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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 Ofloxacin to Pasco panels at concentrations of 0.5 to 16 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 Ofloxacin, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Sizes:
  • S. pneumoniae: 101 strains
  • Non-pneumococcal streptococci: 130 strains
  • Reproducibility: 12 organisms at each of the two sites.
• Data Provenance: The study used both CDC challenge strains and clinical isolates. This suggests a mix of standardized laboratory strains and real-world patient samples. No country of origin is specified, but given the FDA review, it is implied to be within the scope of U.S. regulatory standards (likely U.S.-sourced or compliant with U.S. clinical study requirements at the time). The study is prospective as it involved preparing panels and performing comparative testing specifically for this submission.

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

The document does not specify the number or qualifications of experts used to establish the ground truth. It states that comparative testing was performed against a "reference panel" and mentions "CDC challenge strains," which implies an established gold standard for antimicrobial susceptibility testing, likely based on recognized laboratory methods and expert consensus within microbiology.

4. Adjudication Method

The document does not explicitly describe an adjudication method (like 2+1, 3+1). The "retesting" for S. pneumoniae suggests a method for resolving discrepancies when initial results were not 100%, but the specific process isn't detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. This study focuses on the performance of the device itself (Pasco panels) against a reference method, not on how human readers' performance might improve with or without AI assistance. The device is an in vitro diagnostic for antimicrobial susceptibility, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone (Algorithm Only) Performance Study

Yes, this was a standalone performance study of the Pasco MIC and MIC/ID Panels. The device itself performs the susceptibility testing and provides the results. There's no human-in-the-loop performance being evaluated in terms of interpreting the device's output. The performance metrics (EA, CA, error rates) directly reflect the device's ability to accurately determine MICs and category results compared to a reference method.

7. Type of Ground Truth Used

The ground truth was established by a reference panel and CDC challenge strains. This indicates an established, recognized method for determining antimicrobial susceptibility, likely involving standard laboratory procedures (e.g., broth microdilution, agar dilution) performed by qualified personnel, which serves as the "gold standard" for accuracy in microbiology.

8. Sample Size for the Training Set

The document does not explicitly state a "training set" sample size. This is a traditional in vitro diagnostic (IVD) device, not an AI/machine learning device that typically requires a separate training set. The "Test panels" mentioned were prepared in-house, but this refers to the manufactured product, not a dataset used to train an algorithm. The 101 S. pneumoniae and 130 non-pneumococcal streptococci strains represent the test set used to validate the device's performance.

9. How Ground Truth for the Training Set Was Established

As there's no explicitly defined "training set" in the context of an AI algorithm, this question isn't directly applicable. The device's underlying principles are based on established microbiological methods for detecting bacterial growth inhibition by antimicrobial agents. The development and calibration of the panels (if one were to loosely consider that a form of "training") would rely on decades of microbiological science and standard susceptibility testing guidelines, with the "ground truth" derived from validated reference methods.

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