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Dri-STAT® Enzymatic Bilirubin Reagent, in conjunction with the SYNCHRON® Systems Bilirubin Calibrator, is intended for use in the in vitro diagnostic determination of total bilirubin in human serum and plasma as a User Defined Reagent (UDR) application on SYNCHRON® Systems. Measurements of total bilirubin in serum and plasma are used in the diagnosis and treatment of liver, hemolytic, hematologic, and metabolic disorders, such as jaundice, biliary obstruction, hepatitis and cirrhosis.

Device Description

The Dri-STAT® Enzymatic Bilirubin Reagent may be used in conjunction with the SYNCHRON® Systems Bilirubin Calibrator on the family of SYNCHRON® Systems. The reagent kit contains two reagent bottles that are transferred into a Beckman Coulter User-Defined Cartridge.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implied by the performance characteristics demonstrated to be substantially equivalent to the predicate device. The document states: "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. A finding of substantial equivalence is demonstrated through method comparison, linearity, and imprecision experiments."

Therefore, the performance data presented from these experiments serve as the basis for demonstrating that the device meets the "acceptance criteria" of being substantially equivalent.

Performance Metric	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Dri-STAT® TBE Reagent on Synchron Systems)
Method Comparison	Strong correlation with predicate method	Slope: 1.031 (on Synchron LX), 1.004 (on Synchron CX)
Intercept: 0.016 (on Synchron LX), 0.004 (on Synchron CX)
R: 0.9997 (on both systems)
Linearity	Not explicitly stated, but implied by method comparison and analytical range.	Not explicitly detailed in the provided text.
Imprecision (Within-Run)	Low variability; acceptable %C.V. for clinical use	Serum Control 1: 0.7 mg/dL, 0.03 S.D., 4.8 %C.V. (N=80)
Serum Control 2: 4.0 mg/dL, 0.05 S.D., 1.1 %C.V. (N=80)
Serum Control 3: 7.3 mg/dL, 0.08 S.D., 1.1 %C.V. (N=80)
Human Pool: 19.7 mg/dL, 0.12 S.D., 0.6 %C.V. (N=80)
Imprecision (Total)	Low variability; acceptable %C.V. for clinical use	Serum Control 1: 0.7 mg/dL, 0.03 S.D., 4.8 %C.V. (N=80)
Serum Control 2: 4.0 mg/dL, 0.06 S.D., 1.4 %C.V. (N=80)
Serum Control 3: 7.3 mg/dL, 0.11 S.D., 1.5 %C.V. (N=80)
Human Pool: 19.7 mg/dL, 0.47 S.D., 2.4 %C.V. (N=80)

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

Sample Size for Test Set:
- For the method comparison studies, the sample size was 70 for both the Synchron LX System and the Synchron CX System.
- For the imprecision studies, the sample size was 80 for each of the four samples (Serum Control 1, Serum Control 2, Serum Control 3, Human Pool) in both within-run and total imprecision measurements.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It refers to "Human Pool" samples, implying clinical samples were used, but further details are not provided.

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. For in vitro diagnostic devices like the Dri-STAT® Enzymatic Bilirubin Reagent, ground truth is typically established through reference methods or highly accurate comparative assays, not through expert consensus on qualitative interpretation.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. Adjudication methods are typically used when subjective interpretations are involved, such as in image analysis or clinical diagnosis. For a quantitative chemical assay, the comparison is to a reference method or a predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices that involve human interpretation of results, especially in fields like radiology or pathology. The Dri-STAT® Enzymatic Bilirubin Reagent is a fully automated in vitro diagnostic assay, where human intervention is minimal in the measurement process itself.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance data presented (method comparison, linearity, imprecision) represents the standalone performance of the Dri-STAT® Enzymatic Bilirubin Reagent on the SYNCHRON® Systems. As an automated in vitro diagnostic test, the "algorithm only" performance is the core functionality being evaluated without human interpretation of the measurement output (beyond reading the numerical result).

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation in this context is established by the predicate device (Dri-STAT® Enzymatic Bilirubin Reagent on Cobas Fara) for the method comparison study. For imprecision, it's about the consistency of the assay itself. The comparison to the predicate device demonstrates that the new device measures bilirubin in a substantially equivalent manner, implying its results are "true" in relation to a well-established method.

8. The Sample Size for the Training Set

This document does not mention a training set. For classical in vitro diagnostic reagents like this one, there isn't typically a "training set" in the machine learning sense. The assay is developed and validated, and then its performance is characterized using test samples.

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

As no training set is mentioned or applicable in the provided context, this information is not available.

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