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510(k) Data Aggregation
(90 days)
MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )
To determine antimicrobial agent susceptibility
MicroScan Dried Gram-Negative 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-negative bacilli.
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 an analysis of the provided text, focusing on the acceptance criteria and study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Performance Metric | Acceptance Criteria (Implicit from FDA Guidance) | Reported Device Performance (Ceftazidime) |
|---|---|---|
| Enterobacterales | ||
| Essential Agreement (EA) | (Not explicitly stated, but generally >90%) | 92.1% |
| Categorical Agreement (CA) | (Not explicitly stated, but generally >90%) | 95.2% |
| Pseudomonas aeruginosa | ||
| Essential Agreement (EA) | (Not explicitly stated, but generally >90%) | 91.3% |
| Categorical Agreement (CA) | (Not explicitly stated, but generally >90%) | 96.2% |
| Acinetobacter spp. | ||
| Essential Agreement (EA) | (Not explicitly stated, but generally >90%) | 93.1% |
| Categorical Agreement (CA) | (Not explicitly stated, but generally >90%) | 94.3% |
| Inoculum Reproducibility | Acceptable | Acceptable |
| Instrument Reproducibility | Acceptable | Acceptable |
| Quality Control Testing | Acceptable | Acceptable |
Explanation of Implicit Acceptance Criteria: The document references the "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated August 28, 2009. While the specific numerical acceptance thresholds are not directly stated in this summary, guidance documents for AST devices typically require high percentages (e.g., >90%) for Essential Agreement and Categorical Agreement to demonstrate substantial equivalence to a reference method. The "acceptable" findings for reproducibility and quality control imply that they met predefined internal or regulatory thresholds.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of the total number of isolates. However, the study mentions conducting "external evaluations with fresh, recent and stock Efficacy isolates and stock Challenge strains."
- Data Provenance: Not specified, but the use of "fresh, recent and stock Efficacy isolates and stock Challenge strains" suggests a mix, likely from various clinical and curated collections. The country of origin is not mentioned. The study is retrospective in nature as it uses existing isolates.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the summary. The ground truth is established by the "CLSI frozen Reference panel," which implies a standardized, well-defined method rather than interpretation by individual experts for each case.
4. Adjudication Method for the Test Set
This information is not provided. Since the comparison is against a "CLSI frozen Reference panel," it's a direct comparison against a gold standard method, not typically involving expert adjudication of discrepancies between multiple readers for a single case.
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 vs Without AI Assistance
No, an MRMC comparative effectiveness study was not done. This study evaluates the performance of an automated AST device (MicroScan Dried Gram-Negative MIC/Combo Panel) against a reference method, not the impact of AI on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The device's performance (MicroScan Dried Gram-Negative MIC/Combo Panel) was compared directly to a "CLSI frozen Reference panel" without human intervention for result interpretation within the device's output. The device itself automatically determines the MIC and categorized susceptibility.
7. The Type of Ground Truth Used
The ground truth used was a CLSI frozen Reference panel. This represents a gold standard method for antimicrobial susceptibility testing, based on established Clinical and Laboratory Standards Institute (CLSI) guidelines. It's essentially a highly standardized and validated laboratory method for determining the true MIC for each organism-antimicrobial combination.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. This device is an AST system, which typically relies on established biochemical and growth principles, not a machine learning model that undergoes explicit training on a large dataset in the conventional sense. Therefore, this question is not applicable to the described device.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI/ML model, this question is not applicable. The device's functionality is based on established microbiology principles for determining MICs.
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