(84 days)
The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive bacteria. After inoculation, panels are incubated for 16-20 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation. according to the Package Insert.
This particular submission is for the addition of the antimicrobial Ceftaroline at concentrations of 0.06 to 16 mcg/ml to the test panel.
The gram-positive organisms which may be used for Ceftaroline susceptibility testing in this panel are:
Staphylococcus aureus
methicillin-susceptible and methicillin-resistant isolates - skin isolates only ●
- methicillin-susceptible isolates community-acquired bacterial pneumonia isolates -
MicroScan Dried Gram-Positive MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive bacteria.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial 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 for 16-20 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.
Here's a breakdown of the acceptance criteria and study information for the MicroScan® Dried Gram-Positive MIC/Combo Panels with Ceftaroline, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study that Proves Device Meets Criteria |
|---|---|---|---|
| Overall Performance | Essential Agreement | 99.0% for Ceftaroline | External evaluation comparing panels with CLSI frozen Reference Panel. |
| Reproducibility | Acceptable reproducibility and precision | Demonstrated acceptable for Ceftaroline | Inoculum and instrument reproducibility testing. |
| Quality Control | Acceptable results | Demonstrated acceptable for Ceftaroline | Quality Control testing. |
Study Details
| Information Point | Description Based on Provided Text |
|---|---|
| 1. Sample size for test set | Not explicitly stated as a number. The external evaluation used "fresh and stock Efficacy isolates and stock Challenge strains." S. aureus clinical isolates were also evaluated. |
| 2. Data provenance (country of origin, retrospective/prospective) | Not specified. The study is described as an "external evaluation." It is implied to be prospective for the purpose of validating the device. |
| 3. Number of experts used to establish ground truth & qualifications | Not specified. The reference standard used was a "CLSI frozen Reference Panel" and "Expected Results determined prior to the evaluation" for challenge strains. No mention of human experts establishing ground truth for the test set. |
| 4. Adjudication method | Not applicable, as the ground truth for the test set was established using a CLSI frozen Reference Panel or predetermined "Expected Results" for challenge strains, not expert consensus requiring adjudication. |
| 5. MRMC comparative effectiveness study | No. This study is validating an antimicrobial susceptibility test system, not an AI-assisted diagnostic tool that would typically involve human readers. |
| 6. Standalone (algorithm only without human-in-the-loop) performance | Yes, the device itself is a standalone system for determining MIC. While some reading methods are manual, the performance metrics (Essential Agreement) are for the panel's accuracy against a reference, which is an inherent algorithmic function of the panel's design. The text mentions "read manually" for S. aureus isolates, but also "MicroScan instrumentation" for other readings, indicating both possibilities for interaction with the device outputs. |
| 7. Type of ground truth used | - CLSI frozen Reference Panel: For the external evaluation comparing the MicroScan panels. |
- Expected Results: For challenge strains. |
| 8. Sample size for training set | Not applicable. This device is a diagnostic panel with pre-determined concentrations, not a machine learning algorithm that requires a training set in the conventional sense. The "training" would be the initial development and optimization of the panel's chemistry and design, which is not detailed here. |
| 9. How ground truth for training set was established | Not applicable in the context of machine learning. The "ground truth" for the development of the panel would be based on established microbiology principles and CLSI guidelines for antimicrobial susceptibility testing, which dictate the acceptable range of concentrations and expected results for known organisms. |
§ 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).