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Immunoassay for the in vitro quantitative determination of human follicle stimulating hormone in human serum and plasma.

Sandwich principle. Total duration of assay: 18 minutes.
• 1st incubation (9 min.): 40 µL of sample, a biotinylated monoclonal FSH-specific antibody (80 µL) and a monoclonal FSH-specific antibody labeled with a ruthenium complex (50 µL)** react to form a sandwich complex.
•2nd incubation (9 min.): after addition of streptavidin-coated microparticles (30 µL), the complex becomes bound to the solid phase via interaction of biotin and streptavidin.
**Tris(2,2'-bipyridyl)ruthenium(II) complex (Ru(bpy)) 2+ 3
•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 (0.4 second read frame).
•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.

Here's an analysis of the provided text regarding the Elecsys® FSH Assay, focusing on acceptance criteria and study details.

This document describes a medical device, specifically an in vitro diagnostic (IVD) device. For IVDs, "acceptance criteria" often refer to performance characteristics that demonstrate the device is substantially equivalent to a predicate device and performs reliably. "Device performance" is typically reported through various analytical and sometimes clinical studies.

It's important to note that the provided text is a 510(k) summary, which is a submission to the FDA. It summarizes the information and doesn't always contain the full detail of the underlying studies.

Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: For analytical testing like this, the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device and showing that the new device meets or improves upon the performance characteristics. The document explicitly states: "The Boehringer Mannheim Elecsys® FSH Assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Enzymun® FSH Assay (K900763)." The provided table is the data presented to support this claim.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Precision:
     • Elecsys® FSH Assay: N=60 for each of the three levels (Low, Mid, High).
     • Enzymun® FSH Assay (Predicate): N=120 for Low and High levels, N=119 for Mid level.
   • Method Comparison:
     • Elecsys® FSH Assay: N=160.
     • Enzymun® FSH Assay (Predicate): N=76.
   • Data Provenance: The document does not specify the country of origin. The studies appear to be retrospective analytical studies performed on samples (e.g., serum or plasma) rather than prospective patient cohorts.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For an in vitro diagnostic device measuring a quantitative analyte like FSH, "ground truth" is typically established by reference methods or validated comparative methods, not by expert consensus (like in imaging for example). In this case, the predicate device (Enzymun® FSH Assay) served as the primary comparative 'ground truth' for the method comparison study. There is no mention of human experts establishing ground truth in the context of this analytical performance study.

3. Adjudication method for the test set:

   • Not applicable. This is an analytical performance study for an IVD, not a diagnostic imaging study requiring human adjudication.

4. 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:

   • Not applicable. This is an analytical performance study for an IVD to measure a hormone concentration. It does not involve human "readers" or AI assistance in the interpretation of results in the way a medical imaging AI would.

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

   • Yes, the performance characteristics provided (precision, lower detection limit, linearity, method comparison, interfering substances, specificity) are all standalone analytical performance assessments of the Elecsys® FSH Assay system (instrument + reagents). This is an "algorithm only" type of study in the sense that the device outputs a quantitative result based on its internal processes, without human interpretation influencing the measurement itself.

6. The type of ground truth used:

   • For the method comparison study, the predicate device (Enzymun® FSH Assay) results served as the comparative "ground truth". For other analytical characteristics (precision, linearity, LLD, interference, specificity), the "ground truth" is typically derived from established laboratory protocols using reference materials and verified dilutions.

7. The sample size for the training set:

   • Not applicable in the AI/machine learning sense. This is a traditional IVD device. The term "training set" doesn't apply to the development or validation of this type of electrochemiluminescence assay. The product development would involve chemical, biological, and engineering optimization, and then validation studies like those described.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" in the machine learning context for this device.

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