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510(k) Data Aggregation
(141 days)
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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 | <5% (typical) | Implied to be within acceptable limits. |
Note: The specific numerical performance values (e.g., exact EA/CA percentages, MD/VMD rates for Piperacillin-tazobactam with MTS) are not present in these documents but would be found in the 510(k) summary or full submission.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in the provided documents. For AST devices, this typically involves a large number of clinical isolates and challenge strains. FDA guidance often recommends testing hundreds to thousands of isolates covering various resistance mechanisms for each drug/bug combination.
- Data Provenance: Not explicitly stated. For AST devices, data is usually collected prospectively from clinical laboratories or reference labs, often across multiple sites (e.g., hospitals, public health labs) within the U.S. and potentially internationally.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable (N/A) in the AI/ML sense. For AST devices, "ground truth" is established by a standardized reference method, typically CLSI (Clinical and Laboratory Standards Institute) broth microdilution. The interpretation of these reference method results is based on established CLSI breakpoints, not on expert consensus in the way AI/ML models are often validated. Oversight and review of study data are performed by clinical microbiologists and statisticians.
4. Adjudication method for the test set
- Not Applicable (N/A) in the AI/ML sense. Adjudication is not typically needed for AST ground truth. Results from the reference method (e.g., CLSI broth microdilution) are considered the definitive truth. Any discrepancies between the investigational device and the reference method would be categorized (e.g., EA, CA, MD, VMD) and analyzed, but not "adjudicated" by experts in the context of resolving disagreement on the ground truth itself.
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 (N/A). This is an Antimicrobial Susceptibility Test Powder, not an AI-assisted diagnostic imaging or analysis device. MRMC studies are not relevant for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A) in the AI/ML sense. This is a laboratory diagnostic reagent. Its performance is evaluated intrinsically against a reference method, independently of a human "reading" the result in the AI/ML context. While a human interprets the output of the AST test, it's not "human-in-the-loop" in the way an AI algorithm assists a human.
7. The type of ground truth used
- Reference Method: The ground truth for AST devices is established using a Clinical and Laboratory Standards Institute (CLSI) sanctioned reference method, most commonly broth microdilution, interpreted using CLSI-established breakpoints.
8. The sample size for the training set
- Not Applicable (N/A). This device is not an AI/ML algorithm that requires a "training set." It is a reagent for phenotypic susceptibility testing.
9. How the ground truth for the training set was established
- Not Applicable (N/A). As it's not an AI/ML device, there is no "training set" or ground truth establishment for it in that context.
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