(49 days)
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 5.10(k) notification is for the antimicrobial Daptomycin at concentrations of 0.06 - 8 mcg/ml to Pasco Panels. Daptomycin 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
Enterococcus faecalis (vancomycin-susceptible strains only) Staphylococcus aureus (including methicillin-resistant strains)
Active In Vitro but their clinical significance is unknown
Aerobic Gram-positive microorganisms
Enterococcus faecalis (vancomycin-resistant strains) Enterococcus faecium (including vancomycin-resistant strains) Staphylococcus epidermidis (including methicillin-resistant strains) Staphylococcus haemolyticus
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.
The provided document describes the acceptance criteria and the study conducted for the Pasco MIC and MIC/ID Panels with the inclusion of Daptomycin.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Essential Agreement (EA) | Not explicitly stated as a numerical threshold, but implied to be high based on the "Class II Special Controls Guidance Document". | 99.6% for 413 challenge and clinical Staphylococcus spp. and 365 challenge and clinical Enterococcus spp. |
| QC Endpoints | Acceptable for NCCLS recommended OC organisms (S. aureus ATCC 29213 and E. faecalis ATCC 29212) from both reference and test methodology. | Acceptable |
| Reproducibility (Inter-site) | Not explicitly stated as a numerical threshold. | 100% for all three sites |
| Reproducibility (Intra-site) | Not explicitly stated as a numerical threshold. | 100% for all three sites |
Study Information
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Sample size used for the test set and the data provenance:
- Test Set Size: 413 challenge and clinical Staphylococcus spp. and 365 challenge and clinical Enterococcus spp. (Total = 778 isolates).
- Data Provenance: The document states "Challenge strains, fresh clinical isolates, stock clinical isolates and OC strains were tested concurrently". It also mentions "Testing was conducted at three test sites." The country of origin is not explicitly stated. The nature of "fresh clinical isolates" and "stock clinical isolates" suggests a mix of retrospective and prospective data. "Challenge strains" and "OC strains" are likely laboratory-derived.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- The ground truth was established by "reference methodology." While the document doesn't detail who performs this or their qualifications, it implies a standard, established method, likely overseen by qualified laboratory personnel.
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Adjudication method for the test set:
- Not applicable as the study compares the device's results against a "reference methodology" rather than relying on multiple expert readings for ground truth establishment.
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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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an Antimicrobial Susceptibility Test (AST) system, which typically provides objective measurements (MIC values) rather than interpretation requiring human readers in the same way an imaging AI would. This study focuses on the agreement of the device with a reference method, not on human interpretive improvement with AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone study. The device (Pasco MIC and MIC/ID Panels) is a diagnostic test system that produces a result (MIC values). The study assessed the performance of this system ("Pasco methodology") independently against a "reference methodology." There is no mention of a human-in-the-loop component for the device's primary function or for the evaluation.
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The type of ground truth used:
- The ground truth was established using reference methodology. For Antimicrobial Susceptibility Testing, this typically involves a standardized, validated laboratory method (e.g., agar dilution or broth microdilution following CLSI/NCCLS guidelines) that is considered the gold standard for determining MIC values.
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The sample size for the training set:
- The document does not explicitly mention a "training set" in the context of an algorithm or AI. This study is for a traditional diagnostic panel, not an AI-driven device that requires training. The described isolates are for the "test set" or samples used for validation.
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How the ground truth for the training set was established:
- As there is no mention of a "training set" for an algorithm, this question is not applicable. For the isolates used in the performance study, the ground truth was established by "reference methodology" as described in point 6.
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).