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The CLA® Allergen-Specific IgE Assay is a single use in vitro test for the semi quantitative determination of circulating allergen-specific IgE concentrations in human serum.

The CLA® Allergen-Specific IgE Assay is a solid phase in vitro test used for the semi quantitative determination of multiple circulating allergen-specific IgE concentrations in human serum. This submission is to supplement the compliment of available tests with the addition of the Latex allergen.

The provided document describes the Hitachi Chemical Diagnostics Latex Allergen for CLA® Allergen-Specific IgE Assay's special 510(k) Notification, focusing on its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document defines "excellent clinical performance" and "substantial equivalence" to the predicate device as the goals. While explicit numerical acceptance criteria values are not provided, the reported performance metrics (Sensitivity, Specificity, and Efficiency) implicitly serve as the achieved criteria for comparison.

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

• Sample Size: 196 patient serum samples.
• Data Provenance: The study was conducted at "three clinical sites" but the country of origin is not specified. It is a prospective study as results were compared in parallel with the predicate device. The samples were from "patients," implying real-world data collection.

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

• The document states that 95 patients were "diagnosed as clinically allergic to latex" and 101 patients were "clinically negative." This implies that the ground truth (clinical diagnosis of latex allergy) was established by clinicians/medical professionals.
• Number of Experts: Not explicitly stated. It's likely that clinicians involved in the diagnosis and recruitment of these patients established the ground truth, but the number and their specific qualifications (e.g., years of experience, specialty) are not detailed.

4. Adjudication Method for the Test Set

• The document does not specify an adjudication method for establishing the clinical diagnosis of latex allergy. It simply states patients were "diagnosed" or "clinically negative," implying standard clinical practice was followed.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study compares the performance of the new device against a predicate device directly on the same samples, not human readers with or without AI assistance.

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

• Yes, this study is a standalone performance evaluation of the CLA® Allergen-Specific IgE Assay. The device determines IgE levels, and its results are compared to the predicate device. There is no human-in-the-loop component described for the device's operation or the comparison.

7. The Type of Ground Truth Used

• The ground truth used was clinical diagnosis. Patients were classified as "clinically allergic to latex" or "clinically negative" based on their medical diagnosis.

8. The Sample Size for the Training Set

• The document describes a comparative study for regulatory submission (510(k)), not the development of a novel algorithm with a separate training set. Therefore, a distinct "training set" for the CLA® Allergen-Specific IgE Assay is not applicable in the context of this document. The device technology itself (Chemiluminescent Immunoassay) is a laboratory method, not typically an AI/machine learning algorithm requiring a training set in the conventional sense. The "training" for such a system would involve standardization and calibration procedures, which are not detailed here but would be integral to its development.

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

• As noted above, a distinct "training set" in the context of an AI/machine learning algorithm is not applicable to this device description. The document focuses on the validation of the device's performance against a known predicate and clinical classifications.

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