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Immunoassay for the in vitro qualitative detection of antibodies to hepatitis C virus (HCV) in human adult and pediatric (ages 18 months through 21 years) serum and plasma (potassium EDTA, lithium heparin, sodium heparin, and sodium citrate). Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection. The test does not determine the state of infection or associated disease.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

Immunoassay for the in vitro qualitative detection of antibodies to hepatitis C virus (HCV) in human adult and pediatric (ages 18 months through 21 years) serum and plasma (potassium EDTA, lithium heparin, sodium heparin, and sodium citrate). Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection. The test does not determine the state of infection or associated disease.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
The Elecsys Anti-HCV II Immunoassay employs "ECLIA" technology and is a qualitative serologic, two step sandwich assay. The assay detects total antibodies to HCV in serum and plasma samples. The total duration of the assay is 18 minutes. The basic device methodology is as follows:

1. 1st incubation: 50 µL of sample, 55 µL of a reagent containing biotinylated HCV antigens, and 55 µL of a reagent containing HCV antigens labeled with a ruthenium complex react to form a sandwich complex.
2. 2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin.
3. The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission, which is measured by a photomultiplier.
4. Results are determined automatically by the Elecsys software by comparing the electrochemiluminescence signal obtained from the sample with the cut-off value obtained by the anti-HCV calibration.

The provided text is a 510(k) summary for the Elecsys Anti-HCV II immunoassay, which is an in vitro diagnostic device used to detect antibodies to the Hepatitis C Virus (HCV). This document describes the device's technical updates and demonstrates its substantial equivalence to a previously cleared predicate device.

Here's an analysis based on your request:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" with corresponding "reported device performance" in the format typically seen for AI/ML device studies where metrics like sensitivity, specificity, or AUC are compared against predefined thresholds.

Instead, for this immunoassay device, performance is evaluated through various analytical studies. The document states that "All predefined acceptance criteria was met for the precision experiments." This implies that there were acceptance criteria for precision (e.g., CV% limits for repeatability and intermediate imprecision), but the specific numerical criteria and achieved performance values are not detailed in this summary.

Similarly, for biotin interference, the acceptance criterion implicitly appears to be that "No biotin interference was observed up to 2520 ng/mL." The reported performance is that this criterion was met.

For the method comparison, the acceptance criteria would be for Positive Agreement (PPA) and Negative Agreement (NPA) and are implicitly stated to have been met by the conclusion that "The resulting data support the equivalence of the current non-biotin and biotin-updated assay." No specific thresholds or calculated agreement percentages are provided.

For stability, the acceptance criteria would relate to maintaining performance for the stated shelf-life (12 months), on-board stability (31 days), and calibration stability (1 month). The document states, "The stability studies and acceptance criteria have been reviewed and found to be acceptable. The stability data supports Roche Diagnostic's claims as reported in the package labeling."

Therefore, while acceptance criteria were in place and met, the specific quantitative values for both the criteria and the device's performance against them are not explicitly tabulated in this 510(k) summary.

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

• Precision Study: "The protocol consisted of testing 2 aliquots of each of controls and 5 human serum samples per run, 2 runs per day for 12 days."
  • This implies a total of (2 controls + 5 samples) * 2 aliquots/sample * 2 runs/day * 12 days = 336 measurements for the precision study, although the 'sample size' in terms of unique human serum samples is 5.
• Biotin Interference Study: "three serum samples (negative, low positive and moderate positive)" were used. Each sample was further divided and subjected to a "series of 17 dilution steps."
  • This indicates a sample size of 3 unique serum samples (negative, low positive, moderate positive), from which multiple measurements were taken across 17 dilutions.
• Method Comparison Study: "A total of 219 samples were measured."
• Data Provenance: The document does not specify the country of origin of the data. Given it's a Roche Diagnostics submission, the samples typically originate from multiple sites, often worldwide, but this is not stated. The studies are described as non-clinical/analytical studies, meaning they are laboratory evaluations of the device's performance characteristics rather than studies on patient outcomes in a clinical setting (which would determine retrospective or prospective). Therefore, the "retrospective or prospective" designation is not directly applicable in the same way it would be for a clinical trial. These are laboratory-based characterization studies.

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

This information is not applicable to this type of device and study. The Elecsys Anti-HCV II is an immunoassay designed to detect antibodies to HCV. The "ground truth" for this device's analytical performance (precision, interference, method comparison) is based on:

• Known concentrations/statuses of analytes: For precision, controls and spiked samples with known HCV antibody levels are used.
• Reference methods: For method comparison, it refers to "current Elecsys Anti-HCV II assay," which serves as the reference.
• Spiking experiments: For interference studies, known interfering substances (biotin) are spiked into samples.

There are no human experts "establishing ground truth" in the diagnostic interpretation sense for these analytical performance studies. The studies evaluate the device's ability to accurately measure or detect analytes under controlled laboratory conditions.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation by multiple readers (e.g., radiologists reviewing images) to resolve discrepancies and establish a consensus ground truth. For an immunoassay, the result is a quantitative or qualitative output from the instrument based on chemical reactions.

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

This information is not applicable. The Elecsys Anti-HCV II is an immunoassay, not an AI-powered diagnostic device that assists human readers in interpreting complex data like medical images. It directly measures bio-markers. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant to this device.

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

The device itself is a "standalone" system in the sense that the immunoassay analyzes the sample and provides a result (qualitative detection of HCV antibodies). There isn't an "algorithm only" performance study in the context of AI/ML, but rather the analytical performance of the entire assay system (reagents, analyzer, software) is evaluated. The studies described (precision, interference, method comparison, stability) demonstrate the standalone performance of the device.

7. The type of ground truth used

The ground truth used for these analytical studies is based on:

• Known states/concentrations: For precision and interference, this involves using certified reference materials, quality controls, and samples spiked with known concentrations of HCV antibodies or interfering substances.
• Predicate device's performance: For method comparison, the "current Elecsys Anti-HCV II assay" (the predicate device) serves as the reference standard against which the updated device's performance is compared to demonstrate equivalence.
• Expected assay behaviors: For stability, the ground truth is the expectation that the device should continue to perform within specified limits over time under various storage and operational conditions.

It is not based on expert consensus, pathology, or outcomes data, as those are typically relevant for clinical diagnostic accuracy studies or AI-driven image analysis.

8. The sample size for the training set

This information is not applicable. The Elecsys Anti-HCV II is a traditional immunoassay, not a machine learning or AI-driven device that requires a "training set" in the computational sense. The device's mechanism is based on established biochemical reactions (electrochemiluminescence immunoassay, ECLIA). Its performance characteristics are determined by the design and manufacturing of its components rather than by a model trained on a dataset.

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

This information is not applicable for the same reason as point 8. There is no training set for this type of device.

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