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The HY • TEC™ Specific and Total IgE EIA System is an enzyme immunoassay (EIA) method for the quantitative determination of allergen-specific and/or total IgE concentrations in human serum. The assay is to be used with the HY . TECTM 288 instrument for in-vitro diagnostic use. Measurement of specific allergen antibodies and total IgE may aid in the diagnosis of asthma, allergies and other pulmonary disorders.

The HY . TEC 288 Automated EIA instrument is a fully-automated system, which performs sample dilution and pipetting, incubation, washing, reading and data analysis and prints reports. The new modified MCS (Modified Classification System) Specific/Total IgE assay includes the current set of five calibrators (100, 17.5, 3.5, 0.70 and 0.35 IU/mL) and a new zero calibrator.

The HY . TEC allergy system is standardized using anti-IgE discs and reference sera calibrated against WHO 2nd IRP 75/502 and offers a broad menu of specific allergens. The HY · TEC reagents have been optimized to provide a fast, sensitive sandwich immunoassay with a dynamic range from 0.05 to 100 IU/mL. An allergen-coated paper disc is incubated with a serum sample. Non-specific proteins are removed by washing and the disc is incubated with enzyme-labeled monoclonal anti human IgE conjugate. Following a second wash, substrate color is developed. The results are read spectrophotometrically against a calibration curve; results are reported in both IU/mL and Classes. The HY . TEC MCS Specific/Total IgE assay requires only three hours of total incubation time and completes assay runs within six hours for the maximum assay size of 288 tests.

The provided document is a 510(k) summary for the HY.TEC™ Automated EIA System for Total IgE and Specific IgE. It describes the device and its intended use, and states that it is substantially equivalent to a previously cleared device. However, it does not include a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, ground truth establishment, or expert involvement as requested.

The document states: "Assay performance, including correlation with the predicate, analytical sensitivity, limit of detection, intra and inter assay precision, and dilution linearity demonstrate the acceptability of the zero calibrator." This sentence broadly mentions performance aspects but does not provide the acceptance criteria or reported performance values.

Therefore, I cannot populate the table or answer the specific questions about the study design in detail based solely on the provided text.

Here's an assessment based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample size for test set: Not specified in the provided document.
• Data provenance (country of origin, retrospective/prospective): Not specified in the provided document.

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

• This device is an in-vitro diagnostic system for laboratory use. The "ground truth" in this context would typically be established through reference methods or clinical diagnosis, not by experts adjudicating images or cases in the way described for AI/imaging devices. No information on experts or their qualifications is provided, as it's not directly relevant to this type of device's validation as presented.

4. Adjudication method for the test set:

• Not applicable as this is an in-vitro diagnostic device and its performance is typically assessed through analytical validation (e.g., measuring known concentrations, comparing to a predicate device). No adjudication method for a "test set" is described.

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:

• No. This is an in-vitro diagnostic system, not an AI or imaging device involving human readers or interpretation of complex cases. Therefore, an MRMC study or AI-assistance effect size is not applicable and not mentioned.

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

• The device described is an "Automated EIA System." Its inherent function is standalone (without human intervention once initiated) for sample processing, dilution, incubation, washing, reading, and data analysis. However, "standalone" in the context of AI performance studies usually refers to an AI algorithm's performance without a human in the diagnostic loop. This document doesn't describe AI or machine learning algorithms; it describes an automated laboratory instrument with chemical reactions. The performance validation would be on the instrument's analytical capabilities, which is inherently "standalone" in its operation.

7. The type of ground truth used:

• For an in-vitro diagnostic device like this, ground truth ("truth") is established by:
  • Referenced Calibrators/Standards: The device is standardized using "anti-IgE discs and reference sera calibrated against WHO 2nd IRP 75/502." This serves as a primary form of ground truth for calibrating the system.
  • Comparison to predicate device: The document mentions "correlation with the predicate" as part of the assay performance evaluation, implying the predicate device's results serve as a comparative standard.
  • Known concentrations/samples: Analytical sensitivity, limit of detection, precision, and linearity studies usually involve testing samples with known concentrations of the analyte.

8. The sample size for the training set:

• Not applicable. This device is an automated instrument for performing immunoassays, not an AI model that requires a "training set" in the machine learning sense. The "training" would refer to calibrating the instrument using reference materials (as mentioned in point 7).

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

• As above, not applicable in the typical machine learning sense. The instrument is calibrated using reference sera calibrated against WHO 2nd IRP 75/502. This international standard establishes the "ground truth" for the calibrators used by the system.

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