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Use of HardyDiskTM AST Delafloxacin 5ug (DLX5) , for in vitro agar diffusion susceptibility testing is indicated when there is need to determine the susceptibility of bacteria to Delafloxacin.

The concentration of Delafloxacin 5pg (DLXS), has been shown to be active against susceptible isolates of the following microorganisms both in vitro and in clinical infections: Staphylococcus aureus (including methicillin-resistant and methicillin-sensitive strains) Staphylococcus haemolyticus Streptococcus pvogenes Streptococcus anginosus Group (including S. anginosus, S. intermedius, S. constellatus) Enterococcus faecalis Escherichia coli Klebsiella pneumoniae Enterobacter cloacae Pseudomonas aeruginosa

The concentration of Delafloxacin 5ug (DLXS), has been shown to be active against susceptible isolates of the following microorganisms for in vitro use: Streptococcus dvsgalactiae Enterobacter aerogenes Haemophilus parainfluenzae Klebsiella oxytoca Proteus mirabilis

HardyDiskTM AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.

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The provided text describes the regulatory clearance of a medical device (HardyDisk AST Delafloxacin 5 ug (DLX5)) and outlines its indications for use. However, it does not contain information regarding acceptance criteria or a study proving the device meets those criteria, as typically understood in a performance evaluation context.

The document is a 510(k) clearance letter from the FDA, which determines substantial equivalence to a predicate device. It confirms the device can be marketed but does not delve into the detailed performance metrics, study designs, or ground truth establishment that would be present in a clinical or analytical performance study report.

Therefore, many of the requested items (e.g., table of acceptance criteria, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) cannot be extracted from this document.

Here's what can be stated based on the provided text:

1. A table of acceptance criteria and the reported device performance:
* Not provided. This document is a clearance letter, not a performance study report. It does not contain a specific table outlining acceptance criteria or results of a performance study demonstrating those criteria were met for metrics like sensitivity, specificity, accuracy, etc.

2. Sample size used for the test set and the data provenance:
* Not provided. The document does not describe the test set used for performance evaluation, nor does it mention sample sizes or data provenance (country of origin, retrospective/prospective). To attain 510(k) clearance for antimicrobial susceptibility tests, studies are generally performed according to CLSI (Clinical and Laboratory Standards Institute) guidelines, which specify testing a certain number of isolates (typically challenge and clinical isolates) to demonstrate performance against reference methods. However, the details of such a study are not in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not provided. This information would be specific to how the ground truth for an analytical or clinical performance study was established, which is not detailed here.

4. Adjudication method for the test set:
* Not provided. This is relevant to studies involving human interpretation or expert review, which is not discussed in this regulatory clearance letter.

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:
* Not applicable/Not provided. This device is an antimicrobial susceptibility test disk. It's not an AI-powered diagnostic device that involves human readers interpreting images or data with or without AI assistance. Therefore, an MRMC study and effects on human reader performance are not relevant to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable/Not provided. This is not an algorithmic device. The "performance" of such a disk is evaluated by its ability to accurately determine bacterial susceptibility (zone diameter measurements corresponding to MICs), usually read visually by a trained microbiologist or with an automated reader. The document does not describe a standalone "algorithm only" performance.

7. The type of ground truth used:
* Inferred based on device type, but not explicitly stated in the document. For antimicrobial susceptibility tests, the "ground truth" is typically established by a reference method, such as broth microdilution or agar dilution minimum inhibitory concentration (MIC) testing, often performed in accordance with CLSI standards. The HardyDisk AST Delafloxacin 5ug (DLX5) is used for "in vitro agar diffusion susceptibility testing," implying comparison to a recognized reference method to determine true susceptibility/resistance.

8. The sample size for the training set:
* Not applicable/Not provided. This device is a physical disk for a laboratory test, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:
* Not applicable/Not provided. As above, no training set is relevant for this device.

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