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For in vitro diagnostic use with the IMMULITE® 2000 Analyzer -- for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders. The test results are to be used in conjunction with clinical findings and other laboratory tests.

IMMULITE® 2000 3gAllergy™ Specific IgE is a solid-phase, two-step, chemiluminescent immunoassay that exploits liquid phase kinetics in a bead format. The allergens are covalently bound to a soluble polymer matrix, which in turn is labeled with a ligand. The use of an amino acid co-polymer amplifies the amount of allergen that the matrix can support.

Here's a breakdown of the acceptance criteria and study information for the IMMULITE® 2000 3gAllergy™ Specific IgE Assay, based on the provided text:

Acceptance Criteria and Device Performance

The study evaluates the analytical performance and clinical performance of the device.

Analytical Performance Acceptance Criteria:

The key acceptance criteria for analytical performance are related to precision, linearity, and specificity. While explicit quantitative criteria were provided for precision, linearity had implied criteria based on excellent regression statistics, and specificity was demonstrated by successful inhibition.

Clinical Performance Acceptance Criteria:

The acceptance criteria for clinical performance are based on the agreement of the device's results with clinical diagnosis, measured by sensitivity, specificity, and overall agreement.

Study Details

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Analytical Test Set Sample Size:
  • Precision: For each allergen lot and each positive sample level, N=80 measurements were performed (2 aliquots per run, 2 runs per day, 20 days). For combined lot precision, N=240 (80 measurements x 3 lots) where applicable. Negative controls were also tested.
  • Linearity: 11 or 12 data points (depending on the allergen) from 2-fold serial dilutions, including undiluted (neat) samples.
  • Specificity (Inhibition): Not explicitly stated how many unique serum samples were used "a single serum sample or pool of sera". For cross-reactivity, one positive sample was tested with three unrelated allergen extracts.
• Clinical Test Set Sample Size:
  • Total Patients: 693 individuals were tested (193 clinically positive, 500 clinically normal).
• Data Provenance: Not explicitly stated for either analytical or clinical studies. However, the manufacturer (Siemens Healthcare Diagnostics Inc. and Siemens Healthcare Diagnostics Products, LTD) has locations in Tarrytown, NY, and Llanberis, Gwynedd, UK. It is likely that the data originates from studies conducted or coordinated by these facilities, potentially involving samples from different geographic locations. The document does not specify whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Analytical Studies: No external experts were used; ground truth was established by the experimental design (e.g., known concentrations for linearity, known positive/negative samples for precision and specificity).
• Clinical Studies: The ground truth for clinical performance was "clinical documentation of presence or absence of signs, symptoms and other diagnostic evidence of allergen sensitivity." The number and qualifications of experts (e.g., allergists, physicians) involved in making these clinical diagnoses are not specified in the provided text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Clinical Studies: The document does not describe any specific adjudication method for establishing the "clinical diagnosis." It refers to "clinical findings and other laboratory tests," implying a standard clinical diagnostic process rather than a formalized adjudication among multiple experts for the purpose of the study.
• Analytical Studies: Adjudication is not applicable as ground truth is based on known analytical properties.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic assay for quantitative measurement of allergen-specific IgE in human serum. It is an automated laboratory test, not an imaging device or AI-assisted diagnostic tool that would involve human readers or AI assistance in interpretation. The study evaluates the performance of the analytical device itself.

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

• This is a standalone diagnostic assay. The IMMULITE® 2000 3gAllergy™ Specific IgE Assay, when run on the IMMULITE® 2000 Analyzer, operates as an automated system. The performance data presented (precision, linearity, specificity, and clinical agreement) reflects the "algorithm only" or "device only" performance, without human interpretive input for the final result beyond operating the analyzer and reviewing the quantitative output. The results are quantitative IgE levels, not qualitative interpretations requiring human judgment (e.g., image reading).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Analytical Studies: The ground truth was based on known properties of the samples and experimental design:
  • Precision: Replicates of the same sample, the true value of which is the mean of the replicates.
  • Linearity: Gravimetrically prepared dilutions with known expected concentrations.
  • Specificity: Known inhibitor extracts and known unrelated allergens.
• Clinical Studies: The ground truth for clinical performance was "clinical documentation of presence or absence of signs, symptoms and other diagnostic evidence of allergen sensitivity." This can be classified as a form of clinical diagnosis and outcomes data, likely based on patient history, physical examination, symptom evaluation, and other relevant diagnostic tests, rather than a single definitive pathology result.

8. The sample size for the training set

• Not applicable / Not explicitly stated. This document describes a 510(k) submission for new allergens to an existing IMMULITE® 2000 3gAllergy™ Specific IgE assay. It details the validation and performance studies for these additional allergens. The IMMULITE® 2000 system and the 3gAllergy™ assay are commercially available, validated technologies. The concept of a "training set" as understood in machine learning (where algorithms are "trained" on data) is not directly applicable here. The assay itself uses established immunochemical principles; it's not a machine learning algorithm that undergoes a training phase with a distinct dataset.

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

• Not applicable. As explained above, this device does not involve an "AI algorithm" or "machine learning" in the traditional sense that would require a separate training set and ground truth establishment for that training phase. The analytical and clinical performance studies are for validation of the assay for the specific new allergens.

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