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The Lp(a)-Latex SEIKEN Assay kit is an in vitro diagnostic test for the quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma samples with Hitachi 917 analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.

The Lp(a)-Latex SEIKEN Assay Kit is a latex in vitro diagnostic immunoassay for the quantitative determination of Lipoprotein (a) in human serum and plasma. Antigen in the sample binds to the specific anti-Lp(a) antibody, which has been adsorbed to latex particles, and agglutinates. The agglutination is detected as an absorbance change when read on Hitachi 917 analyzer, with the magnitude of the change being proportional to the quantity of Lp(a) in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentrations.

Here's a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for correlation coefficient, sensitivity, or precision. Instead, it presents the results of the performance studies and concludes that these findings demonstrate the device's "robustness and substantial equivalence to the predicate device."

However, we can infer the implied acceptance criteria from the reported performance, which demonstrates that the device's performance is acceptable for its intended use, especially in comparison to the predicate device.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: 105 donor samples were used for the comparative performance studies.
• Data Provenance: The document does not specify the country of origin for the donor samples. It is also not explicitly stated whether the data was retrospective or prospective. Given the context of a 510(k) summary, it's typically retrospective analysis of collected samples, but this is not definitively stated.

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

This information is not provided in the document. The study compares the performance of the new device against a legally marketed predicate device (SPQ Test System Antibody Reagent Set for Lp(a)), which is assumed to provide the "ground truth" for comparison in terms of its established values. There is no mention of experts establishing a separate ground truth for the test set.

4. Adjudication Method for the Test Set

Not applicable. The study is a comparison of two diagnostic assays, not a subjective assessment requiring adjudication. The predicate device's results are used as the reference.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The device is an in vitro diagnostic assay, not an imaging or clinical assessment device that would typically involve multiple human readers.

6. Standalone Performance Study

Yes, a standalone performance study was done for the Lp(a)-Latex SEIKEN Assay. This included:

• Precision studies: Using medium and high control materials.
• Lower level of detection (sensitivity) and assay range determination.

While this "standalone" performance is compared to the predicate, it doesn't involve human interpretation that would be "human-in-the-loop" in the sense of AI-assisted systems.

7. Type of Ground Truth Used

The ground truth for the comparative study was the measurements obtained from the legally marketed predicate device (SPQ Test System Antibody Reagent Set for Lp(a)). The document states, "The Lp(a)-Latex SEIKEN Assay and the predicate device... have only minor difference that do not affect the performance, safety or effectiveness of the measurement." This implies the predicate device's results are considered valid and serve as the reference.

8. Sample Size for the Training Set

This information is not provided. As the device is a latex in vitro diagnostic immunoassay and not an AI/machine learning algorithm, the concept of a "training set" as understood in AI development is not directly applicable. The assay is based on chemical reactions and optical detection, which do not typically involve data-driven training in the same way.

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

Not applicable, as there is no mention or indication of a training set as understood for AI/ML algorithms. The assay's mechanism is based on antigen-antibody binding.

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