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Immunoassay for the in vitro quantitative determination of carcinoembryonic antigen (CEA) in human serum and plasma.

Measurements of CEA aid in the management of cancer patients by monitoring CEA concentrations.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.

The Elecsys® test principle is based on sandwich principle. Total duration of assay: 18 minutes (37° C).
• 1st incubation (9 minutes): Sample (30 µL), biotinylated monoclonal CEA-specific antibody (60 µL), and a monoclonal CEA-specific antibody labeled with a ruthenium complex (60 µL) react to form a sandwich complex.
• 2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (50 µL), the complex is bound to the solid phase via interaction of biotin and streptavidin.
• 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 (0.4 second read frame).
• Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.

The provided document is a 510(k) summary for the "Elecsys® CEA Assay," a device for the in vitro quantitative determination of carcinoembryonic antigen (CEA). The document focuses on demonstrating substantial equivalence to a predicate device (Enzymun-Test CEA Assay) rather than establishing specific acceptance criteria for a new device and proving its performance against these criteria through a dedicated study.

Therefore, much of the requested information regarding acceptance criteria, a standalone study to prove acceptance, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies is not explicitly stated in the document as it would be for a novel device undergoing a performance study.

However, I can extract information related to performance characteristics that were compared between the new device and the predicate device, which can be interpreted as demonstrating that the new device performs comparably to an already accepted device.

Here's the closest interpretation of your request based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify "acceptance criteria" in the sense of predefined thresholds that the Elecsys® CEA Assay must meet to be approved. Instead, it presents performance characteristics of the Elecsys® CEA Assay and directly compares them to a legally marketed predicate device (Enzymun-Test CEA Assay) to demonstrate substantial equivalence. The implication is that if the new device's performance characteristics are comparable to or better than the predicate, it is considered acceptable.

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

• Precision Test Set N:
  • For Elecsys® CEA: 60 samples at each of 5 levels (Control 1, Control 2, Pool 1, Pool 2, Pool 3). Total N = 300.
  • For Enzymun-Test CEA: 120 samples at each of 3 levels (Low, Mid, High). Total N = 360.
• Method Comparison Test Set N:
  • Elecsys® CEA vs. Enzymun-Test CEA (0-50 ng/mL): N = 397
  • Elecsys® CEA vs. Enzymun-Test CEA (0-600 ng/mL): N = 446
• Clinical Specimens Test Set N: 50 patients with colorectal cancer.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be retrospective comparisons or internal validation studies.

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

Not applicable. This is an immunoassay for quantitative measurement of a biomarker. The "ground truth" for method comparison would be the measurement by the predicate device or a reference method (not explicitly stated as an expert judgment in analytical performance studies). For clinical specimens, the "clinical outcome" serves as the reference, which is typically determined by medical professionals but not described as specific "experts" establishing a ground truth for individual test cases in this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically for qualitative or subjective assessments (e.g., image interpretation), not for quantitative laboratory assays.

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 is an in vitro diagnostic device (an immunoassay) and does not involve human readers or AI assistance in its current form.

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

Yes, the studies presented are essentially standalone performance evaluations of the Elecsys® CEA Assay, as it is a fully automated immunoassay on the Elecsys 2010 analyzer. Its performance is measured directly, without human intervention as part of the "device performance" itself.

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

• For analytical performance (precision, linearity, detection limit, interference, specificity, hook effect): The "ground truth" is established through standard laboratory reference materials, spiked samples, and established analytical methods. For method comparison, the results from the predicate device (Enzymun-Test CEA Assay) serve as the comparative reference.
• For clinical specimens: "Clinical outcome" for 50 colorectal cancer patients was used to evaluate the association with CEA test results. This implies patient management data, medical records, and potentially pathology or follow-up data would contribute to defining the clinical outcome.

8. The sample size for the training set

Not applicable. The Elecsys® CEA Assay is a chemical/immunological assay, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" of the instrument would involve calibration using calibrators from the Elecsys® CEA CalSet and a master curve provided via the reagent bar code.

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

Not applicable in the context of an AI/ML device. For this immunoassay, the "ground truth" in terms of calibration is established by:

• The use of calibrators (Elecsys® CEA CalSet) which share the same formulation as the predicate device's calibrators.
• Assay standardization based on the "1st WHO Reference Standard 73/601".
• A master curve provided via the reagent bar code is used for instrument-specific calibration via a 2-point calibration.

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