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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). ImmunoCAP Specific IgE is to be used with instruments Phadia 100, Phadia 1000, Phadia 2500 and Phadia 5000. 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.

Device Description

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.

AI/ML Overview

This document, referenced as K150854, is a 510(k) premarket notification for ImmunoCAP Specific IgE, specifically the addition of new allergen components (rCor a 14, nCor a 9, rJug r 1, rJug r 3, rAna o 3). The core of the document is an FDA letter of substantial equivalence and a 510(k) summary, which outlines the device, its intended use, and performance characteristics.

Based on the provided text, the device in question is an in vitro diagnostic assay (ImmunoCAP Specific IgE) used for quantitative measurement of allergen-specific IgE in human serum or plasma. The submission K150854 is for the addition of new ImmunoCAP Allergen Components to an already cleared and established system (referenced under K051218).

The document does not describe a typical AI/ML-based device that would require an MRMC study or AI-specific ground truth methodologies. Instead, it describes an in vitro diagnostic test for allergen-specific IgE antibodies. Therefore, the questions related to AI/MRMC and image-based ground truth establishment are not directly applicable. I will interpret the questions in the context of an in vitro diagnostic test.

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

Device: ImmunoCAP Specific IgE, with newly added ImmunoCAP Allergen Components (rCor a 14, nCor a 9, rJug r 1, rJug r 3, rAna o 3).

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The performance characteristics of the new ImmunoCAP Allergen Components were established through studies of Precision including Lot-to-Lot Reproducibility, Linearity and Limit of Detection. Inhibition studies verified the analytical specificity of the allergen components."

While specific numeric acceptance criteria are not explicitly stated in this summary, the reported performance is that these characteristics were "established" and "verified". For an in vitro diagnostic device, these are standard performance characteristics that need to be within predefined acceptable ranges.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Precision	Demonstrates appropriate repeatability and reproducibility (e.g., within established CV% limits)	"Established through studies of Precision including Lot-to-Lot Reproducibility"
Lot-to-Lot Reproducibility	Consistent results across different manufacturing lots (e.g., within established CV% limits)	"Established through studies of... Lot-to-Lot Reproducibility"
Linearity	Accurate measurement across the reportable range (e.g., results proportional to concentration)	"Established through studies of... Linearity"
Limit of Detection (LoD)	Ability to detect the smallest amount of analyte (e.g., determined and met performance specifications)	"Established through studies of... Limit of Detection"
Analytical Specificity	Measures only the intended analyte without interference from other substances	"Inhibition studies verified the analytical specificity of the allergen components."
Comparison to Predicate Devices	Results from new components correlate well with existing extract-based predicate devices (e.g., strong correlation coefficient, acceptable agreement)	"The new ImmunoCAP Allergen Components were compared with the extract based predicate devices with the use of clinical samples, as well as samples from healthy, nonatopic donors." (Implicitly, the results met a pre-defined equivalence or non-inferiority standard to be cleared.)

2. Sample Size and Data Provenance

Test Set Sample Size: The document mentions "clinical samples, as well as samples from healthy, nonatopic donors" were used for comparison with predicate devices. However, the specific number of samples (N) for these studies or for the precision, linearity, and LoD studies is not specified in this 510(k) summary.
Data Provenance: Not explicitly stated. The manufacturer is Phadia AB located in Sweden, and the distributor is Phadia US Inc. in Michigan, USA. It's common for such studies to involve samples from multiple geographical locations, but this is not mentioned. The data provenance is assumed to be from a clinical setting, as "clinical samples" are mentioned.
Retrospective or Prospective: Not explicitly stated. For "clinical samples", they could be either.

3. Number of Experts and Qualifications for Ground Truth

This question is typically relevant for interpretative devices (e.g., imaging AI). For an in vitro diagnostic measuring a biomarker (IgE levels), the "ground truth" is typically the analyte concentration itself, measured using established laboratory methods or reference standards, rather than expert interpretation of a complex image. Therefore, the concept of "experts" establishing ground truth in the typical AI/MRMC sense does not directly apply here.

The "ground truth" for the test samples would be their known IgE levels for the specific allergens, determined by reference methods or clinical diagnosis supported by established criteria (e.g., patient history, other diagnostic tests for allergy). The "experts" involve qualified laboratory personnel following standard operating procedures and clinicians using and interpreting the results in conjunction with other findings.

4. Adjudication Method for the Test Set

Not applicable in the typical sense of adjudicating disagreements among human readers/interpreters. For an in vitro diagnostic test, the "ground truth" is typically quantitative, established by the assay itself (or a reference assay), and consistency/accuracy is verified against known standards or reference methods.

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

Done? No, an MRMC study was not done. This type of study is specifically designed for AI-assisted image interpretation to assess whether AI improves human reader performance. This device is an in vitro diagnostic assay, not an imaging AI system.
Effect Size: Not applicable as no MRMC study was performed. The device's performance is assessed by its ability to accurately and precisely quantify IgE, not by its impact on human reader interpretation.

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

Done? Yes, in a sense, the device's performance characteristics (precision, linearity, LoD, analytical specificity) are assessed as a standalone assay. The ImmunoCAP Specific IgE system with its instruments (Phadia 100, 1000, 2500, 5000) calculates results automatically. The output is a quantitative value of allergen-specific IgE. Human involvement is in sample preparation, loading, and interpretation of the final quantitative results in a clinical context. The performance characteristics studies described are inherently "standalone" in verifying the analytical accuracy of the assay itself.

7. Type of Ground Truth Used

The ground truth for an IVD like this would be:

Reference Standards/Calibration: For linearity, LoD, and precision, the ground truth is often established by using samples with known, carefully prepared concentrations of the analyte (IgE antibodies).
Reference Methods/Predicate Devices: For comparative studies, the results obtained from the new components are compared against extract-based predicate devices which are already established as providing reliable measurements of allergen-specific IgE.
Clinical Samples: Samples from patients with known allergic status (diagnosed by clinical findings, patient history, other diagnostic tests) and healthy, non-atopic controls are used to assess the device's ability to differentiate between populations, aligning with its intended use in clinical diagnosis.

8. Sample Size for the Training Set

This term "training set" is primarily relevant for AI/ML models. For an IVD, the development and optimization of the assay would involve various experimental samples. The document does not specify a "training set" sample size in the AI/ML context. The development process would have involved numerous runs and samples to optimize the assay formulation, protocols, and instrument parameters, but these are not typically quantified as a "training set" in a 510(k) summary for an IVD.

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

Not applicable as there is no "training set" in the AI/ML sense. The "ground truth" for assay development and validation involves:

Biochemical principles: The assay is based on known antigen-antibody binding reactions.
Analytical standards: Use of purified IgE, allergen standards, and calibrators with assigned values.
Comparison to existing methods: The assay development would have aimed to produce results consistent with established and reference methods for allergen-specific IgE measurement.
Clinical correlation: Validation against clinical diagnosis of allergy to ensure the assay provides useful information in a clinical context.

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