(20 days)
IMMULITE® 2000 OM-MA is a solid-phase, chemiluminescent enzyme immunometric assay for use with the IMMULITE® 2000 Automated Analyzer and designed for the quantitative measurement of CA 125 antigen in serum. It is intended strictly for in vitro diagnostic use as an aid in monitoring the response to therapy for patients with epithelial ovarian cancer, and in detecting residual ovarian cancer in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures.
IMMULITE® 2000 OM-MA is a clinical use device intended for use with the IMMULITE® 2000 Automated Immunoassay Analyzer
The provided text is a 510(k) summary for the IMMULITE® 2000 OM-MA, a reagent system for measuring CA 125 antigen. It primarily focuses on the regulatory aspects and intended use of the device, rather than detailed study protocols or performance data.
Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes, and expert qualifications for ground truth establishment is not present in the provided document.
However, based on the available information, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary states, "The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for IMMULITE 2000 OM-MA," but it does not present the actual performance data or the acceptance criteria used to evaluate it.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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 information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not applicable/provided. The device described is a reagent system for measuring a biomarker (CA 125 antigen), not an AI-assisted diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/provided in the context of an "algorithm only" performance study, as this is a laboratory immunoassay device. The device itself is designed for standalone performance in an automated analyzer.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the device's intended use ("aid in monitoring the response to therapy for patients with epithelial ovarian cancer, and in detecting residual ovarian cancer"), the ground truth for establishing its effectiveness would likely be based on clinical outcomes data related to ovarian cancer progression, recurrence, or resolution, potentially correlated with other diagnostic methods or pathology results. However, the document does not explicitly state the specific type of ground truth used in the studies supporting the 510(k) submission.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
In summary, the provided 510(k) document is a high-level regulatory summary, confirming the device's substantial equivalence to a predicate device, but it lacks the detailed study information typically found in clinical trial reports or technical performance documents.
§ 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.