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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 the antimicrobial Gatifloxacin at concentrations of 0.03 - 8 mcg/ml to Pasco Panels for use in testing Streptococcus pneumoniae and Streptococcus spp. other than S. pneumoniae. Gatifloxacin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobic.

Active In Vitro and in Clinical Infectious Against:

Aerobic Gram-positive microorganisms Streptococcus pneumoniae (penicillin-susceptible strains)

Active In Vitro but their clinical significance is unknown

Aerobic Gram-positive microorganisms Streptococcus pneumoniae (penicillin-resistant strains) Streptococcus pyogenes

Pasco Panels are used for quantitatively measuring 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. Varying concentrations of antimicrobial agents (usually in two-fold dilutions) are dispensed into the Pasco microdilution 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.

This document describes the regulatory submission for the PASCO MIC and MIC/ID Panels, specifically for the inclusion of the antimicrobial Gatifloxacin. The study aims to demonstrate that the device, when testing Gatifloxacin, is substantially equivalent to existing methods.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantifiable manner as "x% accuracy" or "y% sensitivity" for the overall device. Instead, the "Substantial Equivalence Testing" section describes performance metrics used to support substantial equivalence. The relevant criteria would be within the guidelines of the "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA."

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

• Sample Size for Test Set: 570 challenge and clinical Streptococcus pneumoniae and Streptococcus spp. other than S. pneumoniae.
• Data Provenance: The data involved "challenge strains, fresh clinical isolates, stock clinical isolates and OC strains." This implies a mix of prospectively collected clinical isolates and retrospectively accessed stock/challenge strains. The country of origin is not specified, but given the FDA submission, it is likely that the testing was conducted in the USA or in facilities adhering to US regulatory standards. The testing was performed at "three test sites."

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

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. However, the ground truth was established by "reference methodology." In the context of Antimicrobial Susceptibility Testing (AST), this typically refers to a standardized laboratory method (e.g., broth microdilution or agar dilution) performed by trained microbiologists following established guidelines (such as those from the National Committee for Clinical Laboratory Standards - NCCLS, now CLSI).

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (like 2+1 or 3+1) for the test set. Given that the ground truth is established by a "reference methodology," it's implied that the reference method's result is considered the gold standard, and the device's results are compared against it. Discrepancies (minor, major, very major errors) are noted, but a post-hoc adjudication process by independent experts is not mentioned for the 570 isolates.

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 an AI/CAD device. The product is an Antimicrobial Susceptibility Test (AST) system. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed. The "reading" of the panels involves observing visible growth or color changes, which is a direct observation by a trained laboratory professional.

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

This is not an AI/CAD device. It is a laboratory diagnostic kit. Therefore, a standalone algorithm performance study is not applicable. The device (the microdilution panel) is the test system, and its output (MIC values) is read by a human.

7. The Type of Ground Truth Used

The ground truth used was reference methodology for antimicrobial susceptibility testing. This would typically involve a standard, validated laboratory method for determining minimum inhibitory concentrations (MICs), such as broth microdilution or agar dilution, performed according to recognized protocols (e.g., NCCLS/CLSI guidelines).

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" in the context of machine learning or AI. This is a conventional diagnostic system, not an AI system that undergoes training in that sense. The "Substantial Equivalence Testing" described with 570 isolates likely served as the primary validation dataset for regulatory submission.

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

As there is no "training set" in the AI sense, this question is not applicable. The primary validation (test set) ground truth was established by "reference methodology."

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