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ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories. ImmunoCAP Specific IgE is to be used with the instruments Phadia 1000, Phadia 2500 and Phadia 5000.

ImmunoCAP Specific IgE reagents are modular in concept and are available individually. For a complete listing of reagents needed to perform the Phadia ImmunoCAP Specific IgE assay, please consult the ImmunoCAP Specific IgE Conjugate Directions for Use.

Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000 instrument systems, and associated software, processes all steps of the assay and calculates results automatically after the assay is completed. Analytical and clinical validation of these components were performed on the representative instrument Phadia 250 and Phadia 1000.

Here's a breakdown of the acceptance criteria and study details for the ImmunoCAP Allergen Components, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for each performance characteristic in a single summary table, but rather presents the results of studies supporting the device's performance. The implied acceptance criteria for most analytical studies would be that the results achieved demonstrate suitable performance for the intended use (e.g., low imprecision, good linearity, sufficient detection limits, absence of significant interference, and adequate stability).

For the purpose of this summary, I'll extract the key performance metrics and the reported results from the provided text.

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

• Precision/Reproducibility:
  • Within-laboratory: 5 or 6 positive samples tested in 4 replicates per day for 20 days (total 80 replicates per sample), except for one sample with 3 replicates for 11 runs over 20 days (33 replicates).
  • Lot-to-lot: 4 or 5 positive samples and 1 negative sample. Each lot (3 lots total) tested with 12 replicates per sample in one run.
  • Provenance: Not explicitly stated, but clinical and non-clinical samples are mentioned in other studies suggesting human samples.
• Linearity: 3 or 4 positive samples, each diluted to generate at least six 2-fold consecutive dilutions. Samples tested with a minimum of 4 replicates in one run.
  • Provenance: Not explicitly stated, but clinical/patient samples are implied.
• Detection Limit: 5 blank samples (for LoB) and 5 low positive samples (for LoD). Blank samples determined in 3 runs with 5 replicates per run. Low positive samples measured in 15 replicates.
  • Provenance: Not stated.
• Analytical Specificity (Inhibition Studies): One positive sample for each ImmunoCAP Allergen component.
  • Provenance: Not stated, implied human.
• Interference (Endogenous Substance): Three samples (two positive and one negative) for each ImmunoCAP Allergen component.
  • Provenance: Not stated, implied human.
• Stability: Three lots of each ImmunoCAP Allergen component. The accelerated stability study for rSes i 1 (f449) used two positive and one negative sample across three lots.
  • Provenance: Not stated.
• Method Comparison Study (vs. Predicate):
  • f433, rTri a 14: 33 positive clinical samples, 10 positive non-clinical samples, 100 negative samples. Total = 143.
  • f416, rTri a 19: 34 positive clinical samples, 14 positive non-clinical samples, 100 negative samples. Total = 148.
  • f449, rSes i 1: 32 positive clinical samples, 30 positive non-clinical samples, 100 negative samples. Total = 162.
  • Provenance: Samples from individuals with clinical history of allergy-like symptoms, sensitized individuals without documented clinical history, and healthy non-atopic donors. The location or retrospective/prospective nature is not specified, but it implies a mix of historical and presumably current clinical samples.
• Clinical Sensitivity and Specificity:
  • f433, rTri a 14: 133 atopic (clinical history of allergy-like symptoms upon exposure to wheat, physician-diagnosed) and 100 non-atopic (healthy, no reported clinical reaction to allergen) samples. Total = 233.
  • f416, rTri a 19: 129 atopic and 100 non-atopic samples. Total = 229.
  • f449, rSes i 1: 35 atopic and 100 non-atopic samples. Total = 135.
  • Provenance: "Selected samples from individuals with a clinical history of allergy-like symptoms upon exposure to wheat/sesame, as diagnosed by a physician" and "samples from healthy subjects with no reported clinical reaction." Location and retrospective/prospective nature not explicitly stated.

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

• For the Clinical Sensitivity and Specificity studies, the ground truth for "atopic" cases was established by "clinical diagnosis of allergy" by a "physician." The specific number or qualifications of these physicians are not detailed in the document. For "non-atopic" cases, it relied on "no reported clinical reaction to the allergen."

4. Adjudication Method for the Test Set

• The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for establishing the clinical diagnosis (ground truth) in the clinical studies. The mention of "diagnosed by a physician" suggests individual physician diagnoses were used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) assay that measures allergen-specific IgE levels, not an imaging device or AI-assisted diagnostic tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

• This device is a standalone diagnostic test in the sense that the assay itself provides quantitative results for specific IgE antibodies. The performance characteristics described (precision, linearity, detection limit, analytical specificity, interference, stability, method comparison, and clinical sensitivity/specificity) are all "algorithm only" or device-only performance measures. The "human-in-the-loop" aspect comes in the interpretation of these quantitative results by a clinician in conjunction with other clinical findings, as stated in the Indications for Use. The clinical studies evaluate how well the device's output correlates with a clinical diagnosis, not how well humans perform with or without the device.

7. The Type of Ground Truth Used

• Clinical Diagnosis (by a physician) / Reported Clinical Reaction: For the clinical sensitivity and specificity studies, the ground truth was based on a "clinical diagnosis of allergy" by a physician for atopic individuals and "no reported clinical reaction" for non-atopic individuals.
• Absence of IgE Antibodies / Healthy Non-atopic Donors: For the method comparison study, "healthy, non-atopic donors" and "undetectable levels of specific IgE antibodies" (<0.1 kUX/L) served as ground truth for negative cases.
• Expected Results: For linearity studies, a calculated "expected result" based on dilution served as the ground truth.
• Defined Concentrations: For precision and detection limit studies, defined concentrations of IgE (or blank samples) were used as a reference.

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set" in the context of device development or machine learning. This is an IVD assay, not an AI/ML device that typically involves a separate training phase with a distinct dataset. The performance data presented are for validation and verification of the device's analytical and clinical performance.

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

• As a "training set" is not explicitly described or applicable in the AI/ML sense for this type of IVD, this question is not directly answered by the document. The "ground truth" used in the various performance studies (as described in point 7) was established through clinical diagnosis, reference methods, or known sample characteristics.

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