(112 days)
The Triage BNP test is intended for use with Beckman Coulter Immunoassay Systems (Access, Access 2, Synchron LXi 725 and UniCel Dxl 800) for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure). The test also is used for the risk stratification of patients with acute coronary syndromes and for the risk stratification of patients with heart failure.
The Triage® BNP test is intended for use with Beckman Coulter Immunoassay Systems (Access, Access 2, Synchron LXi 725 and UniCel Dxl 800) for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant.
The provided text is a 510(k) summary for the Triage BNP Test for the Beckman Coulter Immunoassay Systems. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than describing a new study with explicit acceptance criteria and performance data.
Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, ground truth establishment, and expert involvement are not present in the provided document. The document refers to prior 510(k) clearances and "various peer-reviewed publications" without detailing new studies.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices (K033383, K021317, K051787, R021011, R031170) based on identical principles, reagents, and procedures, rather than presenting new performance data against specific acceptance criteria.
2. Sample size used for the test set and the data provenance
This information is not present in the provided document. While it mentions "various peer-reviewed publications" describing the utility of BNP measurements, it does not detail a specific test set or its provenance for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not present in the provided document.
4. Adjudication method for the test set
This information is not present in the provided document.
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
An MRMC study is not mentioned and is not relevant as this is a quantitative immunoassay device, not an imaging or AI-assisted diagnostic device where human reader performance would be a primary focus.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is an in vitro diagnostic immunoassay. Its performance is inherently "standalone" in the sense that it provides a quantitative measurement. The document implies that the device's performance is demonstrated by its substantial equivalence to previously cleared devices, which would have undergone performance validation studies. However, the details of those specific studies are not provided in this document.
7. The type of ground truth used
This information is not explicitly stated for any new study in this document. For previous clearances of similar BNP tests, ground truth for diagnosis/assessment of heart failure would typically involve clinical diagnosis by cardiologists, imaging (e.g., echocardiography), and patient outcomes data regarding hospitalization or death. The document does state: "Higher BNP concentrations or the lack of a decrease in the BNP concentration from hospital admission to discharge indicate an increased risk of hospitalization or death in patients with heart failure," implying clinical outcomes as the ultimate ground truth for risk stratification.
8. The sample size for the training set
This information is not present as this is not an AI/Machine Learning device that would have a "training set" in that context. The device is a chemical immunoassay system.
9. How the ground truth for the training set was established
Not applicable (see point 8).
§ 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.”