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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 instruments Phadia 100, Phadia 250, and Phadia 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.

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 13 new ImmunoCAP Allergen Components to the existing ImmunoCAP Specific IgE assay. No changes are made to the Intended Use or in the Indications for Use statements.

The provided document is a 510(k) summary for the ImmunoCAP Specific IgE system, which measures allergen-specific IgE antibodies. It describes the device, its intended use, and its substantial equivalence to previously cleared devices. However, the document does not contain specific acceptance criteria, a detailed study report with reported device performance metrics (like sensitivity, specificity, accuracy), sample sizes for test and training sets, information on expert review for ground truth, or details about comparative effectiveness studies (MRMC) or standalone performance.

The document primarily focuses on establishing substantial equivalence for the addition of new ImmunoCAP Allergen Components to an existing, cleared ImmunoCAP Specific IgE assay system. The safety and effectiveness of the base system were established in previous 510(k) submissions (K051218, K962274).

Therefore, based solely on the provided text, I cannot fill in the requested table and answer many of the questions directly. The document states: "The new ImmunoCAP Allergen Components were characterized with and compared to the extract based predicate devices with the use of clinical samples, as well as samples from healthy, non-atopic donors. Inhibition studies verified the immunological specificity of the allergen components." This indicates that some form of comparison and characterization was performed, but the specific metrics, methodologies, and quantitative results are not present in this summary.

Here's what can be inferred or stated based on the provided text, and what is explicitly missing:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in the provided text. For diagnostic assays like this, common acceptance criteria would include things like correlation coefficients (e.g., R-squared) when compared to a predicate, agreement rates (e.g., positive percent agreement, negative percent agreement), precision (intra-assay, inter-assay variability), and linearity.
• Reported Device Performance: Not quantitatively reported in the provided text. The text only mentions that components were "characterized with and compared to the extract based predicate devices" and that "Inhibition studies verified the immunological specificity." No specific performance metrics (e.g., sensitivity, specificity, accuracy, precision, correlation) are given.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided text. The text mentions "clinical samples, as well as samples from healthy, non-atopic donors," but no numbers are given.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The samples are referred to generally as "clinical samples."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided. For this type of in vitro diagnostic, "ground truth" often refers to a reference method result, clinical diagnosis, or a composite clinical diagnosis, rather than expert image interpretation. The document implies comparison to "extract based predicate devices," which would serve as a form of reference.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable/not provided. Adjudication methods are typically used in studies involving human interpretation (e.g., radiology studies). For an in vitro diagnostic assay, the "adjudication" would refer to how the reference method result was determined, which is not detailed here.

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:

• Not applicable. This device is an in vitro diagnostic assay, not an AI system assisting human readers. Therefore, an MRMC study is not relevant to this submission.

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

• This device is a standalone in vitro diagnostic test (an automated quantitative assay). Its performance is inherently "standalone" in that it produces a quantitative result. The study described (though details are scarce) would evaluate this standalone performance by comparing its results to a reference method or predicate device.

7. The type of ground truth used:

• Inferred to be results from "extract based predicate devices" or a similar established method for measuring allergen-specific IgE, along with samples from "healthy, non-atopic donors" to assess specificity. Clinical diagnosis of allergic disorders would also be part of the "ground truth" context for the overall assay.

8. The sample size for the training set:

• Not specified. The document does not describe a machine learning model, so a "training set" in that context is not relevant. If referring to internal validation or optimization while developing the new components, that information is not provided.

9. How the ground truth for the training set was established:

• Not applicable as no AI/ML training set is mentioned.

In summary, the provided 510(k) document is very high-level and serves as a summary establishing substantial equivalence for new components added to an already cleared system. It does not contain the detailed study results, methods, or granular data points that would be needed to complete the requested table and answer many specific questions about acceptance criteria and performance metrics for the device itself.

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