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Establishment of reference curves for the immunochemical determination of human lipoprotein(a) [Lp(a)] in serum or plasma with BN™ Systems.

N L.p(a) Standard SY is a lyophilized standard prepared from human serum with stabilizers and preservative. It is intended to establish reference curves for the olublizative determination of human lipoprotein(a) [Lp(a)] by immunochemical with BN™ Systems.

The provided text describes a 510(k) premarket notification for a medical device called "N Lp(a) Standard SY," which is a calibrator for determining human lipoprotein(a) [Lp(a)] levels. The document primarily focuses on the device's classification, intended use, and substantial equivalence to a predicate device.

Unfortunately, the provided text does not contain information about acceptance criteria, detailed study designs, sample sizes for test or training sets, ground truth establishment, or expert involvement in a way that would allow for a comprehensive response to all the requested points.

Here's a breakdown of what can be extracted and what is missing, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified in the provided text. The document refers to "Dade Behring protocols" for stability evaluation but does not detail the data source (country, retrospective/prospective).

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

• This device is a calibrator, not an imaging or diagnostic algorithm that relies on expert interpretation of results for ground truth. Therefore, the concept of "experts establishing ground truth" in the traditional sense for a test set is not directly applicable here. The ground truth for a calibrator would be its own certified value against a reference measurement. The document does not describe how this was established.

4. Adjudication Method for the Test Set

• Not applicable as the document does not describe a study involving adjudication of a test set by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not applicable. This device is a calibrator for an in vitro diagnostic test, not an AI or imaging device designed to assist human readers. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant to this product.

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

• Not applicable. This device is a biochemical calibrator, not an algorithm.

7. The Type of Ground Truth Used

• For a calibrator, the "ground truth" would be the assigned value of the calibrator itself, derived from a highly accurate reference method or standard. The document states it is "prepared from human serum." It's implied that the concentrations of Lp(a) in the calibrator are precisely known, but how this "truth" (i.e., the certified concentration values) was established is not detailed in the provided text. It mentions "immunochemical determination... with BN™ Systems" for its intended use, but not for the establishment of its own truth.

8. The Sample Size for the Training Set

• Not applicable / Not specified. As a calibrator, it doesn't typically involve a "training set" in the context of machine learning or complex algorithms. Product development might involve studies to optimize its formulation and stability, but these are not framed as "training sets."

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

• Not applicable / Not specified. (See point 8).

Summary of Missing Information:

The provided 510(k) summary focuses on regulatory aspects like device classification, intended use, and substantial equivalence. It provides minimal technical details about the performance studies beyond a high-level statement about stability testing conducted "according to Dade Behring protocols." It lacks the detailed scientific study information (e.g., specific study designs, raw data, statistical analyses, participant characteristics, and ground truth methodologies) that would be needed to fully answer your request. This level of detail is often present in supporting documentation submitted to the FDA but is usually summarized or omitted in the public-facing 510(k) summary.

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