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S. aureus/CNS PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Staphylococcus aureus and/or selected other Staphylococcus species on smears made from positive blood cultures containing Grampositive cocci in clusters observed on Gram stain.

Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth.

S. aureus/CNS PNA FISH is intended as an aid in the diagnosis of S. aureus bacteremia.

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The provided document is a 510(k) clearance letter from the FDA for a diagnostic kit, not a study report. It does not contain the detailed information required to fulfill the request. The document clears the S. aureus and/or other Staphylococcus species PNA FISH® Culture Identification Kit based on its substantial equivalence to predicate devices, but it does not describe the specific acceptance criteria or the study that proves the device meets those criteria in the level of detail requested.

Therefore, I cannot provide the requested table, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case study details, standalone performance, ground truth types, or training set information.

The document only states the Indications for Use:

• Identification of Staphylococcus aureus and/or selected other Staphylococcus species on smears made from positive blood cultures containing Gram-positive cocci in clusters observed on Gram stain.
• Intended as an aid in the diagnosis of S. aureus bacteremia.

It also explicitly states: "Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth." This implies the device is an identification aid, not a complete diagnostic solution for resistance or mixed infections.

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