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Allergen ImmunoCAP™ is the solid phase component of the Pharmacia & Upjohn in vitro immunodiagnostic systems, which measure specific IgE to the respective allergen bound to the ImmunoCAP™. Allergen ImmunoCAP™ are intended to be used with Pharmacia CAP System™ RAST FEIA and UniCAP® Specific IgE in vitro diagnostic assays.

Pharmacia CAP System RAST® FEIA and UniCAP® Specific IgE are intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other findings, and are to be used in clinical laboratories, as well as, physician office laboratories.

Allergen ImmunoCAP™ consists of a cellulose sponge matrix to which allergenic components are covalently coupled. The matrix is encased in a small round plastic capsule. This capsule is at the same time a holder of the matrix for convenient automation and a reaction chamber.

The sponge matrix is manufactured from activated cellulose derivative to which allergen extract solution is added under defined optimized conditions for the allergen coupling. This solid phase is an excellent carrier of allergens and provides favorable reaction conditions.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • The document states that the function of ImmunoCAP™ was verified by testing "clinical serum samples, with a history or indication of allergy to the specific allergen, and established negative samples." However, no specific numerical sample size is provided for either the allergic or negative samples.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Not specified. The wording "established negative samples" and "history or indication of allergy" suggests these might be existing samples, which could imply a retrospective collection for the clinical testing phase, but this is not explicitly stated.

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

• This information is not provided in the text. The document refers to "established negative samples" and samples with "a history or indication of allergy," implying that the ground truth for these clinical samples was determined previously, likely through standard diagnostic methods or patient history, but the role of experts in establishing this ground truth for the test set itself is not detailed.

4. Adjudication Method for the Test Set

• None described. The document states that samples were tested in two systems (Pharmacia CAP System™ and UniCAP™) and showed "outstanding agreement of outcome," but it doesn't describe an adjudication process for disagreeing results or for establishing the initial ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) test kit designed to measure specific IgE antibodies directly from patient serum, not an AI-powered image analysis system or a device that assists human readers. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

• Yes, in essence, standalone performance was assessed. The Allergen ImmunoCAP™ system, used with the Pharmacia CAP System™ RAST FEIA and UniCAP® Specific IgE assays, operates as a standalone diagnostic system. The performance characteristics described (immunological specificity, testing with clinical samples, reproducibility, stability) evaluate the device's ability to accurately measure specific IgE antibodies independently. The "human-in-the-loop" aspect for these types of IVDs is typically limited to the technician performing the assay and interpreting the quantitative results in the context of clinical guidelines, rather than active human interpretation of data generated by an algorithm that then requires assistance.

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

• The ground truth for the clinical samples appears to be based on a combination of:

  • Clinical history/indication of allergy: For the positive samples.
  • Pre-established negativity: For the negative samples.
  • RAST inhibition: Used to verify immunological specificity, acting as a form of reference verification.

  It does not explicitly state expert consensus, pathology, or outcomes data as the primary ground truth for the test set, but these would logically underpin how clinical history and "established negative" statuses are determined.

8. The Sample Size for the Training Set

• Not applicable / not provided. This device is a diagnostic assay kit (ImmunoCAPs for specific IgE measurement), not a machine learning or AI-based device that typically utilizes a training set for algorithm development. The "training" of such a system would involve optimizing the chemical coupling and assay conditions, which is part of product development and manufacturing process control, rather than a data-driven training set in the AI sense.

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

• Not applicable / not provided. As explained above, this device does not involve a training set in the context of AI or machine learning. The "ground truth" during development would relate to the chemical and biological properties of the allergens and the assay's ability to bind IgE truly, established through biochemical characterization and optimization during the development process.

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