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Abbott ARCHITECT™ Total ß-hCG is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative and qualitative determination of betahuman chorionic gonadotropin (ß-hCG) in human serum and plasma on the Abbott ARCHITECT i System for the early detection of pregnancy.

ARCHITECT Total 3-hCG is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative and qualitative determination of ß-hCG in human serum and plasma (lithium heparin, sodium heparin, or potassium EDTA) for the early detection of pregnancy. ARCHITECT Total B-hCG is calibrated with ARCHITECT Total B-hCG Calibrators. ARCHITECT Total {}-hCG Controls are assayed to verify the accuracy and precision of the Abbott ARCHITECT i System.

Here's an analysis of the provided text regarding the Abbott ARCHITECT™ Total ß-hCG device:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The study conducted to demonstrate the safety and effectiveness, and thus substantial equivalence, of the ARCHITECT Total ß-hCG assay involved a direct comparison with a legally marketed predicate device, the AxSYM® Total ß-hCG assay.

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

• Sample Size for Test Set: 337 specimens
• Data Provenance: The document does not explicitly state the country of origin. It also doesn't specify if the study was retrospective or prospective. Given the nature of a 510(k) submission, it's typically retrospective analysis of existing clinical samples or prospectively collected samples for method comparison.

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

This information is not provided in the document. For an immunoassay, the "ground truth" for the test set is typically the result obtained from the predicate device (AxSYM® Total ß-hCG assay) or a reference method. It does not involve human expert consensus in the same way as an imaging device might.

4. Adjudication Method for the Test Set

This information is not applicable in the context of this type of immunoassay comparison study. Adjudication methods like 2+1 or 3+1 are typically used for interpreting subjective data (e.g., medical images) where human readers disagree. For quantitative laboratory tests, the comparison is directly between the numerical results of the candidate and predicate assays.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., imaging devices, pathology slides) and would measure the improvement in human reader performance with AI assistance. The ARCHITECT Total ß-hCG is an automated immunoassay, not one requiring human interpretation of complex visual data.

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

Yes, the study described is essentially a standalone performance study of the ARCHITECT Total ß-hCG assay. It assesses the algorithm's (the assay's) performance in determining ß-hCG levels and compares it to a predicate device, without human intervention in the result determination process itself. The "human-in-the-loop" aspect for such a device would typically be limited to the lab technician running the assay and interpreting the final numerical results against clinical cutoffs, which is not what an MRMC study assesses.

7. The Type of Ground Truth Used

The ground truth for the comparison was the results obtained from the predicate device, the AxSYM® Total ß-hCG assay. The AxSYM assay itself would have been validated against a more fundamental reference method or clinical outcomes during its own clearance process.

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. For substantial equivalence studies of this nature, the focus is typically on performance against the predicate, using a single set of samples. While the ARCHITECT system itself would have undergone internal development, calibration, and optimization, the data presented here is for the final performance evaluation.

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

Since a dedicated training set is not explicitly mentioned with its own ground truth establishment in this document, this information is not provided. For a device like this, calibration and optimization (which can be considered akin to "training") would typically involve a proprietary set of samples with known (or precisely measured by a reference method) ß-hCG concentrations.

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