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Pasco MIC and MIC/ID panels are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement of category results) the susceptibility of rapidly growing aerobic and facultative anaerobic bacterial pathogens to a battery of antimicrobial agents and determining the biochemical identification of those organisms.

This 510(k) notification is for the addition Vancomycin to Pasco panels at concentrations of 0.03 to 2 mcg/ml for use in determining the susceptibility of S. pneumoniae and non-pneumococcal streptococci.

Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco panels and the panels are then frozen. Panels are thawed prior to use, inoculated with the test organisms, incubated the traditional 16-24 hours and panels are then observed for visible growth or color changes as described in the package insert. The lowest concentration of each antimicrobial agent with no apparent visible growth of the test organism is recorded as the minimum inhibitory concentration (MIC). Changes in pH and production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.

Here's a breakdown of the acceptance criteria and study details for the Pasco MIC and MIC/ID Panels for Vancomycin, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • Test set size:
     • S. pneumoniae: 101 strains
     • Non-pneumococcal strains: 130 strains
     • Reproducibility testing: 12 organisms per site (total 24 organisms, though only 12 unique organisms mentioned to have on-scale endpoints in results)
   • Data provenance: Not explicitly stated regarding country of origin. The study was a "comparative testing" performed at "two sites" using "CDC challenge strains and clinical isolates." The use of "clinical isolates" suggests prospective collection.

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

   • Not specified. The ground truth was established by a "reference panel." The methodology for this reference panel (e.g., whether it involved expert readers or a standardized method) is not detailed.

3. Adjudication method for the test set:

   • Not specified. The reference panel served as the comparator.

4. 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, this was not an MRMC study and it does not involve AI. This is a study comparing an antimicrobial susceptibility test panel (Pasco MIC and MIC/ID panels) to a reference panel for determining minimum inhibitory concentrations (MICs).

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

   • Yes, this is essentially a standalone performance evaluation of the Pasco MIC panel against a reference panel. The device itself (the panel) is the "standalone" component being tested for its ability to accurately determine MICs.

6. The type of ground truth used:

   • The ground truth was established by a "reference panel." This reference panel likely followed established microbiological methods for determining antimicrobial susceptibility, acting as the gold standard for comparison.

7. The sample size for the training set:

   • Not applicable. This device is an antimicrobial susceptibility test panel, not an AI/ML algorithm that requires a "training set." The panels are manufactured according to routine procedures, and their performance is evaluated retrospectively or prospectively using challenge and clinical strains.

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

   • Not applicable, as there is no training set for this type of device.

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