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The HY . TECTM Extended Specific IgE EIA, MCS Assay Using The Tecan Freedom EVO® RSP 200 is an enzyme immunoassay (EIA) method for the quantitative determination of allergen-specific IgE concentrations in human serum. The assay system is for in-vitro diagnostic use. Measurement of specific allergen antibodies may aid in the diagnosis of asthma, allergies, and other pulmonary disorders.

The EVO RSP 200 Automated EIA instrument is a fully-automated system, which performs sample dilution and pipetting, incubation, washing, reading and data analysis and prints reports. The EVO RSP 200 Automated EIA System for Specific IgE performs the same functions as the HY . TEC 480 Automated EIA System. The specific IgE assay for both systems, the HY .TEC 480 and the EVO RSP 200, is the same (utilizes same reagents and procedures) except for the following: A zero calibrator is being added to the current set of five calibrators (0.35, 0.7, 3.5, 17.5 and 100 IU/mL) for the EVO Specific IgE assay. The incubation times and temperatures have been changed. The HY . TEC 480 and EVO RSP 200 allergy systems are standardized using anti-IgE discs and reference sera calibrated against WHO 2nd IRP 75/502 and offers a broad menu of specific allergens. 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 provided text describes a 510(k) submission for a medical device called "The HY•TEC™ Extended Specific IgE EIA, MCS Assay Using The Tecan Freedom EVO® RSP 200". This document focuses on demonstrating substantial equivalence to a predicate device and outlines the intended use and a brief comparison.

Unfortunately, the input document does not provide explicit acceptance criteria or detailed results of a study to demonstrate the device meets these criteria. Instead, it states that "Validation of software, instrument functions and assay performance, including correlation with the predicate, intra and inter assay precision, limits of detection and quantitation, and dilution linearity demonstrate the acceptability of the EVO RSP 200." However, it does not present the specific acceptance thresholds for these performance metrics or the actual reported values.

Therefore, I cannot populate most of the requested sections accurately based on the provided text. I will address the points that can be inferred or explicitly stated.

Acceptance Criteria and Study Details:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that these metrics were validated and demonstrated acceptability, but it does not specify the quantitative acceptance criteria or the actual performance values obtained.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "validation of software, instrument functions and assay performance."

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

This information is not provided in the document. The type of device (an in-vitro diagnostic system for quantitative determination of allergen-specific IgE) typically relies on analytical performance studies rather than expert-derived ground truth from images or clinical assessments in the way, for example, a radiology AI would.

4. Adjudication Method for the Test Set

This is not applicable and not provided as the device is an in-vitro diagnostic assay, not a system requiring human expert adjudication for its primary performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices where human readers interpret results, often with and without AI assistance. This device is an in-vitro diagnostic instrument for quantitative measurement of IgE.

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

This device is an in-vitro diagnostic instrument, not an algorithm that operates standalone in a clinical context. Its "standalone" performance would be its analytical performance (precision, accuracy, LoD, LoQ, linearity), which were generally stated to have been validated, but specific study details are not provided. The device itself is "fully-automated" for its specified functions.

7. The Type of Ground Truth Used

For this type of in-vitro diagnostic device, the "ground truth" for analytical performance studies would typically be established through:

• Reference materials/standards: Calibrators (e.g., WHO 2nd IRP 75/502) and controls with known IgE concentrations.
• Comparison to a gold standard method or predicate device: As indicated by "correlation with the predicate" in the document.

The document mentions that the system is "standardized using anti-IgE discs and reference sera calibrated against WHO 2nd IRP 75/502." This suggests the basis for quantitative accuracy.

8. The Sample Size for the Training Set

The document does not provide any information regarding a "training set" or its sample size. This is consistent with an in-vitro diagnostic assay validation rather than a machine learning model development.

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

This is not applicable as the document does not describe a training set in the context of machine learning. The device's "training" in a broad sense would relate to its calibration and standardization, as mentioned with the WHO reference standard.

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