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1. EliA™ CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA™ CENP uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.

2. EliA™ UIRNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to UIRNP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ UIRNP uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.

3. EliATM Sm is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ Sm uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.

4. EliA™ Ro is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Ro in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Sjögren's syndrome and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ Ro uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.

5. EliATM La is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to La in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Siögren's syndrome and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ La uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.

The new devices belong to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments ImmunoCAP 100 and ImmunoCAP 250. The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate. The total IgG calibration is based on a set of six WHOstandardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method specific and general reagents that are packaged as separate units.

The provided text describes EliA™ CENP, EliA™ U1RNP, EliA™ Sm, EliA™ Ro, and EliA™ La immunoassays, which are intended for the semi-quantitative measurement of IgG antibodies to specific antigens in human serum and plasma to aid in the clinical diagnosis of various autoimmune diseases.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria

The document does not explicitly state numerical acceptance criteria for the devices (e.g., minimum sensitivity, specificity, accuracy thresholds). Instead, the method for demonstrating performance is through "comparability" and "substantial equivalence" to predicate devices. The "reported device performance" is summarized as supporting substantial equivalence.

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

The document states that the comparability of the new devices and predicate devices is supported by a "data set" that includes results obtained from:

• A comparison study between new and predicate devices.
• Clinically defined sera.
• Samples from apparently healthy subjects (normal population).

However, the specific sample sizes for these studies are not provided. The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.

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

The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set. The ground truth appears to be based on "clinically defined sera" and "samples from apparently healthy subjects," implying clinical diagnosis rather than expert interpretation of raw data for the immunoassay itself.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study is typically for evaluating the performance of readers with and without AI assistance in interpreting diagnostic images or data. Since these devices are in-vitro diagnostic immunoassays, rather than AI-assisted interpretation tools, a MRMC comparative effectiveness study was not performed or described. Therefore, there is no effect size of human readers improving with AI vs without AI assistance. The study described is a comparison of the new devices against predicate devices and clinical samples.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The EliA™ system is described as a "fully integrated and automated system for immunodiagnostic testing" performed on ImmunoCAP® 100/ImmunoCAP® 250 instruments, which "include software for evaluation of test results." This implies that the device itself is the "algorithm" or automated test. The performance described (comparability to predicate, clinical samples, healthy subjects) is inherently the standalone performance of the device system.

7. Type of Ground Truth Used

The ground truth for the performance evaluation appears to be based on:

• Clinical diagnosis: "clinically defined sera" and diagnoses like scleroderma (CREST Syndrome), mixed connective tissue disease (MCTD), systemic lupus erythematosus (SLE), and Sjögren's syndrome.
• Healthy status: "samples from apparently healthy subjects (normal population)."

This is a form of clinical ground truth, derived from established medical diagnoses and healthy cohorts.

8. Sample Size for the Training Set

The document does not provide information on a separate "training set" sample size. For IVD devices, a dedicated "training set" in the machine learning sense is often not explicitly mentioned in this type of submission unless a new algorithm is being developed. The "calibration" of the device uses six WHO-standardized IgG Calibrators, but this is for assay calibration, not algorithm training data.

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

Since a dedicated "training set" for an algorithm in the machine learning context is not described, the method for establishing its ground truth is not applicable/not provided. The device calibration uses a set of six WHO-standardized IgG Calibrators.

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