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Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Meropenem Sensi-Discs® are intended for use in determining the susceptibility of a wide range of gram-positive and gram-negative bacteria, including Streptococcus peuemoniae (excluding penicillin-resistant strains). Viridans group streptococci, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria meningitidis, Pseudomonas aeruginosa, Bacteroides fragilis, Bacteriodes thetaiotaomicron and peptostreptococcus species to Meropenem. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer. ZENECA Pharmaceuticals, and received FDA approval under NDA No. 50-706.

Use of BBL® Meropenem Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Meropenem.

Meropenem Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Meropenem supplied by the manufacturer, ZENECA Pharmaceuticals, Wilmington, Delaware, Each Meropenem disc is clearly marked on both sides with the agent and content. Meropenem discs are furnished in cartridges of 50 discs each. Meropenem cartridges are packed as either a single cartridge in a single box, or in a package containing ten cartridges.

Agar diffusion methods employing dried filter paper discs impregnated with specific concentrations of antimicrobial agents were developed in the 1940s. In order to eliminate or minimize variability in the testing, Bauer et al. developed a standardized procedure in which Mueller Hinton Agar was selected as the test medium.

Various regulatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the National Committee for Clinical Laboratory Standards (NCCLS) and is periodically updated. The latest NCCLS documents are M2-A5 (12/93) and M100-S6 (12/95).

Discs containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates [or Haemophilus Test Medium Agar for H. influenzae or Mueller Hinton Agar with 5% Sheep Blood for S. pneumoniae1 inoculated with pure cultures of clinical isolates. Following incubation, the plates are examined and the zones of inhibition surrounding the discs are measured and compared with established zone size ranges for individual antimicrobial agents in order to determine the agent(s) most suitable for use in antimicrobial therapy. The determination as to whether the organism in question is susceptible (S), intermediate (I), or resistant (R) to an antimicrobial agent is made by comparing zone sizes to those found in the respective organism tables of National Committee for Clinical Laboratory Standards (NCCLS) Document M2-A5 ("Performance Standards for Antimicrobial Disk Susceptibility tests - Fifth Edition, Approved Standard", 12/93) and of NCCLS Document M100-S6 ("Performance Standards for Antimicrobial Susceptibility Testing", Sixth Informational Supplement, 12/95).

The provided text describes a medical device, Meropenem Sensi-Discs, used for antimicrobial susceptibility testing. However, it does not contain a study demonstrating the device meets acceptance criteria.

The document refers to zone sizes and control organism limits being "determined by the antimicrobic manufacturer, ZENECA Pharmaceuticals, and received FDA approval under NDA No. 50-706." It also states, "See attached ZENECA Pharmaceuticals product insert section on Susceptibility testing Diffusion Techniques for Merrem® IV, (meropenem for Injection)." This indicates that the performance data and acceptance criteria are likely detailed in a separate document or the ZENECA product insert, which is not provided in the input.

Therefore, I cannot provide the requested table or answer most of the questions about the study's specifics because the pertinent information is missing.

Here's what can be inferred or stated about the information that would typically be sought for such a request, based on the provided document:

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

• Acceptance Criteria: These would be the established zone size ranges (susceptible, intermediate, resistant) for Meropenem against specific bacteria, as defined by NCCLS (now CLSI) documents M2-A5 and M100-S6, and potentially specific control organism limits set by ZENECA Pharmaceuticals.
• Reported Device Performance: This would typically involve demonstrating that the Meropenem Sensi-Discs produce inhibition zones that fall within the established ranges for various strains, especially control strains, when tested according to the standardized procedures.

As the actual data is not provided, this table cannot be constructed.

Regarding the other points without the study data:

• 2. Sample size used for the test set and the data provenance: This information would be found in the performance study, which is not provided.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable in this context. The "ground truth" for antimicrobial susceptibility testing is typically based on validated laboratory methods (e.g., broth microdilution, agar dilution) which establish the Minimum Inhibitory Concentration (MIC), or by comparing disk diffusion results to these reference methods. Expert consensus usually relates to clinical diagnosis or image interpretation, not direct lab measurements like this.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for establishing ground truth in this type of laboratory test.
• 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. This device is a test disc and the procedure involves human measurement of inhibition zones, but it's not an AI-driven image interpretation system.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The procedure inherently involves a human reading and measuring the zone of inhibition.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For antimicrobial susceptibility testing, the "ground truth" is typically the Minimum Inhibitory Concentration (MIC) determined by a reference method like broth microdilution or agar dilution. The disk diffusion method's performance is assessed by how well its S/I/R categorization correlates with the S/I/R categorization derived from the MIC.
• 8. The sample size for the training set: Not applicable. This device is a physical diagnostic disc, not a machine learning algorithm requiring a "training set."
• 9. How the ground truth for the training set was established: Not applicable.

In summary: The provided text describes the product and its intended use, citing that performance data exists and was approved by the FDA as part of NDA No. 50-706 for Merrem® IV. However, the actual performance data and details of the studies proving the device meets acceptance criteria are not included in this document excerpt.

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