(38 days)
PASCO MIC AND MIC/ID 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.
This 510(k) notification is for the addition of the antimicrobial Telithromycin at concentrations of 0.015 - 4 mcg/ml to Pasco Panels. Telithromycin has been shown to be active in vitro against most isolates of the following microorganisms; as described in the FDA-approved package insert for this antimicrobic.
Active In Vitro and in Clinical Infectious Against:
Aerobic Gram-positive microorganisms
Staphylococcus aureus (methicillin and erythromycin susceptible isolates only)
Pasco MIC and MIC/ID 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 inoculation 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 and production of specific metabolites from growth in biochemical substrates are interpreted as described in the package insert for conventional tubed media.
The provided text describes the 510(k) summary for the Pasco MIC and MIC/ID Panels, specifically for the addition of Telithromycin. Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (Essential Agreement - EA) |
|---|---|
| Not explicitly stated as a numerical threshold in the provided text, but implied to be high enough to support "Substantial Equivalence". | 100% Essential Agreement for Telithromycin based on testing 207 challenge and clinical Staphylococcus aureus isolates. |
Note: While a numerical acceptance criterion for Essential Agreement is not explicitly stated, the FDA typically looks for very high agreement (often >90-95%) for antimicrobial susceptibility tests to be deemed substantially equivalent. The 100% reported performance clearly meets such an implied high standard.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 207 challenge and clinical Staphylococcus aureus isolates were tested.
- Data Provenance: Not explicitly stated as a country of origin. The data is from a "multi-site" study (three test sites). The methodology involved "challenge strains, fresh clinical isolates, stock clinical isolates and QC strains," indicating a mix of laboratory curated strains and real-world clinical samples. The study is prospective in the sense that these tests were performed specifically for the 510(k) submission using the device and reference methodology concurrently.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This information is not provided in the given text. The ground truth (reference methodology) is implied to be established by the "reference methodology," but the human expert involvement in reading or interpreting these reference results, or setting up the "challenge strains," is not detailed.
4. Adjudication Method for the Test Set:
- This information is not provided in the given text. It is usual for AST studies to compare the device's results against a well-established reference method, often without explicit expert adjudication of discrepancies, as the reference method itself is considered the gold standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- No, this was not an MRMC comparative effectiveness study. This device is an Antimicrobial Susceptibility Test (AST) panel, which provides quantitative measurements (Minimum Inhibitory Concentration - MIC) of bacterial susceptibility to antibiotics. It is not an AI-assisted diagnostic tool that helps human readers interpret images or complex data in the traditional sense of an MRMC study. Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not apply here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- The Pasco MIC and MIC/ID Panels are standalone devices in that they provide results (MIC values and biochemical identifications) based on the growth patterns and color changes in the microdilution wells. While human observation and interpretation of these changes are required, the "algorithm" that determines susceptibility is inherent in the design and formulation of the wells (e.g., specific concentrations of antimicrobials). The results are directly read from the panel after incubation. The study compares the device's output to a reference methodology, which is a standalone performance comparison.
7. The Type of Ground Truth Used:
- The ground truth was established by "reference methodology." While not explicitly detailed, for AST devices, this typically refers to a standardized laboratory method, such as broth microdilution or agar dilution, performed according to guidelines from organizations like the Clinical and Laboratory Standards Institute (CLSI) or NCCLS (as cited in the text). This is a well-established and accepted laboratory standard for determining MIC values.
8. The Sample Size for the Training Set:
- This information is not applicable/provided in the context of this device. The Pasco MIC and MIC/ID Panels are not machine learning or AI-based devices that require a "training set" in the computational sense. Their performance is based on chemical and biological reactions, and their development would involve iterative design and testing rather than algorithm training.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable as there is no "training set" in the context of a machine learning algorithm. The device's underlying principles are based on established microbiology and pharmacology.
§ 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).