(77 days)
The MicroScan® ESBL plus ESBL Confurmation Panel is designed for use in the determination of antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing gram negative bacilli and for the detection of ESBL production in Escherichia coli, Klebsiella oxytoca and Klebsiella pneumoniae. After inoculation, panels are incubated for a minimum of 16 hours at 35°C in a non-CO2 incubator, and read visually, according to the Package Insert.
This particular submission is for the addition of the antimicrobials Ceftazidime (0.5-128 ug/ml), Cefotaxime (0.5-128 ug/ml), Ceftazidime/Clavulanic Acid (0.12/4-32/4 ug/ml) and Cefotaxime/Clavulanic Acid (0.12/4-32/4 µg/ml) to the test panel.
The Gram-Negative organisms which may be used for detection of ESBL production in this panel are:
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobials agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water, after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator at 35 °C for a minimum of 16 hours, the minimum inhibitory concentration (MIC) for the test organism is determined by observing the lowest antimicrobial concentration showing inhibition of growth.
The provided text describes the acceptance criteria and the study conducted for the MicroScan® Dried Gram Negative MIC/Combo Panels.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Overall Agreement for ESBL detection | > 90% |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical count of individual samples or isolates. The text refers to "ESBL producing strains" and "non-ESBL producing strains."
- Data Provenance: The study involved "Efficacy and Challenge testing with MicroScan® Dried Gram Negative panel with Ceftazidime, Ceftazidime/Clavulanic Acid, Ceftriaxone and Ceftriaxone/Clavulanic Acid was conducted with both ESBL producing strains including AmpC and HiK 1 type strains." This indicates a controlled, challenge-based study rather than retrospective or purely prospective clinical samples. The origin of these strains (e.g., country) is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the text.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the text.
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 versus without AI assistance:
This was not an MRMC study involving human readers and AI assistance. The device is a diagnostic panel for antimicrobial susceptibility testing and ESBL detection, not an AI-assisted interpretation tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone diagnostic panel. The performance reported (>90% agreement) reflects the panel's ability to detect ESBL production based on its chemical reactions, which are then read visually. While the reading is human-in-the-loop (visual interpretation), the reported performance is of the device in producing the interpretable result. The study appears to be evaluating the intrinsic performance of the panel.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth was established by "previously generated molecular characterization data." This suggests a highly definitive and objective method for determining the presence or absence of ESBL genes or other molecular markers responsible for ESBL production.
8. The sample size for the training set:
This information is not applicable as the device is a chemical diagnostic panel, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable as the device is a chemical diagnostic panel, not a machine learning model that requires a training set.
§ 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).