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The APOLOWAKO T-CHO is for the quantitative determination on the APOLOWAKO analyzer of total cholesterol in whole blood. The APOLOWAKO HDL-C is for the quantitative determination on the APOLOWAKO analyzer of HDL cholesterol in whole blood. The APOLOWAKO TG is for the quantitative determination on the APOLOWAKO analyzer of triglycerides in whole blood. In conjunction with the above values, the APOLOWAKO analyzer also calculates LDL cholesterol for triglyceride values up to 400 mg/dL and T-CHO/HDL-C ratio.

APOLOWAKO Analyzer is a discrete photometric chemistry analyzer for clinical use in both central laboratories and in point of care sites. The device is intended to duplicate manual analytical procedures by automatically performing various steps such as pipetting, mixing and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in whole blood samples.

The measurements of total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol (by calculation for triglyceride values up to 400 mg/dL) when used in conjunction with other biochemical markers and coronary risk factors, is useful in the prediction of CHD/CVD risk and the assessment of CHD/CVD severity.

The APOLOWAKO analyzer is a fully-integrated POC test system that can perform up to six analytical tests per individual sample. The analyzer automatically separates plasma from whole blood for testing. Once the plasma has been separated, it is transferred to a cell on a measurement disk where the chemical reactions take place. The analyzer uses liquid reagents which are packaged into kits. Each kit contains 2 reagent units. Each unit is composed of two enzyme color reagents and a lyophilized calibrator. All of the reagents have a reagent information tag applied to the back of each bottle which controls the reagent parameters and conditions such as, calibration, reagent quantity, shelf-life, and lot number. The instrument contains an automated liquid dispenser, temperature controlled reagent carrousel, analysis compartment, and sample holder. The instrument is designed to automatically and constantly monitor the reagents, dispensing system, measurement disk, and measurement process to ensure that no erroneous results are shown. The APOLOWAKO's lipid panel will include, total cholesterol, HDL cholesterol, LDL cholesterol (by calculation), and triglycerides in tubed venous whole blood. The test system is designed for professional use and consists of a small table top instrument (31 cm wide x 47.5 cm high x 56 cm deep, weight: 25 kg).

The provided text describes the Wako Diagnostics APOLOWAKO Lipid Panel and Analyzer, a point-of-care test system designed for the quantitative determination of total cholesterol, HDL cholesterol, and triglycerides in whole blood, with calculated LDL cholesterol. The device aims for substantial equivalence to the CHOLESTECH LDX system.

Here's an analysis of the acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a separate section. Instead, the performance characteristics (imprecision, linearity, interference) of the APOLOWAKO system are compared against or shown to be superior to those of the predicate device (Cholestech LDX) and demonstrate acceptable analytical performance. The substantial equivalence conclusion is based on comparable or better performance characteristics.

2. Sample size used for the test set and the data provenance:

• Sample Size (Clinical Data/Method Comparison): 388 samples for Total Cholesterol and Triglycerides. 384 samples for HDL-cholesterol (4 samples out of detectable range).
• Data Provenance: Not explicitly stated, but the study refers to "rigorous conditions sufficient to meet the requirements for CLIA Waiver," which implies a clinical setting. No specific country of origin is mentioned. The study appears to be prospective as it's for premarket notification of a new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable. The ground truth for the method comparison study was established by FDA-cleared comparison (reference) methods, not by expert consensus on image interpretation or similar qualitative assessments.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. The evaluation relies on quantitative measurements against reference methods, not subjective adjudication of results.

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:

• MRMC Study: No. This is a diagnostic device for quantitative chemical analysis, not an imaging or qualitative assessment device that would typically involve human readers or AI assistance in interpretation in the context of an MRMC study.

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

• Standalone Performance: Yes, the device's performance as a standalone analytical instrument is demonstrated through the non-clinical (imprecision, linearity, interference) and clinical (method comparison) studies. It performs the measurements and calculations independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Ground Truth: For the clinical data (method comparison study), the ground truth was established by FDA-cleared comparison methods (reference methods) for total cholesterol, triglycerides, and HDL-cholesterol.

8. The sample size for the training set:

• Training Set Sample Size: Not explicitly mentioned. For this type of chemical analyzer, the "training" (calibration and initial validation of reagents) is inherent in the design and manufacturing process, and performance is demonstrated through studies on defined analytical controls and clinical samples. It's not a machine learning model with a distinct "training set" in the traditional sense. Calibration is performed when the reagent is opened.

9. How the ground truth for the training set was established:

• Ground Truth for Training Set: The document mentions "lyophilized calibrator" included in each reagent unit. This calibrator, traceable to recognized standards, would establish the ground truth for the calibration process and ensure accurate measurement by the device. The methodology is enzyme-based colorimetric, requiring calibration against known concentrations.

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