(74 days)
To determine antimicrobial agent susceptibility
To determine gram-positive bacterial susceptibility against the antimicrobial agent Meropenem. Organisms with indications for testing* include: Gram-Positive Bacteria Viridans group streptococci
Although viridans streptococci are indicated for testing* with the antimicrobial agent Meropenem, they are contraindicated for use with Meropenem on MicroScun Dried Gram-Positive MIC/Combo Panels.
- As taken from the Indications and Usage section of each manufacturers' package insert (Zeneca).
Microdilution Minimum Inhibitory Concentration (MIC) Panels
MicroScan® Dried Gram-Positive MIC/Combo Panels
The provided text describes the 510(k) submission for the Dade MicroScan Inc. MicroScan Dried Gram-Positive MIC/Combo Panels with Meropenem. Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Overall Essential Agreement with NCCLS Frozen Meropenem Reference Panel | 97.2% |
| Reproducibility and Precision | Acceptable |
| Quality Control Performance | Acceptable |
Note: The document references "FDA DRAFT document 'Review Criteria for Assessment of Antimicrobial Susceptibility Devices' (dated May 31, 1991)" as defining the acceptability. Specific numerical thresholds for "acceptable reproducibility" and "acceptable quality control performance" are not explicitly stated in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated in terms of a specific number of isolates or tests. The document mentions "gram-positive external evaluations were conducted with fresh and stock Efficacy isolates and stock Challenge strains." However, the exact number is not provided.
- Data Provenance: The evaluations were "external", but the country of origin is not specified. The data is retrospective as it involves testing with "fresh and stock Efficacy isolates and stock Challenge strains" that were pre-existing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set:
- The ground truth was established by comparison with an "NCCLS frozen Meropenem Reference panel." This implies a reference standard rather than human adjudication of results from the device itself. No explicit human adjudication method (e.g., 2+1, 3+1) is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The study focuses on the performance of the device against a reference method, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance:
- Yes, the described study is effectively a standalone performance evaluation. The device (MicroScan Dried Gram-Positive MIC/Combo Panel with Meropenem) is evaluated for its ability to determine antimicrobial susceptibility independently, without human-in-the-loop interaction for the primary measurement. The overall Essential Agreement of 97.2% is a measure of its standalone performance against a reference.
7. Type of Ground Truth Used:
- The ground truth used was a reference standard: the "NCCLS frozen Meropenem Reference Panel." This is a laboratory-based, established method for determining antimicrobial susceptibility.
8. Sample Size for the Training Set:
- The document does not provide information about a separate "training set" or its sample size. The description refers to evaluation against a reference panel, indicating a validation or verification study rather than a development and training process for an AI/algorithm in the contemporary sense. This product precedes modern AI development frameworks.
9. How the Ground Truth for the Training Set Was Established:
- As no training set is described, this information is not applicable based on the provided document. The device's performance was compared to an NCCLS reference method for validation.
§ 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).