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The Optilite Low Level Albumin Kit is intended for the quantitative in vitro measurement of albumin in CSF, urine and serum using the Binding Site Optilite analyser to aid in the diagnosis of kidney and intestinal diseases. This test should be used in conjunction with other laboratory and clinical findings.

The Optilite Low Level Albumin Kit is comprised of the following reagents: Antiserum, Calibrator and Controls, and Reaction Buffer. In Optilite kits, the antiserum reagent and reaction buffer are supplied in a single wedge with a chamber for each fluid. They are therefore labelled as a single component Optilite LLAlb Reagent. The Antigen Excess Control does not have an assigned value.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Sizes Used for Test Set and Data Provenance:

   • Precision Study: 5 sample preparations for each matrix (CSF, Urine, Serum) were tested. Each preparation was tested 2 runs per day (each run in duplicate) over 21 days, using 3 analysers. This amounts to 5 samples * 2 runs/day * 2 duplicates/run * 21 days = 420 measurements per sample preparation across all analysers, and 5 samples * 3 analysers = 15 sample preparations across all analysers. The tables specify 'N=84' for each sample number, which likely represents the total number of individual results for a particular sample preparation across the entire study.
   • Linearity Study: A dilution series comprising a high pool and low pool for each sample matrix (CSF, Urine, Serum) was tested. Each dilution was tested in 3 replicates. The exact number of samples in the dilution series is not specified.
   • Analytical Specificity (Interference) Study: Samples for each sample matrix (CSF, Urine, Serum) were spiked with interfering substances and tested. The number of samples for each matrix is not specified.
   • Method Comparison Study:
     • CSF: 166 samples
     • Urine: 191 samples
     • Serum: 142 samples
   • Expected Values/Reference Range Verification: 50 adult donor samples for urine and 50 for serum were tested.
   • Data Provenance: Not explicitly stated whether retrospective or prospective, or country of origin. However, the study involved testing of samples, suggesting prospective testing or using banked samples. The applicant is "The Binding Site Ltd." in the UK, so data may originate from there.

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

   • This is an in vitro diagnostic (IVD) device designed for quantitative measurement of albumin. Ground truth is established by analytical methods and reference standards, not by expert interpretation in the same way as imaging or pathology devices.
   • The calibration of the assay is traceable to ERM DA470k/IFCC, which is an international reference material, serving as the "ground truth" for quantitative accuracy.

3. Adjudication Method for the Test Set:

   • Not applicable in the context of this IVD device. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of data where consensus among experts is needed to establish ground truth (e.g., classifying medical images). For quantitative measurements, the ground truth is established through metrological traceability to reference standards.

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

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices that assist human readers (e.g., AI for radiology), not for standalone quantitative IVD tests.

5. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

   • Yes, the performance characteristics presented (precision, linearity, analytical specificity, detection limit) are for the standalone device/algorithm (Optilite® Low Level Albumin Kit used with the Optilite Analyser). The device provides a quantitative measurement directly. While the indication for use states it should be used in conjunction with other laboratory and clinical findings, the performance data provided is purely instrumental.

6. Type of Ground Truth Used:

   • Reference Standards and Analytical Methods:
     • Calibration is traceable to ERM DA470k/IFCC.
     • Analytical performance studies (precision, linearity, detection limits) rely on well-defined statistical methods (e.g., CLSI EP5-A2, EP6-A, EP17-A) using known concentrations or carefully prepared samples.
     • Method comparison was done against a legally marketed predicate device, indicating its measurements serve as a comparative reference.

7. Sample Size for the Training Set:

   • This is an IVD device and not an AI/machine learning algorithm that requires a separate "training set" in the conventional sense. The development of such assays involves reagent formulation, optimization, and extensive analytical validation. The term "training set" is not applicable here as it would be for AI models.

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

   • Not applicable as there is no "training set" in the AI/ML sense. The "ground truth" for developing and validating such an assay comes from established laboratory principles, reference methods, and internationally recognized standards (like ERM DA470k/IFCC).

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