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Immunoassay for the in vitro quantitative determination of c1-fetoprotein in human serum and in the management of patients with non-seminomatous germ cell tumors.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e immunoassay analyzers.

Immunoassay for the in vitro quantitative determination of αι-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 cobas e immunoassay analyzers.

Elecsys AFP utilizes a sandwich test principle and has a total test duration of 18 minutes.

• 1st incubation: 10 uL of sample, a biotinylated monoclonal AFP specific antibody, and . a monoclonal AFP specific antibody labeled with a ruthenium complex® react to form a sandwich complex.
• 2nd incubation: After addition of streptavidin-coated microparticles, the complex . becomes 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/ProCell M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.
• Results are determined via a calibration curve which is instrument-specifically . generated by 2 point calibration and a master curve provided via the reagent barcode or e barcode.
• a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy) )

The reagent rackpack (M, R1, R2) is labeled as AFP:

• M: Streptavidin-coated microparticles (transparent cap), 1 bottle. 12 mL: Streptavidin-. coated microparticles 0.72 mg/mL; preservative.
• R1: Anti-AFP-Ab~biotin (gray cap), 1 bottle, 17 mL: Biotinylated monoclonal anti-. AFP antibodies (mouse) 4.5 mg/L; phosphate buffer 100 mmol/L, pH 6.0; preservative.
• R2: Anti-AFP-Ab~Ru(bpy) (black cap), 1 bottle, 17 mL: Monoclonal anti-AFP . antibodies (mouse) labeled with ruthenium complex 12.0 mg/L; phosphate buffer 100 mmol/L, pH 6.0; preservative.

The provided text describes a 510(k) premarket notification for the Elecsys AFP immunoassay. While it details numerous non-clinical tests conducted to prove the device's performance, it does not describe a study involving a "human-in-the-loop" or "algorithm-only" performance study in the context of an AI/ML device. The device described is an "immunological test system" and its performance is evaluated based on quantitative analytical metrics rather than the type of diagnostic performance (e.g., sensitivity, specificity, accuracy) typically associated with AI/ML devices interpreting medical images or complex data for diagnostic purposes.

Therefore, many of the requested items (e.g., number of experts, adjudication methods, MRMC studies, effect size of human reader improvement with AI) are not applicable or cannot be extracted from the provided text for this specific device.

However, I can extract information related to the acceptance criteria and performance of the described immunoassay device based on the non-clinical tests performed.

Here's a breakdown of the available information based on your request, focusing on what can be extracted and noting what cannot (due to the nature of the device and the provided document):

Device: Elecsys AFP Immunoassay (K220176)

Purpose of the study (as described in the document): To demonstrate substantial equivalence of the updated Elecsys AFP assay to a predicate device (K981282) by improving biotin tolerance and reducing streptavidin interference. The studies are non-clinical evaluations of the analytical performance of the immunoassay.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All predefined acceptance criteria was met" for the various tests. While the specific numerical acceptance criteria (e.g., acceptable range for precision, linearity, interference limits) are not fully detailed, the reported performance is often given or implied by the "met" statement and the claimed range/limits.

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

• Precision (Repeatability, Intermediate Precision): Not explicitly stated, but CLSI EP05-A3 typically involves multiple runs over several days with specific sample replicates.
• Lot-to-lot Reproducibility: Used "three reagent lots."
• Limit of Blank/Detection/Quantitation: Not explicitly stated, but CLSI EP17-A2 involves specific sample types and replicates.
• Linearity: Evaluated on "one cobas e 601 analyzer" using samples spanning the linearity range, but the number of distinct samples or replicates is not specified beyond "0.58 IU/mL - 1129 IU/mL".
• High-Dose Hook Effect: Assessed on "one cobas e 601 analyzer" in "two-fold determination" for "both samples."
• Interference (Endogenous): "Seven endogenous substances were evaluated."
• Interference (Exogenous): "17 commonly used and ten specially used pharmaceutical compounds" were evaluated.
• Method Comparison: "A total of 181 serum sample concentrations were between 1.58 and 966 IU/mL."
• Anticoagulant Effect: "native, single-donor samples drawn into serum, Li-Heparin, K2-EDTA, and K3-EDTA plasma primary tubes." (Number of samples or donors not specified).
• Data Provenance: The document does not specify the country of origin for the samples/data or if they were retrospective or prospective. Given the nature of analytical validation studies for IVD devices, they are typically prospective studies performed in a controlled laboratory setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. This is an immunoassay, not an AI/ML device relying on expert interpretation for ground truth. The "ground truth" for these analytical studies is derived from established laboratory methods, reference materials, and defined analytical ranges.

4. Adjudication Method for the Test Set:

• Not Applicable. No human adjudication process as typically seen in AI/ML diagnostic studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This is not an AI/ML device; therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or was not performed.

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

• Not Applicable (in the context of AI/ML). The device itself is an automated immunoassay. Its performance is inherently "standalone" in that it produces a quantitative result without human "interpretation" of a complex output, but this is a very different concept than an AI algorithm's standalone diagnostic performance. The document describes the analytical performance of the automated assay system.

7. The Type of Ground Truth Used:

• The "ground truth" for these types of analytical studies is based on:
  • Reference Methods/Materials: For linearity, analytical range, LoB/LoD/LoQ determinations, often using diluted/spiked samples with known concentrations.
  • Comparative Analysis: The "method comparison" compares the new assay's results against the existing (predicate) assay.
  • Defined Limits/Spiked Samples: For interference studies, known amounts of interferents are added to samples.
  • Established CLSI Guidelines: The studies explicitly state adherence to CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., EP05-A3, EP17-A2, EP06-A) for methodology, which dictate how "truth" is assessed for analytical performance.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device that requires a "training set" in the computational sense. The device's performance is based on its chemical and technological design, and its validation involves analytical testing rather than machine learning on a dataset.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. As above, no "training set" in the AI/ML context.

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The Elecsys AFP CalSet II is used for calibrating the quantitative AFP assay on the Elecsys immunoassay systems.

The Elecsys® AFP CalSet II consists of a lyophilized human serum matrix with added AFP in two concentrations.

The provided text describes a 510(k) summary for the "Elecsys® AFP CalSet II" device, which is a calibrator for an immunoassay system. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy for diagnosing conditions.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Elecsys® AFP Calset, K981282) by comparing their intended use, matrix, storage form, levels, standardization, and stability.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an analysis based on the information provided:

1. A table of acceptance criteria and the reported device performance

• Not Available: The document does not specify acceptance criteria for clinical or analytical performance metrics (e.g., accuracy, precision, bias) for the calibrator itself. The comparison table focuses on the characteristics of the calibrator device and its predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Available: The document describes a calibrator and its characteristics, not a diagnostic test with a "test set" in the traditional sense of patient samples. Therefore, no information on sample size or data provenance for a test set is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable/Not Available: This question is relevant for diagnostic devices that interpret patient data, where expert review is used to establish ground truth for a test set. This document describes a calibrator; therefore, this information is not relevant or provided.

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

• Not Applicable/Not Available: As with point 3, this is not relevant for a calibrator device.

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 document describes a calibrator, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related information is provided.

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

• Not Applicable: This is a calibrator, not an algorithm, so a standalone performance study is not relevant.

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

• Not Applicable: The concept of "ground truth" in the context of diagnostic accuracy for patient samples does not apply to a calibrator itself. The calibrator is standardized against a reference standard (1st IRp WHO reference standard 72/225), which serves as its "truth" for concentration determination.

8. The sample size for the training set

• Not Applicable/Not Available: This information pertains to machine learning models, which are not described in the context of this calibrator product.

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

• Not Applicable/Not Available: See point 8.

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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

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Immunoassay for the in vitro quantitative determination of α₁-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 immunoassay analyzers.

The Elecsys® test principle is based on the sandwich principle. Total duration of assay: 18 minutes. 1st incubation: 15 µl of sample, a biotinylated monoclonal AFP-specific antibody and a monoclonal AFP-specific antibody labeled with a ruthenium complex react to form a sandwich complex. 2nd incubation: after the addition of streptavidin-coated microparticles, the complex becomes 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. Results are determined via a calibration curve which is instrumentspecifically generated by 2-point calibration and a master curve provided via the reagent bar code.

Here's a breakdown of the acceptance criteria and study information for the Elecsys AFP device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for K973351 primarily describes the device and its comparison to a predicate device, but it does not explicitly state specific numerical acceptance criteria for each performance characteristic. Instead, it lists the types of studies performed to demonstrate substantial equivalence.

However, based on the types of studies listed, we can infer the aspects of performance that were evaluated and for which the device was considered acceptable. The "Reported Device Performance" below reflects what the submission claims to have demonstrated.

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

The submission does not explicitly state the numerical sample sizes used for the various tests mentioned (precision, linearity, interference, etc.). It only describes the types of studies performed.

The data provenance is not explicitly mentioned (e.g., country of origin). The studies appear to be retrospective in nature, as they involve comparisons with an existing predicate device and samples from "serially monitored patients diagnosed and treated for testicular cancer," suggesting pre-collected samples.

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

This information is not provided in the submission. For an in vitro diagnostic (IVD) like the Elecsys AFP, the "ground truth" for performance studies typically comes from reference methods (like the predicate device) or known concentrations/spiked samples, rather than human expert interpretation of images or clinical data. However, the diagnosis of "testicular cancer" in the patient samples would have been established by medical professionals, but the details of who and how many are not discussed in relation to the device's technical validation.

4. Adjudication Method for the Test Set

This is not applicable and therefore not mentioned for this type of IVD device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human readers or interpretation of complex medical data (e.g., imaging studies) where there might be inter-reader variability in establishing ground truth. For an automated immunoassay, the "ground truth" is established through analytical methods and reference standards.

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 comparative effectiveness study was not conducted and is not applicable for this type of IVD device. This device is an automated immunoassay, not an AI-powered diagnostic image analysis tool that assists human readers.

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

Yes, the studies described are standalone performance evaluations of the Elecsys AFP immunoassay. The device itself is an automated system for quantitative determination of AFP; there is no human-in-the-loop in the assay run or measurement process. Results are then interpreted by clinicians, but the device's performance characteristics (precision, linearity, correlation, etc.) are inherent to the algorithm and instrument.

7. The Type of Ground Truth Used

The ground truth used for various aspects of the study includes:

• Reference materials/standards: For linearity, lower detection limit, and potentially stability, calibrated reference materials or spiked samples of known concentrations would be used.
• Predicate device: The Enzymun-Test® AFP served as the primary "ground truth" or reference for comparative performance (correlation).
• Known clinical status: For the patient sample comparisons, the "serially monitored patients diagnosed and treated for testicular cancer" represent samples with a known clinical diagnosis, allowing for comparison of the new device's performance in a clinically relevant population against the predicate.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The Elecsys AFP is a chemistry immunoassay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "calibration curve" is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code; this is a form of calibration, not model training.

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

As explained in point 8, there is no "training set" in the context of machine learning for this device. The closest equivalent would be the calibration process. The ground truth for this would be:

• Calibrators with known, traceable concentrations: Used to establish the device's response curve. The master curve is provided via the reagent bar code, implying that the manufacturer pre-established the curve characteristics using highly controlled and validated calibrators.
• 2-point calibration: This periodic user calibration adjusts the master curve to account for minor variations in reagents or instrument performance, using calibrators with known values.

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