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Immunoassay for the in vitro quantitative determination sex hormone binding globulin in human serum and plasma. The Elecsys SHBG Immunoassay is intended for use as an aid in the diagnosis of androgen disorders including hirsuitism, virilization, polycystic ovarian syndrome, adrenogenital syndrome, and hyperandrogenism; the correct interpretation of testosterone and estradiol concentrations; investigation of the androgen-estrogen balance in gonadal and sexual dysfunction; assessment of the peripheral effect of hormones which regulate SHBG concentrations. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of analyzers.

A device for the measurement of human SHBG in serum or plasma.

This document is a 510(k) summary for the Elecsys® SHBG Immunoassay by Roche Diagnostics Corporation, submitted to the FDA in 2003. It primarily focuses on demonstrating substantial equivalence to a predicate device, the DPC Immulite SHBG. The information provided is characteristic of a medical device submission rather than a clinical study evaluating AI performance.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of a modern AI-driven device are not present in this document. This submission is for an in-vitro diagnostic immunoassay, not an AI device.

Here's an analysis of the provided text based on your request, with a clear distinction for information that is not available from this document given its nature:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the way one might for an AI device. Instead, it presents performance characteristics of the Elecsys SHBG Immunoassay and compares them to a predicate device to demonstrate substantial equivalence. The "reported device performance" refers to the characteristics of the Elecsys SHBG Immunoassay.

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 available in the provided 510(k) summary. A 510(k) summary typically doesn't detail the specific sample sizes used for each performance characteristic study (e.g., precision, interference) or the demographic/provenance of the samples. These details would be in the full submission, but not summarized here.

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 is not applicable as this is an immunoassay measuring a biochemical marker, not an AI device interpreting images or other data requiring expert human-established ground truth. The "ground truth" for an immunoassay is typically established by comparing its measurements to a reference method or validated standard, not by expert consensus on interpretations.

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

This is not applicable for an immunoassay. Adjudication methods are relevant for subjective interpretations, often in diagnostic imaging with multiple readers.

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 is not applicable. This document describes an immunoassay, not an AI system. Therefore, no MRMC study involving human readers and AI assistance would have been performed or reported.

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

This refers to the performance of the immunoassay device itself. The listed performance characteristics (precision, measuring range, analytical sensitivity, hook effect, interference) reflect the standalone performance of the Elecsys SHBG Immunoassay system (reagents + analyzer) as it would be used in a laboratory setting. Human intervention is involved in operating the analyzer and interpreting the quantitative results, but the "algorithm" equivalent is the chemical reaction and detection method within the instrument.

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

For an immunoassay, the "ground truth" for accuracy and calibration is typically established using:

• Reference materials/standards: The document states "1st International Standard for SHBG NIBSC code 95/560" for traceability/standardization. This is the primary "ground truth" for ensuring the assay accurately measures SHBG.
• Known concentrations: For studies like precision, known concentrations of SHBG are used.
• Comparison to established/predicate methods: The entire 510(k) process is about demonstrating equivalence to an already legally marketed device (predicate), implying that the predicate's measurements serve as a comparative "truth"
• Clinical correlation: The "Intended Use" and "Indications for Use" connect the measured SHBG levels to clinical conditions, but the direct ground truth for the measurement itself comes from reference standards.

8. The sample size for the training set

This information is not available as the concept of a "training set" in the context of machine learning/AI does not apply to this immunoassay. The development of an immunoassay involves optimization and validation using various samples, but these are not referred to as a "training set" in the AI sense.

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

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

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