Search Results
Found 1 results
510(k) Data Aggregation
(73 days)
PASCO MIC AND MIC/ID PANELS, TROVAFLOXACIN
PASCO MIC AND MIC/ID PANELS are used for quantitatively measuring (with the exception of the Breakpoint/ID panel which provides qualitative measurement or 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 8-0.03 mcg/ml for use in determining the susceptibility of S. ppeumoniae and non-pneumococcal streptococci.
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 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.
Acceptance Criteria and Device Performance for Pasco MIC and MIC/ID Panels with Trovafloxacin
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (from FDA draft document "Review Criteria For Assessment Of Antimicrobial Susceptibility Devices" (May 1991)) | Reported Device Performance (Trovafloxacin with S. pneumoniae) | Reported Device Performance (Trovafloxacin with Non-pneumococcal streptococci) |
|---|---|---|---|
| Essential Agreement (EA) | Not explicitly stated as a numerical threshold in the provided text, but implied as "acceptable Essential Agreement" | 98.7% | 99.3% |
| Major Errors (M) | Not explicitly stated as a numerical threshold in the provided text, but implied as "acceptable" (i.e., low or none observed) | 0 | 0 |
| Very Major Errors (VM) | Not explicitly stated as a numerical threshold in the provided text, but implied as "acceptable" (i.e., low or none observed) | 0 | 0 |
| Minor Errors | Not explicitly stated as a numerical threshold in the provided text, but implied as "acceptable" (i.e., low or none observed) | 0 | 0 |
| Category Agreement (CA) | Not explicitly stated as a numerical threshold in the provided text, but implied as "acceptable" | 100% | 100% |
| Random Minor Errors | Not explicitly stated as a numerical threshold in the provided text, but implied as "acceptable" (i.e., low or none observed) | 0 | 0 |
| QC Endpoints (S. pneumoniae ATCC 49619) | Within recommended NCCLS acceptable range | Within recommended NCCLS acceptable range | Not applicable (Specific to S. pneumoniae) |
| Reproducibility | Overall reproducibility within plus or minus 1 dilution | 100% within acceptable plus or minus 1 dilution | 100% within acceptable plus or minus 1 dilution |
2. Sample Sizes and Data Provenance
- Test Set Sample Sizes:
- S. pneumoniae strains: 101
- Non-pneumococcal streptococci strains: 130
- Reproducibility testing: 12 organisms at each of two sites, with 10 organisms having on-scale endpoints.
- Data Provenance: The comparative testing was performed at two sites (specific locations not provided in the text). The data utilized CDC challenge strains and clinical isolates. The text does not specify the country of origin, but the submission is to the US FDA. The study appears to be prospective, as it involves newly prepared panels and comparative testing against a reference panel.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts used to establish the ground truth for the test set or their qualifications. The "reference panel" is used for comparative testing, suggesting that its results served as the ground truth. However, details on how the reference panel's results were established or verified by experts are not provided.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set results. The comparison is made between the Pasco test panel and a "reference panel."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This study is focused on the performance of the automated antimicrobial susceptibility testing device itself against a reference method, not on human reader performance with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done. The "Test results of the 101 S. pneumoniae strains" and "Test results of the 130 non-pneumococcal streptococci strains" indicate the performance of the Pasco MIC and MIC/ID panels (the algorithm/device) in determining antimicrobial susceptibility (MIC values and categorical interpretations) against a reference method. The "reproducibility testing" also evaluates the standalone consistency of the device.
7. Type of Ground Truth Used
The ground truth for the comparative testing was established by a reference panel. The document states, "Comparative testing of the Pasco test panel to a reference panel was performed..." This implies that the MIC results obtained from the reference panel were considered the gold standard against which the Pasco panels were evaluated for essential agreement and categorical agreement. The nature of this reference panel (e.g., whether it used a manual broth microdilution method, another cleared automated system, or expert-read plates) is not detailed.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. This type of submission (510(k)) for an antimicrobial susceptibility test typically focuses on validation and comparison to an established reference method rather than describing the development and training of a machine learning model.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, there is no information on how its ground truth was established.
Ask a specific question about this device
Page 1 of 1