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Immunoassay for the in vitro quantitative determination of Prostate-Specific Antigen in human serum and plasma. The Elecsys PSA assay is further indicated for serial measurement of PSA to aid in the management of cancer patients.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.

The Elecsys® test principle is based on sandwich principle. Total duration of assay: 18 minutes (37° C).
• 1st incubation (9 minutes): Sample (20 µL), a biotinylated monoclonal PSA-specific antibody (70 µL), and a monoclonal PSA-specific antibody labeled with a ruthenium complex (70 µL) react to form a sandwich complex.
• 2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (40 µL), the entire complex is bound to the solid phase via interaction of biotin and streptavidin.
·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-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® PSA assay, structured to address your specific questions.

It's important to note that this document is a 510(k) summary for a diagnostic assay (a lab test), not a medical imaging device or an AI-powered system in the modern sense. Therefore, some of your questions, particularly those related to imaging, AI performance, human readers, and ground truth establishment for AI, are not directly applicable or addressable by this type of submission. This summary focuses on the analytical performance of the assay itself compared to a predicate assay.

Acceptance Criteria and Study Details for Elecsys® PSA Assay

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" for each performance characteristic in a formalized table. Instead, it presents performance data for the new device (Elecsys PSA, 2nd Gen) and the predicate device (Elecsys PSA, 1st Gen) side-by-side, implying that the new device's performance should be comparable or improved relative to the predicate to establish substantial equivalence.

Based on the "Performance Characteristics" section, here's a table summarizing the reported device performance and implicitly accepted levels (by showing equivalence to the predicate):

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

• Precision: For each level (HS1, HS2, HS3, PC-TM1, PC-TM2), the sample size (N) was 60. The submission does not specify the country of origin or whether the data was retrospective or prospective. Given the nature of a lab assay performance study, these are typically prospective laboratory testing results.
• Method Comparison: The sample size (N) for the method comparison study was 108. No information on data provenance (country, retrospective/prospective) is provided.

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

This question is not applicable to this submission. For an in vitro diagnostic (IVD) assay like Elecsys® PSA, "ground truth" for the test set is established by the reference measurement procedure (i.e., the predicate device or a recognized reference method) or by the known concentrations of calibrators/controls used for analytical performance studies like precision and linearity. There are no "experts" in the sense of human readers/adjudicators for interpreting results in this context; performance is based on analytical measurements.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 refer to human expert consensus for interpreting images or clinical data, which is not relevant for an analytical assay.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable. This is an in vitro diagnostic assay, not an AI-powered medical imaging or decision support system that involves human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable in the usual sense of an "algorithm" as an AI. This is an automated immunoassay system. The "standalone" performance is what is presented in the Precision, Sensitivity, Linearity, and Hook Effect sections, as it describes the analytical performance of the instrument/reagent system without human interpretation beyond pipetting and loading. The "algorithm" here refers to the instrument's calibration and calculation of results from the chemiluminescent signal.

7. The Type of Ground Truth Used

For the Elecsys® PSA assay, the "ground truth" for the performance studies would be:

• For Precision: The known target concentrations of the quality control samples (HS1, HS2, HS3, PC-TM1, PC-TM2).
• For Sensitivity/Linearity: The gravimetrically or otherwise accurately prepared concentrations of PSA in dilution series.
• For Method Comparison: The results obtained from the predicate device (Elecsys PSA, 1st Gen) on the same samples.
• For Hook Effect: Samples with extremely high, known concentrations of PSA.

8. The Sample Size for the Training Set

Not applicable in the context of machine learning. This is an IVD assay, not an AI algorithm that undergoes a "training phase" on a dataset. The assay involves chemical reactions and signal detection, with a calibration curve set up using internal calibrators.

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

Not applicable. As explained above, there isn't a "training set" in the AI sense. Calibration curves, which are analogous to a "trained model" for converting signal to concentration, are established using known concentrations of PSA calibrators provided with the reagent kit.

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Immunoassay for the in vitro quantitative determination of Prostate-Specific Antigen (PSA) in human serum and plasma. The Elecsys PSA assay is further indicated for serial measurement of PSA to aid in the management of cancer patients.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 2010 and 1010 immunoassay analyzers.

The Elecsys® test principle is based on sandwich principle. Total duration of assay: 18 minutes (37° C).
•1st incubation (9 minutes): Sample (20 µL), a biotinylated monoclonal PSA-specific antibody (70 µL), and a monoclonal PSA-specific antibody labeled with a ruthenium complex (70 µL) react to form a sandwich complex.
•2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (40 µL), the entire complex is bound to the solid phase via interaction of biotin and streptavidin.
•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-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® PSA on Elecsys 1010, focusing on acceptance criteria and the supporting study:

The document is a 510(k) summary for the Elecsys® PSA Assay on the Elecsys 1010 analyzer. It seeks to establish substantial equivalence to the same assay run on the Elecsys 2010. The study presented is a method comparison study.

Acceptance Criteria and Reported Device Performance:

The document implicitly uses the performance of the predicate device (Elecsys® PSA on Elecsys 2010) as the de facto acceptance criteria for the new device (Elecsys® PSA on Elecsys 1010). The goal is to demonstrate that the performance characteristics of the Elecsys 1010 system are comparable to the Elecsys 2010 system.

Study Details:

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

   • Sample Size: 154 samples were used for the method comparison study.
   • Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

   • This is an in vitro diagnostic device (immunoassay for PSA levels), not an imaging or diagnostic AI device where human experts establish ground truth for a test set.
   • The "ground truth" for the test set in this context is the measurement obtained from the predicate device (Elecsys 2010).

3. Adjudication method for the test set:

   • Not applicable. As this is an in vitro diagnostic device comparing its results to a predicate device, there is no adjudication process involving multiple human readers for a test set in the traditional sense.

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:

   • No, an MRMC study was not done. This type of study is relevant for AI-assisted diagnostic tools that involve human interpretation of images or other complex data. This submission is for an automated immunoassay.

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

   • Yes, this is essentially a standalone algorithm performance study. The Elecsys® PSA assay on the Elecsys 1010 operates as an automated system, and its performance is evaluated directly against the predicate device. There is no human "in the loop" in generating the raw quantitative PSA result, though the result would be interpreted by a clinician.

6. The type of ground truth used:

   • The "ground truth" for the method comparison study is the results obtained from the predicate device, the Elecsys® PSA Assay on the Elecsys 2010 analyzer. The objective is to show agreement between the new device and the predicate.

7. The sample size for the training set:

   • This being a 510(k) for an immunoassay, the concept of a "training set" for an AI model's ground truth is not directly applicable. The assay itself is a chemical and mechanical process, not a machine learning algorithm that learns from data.
   • However, the calibration of the Elecsys 1010 (and 2010) involves a 2-point calibration and a master curve provided via the reagent bar code. The data used to establish these calibration curves and the assay parameters would be analogous to a "training" process in a broader sense, but no sample size for this is provided.

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

   • Again, the typical "ground truth for training set" framework for AI is not applicable here.
   • For the immunoassay, the "ground truth" for calibration and assay development would have been established through a rigorous process of using reference materials, certified calibrators, and possibly comparison to established reference methods (though not detailed in this summary). This process ensures the accuracy and reliability of the assay's measurements.

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