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HiChem Cholesterol Reagent is intended for the quantitative determination of total cholesterol in serum and plasma for the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Device Description

The HiChem Cholesterol Reagent determines cholesterol through the enzymatic action of cholesterol esterase, cholesterol oxidase and peroxidase. The resulting increase in absorbance at one of interested estable concessed on concentration in the sample.

AI/ML Overview

Here's an analysis of the acceptance criteria and the studies performed for the HiChem Cholesterol Reagent, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes two scenarios: the HiChem Cholesterol Reagent as a manual procedure and the HiChem Cholesterol Reagent used as a secondary reagent on Beckman® SYNCHRON CX® Systems. The acceptance criteria are largely implied by the reported performance figures, as specific pre-defined thresholds aren't explicitly stated as "acceptance criteria." However, the comparisons to the predicate device and specified ranges (e.g., linearity) serve as the de facto criteria.

Scenario 1: HiChem Cholesterol Reagent (Manual Procedure)

Metric	Acceptance Criteria (Implied)	Reported Device Performance
Linearity	Performance should be linear from 5 mg/dL to 750 mg/dL.	Linear from 5 mg/dL to 750 mg/dL. Regression: (HiChem Recoveries) = 3.7 mg/dL + 0.975 × (Standard Factors), r² = 1.000 Sv.x = 4.11 mg/dL. df = 11
Precision (Within-run)	Not explicitly stated, but expected to be low for control sera.	Serum control 1 (109 mg/dL): 0.85 mg/dL Serum control 2 (226 mg/dL): 1.46 mg/dL Serum control 3 (501 mg/dL): 3.12 mg/dL
Precision (Total)	Not explicitly stated, but expected to be low for control sera.	Serum control 1 (109 mg/dL): 0.92 mg/dL Serum control 2 (226 mg/dL): 1.90 mg/dL Serum control 3 (501 mg/dL): 4.47 mg/dL
Method Comparison	Results should be equivalent to the Beckman® Cholesterol Reagent.	(HiChem Results) = 12 mg/dL + 0.957 × (Beckman® Results) r² = 0.966 S(y.x) = 8.1
Anticoagulant Interference	Bias due to additives should be minimal.	Bias < 2.5 mg/dL cholesterol.
Detection Limit	Claimed limit of 5 mg/dL should be met or exceeded.	Observed detection limit: 3.2 mg/dL (below claimed 5 mg/dL).

Scenario 2: HiChem Cholesterol Reagent on Beckman® SYNCHRON CX® Systems

Metric	Acceptance Criteria (Implied)	Reported Device Performance
Linearity	Performance should be linear from 5 mg/dL to 750 mg/dL.	Linear from 5 mg/dL to 750 mg/dL. Regression: (HiChem Recoveries) = -1.0 mg/dL + 0.964 × (Standard Factors), sv.x = 8.9 ma/dL. df = 11
Precision (Within-run)	Not explicitly stated, but expected to be low for control sera.	Serum control 1 (105 mg/dL): 1.8 mg/dL Serum control 2 (217 mg/dL): 1.2 mg/dL Serum control 3 (504 mg/dL): 2.8 mg/dL
Precision (Total)	Not explicitly stated, but expected to be low for control sera.	Serum control 1 (105 mg/dL): 1.4 mg/dL Serum control 2 (217 mg/dL): 2.5 mg/dL Serum control 3 (504 mg/dL): 2.5 mg/dL
Method Comparison	Results should be equivalent to the Beckman® CHOL Reagents.	(HiChem Results) = -3.6 mg/dL + 0.993 x (Beckman® Results) r² = 0.983 S(y.x) = 6.1
Anticoagulant Interference	Bias due to additives should be minimal.	Bias < 1 mg/dL cholesterol and statistically insignificant.
Detection Limit	Claimed limit of 5 mg/dL should be met or exceeded.	Observed detection limit: 2.7 mg/dL (below claimed 5 mg/dL).
Calibration Stability	Changes in recoveries over 14 days < 2.6% (and < 3% manufacturer's precision claim).	Changes < 2.6% over 14 days.
Reagent Stability	Changes in recoveries over 30 days < 2.6% (and < 3% manufacturer's precision claim).	Changes < 2.6% over 30 days.

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

Manual Procedure Test Set:
- Linearity Standards: 12 points (df=11, representing n=12 measurements or independent standards).
- Precision Control Sera:
  - Serum control 1: n = 29 replicates
  - Serum control 2: n = 30 replicates
  - Serum control 3: n = 30 replicates
- Method Comparison (Serum/Plasma): 113 mixed serum and plasma specimens.
- Anticoagulant Interference: Spiked and unspiked serum pools (number not specified).
- Detection Limit: Repetitive assay of a cholesterol standard (number of replicates not specified, but sufficient to calculate 3 standard deviations).
Beckman® SYNCHRON CX® Systems Test Set:
- Linearity Standards: 12 points (df=11, representing n=12 measurements or independent standards).
- Precision Control Sera:
  - Serum control 1: n = 60 replicates
  - Serum control 2: n = 60 replicates
  - Serum control 3: n = 60 replicates
- Method Comparison (Serum/Plasma): 154 mixed serum and plasma specimens.
- Anticoagulant Interference: Spiked and unspiked serum pools (number not specified).
- Detection Limit: 30 replicate study of a cholesterol standard.
- Stability Studies: Serum controls assayed over claimed periods (number of controls and frequency not specified).
Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective as they are designed experiments to test the performance of the HiChem reagent under controlled conditions, rather than analysis of pre-existing clinical data.

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

This type of information is not applicable to this device. The HiChem Cholesterol Reagent is an in vitro diagnostic (IVD) reagent intended for quantitative determination of a chemical analyte (cholesterol). The "ground truth" for linearity, precision, and agreement with a predicate device is established through:

Controlled standards with known concentrations.
Reference methods or predicate devices (Beckman® SYNCHRON® Systems Cholesterol Reagent).
Statistical analysis of repeated measurements.

There are no human experts "establishing ground truth" in the way one might for image analysis or disease diagnosis.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the assessment involves comparing numerical results to established standards or a predicate device, not subjective interpretation requiring adjudication among experts.

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

Not applicable. This device is an IVD reagent, not an AI-assisted diagnostic tool that would involve human readers interpreting results.

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

The studies conducted for the HiChem Cholesterol Reagent can be considered standalone in the sense that they evaluate the performance of the reagent (and the associated analytical system) without human interpretation of the results to establish a diagnosis. The "human-in-the-loop" aspect here is the laboratory technician performing the test or operating the analyzer, but their role is instrumental, not interpretive in establishing the final quantitative value. The performance metrics (linearity, precision, correlation) are direct outputs of the device system.

7. The Type of Ground Truth Used

The ground truth used in these studies consists of:

Known concentrations of linearity standards: For linearity studies.
Reference measurements from the predicate device (Beckman® SYNCHRON® Systems Cholesterol Reagent): For method comparison studies.
Expected values of commercially available control sera: For precision and stability studies.
Spiked samples with known additive concentrations: For anticoagulant interference studies.
Statistical determination from repeated measurements: For detection limit.

8. The Sample Size for the Training Set

Not applicable. This device is a chemical reagent and an enzymatic assay, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithm development. The performance characteristics are inherent to the chemical reactions and analytical methods.

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

Not applicable (as it's not an AI/ML device). If considering the development and optimization of the reagent itself, the "ground truth" for developing the formulation would have been established through iterative biochemical testing and optimization against known cholesterol standards and samples, similar to how the performance is validated.

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