid Cefiderocol Disc (30μg) FDC30 can be used to determine susceptibility to Cefiderocol against the following bacteria for which Cefiderocol has been shown to be active both clinically and in vitro:

For Complicated Urinary Tract Infections (cUTI): Gram-negative bacteria Enterobacter cloacae complex Escherichia coli Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruqinosa

For Hospital Acquired Bacterial Pneumonia and ventilator-associated bacterial pneumonia (HABPN VABP):

• Gram-neqative bacteria Enterobacter cloacae complex Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa Serratia marcescens

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The provided text is a 510(k) premarket notification determination letter for the Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30. It outlines the FDA's decision that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this document specifies the regulatory classification and indications for use of the device, but it does not contain the detailed acceptance criteria and study results typically found in a clinical study report or a summary of safety and effectiveness data (SSED).

Therefore, I cannot provide the information requested in your prompt based solely on the provided text. The prompt asks for specifics like:

• A table of acceptance criteria and reported device performance.
• Sample sizes and data provenance for test sets.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC study results.
• Standalone performance.
• Type of ground truth used.
• Training set sample size and ground truth establishment.

This type of information is usually found in the submission itself (which this letter refers to as having been reviewed) or in a separate clinical study report, not in the FDA's determination letter.

To answer your request, I would need access to the actual study data, which is not present in this regulatory letter.

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