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The Staphylococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Staphylococcus aureus and/or coagulasenegative staphylococci commonly isolated from human blood cultures, on smears prepared from positive blood cultures containing gram-positive cocci in clusters observed on Gram stain.

Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, and/or differentiation of mixed growth.

Staphylococcus QuickFISH BC is indicated as an aid in the diagnosis of S. aureus bacteremia and/or coagulase-negative staphylococci commonly isolated from human blood cultures.

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The provided text is a 510(k) clearance letter from the FDA for a device called "Staphylococcus QuickFISH BC." This document primarily focuses on the regulatory clearance for the device and its intended use, rather than a detailed study report with specific acceptance criteria and performance data.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its 510(k) clearance.

However, I can extract the following information:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The FDA letter is a clearance notification and does not detail the specific performance metrics or acceptance criteria used in the underlying studies that led to the clearance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. The letter does not describe the specific studies or their methodologies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not provided and is likely not applicable. The device, "Staphylococcus QuickFISH BC," is described as a "qualitative nucleic acid hybridization assay" for identifying bacteria directly from blood cultures. This is an in-vitro diagnostic (IVD) test, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

While the document doesn't explicitly state "standalone performance study," the nature of an in-vitro diagnostic test like the QuickFISH BC implies that its performance is evaluated in a standalone manner, separate from human interpretation of complex images or data that AI might assist with. The test itself provides a qualitative result. However, the details of such evaluation are not provided here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not provided in the document. For an in-vitro diagnostic test, ground truth would typically be established by established microbiological culture methods and advanced molecular techniques for bacterial identification.

8. The sample size for the training set:

This information is not provided in the document.

9. How the ground truth for the training set was established:

This information is not provided in the document.

Summary based on the provided document:

The provided document is an FDA 510(k) clearance letter, which confirms that the Staphylococcus QuickFISH BC device is deemed substantially equivalent to existing devices and can be marketed. It defines the "Indications for Use" for the device, which involves the identification of Staphylococcus aureus and/or coagulase-negative staphylococci from positive blood cultures with gram-positive cocci in clusters. It also notes that sub-culturing is still necessary for susceptibility testing.

However, the letter does not contain the detailed study data, acceptance criteria, sample sizes, ground truth methodologies, or expert qualifications that would typically be found in a study report or a more extensive FDA review summary. These details would have been part of the 510(k) submission made by AdvanDx, Inc.

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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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S. aureus PNA FISH is a qualitative nucleic acid hybridization assay intended for identification of Staphylococcus aureus on smears made from positive blood cultures containing Gram-positive cocci in clusters observed on Gram stain.

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

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

Not Found

The provided document is a 510(k) clearance letter for the S. aureus PNA FISH® Culture Identification Kit. It does not contain the detailed study information regarding acceptance criteria and performance metrics. Substantial equivalence is determined by comparing the device to a legally marketed predicate device, but the specifics of the study design, sample sizes, expert qualifications, and ground truth establishment are not included within this regulatory letter.

Therefore, I cannot extract the requested information from this document.

Ask a specific question about this device

S. aureus PNA FISH is a qualitative nucleic acid hybridization assay intended for presumptive identification of Staphylococcus aureus from blood cultures.

Not Found

This document is a 510(k) clearance letter for the S. aureus PNA FISH device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. It mainly focuses on the regulatory aspects of the device's clearance.

Therefore, I cannot answer your request based on the provided text.

Ask a specific question about this device