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Antimicrobial Susceptibility Test Discs are indicated for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Enterobacteriacae, Pseud. aeruginosa, Acinetobacter spp., and Staphylococcus spp.

Oxoid Compound Sulphonamide Antimicrobial Susceptibility Test Discs

The provided document is a 510(k) summary for the Oxoid Compound Sulphonamides Susceptibility Test Disc. It states that the device performs in accordance with NCCLS (National Committee for Clinical Laboratory Standards, now Clinical and Laboratory Standards Institute - CLSI) Approved Performance Standards. However, it does not provide specific details of a study with acceptance criteria and results.

The document states: "Performance Data: Oxoid Compound Sulphonamide Antimicrobial Susceptibility Test Discs perform in accordance with NCCLS Approved Performance Standard. Product performance is in accordance with NCCLS Performance Standard for Antimicrobial Disk Susceptibility Tests - Fifth Edition Approved Standard - M2-A5 Vol. 13 No.24, and Performance Standards for Antimicrobial Susceptibility Testing M100 - S6 Vol 15 No.14."

This indicates that the device's performance was evaluated against the established NCCLS standards for antimicrobial disk susceptibility testing. These standards define the methodology for testing, zone size interpretive criteria, and acceptable ranges for quality control organisms. The 510(k) submission asserts that the device meets these standards, but the actual data and specific acceptance criteria tables are not included in the provided text. The document states, "Data provided in this submission will be made available to any person within 30 days of a written request," implying the detailed study data is part of the full submission but not present in this summary.

Therefore,Based on the provided information:

1. Table of acceptance criteria and reported device performance:
   The document states that the Oxoid Compound Sulphonamide Antimicrobial Susceptibility Test Disc performs "in accordance with NCCLS Approved Performance Standard." Specifically, it references:

   • NCCLS Performance Standard for Antimicrobial Disk Susceptibility Tests - Fifth Edition Approved Standard - M2-A5 Vol. 13 No.24
   • Performance Standards for Antimicrobial Susceptibility Testing M100 - S6 Vol 15 No.14.

   These NCCLS/CLSI standards define the acceptance criteria including:

   • Zone diameter interpretive criteria: Specific zone diameter ranges (in mm) that classify an isolate as Susceptible, Intermediate, or Resistant to the antimicrobial.
   • Quality Control (QC) ranges: Acceptable zone diameter ranges for specified QC strains tested with the antimicrobial disc.
   • Essential agreement (EA): Agreement between the test method and a reference method (e.g., broth microdilution or agar dilution) within +/- 1 dilution for MIC, or within a specified number of mm for zone diameters.
   • Category agreement (CA): Agreement in the interpretive category (Susceptible, Intermediate, Resistant) between the test method and the reference method.

   However, the document does not provide the specific acceptance criteria values from the NCCLS standards nor the reported performance data (e.g., specific zone diameter ranges, QC results, or agreement rates) that were observed in the study. It only states that the product performs "in accordance" with these standards.

2. Sample size used for the test set and the data provenance:
   This information is not provided in the document. The general claim is that the device "performs in accordance with NCCLS Approved Performance Standard," which typically involves testing a defined number of clinical isolates and QC strains. Data provenance (e.g., country of origin, retrospective/prospective) is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided. For antimicrobial susceptibility testing, the "ground truth" (or reference method) is usually an established laboratory method like broth microdilution or agar dilution, interpreted by trained microbiologists following standard guidelines, rather than a consensus of external experts on individual cases.

4. Adjudication method for the test set:
   This information is not provided.

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 is not applicable to an antimicrobial susceptibility test disc. This device is a diagnostic reagent for laboratory use, not an AI-assisted diagnostic tool that would involve human readers interpreting images or complex data with or without AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This is not applicable for this type of device. The device itself is a disc containing an antimicrobial agent, and its performance is assessed by measuring zones of inhibition, which is a standardized laboratory procedure, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For antimicrobial susceptibility test discs, the ground truth is established by a reference susceptibility testing method, typically broth microdilution or agar dilution, as defined by organizations like NCCLS/CLSI. These methods determine the Minimum Inhibitory Concentration (MIC) for an antimicrobial against a microorganism, from which the interpretive category (S/I/R) is derived. The document does not explicitly state which reference method was used but cites adherence to NCCLS standards, which would imply the use of such a reference method.

8. The sample size for the training set:
   This is not applicable as this device does not involve a "training set" for an algorithm. Its performance is chemical and biological, assessed through adherence to standardized laboratory protocols.

9. How the ground truth for the training set was established:
   This is not applicable for the reasons stated above.

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