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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 or 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 of Cefepime to Pasco panels at concentrations of 0.03-4 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.

The provided document describes the 510(k) submission for the Pasco MIC and MIC/ID Panels, specifically for the addition of Cefepime. The document outlines the studies performed to demonstrate substantial equivalence to predicate devices.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the acceptable Essential Agreement (EA) was met for both S. pneumoniae and non-pneumococcal strains, and no major, very major, or minor errors were observed for either group in relation to the primary agreement metrics. The minor errors mentioned were noted as "all of which were within EA," implying they did not impact the overall essential agreement. The specific numerical thresholds for "acceptable" EA, Major, Very Major, and Minor errors are not explicitly listed in this document but are standard for antimicrobial susceptibility testing devices.

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

• Test Set Sample Size:
  • S. pneumoniae strains: 101
  • Non-pneumococcal strains: 130
  • Reproducibility testing: 12 organisms at each of two sites (totaling 24 organisms, though only 9 yielded on-scale endpoints).
• Data Provenance: Retrospective and prospective. The document states "Comparative testing of the Pasco test panel to a reference panel was performed at two sites using CDC challenge strains and clinical isolates." "Clinical isolates" imply prospective or recently isolated samples, while "CDC challenge strains" are laboratory-maintained reference strains. The country of origin is not explicitly stated but is implicitly the USA, given the FDA submission.

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

The document does not specify the number of experts or their qualifications for establishing the ground truth. The comparison was made against a "reference panel," which typically implies a validated method (like broth microdilution or agar dilution as per CLSI/NCCLS standards) rather than direct expert interpretation of raw results. The expertise would lie in the laboratory personnel conducting these reference methods.

4. Adjudication method for the test set

The document does not describe an adjudication method involving multiple readers. The comparison is between the Pasco panel's results and a "reference panel," implying a single, established reference method for each isolate's susceptibility determination.

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 comparative effectiveness study involving human readers and AI assistance was not mentioned. This document pertains to an antimicrobial susceptibility test panel, which is an in-vitro diagnostic device, not an AI-powered image analysis or diagnostic tool for human readers.

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

This refers to the performance of the Pasco MIC and MIC/ID Panels as a standalone device, without human intervention in the primary measurement function. The device itself generates the MIC values based on visible growth or color changes after incubation. Human input is involved in inoculating the panels, incubating them, and visually interpreting the results (or potentially using an automated reader, though not specified here). The "standalone" performance here refers to the accuracy of the device's output compared to a reference standard. The study demonstrates the standalone performance of the Pasco panel in determining MICs.

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

The ground truth was established by comparison to a "reference panel." This typically refers to a validated reference method for antimicrobial susceptibility testing, such as broth microdilution or agar dilution, which are considered the gold standard for determining MIC values. The results from this reference method serve as the ground truth against which the Pasco panel's performance (Essential Agreement and Category Agreement) is measured. The "CDC challenge strains" are also a form of standardized ground truth.

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of machine learning or AI. This is a traditional in-vitro diagnostic device, and the method for developing these panels involves established microbiological and manufacturing processes, not algorithm training. The "test panels containing Cefepime... were prepared in-house at Pasco using routine manufacturing procedures," indicating standard product development rather than a specific algorithmic training phase.

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

As there's no mention of a "training set" in the context of an algorithm, this question is not applicable. The device itself (the panel with varying concentrations of antimicrobial agents) is the product, and its performance is validated against established reference methods.

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