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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 PBNP CAL is an in vitro diagnostic product for the calibration of the N-Terminal Pro-Brain Natriuretic Peptide (PBNP) method for the Dimension Vista® System.

The PBNP method is a one-step sandwich chemiluminescent immunoassay based on LOCI® technology. LOCI® reagents include two synthetic bead reagents and a biotinylated monoclonal 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/NT-proBNP/biotiny|ated antibody sandwich. Sensibeads then are added and bind to the biotin 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 Nterminal pro-brain natriuretic peptide in bovine albumin matrix with stabilizers and preservative. The kit consists of ten vials, two vials per level (A, B, C, D, and E), 1.0 mL per vial.

The provided 510(k) summary describes a re-submission for the Siemens Healthcare Diagnostics Inc. Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide (PBNP) Flex® Reagent Cartridge and Calibrator (K080578). This submission claims substantial equivalence to a previously cleared device (K061795). Therefore, the "acceptance criteria" and "device performance" are primarily focused on demonstrating this substantial equivalence, rather than establishing new performance benchmarks for a novel device.

The document indicates that comparative testing was performed, but it does not provide the specific quantitative results of this testing. Instead, it lists the features of the new device and the predicate device, highlighting their similarities and differences. The conclusion states that "Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance." However, the details of that protocol and its specific results are not included in the provided text.

Here's an attempt to answer the questions based only on the provided information, noting where details are explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implied to be that the new device's performance is comparable to the predicate device's performance across the listed features. The "reported device performance" is the specification of the current device.

Note on Differences: The primary differences noted between the new device and the predicate device are:

• Antibody type: The new device uses a monoclonal sheep antibody, while the predicate used a polyclonal sheep antibody.
• Calibrator Volume & Levels: The new calibrator has 10 vials (5 levels) compared to the predicate's 12 vials (6 levels) and the specific levels differ.
• Hemoglobin Interference Limit: The new device tolerates higher hemoglobin levels (1000 mg/dL) than the predicate (680 mg/dL).

The submission argues that despite these differences, "Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance." The specific quantitative results of this comparative testing are not provided in the summary.

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance."

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

This information is not applicable and not provided. This device is an in vitro diagnostic assay for biomarker measurement, not an imaging AI device that would typically rely on expert human interpretation for ground truth. Ground truth for such a device would involve reference methods or confirmed clinical states.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As explained in point 3, the concept of "adjudication" by experts for image interpretation is not relevant here.

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 applicable and not provided. This is an in vitro diagnostic (IVD) assay for measuring a biomarker, not an AI-powered diagnostic imaging tool intended to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

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

Yes, the device operates as a standalone algorithm/assay. The method describes a "one-step sandwich chemiluminescent immunoassay" that quantitatively measures NT-proBNP. This is a laboratory-based test where the result is generated directly by the instrument based on the sample, without human interpretative input in the measurement itself, other than proper sample handling and instrument operation.

7. The Type of Ground Truth Used

The "ground truth" for an IVD device like this typically refers to a reference method or a definitively established clinical state. While the document doesn't explicitly state the "type of ground truth used" for the comparative testing, for a quantitative assay measuring a biomarker, it would generally involve:

• Reference method/Comparative method: Comparing the device's results against a gold standard method or another established, cleared method for NT-proBNP measurement.
• Clinical correlation: Demonstrating the assay's ability to differentiate between patient populations (e.g., CHF vs. non-CHF, or different severities of CHF) based on established clinical diagnostic criteria or outcomes data, as implied by its intended use "as an aid in the diagnosis and assessment of severity" and "risk stratification."

The specific details of how the ground truth was established for the comparative performance study are not provided in this summary.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is a biomarker assay based on immunoassay technology, not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" of an immunoassay system involves calibration and optimization of reagents and instrument parameters, rather than a data-driven machine learning process.

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

This information is not applicable and not provided, for the same reasons as in point 8.

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