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510(k) Data Aggregation
(77 days)
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/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.
The provided document describes the 510(k) summary for Beckman Coulter's MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem, a device used to determine antimicrobial agent susceptibility.
Here's an analysis of the acceptance criteria and study details:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (as per FDA Guidance "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated August 28, 2009) | Reported Device Performance |
|---|---|---|
| Essential Agreement (EA) | Not explicitly stated in the provided text, but generally, for AST devices, EA is expected to be ≥ 90%. | Enterobacteriaceae: 95.5% |
| Pseudomonas aeruginosa: 93.1% | ||
| Categorical Agreement (CA) | Not explicitly stated in the provided text, but generally, for AST devices, CA is expected to be ≥ 90%. | Enterobacteriaceae: 98.8% |
| Pseudomonas aeruginosa: 92.4% | ||
| Reproducibility and Precision | Acceptable reproducibility and precision | Demonstrated acceptable reproducibility and precision with meropenem, regardless of inoculum method (Turbidity or Prompt) or instrument (autoSCAN-4 or WalkAway). |
| Quality Control (QC) | Acceptable QC results | Demonstrated acceptable results for meropenem. |
The device demonstrated acceptable performance by meeting the (unstated, but implied typical) thresholds for Essential Agreement and Categorical Agreement, as well as showing acceptable reproducibility and quality control.
2. Sample Size and Data Provenance
The document does not explicitly state the exact sample sizes for the test set. However, it indicates:
- "The external evaluations were conducted with fresh, recent and stock Efficacy isolates and stock Challenge strains."
- Data Provenance: The document does not specify the country of origin. The study was retrospective as it used "stock Efficacy isolates and stock Challenge strains" implying pre-existing samples. "Fresh, recent" isolates suggest some prospective collection, but the overall context of "external evaluations designed to confirm" typically refers to testing against a well-characterized panel.
3. Number of Experts and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing the ground truth.
4. Adjudication Method
The document does not specify an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. The study focuses on comparing the device's performance against a CLSI frozen Reference Panel, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone study was conducted. The "Dried Gram-Negative Panel inoculated with Prompt® and read on the WalkAway instrument demonstrated acceptable performance" compared to the CLSI frozen Reference Panel. This describes the performance of the device (algorithm/system) itself without human interpretation as the primary endpoint beyond the initial setup.
7. Type of Ground Truth Used
The ground truth used was a CLSI frozen Reference Panel. This is a standardized and well-characterized panel typically used for evaluating antimicrobial susceptibility test systems, representing a robust and accepted form of ground truth in this field.
8. Sample Size for the Training Set
The document does not provide any information about the sample size for a training set. This is typical for submissions focused on the validation of an in-vitro diagnostic device against a reference method, rather than the development of a novel algorithm through machine learning, where training sets are usually discussed.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (see point 8), there is no information on how its ground truth would have been established. The focus is solely on the performance against the CLSI frozen Reference Panel during evaluation.
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