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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 Erythromycin to Pasco panels at concentrations of 2-0.015 mcg/ml for use in determining the susceptibility of 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 (Erythromycin), structured according to your request:

Acceptance Criteria and Device Performance

Study Information

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: 130 non-pneumococcal streptococci strains.
   • Data Provenance: The strains included "CDC challenge strains and clinical isolates." The testing was performed at "two sites." The document does not specify the country of origin, but given the FDA submission, it's highly likely to be U.S.-based. The study appears to be prospective comparative testing.

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

   • The document does not specify the number of experts or their qualifications. It mentions "a reference panel" and "reference method results," implying an established and accepted method for determining the true susceptibility.

3. Adjudication Method for the Test Set:

   • The document does not explicitly describe an adjudication method for discrepancies. It notes that "One major (M) error was observed upon initial testing," and for this error, "retest results were acceptable, this error was not considered resolved since the reference method results did not change." This implies that the reference method was considered the definitive truth without further expert review for adjudication.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

   • No, an MRMC comparative effectiveness study was not done. This study assesses the performance of an AST device, which typically involves comparing the device's output to a reference method, rather than comparing human readers' performance with and without AI assistance.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:

   • Yes, this was a standalone study. The Pasco MIC and MIC/ID panels are devices that provide automated or semi-automated susceptibility results. The study evaluates the performance of the device itself (the "Pasco test panel") against a "reference panel" or "reference method." While human technicians are involved in the operation of the device and reading results, the performance metrics (EA, M error, CA, reproducibility) directly reflect the device's ability to produce accurate susceptibility measurements, not the performance of human interpretation assisted by the device.

6. The Type of Ground Truth Used:

   • The ground truth was established by a "reference panel" and "reference method results." For Antimicrobial Susceptibility Testing (AST) devices, the reference method is typically a standardized broth microdilution method or an agar dilution method, which is considered the gold standard for determining minimum inhibitory concentrations (MICs).

7. The Sample Size for the Training Set:

   • The document does not provide information regarding a distinct training set. This is common for device studies that focus on analytical performance against a known reference standard, rather than machine learning algorithm development which would typically involve separate training and test sets. The "CDC challenge strains and clinical isolates" used in the comparative testing effectively serve as the evaluation set.

8. How the Ground Truth for the Training Set Was Established:

   • As no distinct training set is mentioned for an algorithm, the method for establishing ground truth for a training set is not applicable in this context. If any internal development/calibration involved data, the ground truth would similarly be established by a reference method.

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