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Immunoassay for the in vitro quantitative determination of alpha fetoprotein (AFP) in human serum and plasma.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Roche Diagnostics/Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.
Immunoassay for the in vitro quantitative determination of alpha-fetoprotein in human serum and plasma to aid in the management of patients with non-seminomatous germ cell tumors.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.

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 AFP- specific antibody (60 µL), and a monoclonal AFP-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.

Here's an analysis of the provided information, focusing on the acceptance criteria and study details for the Elecsys® AFP Assay on the Elecsys® 1010 analyzer.

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't explicitly state "acceptance criteria" but rather presents "Performance Characteristics" for both the new device (Elecsys® 1010) and the predicate (Elecsys® 2010). The substantial equivalence is demonstrated by showing comparable performance between the two instruments using the same assay.

Notes on Acceptance Criteria:

• For a 510(k) submission demonstrating substantial equivalence, the primary acceptance criterion is that the new device performs as well as or comparably to the predicate device for all relevant performance characteristics.
• The document does not specify explicit numerical acceptance criteria for precision (e.g., "%CV must be < X"). Instead, it provides the observed performance for both the new and predicate devices, and the implicit criterion is that the new device's performance should be similar to or better than the predicate's. The reported values for the Elecsys 1010 generally meet or exceed the performance of the Elecsys 2010.

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

• Precision Test Set: Not explicitly clinical samples.
  • HS (High Sensitivity) Samples: 3 levels (HS1, HS2, HS3). For each level, N=60 measurements were performed for both Elecsys® 1010 and Elecsys® 2010 to derive Within-Run and Total %CV. These are typically prepared human serum samples with known AFP concentrations.
  • Control Samples: 2 levels (Control 1, Control 2). For each level, N=60 measurements were performed for both Elecsys® 1010 and Elecsys® 2010 to derive Within-Run and Total %CV. These are typically manufactured quality control materials.
• Method Comparison Test Set: N=153 samples.
  • The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given the nature of a laboratory assay validation for a 510(k), these samples would typically be human serum and plasma samples, likely from a patient population, and the study would be prospective to collect data simultaneously on both instruments.

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

This information is not applicable to this type of device. The Elecsys® AFP Assay is an in vitro diagnostic (IVD) device that measures a biomarker (Alpha-Fetoprotein) quantitatively. The "ground truth" for such measurements is established by:

• Reference methods or certified reference materials for calibration and accuracy.
• The inherent precision of the assay itself compared to well-established analytical performance standards.
• Comparison to a legally marketed predicate device.
  There are no human "experts" establishing a subjective "ground truth" for the test results in the way there would be for image interpretation or clinical diagnosis by human readers.

4. Adjudication Method for the Test Set

This information is not applicable as there is no subjective interpretation requiring adjudication. Performance is based on quantitative analytical measurements.

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

• No, an MRMC study was not done. This is an in vitro diagnostic device for quantitative measurement of a biomarker, not an imaging device or an AI-powered diagnostic tool requiring human interpretation. Therefore, there is no concept of "human readers improving with AI assistance" in this context.

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

• Yes, in essence, the performance evaluation represents a standalone performance. The Elecsys® AFP Assay on the Elecsys® 1010 (or 2010) is an automated immunoassay. The device performs the measurement, and the result is a quantitative number. There isn't a "human-in-the-loop" performing interpretation of the raw signal that then gets augmented by the device. The device is the algorithm/system that produces the final result.

7. The Type of Ground Truth Used

The "ground truth" for this IVD device is based on:

• Analytical Standards: For precision, the "ground truth" is statistical reproducibility (e.g., %CV around the mean concentration).
• Reference Methods/Materials: For accuracy and linearity, the "ground truth" is often established via comparison to a more definitive reference method or against samples with assigned values from certified reference materials.
• Predicate Device Performance: For substantial equivalence, the "ground truth" for acceptable performance is largely defined by the performance characteristics of the legally marketed predicate device (Elecsys® AFP Assay on Elecsys® 2010). The method comparison study directly demonstrates how closely the new device's results align with the predicate's results.

8. The Sample Size for the Training Set

• The document does not explicitly state a training set size in the context of machine learning or AI. This is not an AI/ML device.
• For an IVD assay, "training" primarily refers to:
  • Calibration: The instrument is calibrated using specific calibrator materials. The document mentions "2-point calibration and a master curve provided via the reagent bar code." The sample size for these calibrators isn't typically given as a "training set" but rather as a set of material used to define the measurement curve.
  • Method Development & Validation: The assay itself was developed and optimized using various samples to establish reagents, reaction conditions, and measurement parameters. This "development data" is not typically reported as a "training set" in 510(k) summaries but is part of the overall assay validation.

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

As noted above, "training set" is not a direct concept here for an IVD.

• For Calibration: The calibrator materials would have their AFP concentrations assigned through rigorous analytical methods, often traceable to international reference standards or highly accurate reference laboratories.
• For Method Development: The "ground truth" during development would have been established by comparing prototype assay results against established reference methods or by using samples with known, validated AFP concentrations.

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