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510(k) Data Aggregation
(57 days)
To determine bacterial antimicrobial agent susceptibility
The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert.
This particular submission is for the addition of the antimicrobial Cefaclor at concentrations of 0.5 to 8 mcg/ml to the test panel
The organisms which may be used for Cefaclor susceptibility testing in this panel are:
Streptococcus pneumoniae
The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.
Acceptance Criteria and Study Details for MicroScan® MICroSTREP plus™ Panel with Cefaclor
The MicroScan® MICroSTREP plus™ Panel's acceptance criteria and performance are based on its ability to accurately determine the minimum inhibitory concentration (MIC) for Cefaclor against Streptococcus pneumoniae.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Essential Agreement (EA) with Reference Panel: The device should demonstrate substantially equivalent performance to an NCCLS frozen Reference Panel. The FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (March 8, 2000) is referenced as defining acceptable performance. | Overall Essential Agreement (EA) > 98% with the frozen Reference panel. | This indicates a strong correlation between the device's MIC readings and the established reference standard. |
| Reproducibility: The device should demonstrate acceptable reproducibility and precision. | Acceptable reproducibility and precision demonstrated. | This confirms the device consistently produces similar results under the same conditions. Specific quantitative metrics for reproducibility are not provided in the summary. |
| Quality Control (QC) Testing: The device should produce acceptable results during quality control testing. | Acceptable results demonstrated for Cefaclor. | This indicates the device functions correctly within defined quality standards. Specific QC parameters and results are not provided in the summary. |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document refers to "fresh and stock Efficacy isolates and stock Challenge strains" for the external evaluation. However, the exact sample size (number of isolates/strains) used for the test set is not explicitly stated in the provided summary.
- Data Provenance: The data was generated through an "external evaluation." While the country of origin is not specified, it can be inferred that the studies were conducted within the context of FDA regulatory requirements, likely in the US or in conjunction with US-based standards (NCCLS). The study was prospective in the sense that it was designed to confirm the acceptability of the proposed panel by comparing its performance to a reference standard specifically for this submission.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1, none) for the test set. The comparison is made against an "NCCLS frozen Reference Panel," which implies that the reference panel itself serves as the established ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed. The study focuses on the performance of the device itself against a reference standard, not on human reader improvement with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done. The external evaluation directly compares the performance of the MicroScan® MICroSTREP plus™ Panel (the algorithm/device) to the NCCLS frozen Reference Panel without human intervention affecting the core measurement of MIC. The MICs are "manually read by observing the lowest antimicrobial concentration showing inhibition of growth," meaning a human interprets the results of the device, but the device itself generates the dilutions and the growth patterns.
7. Type of Ground Truth Used
The type of ground truth used is an expert consensus reference standard, specifically an "NCCLS frozen Reference Panel." NCCLS (National Committee for Clinical Laboratory Standards, now Clinical and Laboratory Standards Institute - CLSI) panels are established based on validated methods and expert consensus to provide a reliable benchmark for antimicrobial susceptibility testing.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This is typical for devices that measure a specific biological parameter against a pre-existing reference. The "training" for such a device would likely involve R&D and optimization by the manufacturer, rather than a separate, identified training set for regulatory submission in the same way an AI model would have one.
9. How Ground Truth for the Training Set Was Established
As no training set is described in the context of this regulatory submission, the method for establishing its ground truth is not applicable and not provided.
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