(67 days)
The Triage® BNP Test is intended for use with the Triage® Meter for the rapid in vitro quantitative measurement of B-Type Natriuretic Peptide (BNP) in human whole blood or plasma specimens using EDTA as the anticoagulant. The test is used as an aid in the diagnosis and assessment of severity of congestive heart failure. The test also is used for the risk stratification of patients with acute coronary syndromes.
The Triage® BNP Test is intended for use with the Triage® Meter for the rapid in vitro quantitative measurement of B-Type Natriuretic Peptide (BNP) in human whole blood or plasma specimens using EDTA as the anticoagulant. The test is used as an aid in the diagnosis and assessment of severity of congestive heart failure. The test also is used for the risk stratification of patients with acute coronary syndromes.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Triage® B-Type Natriuretic Peptide (BNP) Test:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or thresholds for the device's performance in a table format. Instead, it focuses on the device's intended use, its substantial equivalence to a predicate device for the methodology, and its substantial equivalence to other predicate methods for the conceptual use of a biochemical marker for prognostic information.
However, the summary does describe the performance in the context of risk stratification for ACS patients:
| Metric (Implied Acceptance Criteria) | Reported Device Performance (as demonstrated in the study) |
|---|---|
| Aid in risk stratification of patients with Acute Coronary Syndromes (ACS) by identifying patients at higher risk for adverse outcomes. | Patients whose BNP concentration was at least 80 pg/mL had higher rates of death, myocardial infarction, and Congestive Heart Failure (CHF) both at 30 days and at 10 months after presentation, compared to patients whose BNP concentration was below 80 pg/mL. This indicates the test provides "useful predictive information to aid in the risk stratification of patients with ACS." |
| Substantial equivalence to predicate methods for the physical test method (sandwich ELISA) and calibration. | "The device and test method described in the labeling are identical to the predicate device, the Triage® BNP Test. The antibodies used in the microplate assays and the Triage® BNP Test are identical, and both platforms utilize a sandwich ELISA assay. Furthermore, the same reagents used to calibrate the Triage® BNP Test also were used to calibrate the microplate assays." (Implies the new device performs equivalently to the existing Triage® BNP Test in terms of its underlying technology and calibration). |
| Substantial equivalence to predicate methods for the conceptual use of a biochemical marker to provide prognostic information to a physician. | "The Dade Stratus Cardiac Troponin-I and Dade Dimension RxL Cardiac Troponin-I are used as predicate methods for the conceptual description of how a biochemical marker can be used to provide prognostic information to a physician. Although these predicate methods describe a different analyte, the description of how the test results should be interpreted with respect to the prognosis of the patient are substantially equivalent." (Implies the utility of BNP as a prognostic marker is conceptually similar to established cardiac troponin markers, even though the specific analyte is different). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 2525 high-risk ACS patients.
- Data Provenance: The study was observational and retrospective. The patients were from a population that met standard diagnostic criteria for ACS. The country of origin is not explicitly stated in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not explicitly state the number of experts used to establish the ground truth for the test set.
- It mentions "standard diagnostic criteria for ACS," implying that the initial diagnosis of ACS for the patient cohort was established through accepted medical protocols, likely involving physician diagnosis, clinical presentation, and other diagnostic tests.
- The "ground truth" for the device's prognostic utility seems to have been based on subsequent clinical outcomes (death, myocardial infarction, CHF at 30 days and 10 months), rather than an expert consensus on individual BNP values.
4. Adjudication Method for the Test Set
- The document does not specify an adjudication method for the test set in terms of expert review of cases. The study's nature was observational and retrospective, linking BNP levels to subsequent clinical outcomes.
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, an MRMC comparative effectiveness study was not done. This study assesses the prognostic utility of a quantitative biochemical marker (BNP), not the performance of human readers with or without AI assistance in interpreting images or clinical data. The device is an in vitro diagnostic test, not an AI imaging or diagnostic algorithm designed to assist human interpretations of complex cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone study was done. The study's focus was on the quantitative measurement of BNP and its ability to predict future clinical events (death, MI, CHF) without direct human intervention in the interpretation of the BNP value for individual patient prognosis within the study design. The test itself, performed by the Triage® Meter, provides a quantitative result. The interpretation of that result for risk stratification is then done by a healthcare professional, but the study validates the standalone predictive power of the BNP value.
7. The Type of Ground Truth Used
- The type of ground truth used to evaluate the device's prognostic utility was outcomes data. Specifically, the endpoints were:
- Death
- Myocardial Infarction
- Congestive Heart Failure
- These outcomes were observed at 30 days and 10 months after presentation.
8. The Sample Size for the Training Set
- The document does not mention a separate "training set" in the context of an algorithm or machine learning. The clinical study described with 2525 patients appears to be the sole clinical study presented to support the prognostic claim. For a traditional medical device (like an IVD), "training set" is typically not applicable in the same way it is for AI/ML. The 2525 patient cohort was used to demonstrate the association between BNP levels and outcomes.
9. How the Ground Truth for the Training Set Was Established
- As a training set is not explicitly mentioned in the context of an algorithm, this question is not directly applicable. If we consider the 2525 patient cohort as the dataset used to establish the evidence for the claim, the "ground truth" was established based on clinical outcomes (death, MI, CHF) observed for these patients over 30 days and 10 months, following their diagnosis of ACS based on "standard diagnostic criteria."
§ 862.1117 B-type natriuretic peptide test system.
(a)
Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.(b)
Classification. Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”