Search Results

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 Trovafloxacin to Pasco panels at concentrations of 0.03 to 16 mcg/ml for use in determining the susceptibility of C. freundi, E. aerogenes, E. coli, K. pneumoniae, Morganella morganii, P. mirabilis, P. vulgaris, P. aeruginosa, E. faecalis and methicillin susceptible strains of S. aureus and S. evidermidis. Clinical testing of S. pneumoniae with Trovafloxacin has not been performed with the Pasco system.

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 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.

Acceptance Criteria and Device Performance Study for Pasco MIC and MIC/ID Panels with Trovafloxacin

The information below describes the acceptance criteria and the study proving the device meets these criteria, specifically for the addition of Trovafloxacin to the Pasco MIC and MIC/ID panels.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for antimicrobial susceptibility testing devices typically involve evaluating Essential Agreement (EA), Category Agreement (CA), Major Errors (M), and Very Major Errors (VM) against a reference method. The "Review Criteria For Assessment Of Antimicrobial Susceptibility Devices" (May 1991) by the FDA is referenced as the guideline for these criteria, though specific numerical thresholds are not explicitly stated in the provided text. However, the reported performance metrics indicate acceptable levels for these criteria.

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

• Sample Size for Test Set: Not explicitly stated as a number. The study used "CDC challenge strains and clinical isolates." The results are presented for "gram-negative isolates" and "gram-positive isolates," indicating multiple species within each group were tested. Given the detail of percentages for EA, CA, and errors, it implies a substantial number of isolates were tested to achieve these statistics.

• Data Provenance: The study was "performed at two sites." The specific country of origin is not explicitly stated. The use of "CDC challenge strains" suggests a U.S. context or at least strains relevant to infectious disease surveillance by the CDC. The use of "clinical isolates" suggests a prospective or retrospective collection from patient samples at the two testing sites. The document doesn't specify if it was purely prospective or included retrospective samples.

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

This information is not provided in the given text. While a "reference panel" was used for comparative testing, the process for establishing the ground truth of this reference panel (e.g., number of expert microbiologists, their experience) is not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the given text. It is stated that a Major error observed in gram-positive isolates was "resolved upon retest," which suggests some form of review or re-evaluation process but not a formal adjudication method (like 2+1 or 3+1 expert consensus).

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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor is there any mention of Artificial Intelligence (AI) assistance in this context. This device is an in-vitro diagnostic assay, not an AI-powered image analysis or diagnostic tool.

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

This study evaluates the performance of the Pasco MIC and MIC/ID panels, which are laboratory devices that produce results (MIC values, qualitative categories) based on biochemical reactions and growth patterns. The "algorithm" here is the interpretive criteria used by the device, and its "standalone" performance is what is being directly measured against a reference panel. There isn't a human-in-the-loop component in the device's direct output that would typically be evaluated in such a study for an AI system. The final reading of the panel might involve human observation, but the device itself is designed to provide results directly.

7. The Type of Ground Truth Used

The ground truth for the test set was established by a reference panel. The specific methodology of this reference panel, but it is implied to be a well-established and accepted method for antimicrobial susceptibility testing, as it is used for comparison in regulatory submissions. Given the context, this reference panel likely utilizes a recognized method (e.g., broth microdilution or agar dilution as defined by NCCLS standards) interpreted by experienced microbiologists to determine the true MIC and category.

8. The Sample Size for the Training Set

This information is not applicable in the context of this 510(k) submission as described. The device is a traditional in-vitro diagnostic (antimicrobial susceptibility test) and does not rely on a machine learning model that would require a dedicated "training set" in the sense of AI/ML development. The "training" for such devices typically involves the manufacturer's internal development and optimization processes, rather than a separate, formally defined "training set" for the purpose of a regulatory study.

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

As explained in point 8, a formal "training set" with ground truth in the context of AI/ML is not relevant here. The device's operational parameters (e.g., concentration ranges, interpretive criteria) are established through a combination of scientific principles, prior research, and adherence to recognized standards like those from NCCLS (now CLSI).

Ask a specific question about this device