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Elecsys CA 125 II is an immunoassay for the in vitro quantitative determination of OC 125 reactive determinants in human serum, Li heparin, K2-EDTA, as well as Li-heparin plasma tubes containing separating gel on the cobas e 411 analyzer.

These determinants are associated with a high molecular weight glycoprotein in serum and plasma of women with primary epithelial invasive ovarian cancer (excluding those with cancer of low malignant potential).

This immunoassay is indicated for use as an aid in the detection of recurrent ovarian carcinoma. This immunoassay is further indicated for use in monitoring patients for disease progress or response to therapy.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 411 immunoassay analyzers.

For use in the verification of the callbration established by the Elecsys CA 125 II reagent on the Elecsys and cobas e immunoassay analyzers.

The CA 125 II assay employs a sandwich test principle using biotinylated monoclonal CA 125-specific antibody and a monoclonal CA 125-specific antibody labeled with a ruthenium complex to form a sandwich complex. The use of streptavidin-coated microparticles serves as the solid phase for the electrochemiluminescence detection.

Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve (5-point-calibration) provided with the reagent bar code.

The CA 125 II application is identical to the predicate assay (K972162). This submission is being done to modernize the labeling by adding the LoB, LoD and LoQ data and to change the sample:reagent ratio from 40:60μL to 20:70μL. Additionally, based on internal stability data the calibration frequency has been extended from 4 to 8 weeks.

The Elecsys CA 125 II CalCheck is a lyophilized product consisting of equine serum in level 1 and human serum matrix for levels 2 and 3. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

Here's a breakdown of the acceptance criteria and the study details for the Elecsys CA 125 II Assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comparison table (Table 1) between the predicate device (Elecsys CA 125 II, K972162) and the candidate device (Elecsys CA 125 II Assay), highlighting both similarities and differences, including labeled performance characteristics. Since explicit "acceptance criteria" are not given in a numerical form that can be directly compared to "reported performance" for each item, I will present the key performance characteristics detailed for the candidate device as its reported performance, implicitly indicating what was demonstrated to FDA for substantial equivalence.

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The Elecsys CA 125 II CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys CA 125 II reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.

The Elecsys CA 125 II CalCheck 5 is a lyophilized product consisting of equine serum in level 1 and human serum matrix for levels 2-5. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

The provided text describes a 510(k) submission for the Elecsys CA 125 II CalCheck 5, a device intended for calibration verification and assay range verification in immunoassay analyzers. The document focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a study with acceptance criteria in the manner typically seen for clinical diagnostic devices that provide patient-specific results.

Therefore, the requested information elements related to clinical study design, ground truth establishment, expert adjudication, MRMC studies, and training set information are not applicable in this context, as this submission is for a quality control material and not a diagnostic algorithm. The "performance characteristics" section is very brief and refers to "value assignment" and "stability," which are typically internal validation metrics for quality control materials.

Here's the breakdown of the information as it relates to the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state numerical acceptance criteria in the format typically seen for diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to existing predicate devices based on shared characteristics and intended use. The "Performance Characteristics" section merely states: "The Elecsys CA 125 II CalCheck 5 was evaluated for value assignment and stability."
The comparison table implies equivalence based on similar design, intended use, format, handling, and stability characteristics with the predicate devices.

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

This is not applicable as the document describes a 510(k) submission for a quality control material, not a clinical diagnostic device requiring a "test set" from patient data. The "evaluation" for value assignment and stability would involve a series of laboratory experiments on the manufacturing lots of the CalCheck 5 product itself. The provenance of such data would be internal to the manufacturer (Roche Diagnostics).

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

This is not applicable. The concept of "ground truth" derived from expert consensus is typically relevant for diagnostic devices that interpret patient results (e.g., imaging devices, pathology slides). For a quality control material, "ground truth" (or target values) for analyte concentration are established through a robust value assignment process using reference methods and calibrated instruments, overseen by internal experts in analytical chemistry and quality control, not clinical experts for diagnostic interpretation.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as #3. Adjudication is relevant for resolving discrepancies in expert interpretations of diagnostic findings, which is not pertinent to the evaluation of a quality control material.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance

This is not applicable. MRMC studies are used to evaluate the diagnostic performance of devices, especially those involving human interpretation, and are particularly relevant for AI-assisted diagnostic tools. The Elecsys CA 125 II CalCheck 5 is a quality control product, not a diagnostic device, and does not involve human readers interpreting cases or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This is not applicable. This device is a biochemical control material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for a quality control material like Elecsys CA 125 II CalCheck 5 would be the assigned target values for CA 125 concentration at each of the five levels, determined through rigorous analytical methods using reference standards and calibrated instruments. This is an analytical/chemical ground truth, not a clinical one (like pathology, expert consensus on images, or patient outcomes).

8. The Sample Size for the Training Set

This is not applicable. The device is a quality control material and does not involve an AI algorithm with a "training set" of data.

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

This is not applicable for the same reasons as #8.

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Immunoassay for the in vitro determination of OC 125 reactive determinants. These determinants are associated with a high molecular weight glycoprotein in serum and plasma of women with primary epithelial invasive ovarian cancer, excluding those with cancer of low malignant potential. The Elecsys® CA 125II is indicated for use as an aid in the detection of residual or recurrent ovarian carcinoma in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures. The Elecsys CA 125II assay is further indicated for serial measurement of CA 125II to aid in the management of cancer patients.

The Elecsys® CA 125 IITM employs a sandwich test principle with monoclonal antibodies directed against CA 125 II and with streptavidin microparticles and electrochemiluminescence detection.
Total duration of assay: 18 minutes.
• 1st Incubation: 40 µl of sample a biotinylated monoclonal CA 125 II- specific antibody and a monoclonal CA 125 II-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 instrument- specifically generated by 2-point calibration and a master curve provided via the reagent bar code.

The provided text describes a 510(k) summary for the Elecsys® CA 125 IITM device, an immunoassay for the determination of OC 125 reactive determinants. While the document outlines the device description, intended use, and comparison to a predicate device, it does not explicitly state specific acceptance criteria or provide a detailed study that proves the device meets those criteria in a format that allows direct extraction of all requested information.

However, based on the information provided, we can infer some aspects of the performance evaluation and present what is available.

Here's an attempt to answer your questions based on the given text, acknowledging the limitations:

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

The document does not present a formal table of acceptance criteria with corresponding performance metrics. Instead, it lists studies performed as part of the comparison to the predicate device. The underlying acceptance for these studies would implicitly be substantial equivalence to the predicate device (CENTOCOR® CA 125 IITM RIA).

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

• Sample Size for Test Set: Not explicitly stated. The text mentions "samples from serially monitored patients diagnosed and treated for ovarian cancer" for clinical correlation, but no number is given.
• Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or its country of origin.

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)

This device is an immunoassay (laboratory test), not an imaging device requiring expert interpretation in the same way a radiologist would. Therefore, the concept of "experts" establishing ground truth for a test set in this context would typically refer to reference laboratory methods or established clinical diagnoses. The document does not provide details on how the ground truth was established for the comparison studies, nor does it mention specific experts or their qualifications for interpreting the test results in the "test set" (i.e., patient samples).

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

Not applicable in the context of this immunoassay. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments or image interpretations where multiple human readers disagree. For an immunoassay, the "ground truth" (or reference method) is generally determined by a standardized lab procedure, not a consensus of human reviewers of the test result itself.

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

The device is an automated immunoassay. It does not involve human readers interpreting images or data that would be "assisted" by AI. Therefore, an MRMC study or AI assistance is not applicable to this device.

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

Yes, the Elecsys® CA 125 IITM is a standalone diagnostic device (an algorithm/automated system). Its performance described in the document is inherently "standalone" as it produces numerical results without direct human intervention in the result generation process itself, though clinical interpretation by a physician would follow.

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

The document implies clinical diagnostic information ("serially monitored patients diagnosed and treated for ovarian cancer") as the context for the comparison studies. For the analytical performance studies (precision, linearity, LLD), the ground truth would be based on known concentrations in control materials or reference measurements. For correlation with the predicate device, the "ground truth" for comparison is the results from the CENTOCOR® CA 125 IITM RIA.

8. The sample size for the training set

This document describes a 510(k) submission for a diagnostic immunoassay, not a machine learning or AI-based device. Therefore, the concept of a "training set" in the context of developing an algorithm is not applicable. The device is based on established immunochemical principles.

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

As there is no "training set" in the AI/ML sense for this type of device, this question is not applicable. The calibration curve is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code. These calibration materials serve a similar function to "training" by setting the operational parameters for measurement.

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