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The PBNP method is an in vitro diagnostic assay for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum and plasma on the Dimension Vista™ System. In individuals suspected of having congestive heart failure (CHF) measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure.

The Dimension Vista™ NT-proBNP (PBNP) calibrator is an in vitro diagnostic product for the calibration of the N-terminal pro-brain natriuretic peptide (PBNP) method on the Dimension Vista™ System.

The PBNP method is a one-step sandwich chemiluminescent immunoassay based on Luminescent Oxygen Channeling Immunoassay (LOCI™) technology. LOCI™ reagents include two latex bead reagents and a biotinylated polyclonal antibody fragment which recognize an epitope located in the N-terminal part of proBNP. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. The second bead reagent (Chemibeads) is coated with a second antibody specific for a second independent epitope on NT-proBNP and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a particle/NTproBNP/biotinylated antibody sandwich. Sensibeads then are added and bind to form a bead-aggregated immunocomplex. Illumination of the complex by light at 680 nm generates singlet oxygen from Sensibeads, which diffuses to the Chemibeads and triggers a chemiluminescent reaction. The resulting chemiluminescent signal is measured at 612 nm and is directly proportional to the concentration of NT-proBNP in the sample.

The PBNP Calibrator is a frozen liquid product containing synthetic human N-terminal pro-brain natriuretic peptide in a bovine albumin matrix with stabilizers and preservative. The kit consists of eight vials, two each of four levels (A, B, C, and D), 1.0 mL per vial for levels A, C, and D and 1.5 mL per vial for level B.

The provided text describes a 510(k) premarket notification for a medical device, the Dimension Vista™ PBNP reagent cartridge and calibrator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with explicit statistical results.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, ground truth for training set) are not present in this type of summary document, as the focus is on comparative performance against an already approved device rather than establishing de novo performance against a predefined independent standard.

However, based on the information available, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on demonstrating "substantial equivalence" to the predicate device, the Roche Diagnostics Elecsys® proBNP immunoassay and proBNP CalSet Calibrator (K032646/K022516). The "reported device performance" are the features and characteristics of the new device that are compared to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Comparative data for human secure and plasma samples demonstrate good analytical and clinical agreement between the r nethods." However, specific sample sizes for the test set and data provenance (e.g., country of origin, retrospective/prospective) are not provided in this summary. This information would typically be in a more detailed study report.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided as this is an in vitro diagnostic device for quantitative measurement, and the "ground truth" for its performance is typically established through analytical studies (e.g., linearity, precision, interference) rather than expert interpretation of images or clinical cases in the same way a diagnostic imaging AI might require. The "ground truth" for NT-proBNP levels would be the actual concentration of the analyte, typically determined by reference methods or gravimetric preparation for spiked samples.

4. Adjudication Method for the Test Set

This is not applicable/not provided given the nature of the device as an in vitro diagnostic assay directly measuring an analyte. Adjudication methods are typically used in studies involving human interpretation or clinical endpoint assessments, not for analytical performance of a biochemical assay.

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 is not applicable. The device is an in vitro diagnostic assay, not an AI system designed to assist human readers (e.g., radiologists interpreting images). Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is implicitly the primary performance claim. The device (Dimension Vista™ PBNP method) is a standalone in vitro diagnostic assay. Its performance is measured directly by its analytical characteristics (sensitivity, specificity, linearity, precision, interference, etc.) in quantifying NT-proBNP. The entire submission focuses on the standalone performance of this assay in comparison to the predicate.

7. The Type of Ground Truth Used

For analytical performance (e.g., precision, linearity, interference), the ground truth is established by:

• Known concentrations of NT-proBNP in prepared samples (e.g., spiked samples, calibrator materials).
• Reference methods or comparison to established, legally marketed devices (the predicate in this case) for patient samples.
• Clinical outcomes for the intended use in diagnosis and risk stratification (though the summary states "good analytical and clinical agreement," specific clinical outcome data or its use as ground truth is not detailed here for the studies presented).

8. The Sample Size for the Training Set

This information is not provided in the 510(k) summary. For biochemical assays, a "training set" might refer to samples used during assay development and optimization, but specific sizes are not typically reported in this type of regulatory document unless it's a machine learning algorithm. The closest equivalent might be the samples used to establish analytical performance characteristics.

9. How the Ground Truth for the Training Set Was Established

This information is not provided. As above, for biochemical assays, "ground truth" during development would be based on known concentrations of the analyte or reliable reference methods.

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