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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. ImmunoCAP Specific IgE is to be used with the instruments ImmunoCAP 100, ImmunoCAP 250 and ImmunoCAP 1000. 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.

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 update of ImmunoCAP Allergen f20, Almond. No changes are made to the Intended Use or in the Indications for Use statements.

The updated version of ImmunoCAP Allergen f20, Almond was verified in a comparison study between the currently cleared and the updated ImmunoCAP Allergen f20, Almond. In the comparison study clinical and positive samples, as well as samples from healthy, non-atopic donors were used. Inhibition studies verified the immunological specificity of almond specific IgE antibody binding.

The provided text describes the update of the ImmunoCAP Allergen f20, Almond device, which is an in vitro quantitative assay for measuring allergen specific IgE. The study focuses on demonstrating substantial equivalence to previously cleared devices.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or agreement. Instead, the study's goal was to demonstrate substantial equivalence to an existing predicate device (UniCAP 100 / ImmunoCAP Specific IgE, K962274 and K051218). The reported performance is summarized as follows:

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

• Sample Size: The document does not specify an exact number for the sample size. It states that "clinical and positive samples, as well as samples from healthy, non-atopic donors were used."
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It refers to "clinical and positive samples" and "healthy, non-atopic donors," suggesting human samples were used in a clinical context.

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 document. The study is a comparison between two in-vitro diagnostic devices, not a study involving expert human interpretation of images or clinical assessments to establish ground truth in the traditional sense for diagnostic imaging AI. The "ground truth" for this type of device would typically be derived from the established measurement of IgE antibodies in the samples.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Since the study compares the analytical performance of two in-vitro diagnostic assays, there isn't a need for an adjudication method in the way it's used for interpreting ambiguous human assessments or imaging results. The comparison would involve statistical methods to assess agreement and correlation between the two assays.

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 type of study is relevant for AI systems that assist human readers in tasks like image interpretation. The device described here is an automated in-vitro quantitative assay,
not an AI-assisted diagnostic tool for human readers.

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

Yes, the ImmunoCAP Allergen f20, Almond device operates as a standalone algorithm/device. It is an "in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma" utilizing instruments like ImmunoCAP 100, 250, and 1000, which "process all steps of the assay and print results automatically after the assay is completed." This indicates an automated system without direct human-in-the-loop performance during the assay itself.

7. The Type of Ground Truth Used

The ground truth is implied to be the established IgE levels in the patient and control samples. Since the study is a comparison between a new version of the assay and a previously cleared version, the existing, cleared assay's results would serve as a reference or a highly correlated comparator. For "inhibition studies," the concept of "ground truth" refers to the known immunological principle of specific binding and its inhibition.

8. The Sample Size for the Training Set

This information is not provided and is likely not applicable in the context of this device update. ImmunoCAP systems are based on established immunoassay principles, not typically on machine learning models that require distinct "training sets" in the way AI algorithms do. The "development" of the reagent would involve biochemical optimization, not machine learning training.

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

This information is not provided and is likely not applicable for the same reasons mentioned in point 8.

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