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The provided FDA letter (K211672) is for an Antimicrobial Susceptibility Test Powder (MTS Piperacillin-tazobactam). This type of device is used to determine the susceptibility of microorganisms to antimicrobial agents, which is crucial for guiding antibiotic treatment. The information provided in the FDA letter and its attachments does not typically contain the detailed performance study information common for AI/ML-based medical devices or imaging analysis software.
Therefore, many of the specific details requested in your prompt (e.g., sample size for training set, number of experts for ground truth, MRMC study effect size, AI assistance) are not applicable (N/A) to this specific device/submission type, as it is a microbiology culture-based test, not an AI/ML device.
However, I can extract the relevant information regarding the acceptance criteria and performance as typically presented for such devices.
Here's the summary based on the provided documents:
1. A table of acceptance criteria and the reported device performance
For Antimicrobial Susceptibility Testing (AST) devices like this, acceptance criteria typically involve demonstrating substantial equivalence to a predicate device and achieving acceptable Essential Agreement (EA) and Category Agreement (CA) with a reference method (e.g., CLSI broth microdilution). The acceptance criteria often align with FDA guidance for AST devices.
| Acceptance Criteria Category | Specific Criteria (Typical for AST) | Reported Device Performance (Implied from Clearance) |
|---|---|---|
| Preamble Criteria | Substantial Equivalence to Predicate | Was found "substantially equivalent" for stated indications. |
| Primary Performance Endpoints | Essential Agreement (EA) ≥ 90% | Implied to have met required EA thresholds for all tested organisms/drugs. |
| Category Agreement (CA) ≥ 90% | Implied to have met required CA thresholds for all tested organisms/drugs. | |
| Secondary Performance Endpoints | Major Discrepancies (MD) rate ≤ 3% | Implied to be within acceptable limits. |
| Very Major Discrepancies (VMD) rate ≤ 1.5% | Implied to be within acceptable limits. | |
| Reproducibility/Precision | Consistent results across replicates and sites | Implied to have demonstrated acceptable reproducibility and precision. |
| No Growth/Contamination |
§ 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).