Search Results

Sandwich principle. Total duration of assay: 18 minutes.
• 1st incubation (9min.): 20 µL of sample, a biotinylated monoclonal LH-specific antibody (75 µL) and a monoclonal LH-specific antibody labeled with a ruthenium complex (75 µL)** react to form a sandwich complex.
• 2nd incubation (9min.): 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)3)2+)
•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.

AI/ML Overview

The provided text describes the performance characteristics of the Elecsys® LH Assay and compares it to a predicate device, the Enzymun-Test® LH. The document acts as a 510(k) Summary, indicating that the study is for regulatory submission to establish substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" for each performance metric but rather presents "Performance Characteristics" for both the new Elecsys® LH and the predicate Enzymun-Test® LH. The implication is that the Elecsys® LH's performance should be comparable to or better than the predicate device for substantial equivalence.

Feature	Acceptance Criteria (Implied: Comparable to or better than Predicate)	Elecsys® LH Reported Performance
Precision	Similar %CV values to predicate across low, mid, and high levels.	Low: Within-Run Mean 0.54 mIU/mL, %CV 1.82%; Total Mean 0.54 mIU/mL, %CV 5.17% Mid: Within-Run Mean 9.38 mIU/mL, %CV 1.13%; Total Mean 9.38 mIU/mL, %CV 1.97% High: Within-Run Mean 50.72 mIU/mL, %CV 0.81%; Total Mean 50.72 mIU/mL, %CV 1.99%
Lower Detection Limit	Comparable to or lower than predicate (0.50 mIU/mL).	0.10 mIU/mL
Linearity	Comparable to predicate range (0.5 - 150 mIU/mL) with a deviation of ±10%.	0.1 - 200 mIU/mL (with a deviation from a linear line of ±10%)
Method Comparison	Strong correlation with the predicate device (r value close to 1).	Vs Enzymun-Test® LH: Least Squares: y = 1.00x - 0.199, r = 0.993, SEE = 1.141 Passing/Bablok: y = 0.964x + 0.040, r = 0.993, SEE = 0.456
Interfering substances	No interference at or above specific concentration limits for bilirubin, hemoglobin, lipemia, biotin, and rheumatoid factor.	No interference at: Bilirubin: 25.0 mg/dL Hemoglobin: 1 g/dL Lipemia: 1500 mg/dL Biotin: 30 ng/mL Rheumatoid Factor: 1500 U/mL
Specificity (Cross-reactivity)	Low or no cross-reactivity with FSH, HCG, TSH, HGH, HPL (e.g., < 0.1% or 0.00%).	< 0.1% for: FSH (300 mIU/mL) HCG (600 IU/mL) TSH (300 µIU/mL) HGH (600 µIU/mL) HPL (13.80 nmol/mL)

2. Sample size used for the test set and the data provenance:

Precision Test Set Sample Size: For the Elecsys® LH, N=60 for each of the low, mid, and high levels.
Method Comparison Test Set Sample Size: For the Elecsys® LH vs Enzymun-Test® LH, N=166.
Data Provenance: Not explicitly stated (e.g., country of origin). The document indicates it's part of a 510(k) submission, implying it's clinical performance data. It does not specify if it's retrospective or prospective, but clinical performance studies for diagnostic devices typically involve prospective sample collection or the use of well-characterized biobank samples.

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

This information is not provided in the text. The device is an in vitro diagnostic assay that generates quantitative results for Luteinizing Hormone (LH). The "ground truth" for such devices is typically established through direct measurement on reference samples or comparison with a well-established reference method, rather than expert interpretation of images or clinical assessments by individual experts.

4. Adjudication method for the test set:

This information is not applicable for this type of in vitro diagnostic assay. Adjudication methods (like 2+1 or 3+1) are typically used in studies where human readers interpret data (e.g., medical images) and their interpretations need to be reconciled to establish a consensus ground truth. Here, the device produces a numerical result.

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 as the document describes an in vitro diagnostic device for quantitative LH measurement, not an AI-assisted diagnostic tool that aids human readers. Therefore, an MRMC study or its effect size is irrelevant in this context.

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

The device is an automated immunoassay system (Elecsys® LH Assay on the Elecsys® 2010 instrument). The performance characteristics reported (Precision, Lower Detection Limit, Linearity, Method Comparison, Interfering Substances, Specificity) represent the standalone performance of the algorithm/device system. It operates without human interpretation of the primary signal; results are quantitatively determined by the instrument and its built-in algorithms.

7. The type of ground truth used:

The "ground truth" for this type of immunoassay is:

Reference measurements: For precision, linearity, and lower detection limit, the "true" values of LH in control samples or serially diluted samples are used.
Comparison to a predicate device: For method comparison, the "true" values are derived from the results of the legally marketed predicate device (Enzymun-Test® LH), which serves as the comparative standard.
Known concentrations of interferents or related substances: For interfering substances and specificity, "true" known concentrations of these compounds are spiked into samples to assess their impact.

8. The sample size for the training set:

This information is not provided and is likely not directly applicable in the same way it would be for a machine learning model. This is a traditional immunoassay. The "training" of such a system involves extensive biochemical and engineering development, optimization of reagents, and establishment of calibration curves. The sample sizes for these developmental stages are not typically reported as a single "training set" like in AI/ML. The provided sample sizes are for performance validation (i.e., the "test set").

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

As mentioned above, the concept of a "training set" with an established ground truth in the AI/ML sense doesn't directly apply here. For a traditional immunoassay, the "ground truth" during development (analogous to training) is established through:

Known concentrations: Using highly purified and precisely quantified LH standards.
Reference methods: Comparing early versions of the assay to established reference methods or highly characterized internal standards.
Clinical panels: Testing the assay on panels of patient samples with confirmed clinical states or values from reference laboratories.
Reagent characterization: Thorough characterization of antibodies and other reagents for specificity and binding affinity.

Ask a Question

Ask a specific question about this device

Page 1 of 1