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Reagent:

HDL reagent, when used in conjunction with SYNCHRON LX® System(s) and SYNCHRON® Systems Lipid Plus Calibrator, is intended for the quantitative determination of HDL Cholesterol (HDL) in the high density lipoprotein (HDL) fraction of human serum or plasma.

HDL reagent, when used in conjunction with SYNCHRON CX® CE/DELTA/PRO System(s) and SYNCHRON® Systems Lipid Plus Calibrator, is intended for the quantitative determination of HDL Cholesterol (HDL) in the high density lipoprotein (HDL) fraction of human serum or plasma.

Calibrator:

The SYNCHRON® Systems Lipid Plus Calibrator 1& 2, in conjunction with specified assays on the SYNCHRON® Systems, are intended to provide points of reference in the measurement of selected human lipids and proteins.

Reagent:

The SYNCHRON LX® and CX® CE/DELTA/PRO System(s) HDL reagent is designed for optimal performance on the SYNCHRON LX® and CX® CE/DELTA/PRO System(s). The reagent kit contains two 200-test cartridges that are packaged separately from the associated calibrators.

Calibrator:

The SYNCHRON® Systems Lipid Plus Calibrator set is a two level readyto-use human serum-based liquid calibrator set manufactured by Beckman Coulter, Inc. Each kit contains 1 X 3 mL bottles of each level of calibrator (identified as Level 1 and Level 2).

This document describes the SYNCHRON® Systems HDL Cholesterol (HDL) Reagent and SYNCHRON® Systems Lipid Plus Calibrators 1 & 2.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds in the typical sense for a diagnostic device algorithm. Instead, it presents performance data to demonstrate substantial equivalence to a predicate device. The performance is assessed through method comparison and imprecision studies.

Since the device is a reagent and calibrator for laboratory analysis, the "acceptance criteria" are implicitly met when the performance data shows comparable results to the predicate device and within expected analytical ranges for such tests. For this type of device, the correlation (r-value) in method comparison and precision (CV%) are key indicators of performance.

Implicit Acceptance Criteria and Reported Performance for SYNCHRON® Systems HDL Reagent:

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

• Test Set (Method Comparison): n = 79 samples were used for the method comparison study conducted on both the SYNCHRON CX and SYNCHRON LX instruments.
• Test Set (Imprecision/Precision):
  • For SYNCHRON CX: n = 80 for each of the three levels (Level 1, Level 2, Level 3) for both within-run and total imprecision.
  • For SYNCHRON LX: n = 80 for each of the three levels (Level 1, Level 2, Level 3) for both within-run and total imprecision.
• Data Provenance: The document does not specify the country of origin of the data. It appears to be from internal studies conducted by Beckman Coulter, Inc., as part of their 510(k) submission. The data is retrospective in the sense that it was collected prior to submission for regulatory clearance, but it is generated specifically for this filing.

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

This product is a chemical reagent and calibrator, not an AI or imaging device that requires interpretation by experts to establish ground truth.

• Ground Truth: For method comparison, the "ground truth" and reference method is the predicate device, SYNCHRON HDLD. Its measurements are used as the reference against which the new device's measurements are compared. The accuracy of the predicate device's measurements is assumed/established through its own validation and regulatory clearance.
• No Experts: Therefore, no human experts were involved in establishing "ground truth" for the test set in the way you might for an AI diagnostic device (e.g., radiologists reviewing images). The ground truth is analytical measurement against a validated reference method.

4. Adjudication Method for the Test Set:

Not applicable. As explained in point 3, this is a chemical assay, not an interpretive task requiring expert adjudication. The comparison is quantitative to a reference method.

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

Not applicable. This is a chemical reagent and calibrator, not an AI or imaging diagnostic device that would involve human readers. Therefore, an MRMC study and effect size of human improvement with AI assistance are not relevant to this type of product.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This device is a reagent and calibrator used on an automated instrument (SYNCHRON LX and CX systems). Its performance is inherently "standalone" in the sense that the instrument processes the sample and measures the HDL cholesterol concentration without human interpretation of the raw signal to determine the result. The human element is in operating the instrument, loading samples, and reviewing the final numerical result. The performance data presented (method comparison, imprecision) reflects the standalone analytical performance of the reagent/calibrator/instrument system.

7. Type of Ground Truth Used:

The ground truth used for the method comparison study is the analytical measurement obtained from the predicate device (SYNCHRON HDLD). This implicitly relies on the established accuracy and precision of the predicate device. For imprecision studies, the ground truth is the mean value of the repeated measurements for each sample level.

8. Sample Size for the Training Set:

This document describes a chemical reagent and calibrator, not a machine learning or AI model that requires a "training set" in the context of algorithm development. The development process for such a product involves formulation, optimization, and rigorous testing, but not "training data" in the AI sense.

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

Not applicable, as there is no "training set" for this type of product. The "ground truth" for the development and validation of such a chemical assay involves established analytical chemistry principles, reference materials, accuracy assessments against recognized methods (e.g., CDC reference methods, if applicable), and internal quality control processes.

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