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Use of Gemifloxacin 5μg, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Gemifloxacin. Indicated when there in a need witro against most strains of microorganisms listed below, as described in the FDA approved drug insert for this antimicrobic.

Active In Vitro and in clinical infections against:
Aerobic gram-positive microorganisms Streptococcus pneumoniae (including multidrug resistant strains)
Aerobic gram-negative microorganisms Haemophilus influenzae Haemophilus parainfluenzae Klebsiella pneumoniae (many strains are only moderately susceptible)

Active In Vitro Against:
Aerobic gram-positive microorganisms Staphylococcus aureus (methicillin-susceptible strains only) Streptococcus pyogenes

Aerobic gram-negative microorganisms Acinetobacter lwoffi Klebsiella oxytoca Proteus vulgaris

Gemifloxacin 5μg BBL™ Sensi-Disc™ is prepared by impregnating high quality paper with accurately determined amounts of Gemifloxacin supplied by the drug manufacturer. Each Gemifloxacin disk is clearly marked on both sides with the agent and drug content. Gemifloxacin cartridges each contain 50 impregnated disks that are packed as either a single Gemifloxatin a single box, or in a package containing ten cartridges. Gemifloxacin disks are used for semi-quantitative in vitro susceptibility evaluations by the agar diffusion test method.

The provided text is a 510(k) summary for a medical device called "GEMIFLOXACIN 5µg, BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks." This document is a regulatory submission to the FDA, not a study report. Therefore, it does not contain the detailed information typically found in a study proving a device meets acceptance criteria.

Specifically, the document does not provide a table of acceptance criteria or reported device performance metrics in the format requested. It also does not detail a specific study design (e.g., sample sizes, data provenance, expert methodologies, or statistical analyses) to demonstrate the device meets acceptance criteria.

The document states: "Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer and received FDA approval under NDA Number 21-158." This implies that the performance characteristics (zone size ranges) were established and approved elsewhere, likely as part of the drug's (Gemifloxacin's) New Drug Application (NDA). The 510(k) process for this device relies on demonstrating substantial equivalence to a predicate device (Ciprofloxacin 5 µg Sensi-Disc) and adhering to established standards (NCCLS Documents M2 and M100) for antimicrobial susceptibility testing.

Therefore, many of the specific questions cannot be answered directly from the provided text.

However, based on the information provided and common practices for such devices, here's what can be inferred or stated about the "acceptance criteria" and the "study" (or basis of claims):

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the zone sizes for interpretation and control organism limits "were determined by the antimicrobic manufacturer and received FDA approval under NDA Number 21-158." It also refers to NCCLS Documents M2 and M100 for categorical interpretations (Susceptible, Intermediate, Resistant).

Therefore, the "acceptance criteria" for the performance of the Gemifloxacin Sensi-Disc would be the specific zone diameter breakpoints and control ranges detailed in the FDA-approved drug insert for Gemifloxacin and the relevant NCCLS documents. These criteria are performance specifications for determining antibiotic susceptibility, not performance metrics of the Sensi-Disc itself (like accuracy or precision in measuring zone sizes).

The document does not report actual device performance data (e.g., how accurately the Sensi-Disc produces zones that align with these breakpoints). It presumes that if used correctly according to the established methodology, the resulting zone sizes can be interpreted according to the approved criteria.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the document. The document refers to the drug package insert ("Susceptibility Tests: Diffusion Techniques") for "SUBSTANTIAL EQUIVALENCE TESTING DATA." This implies the underlying data supporting the zone size breakpoints were part of the NDA for the drug, not specifically generated for this device's 510(k). The Indications for Use section lists various microorganisms, suggesting a broad range was tested, but no specific numbers are given.
• Data Provenance: Not specified. Again, likely part of the NDA for Gemifloxacin, so methodology would be governed by those studies. Retrospective or prospective is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not specified. The establishment of "ground truth" (i.e., true susceptibility) for a new antibiotic typically involves a combination of in vitro MIC testing (often broth microdilution or agar dilution) correlated with clinical outcomes, ideally guided by expert panels in microbiology and infectious diseases. This process would have occurred during the development and approval of the Gemifloxacin drug (NDA 21-158), not during the 510(k) for this specific Sensi-Disc.

4. Adjudication method for the test set:

• Not specified. The methodology for setting breakpoints typically involves robust statistical analysis and expert consensus, but the specific adjudication method for a test set is not detailed here.

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:

• No, an MRMC study was not done. This type of study (MRMC, AI-assisted reading) is not relevant to an antimicrobial susceptibility disc. This device is a manual, semi-quantitative test that relies on a trained technologist measuring zone diameters and interpreting them against established standards. AI is not mentioned or implied in its use.

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

• No. This device is a manual test and requires human interaction (applying the disk, incubating, measuring zone, interpreting). There is no "algorithm only" component.

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

• The "ground truth" for antimicrobial susceptibility testing is typically based on Minimum Inhibitory Concentration (MIC) values determined by standardized reference methods (e.g., broth microdilution). These MIC values are then correlated with clinical outcomes data. Expert committees (like CLSI, which evolved from NCCLS) use this data to establish clinical breakpoints for interpretation (S/I/R). The document refers to NCCLS M2 and M100, indicating that this is the basis for interpretation.

8. The sample size for the training set:

• Not specified. As mentioned, the underlying data for establishing breakpoints comes from the drug's NDA and subsequent expert panel work, not a "training set" in the machine learning sense for this device's 510(k).

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

• Not applicable in the machine learning "training set" context. The ground truth for interpreting susceptibility to Gemifloxacin was established through extensive microbiological studies (MIC determination) and clinical trials during the drug's development, reviewed by regulatory bodies and expert panels, leading to the approved breakpoints in the drug insert and NCCLS standards.

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