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For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur® System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart failure. This assay is not intended for use on any other system.

For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ACS:180® Automated Chemiluminescence System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict the likelihood of future heart failure. This assay is not intended for use on any other system.

The ACS:180 and ADVIA Centaur BNP assays are fully automated two-site sandwich immunoassays using direct chemiluminescent technology. The first antibody, in the Reagent, is an acridinium ester labeled monoclonal mouse anti-human antibody specific to the N-terminal portion of BNP. The second antibody, in the Solid Phase Reagent, is a biotinylated monoclonal mouse anti-human antibody specific to the C-terminal portion of BNP, which is coupled to streptavidin coated magnetic particles. Patient sample (calibrators or control materials) is incubated for 5 minutes at 37°C with the Solid Phase Reagent and the tracer antibody conjugate. Subsequently, Solid Phase Reagent is added and incubated for 2.5 minutes at 37°C. An immuno-complex is formed between the unbound antibody conjugates are washed away. Following incubation, the immuno-complex signal is measured in a luminometer. The chemiluminescent signal will have a minimum amount of bound AE label, while Samples with high levels of BNP will have maximum label complex bound. Thus, a direct relationship exists between the amount of BNP present in the patient sample and the relative light units (RLUs) detected by the system.

Here's an analysis of the provided text regarding the Bayer Diagnostics ADVIA Centaur BNP Assay, broken down by your requested criteria:

The provided document is a Summary of Safety and Effectiveness for the Bayer Diagnostics ADVIA Centaur BNP Assay and ACS:180 BNP Assay, primarily focusing on its updated indications for use and substantial equivalence to previously cleared devices. It describes the technological and performance characteristics but does not contain detailed study results like typical acceptance criteria tables for accuracy or precision studies against a defined benchmark. Instead, it states that the characteristics (like precision, measuring range, analytical sensitivity, etc.) are "Same" as the predicate device.

Therefore, for aspects like "reported device performance" against acceptance criteria, "sample sizes used for the test set," "number of experts," "adjudication method," "MRMC study effect size," and "standalone performance," the provided document does not contain this information. It relies on the previously cleared predicate devices for establishing performance equivalency without re-presenting the detailed studies.

Here's what can be extracted based on the information available:

1. A table of acceptance criteria and the reported device performance

The provided document does not explicitly present a table of acceptance criteria with corresponding device performance from new studies following the format typically seen for a new device's primary validation. Instead, it compares the proposed device's characteristics to a predicate device, largely stating they are "Same."

However, we can infer some "performance characteristics" that are deemed acceptable by virtue of being equivalent to the predicate.

The study that "proves the device meets the acceptance criteria" is implicitly the previous 510(k) clearances for the predicate devices (K031038 and K040425). The current submission (K043228) relies on substantial equivalence to these predicate devices for its performance characteristics. The document explicitly states: "The Bayer B-type Natriuretic Peptide (BNP) assays on the ACS:180® and ADVIA Centaur® are substantially equivalent to ADVIA Centaur® BNP assay." And for the technological and performance tables, it consistently lists "Same" for the proposed device's characteristics when compared to the current (predicate) one.

2. Sample size used for the test set and the data provenance

• Sample size: Not specified in the provided document for the current submission's validation. The document states "Same" for all performance characteristics, implying reliance on the studies for the predicate devices (K031038 and K040425).
• Data provenance: Not specified in the provided document. As the submission relies on substantial equivalence to predicate devices, the original data provenance would be from those prior submissions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document as it focuses on an in vitro diagnostic assay, not an imaging device requiring expert interpretation for ground truth.

4. Adjudication method for the test set

This information is not provided as it is not relevant to this type of IVD device submission.

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

This information is not provided. This type of study (MRMC for AI assistance) is not applicable to an in vitro diagnostic assay like a BNP test.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is an in vitro diagnostic assay. Its performance is inherently standalone in the sense that it measures BNP levels from a sample without human interpretive assistance for the measurement itself. The results are then used by clinicians. The performance characteristics described (precision, sensitivity, range, etc.) are its standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For an in vitro diagnostic assay like BNP, the "ground truth" for accuracy and calibration would typically be established against:

• A reference standard system (e.g., highly pure synthetic human BNP (amino acid 77 to 108) as mentioned for traceability).
• Known concentrations of analytes (for linearity, sensitivity verification).
• Clinical correlation (for assessing diagnostic utility against patient outcomes or established clinical diagnoses, such as heart failure diagnosis confirmed by other clinical methods or follow-up).
  The document mentions "Reference standard - synthetic human BNP (amino acid 77 to 108) in buffer based matrix" for traceability.

8. The sample size for the training set

This information is not provided. Given that this is an immunoassay and the submission is for substantial equivalence, the concept of a "training set" in the context of machine learning/AI (which your question implies) is not applicable here. The assay development would involve extensive analytical validation, but not typically a machine learning "training set."

9. How the ground truth for the training set was established

As above, the concept of a "training set" for AI is not applicable to this immunoassay. The ground truth for analytical validation (e.g., establishing accurate measurement, precision) is based on reference materials, calibrators, and controlled experimental conditions.

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