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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 of Ceftriaxone to Pasco panels at concentrations of 4-0.015 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 an analysis of the provided text regarding the acceptance criteria and study for the Pasco MIC and MIC/ID Panels, specifically for the inclusion of Ceftriaxone:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implicitly defines acceptance criteria by stating "acceptable Essential Agreement (EA)" and "acceptable plus or minus 1 dilution" for reproducibility, indicating that these are the targets based on the FDA draft document "Review Criteria For Assessment Of Antimicrobial Susceptibility Devices (May 1991)". Specific percentage thresholds for EA, CA, and error rates are not explicitly stated in this summary.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • S. pneumoniae strains: 101 isolates
  • Non-pneumococcal strains: 130 isolates
  • Reproducibility testing: 12 organisms at each of two sites (total 24 tests, though results are combined as "100% within acceptable +/- 1 dilution")
  • QC organism: S. pneumoniae ATCC 49619
• Data Provenance: The study used "CDC challenge strains and clinical isolates." This indicates a mix of well-characterized laboratory strains (CDC challenge strains) and real-world patient samples (clinical isolates). The country of origin is not explicitly stated, but given the submission to the FDA, it's highly likely to be U.S.-based. The study appears to be prospective comparative testing, as it describes "Comparative testing of the Pasco test panel to a reference panel was performed at two sites."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not explicitly state the number of experts used or their qualifications for establishing the ground truth. In antimicrobial susceptibility testing (AST), the "ground truth" is typically established by an independent, validated reference method (e.g., broth microdilution or agar dilution) interpreted by trained laboratory technologists following established guidelines (like NCCLS, now CLSI). The text mentions "a reference panel," which implies such a method was used, but details on who performed or interpreted it are not provided.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method for reconciling discrepancies, such as 2+1 or 3+1. However, the mention of "a reference panel" suggests that the results from the Pasco panel were compared directly to the results from this established reference method, and deviations were categorized as errors (Major, Very Major, Minor). The "ground truth" established by the reference method itself would likely be considered definitive without further adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is focused on the device's accuracy in determining antimicrobial susceptibility compared to a reference method, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this study is inherently a standalone performance evaluation of the Pasco MIC and MIC/ID Panels. The device itself performs the susceptibility testing, and the output (MIC values, category results) is then compared to a reference standard. There is no mention of a human-in-the-loop component for the interpretation of the device's primary results in this context; the device provides the MIC, which is then interpreted by a technologist. The comparison is between the device's output and the reference method's output.

7. The Type of Ground Truth Used

The ground truth used was based on a reference panel. This implies a standardized, validated antimicrobial susceptibility testing method (e.g., standard broth microdilution or agar dilution) performed by experts according to established protocols (like those from NCCLS).

8. The Sample Size for the Training Set

The document does not mention a training set or the sample size for a training set. This is not a machine learning or AI-driven device in the contemporary sense. It's a biochemical panel system, and its performance is evaluated against a reference method rather than through a training/validation split. "Test panels containing Ceftriaxone...were prepared in-house at Pasco using routine manufacturing procedures" describes how the test panels themselves were made, not a training process for an algorithm.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned for this type of device, the concept of establishing ground truth for a training set is not applicable to this 510(k) summary.

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