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Abbott ARCHITECT Testosterone is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma on the Abbott ARCHITECT i System. Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females, hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

ARCHITECT Testosterone is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma (lithium heparin, sodium heparin or potassium EDTA). ARCHITECT Testosterone is calibrated with Abbott ARCHITECT Testosterone Calibrators. Abbott ARCHITECT Testosterone Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT i System.

The provided document describes the 510(k) summary for the Abbott ARCHITECT™ Testosterone assay, which is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma. The study presented aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than defining and proving arbitrary acceptance criteria.

The acceptance criteria for substantial equivalence are inherently tied to the performance of the predicate device. Therefore, the "acceptance criteria" here is defined by showing comparable performance to the Chiron Diagnostics ACS:180® Testosterone assay.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size: 607 specimens
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, given it's part of a 510(k) submission for a diagnostic device, it's highly likely to be prospective clinical samples or a mix of prospective and banked retrospective samples relevant to the intended use.
• Test Set Description: The "test set" here refers to the 607 specimens used for the comparative method study.

3. Number of Experts and Qualifications for Ground Truth

This type of information is not applicable to this study. The study is a method comparison, not an evaluation of diagnostic accuracy against an expert-determined ground truth for a medical image or clinical diagnosis. The "ground truth" for this purpose is the measurement obtained from the predicate device, the Chiron Diagnostics ACS:180® Testosterone assay.

4. Adjudication Method for Test Set

Not applicable. There was no human adjudication process involved as the comparison was between two automated quantitative assays.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This was not an MRMC study. MRMC studies are typically used for evaluating human reader performance, often in diagnostic imaging, with and without AI assistance. This study compared the performance of two automated diagnostic assays.

6. Standalone (Algorithm Only) Performance Study

Yes. This study primarily demonstrates the standalone performance of the ARCHITECT Testosterone assay by comparing its quantitative results against a legally marketed predicate device. The output is a numerical value of testosterone concentration, and its performance is evaluated based on its agreement with the predicate. There is no human-in-the-loop interaction described as part of its primary function.

7. Type of Ground Truth Used

The "ground truth" in this context is the quantitative testosterone measurement obtained from the predicate device, the Chiron Diagnostics ACS:180® Testosterone assay. This is a form of comparative effectiveness against an established method.

8. Sample Size for the Training Set

The document does not explicitly state a separate training set or its size. In a traditional 510(k) for an in vitro diagnostic (IVD) device like this, the "training" analogous to machine learning would be the assay's development and optimization process, which can involve numerous samples for calibration development, reagent formulation, and internal verification. The 607 specimens mentioned are for the final method comparison study used for the 510(k) submission.

9. How Ground Truth for Training Set Was Established

Since a distinct "training set" with ground truth in the machine learning sense is not explicitly described, the method for establishing its ground truth is not provided. For IVD assays, the "ground truth" for developing calibration and control materials is typically established through rigorous analytical methods, often involving reference methods or gravimetric preparation of highly pure analytes, and then validated through extensive testing.

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