(282 days)
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).
| Acceptance Criteria (Inferred from study types) | Reported Device Performance (Summary from text) |
|---|---|
| Assay Precision (NCCLS recommendations) | Evaluated according to NCCLS recommendations. (Specific metrics like %CV or SD are not provided in this summary.) |
| Lower Detection Limit | Determination of the lower detection limit. (Specific value is not provided.) |
| Linearity | Demonstration of linearity. (Specific range or r-squared value is not provided.) |
| Correlation with Predicate Device | Correlation with the predicate device. (Specific correlation coefficient or agreement percentage is not provided.) |
| Interference (Endogenous substances, drugs) | Evaluation of the effect of various endogenous substances (hemoglobin, biotin, triglyceride, bilirubin, and rheumatoid factor), and commonly used pharmaceutical compounds, and serum / plasma sample comparisons. (Specific impact or findings are not provided.) |
| Hook Effect | Determination of hook effect. (Specific findings are not provided.) |
| Stability | Stability studies. (Specific stability period or conditions are not provided.) |
| Clinical Correlation | Comparisons of the Elecsys CA 125 II and the predicate device were performed with samples from serially monitored patients diagnosed and treated for ovarian cancer. (Specific clinical outcomes or direct comparative stats are not provided, but implies similar performance given the "substantial equivalence" claim.) |
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.
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.