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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. 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, as well as physician office laboratories. ImmunoCAP Allergen f338, Scallop is to be used with the ImmunoCAP Instrument System, ImmunoCAP 100°, ImmunoCAP 250, and ImmunoCAP 1000.

The safety and effectiveness of the cleared device. ImmunoCAP Specific IgE system for the determination of specific IgE antibodies, have been established in previous 510(k) submissions. This submission covers the addition of a new allergen, ImmunoCAP Allergen, f338, Scallop to the existing ImmunoCAP Specific IgE assay. No changes are made to the Intended Use or in the Indications for Use statements.

The new ImmunoCAP Allergen, f338, Scallop was characterized with the use of samples from patients with case histories of suspected clinical reactions to scallop and/or food intolerance, as well as samples from healthy, non-sensitized donors. Inhibition studies verified the immunological specificity of scallop specific IgE antibody binding.

The provided document is a 510(k) premarket notification for an in vitro diagnostic device (ImmunoCAP Allergen f338, Scallop). It focuses on establishing substantial equivalence to a predicate device for the addition of a new allergen, rather than detailing a clinical study to prove the device meets specific acceptance criteria in the context of AI/ML or image analysis.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission. This document describes a new reagent for an existing immunoassay system, not a device primarily based on AI/ML.

However, I can provide what information is available based on the document's content:

Acceptance Criteria and Study Details for ImmunoCAP Allergen f338, Scallop

This submission is for the addition of a new allergen (f338, Scallop) to an existing ImmunoCAP Specific IgE assay system. The primary goal is to demonstrate substantial equivalence to the predicate device (ImmunoCAP Specific IgE, K051218) for this new allergen. The "acceptance criteria" here refer to demonstrating that the new allergen reagent functions acceptably within the established ImmunoCAP system and shows immunological specificity.

1. Table of Acceptance Criteria and Reported Device Performance

The specific quantitative acceptance criteria (e.g., precision limits, correlation coefficients) are not explicitly stated in the provided summary. However, the study's general objectives and outcomes are described.

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

• Test Set Size: Not explicitly stated. The document mentions "samples from patients with case histories of suspected clinical reactions to scallop and/or food intolerance, as well as samples from healthy, non-sensitized donors." However, the exact number of samples for each group or overall is not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin). The data is retrospective, as it involves "case histories" and collected samples.

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

• Not Applicable: This is not a study requiring expert readers/interpreters (like radiologists). The "ground truth" for the test samples would be established by the patient's clinical history of allergic reactions to scallop (or lack thereof) and independent diagnostic methods, likely including other allergy tests or clinical diagnosis by allergists. The number and qualifications of these clinicians involved in establishing patient histories are not mentioned.

4. Adjudication Method for the Test Set

• Not Applicable: No adjudication method for expert interpretation is mentioned, as this is an in vitro diagnostic device for measuring biochemical markers, not a device requiring human interpretation of complex images or data.

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

• No: An MRMC comparative effectiveness study was not done. This type of study is relevant for devices that assist human readers in interpreting clinical data (e.g., radiology AI), which is not the function of this immunoassay.

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

• Yes (Implicit): The study described is fundamentally a standalone performance study of the reagent within the ImmunoCAP instrument system. The ImmunoCAP system (ImmunoCAP 100°, ImmunoCAP 250, and ImmunoCAP 1000) is automated, processes "all steps of the assay and print results automatically." The new allergen f338 simply functions as a component in this automated system. The evaluation focused on the ability of the f338 to specifically bind IgE, which is a standalone function of the reagent. Human interpretation comes later in the clinical use of the IgE concentration result, but the device itself provides the quantitative measurement without human in-the-loop performance for that specific measurement.

7. Type of Ground Truth Used

• Clinical History/Diagnosis: The samples for evaluation were chosen based on "case histories of suspected clinical reactions to scallop and/or food intolerance," indicating that the clinical presentation and diagnosis of allergy (or non-allergy for healthy donors) served as the reference standard or "ground truth" for selecting and categorizing the samples.
• Immunological Specificity: "Inhibition studies verified the immunological specificity of scallop specific IgE antibody binding." This indicates an in-vitro biochemical test as a component of establishing specificity.

8. Sample Size for the Training Set

• Not Applicable (in the AI/ML sense): This device is an immunoassay reagent, not an AI/ML algorithm that requires a "training set" in the computational sense. The "characterization" of the new allergen involved laboratory testing with various samples, but this is not analogous to training an algorithm.

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

• Not Applicable: As there is no AI/ML training set, this question is not relevant. The "ground truth" for characterizing the allergen's performance related to its ability to detect IgE in clinically defined samples, as described in point 7.

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