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The GSP Neonatal Thyroxine (T4) kit is intended for the quantitative determination of human thyroxine (T4) in blood specimens dried on filter paper as an aid in screening newborns for congenital (neonatal) hypothyroidism using the GSP instrument.

The GSP Neonatal T4 assay is a solid phase time-resolved fluoroimmunoassay based on the competitive reaction between europium-labeled T4 and sample T4 for a limited amount of binding sites on T4 specific monoclonal antibodies (derived from mice). The use of 8-anilino-1-naphthalenesulfonic acid (ANS) and salicylate in the T4 Assay Buffer facilitates the release of T4 from the binding proteins. Thus the assay measures the total amount of T4 in the test specimen. A second antibody, directed against mouse IgG, is coated to the solid phase, and binds the IgG-thyroxine complex, giving convenient separation of the antibody-bound and free antigen. DELFIA Inducer dissociates europium ions from the labeled antibody into solution where they form highly fluorescent chelates with components of DELFIA Inducer. The fluorescence in each well is then measured. The fluorescence of each sample is inversely proportional to the concentration of T4 in the sample.

The provided text describes a 510(k) premarket notification for an in vitro diagnostic device, the GSP Neonatal Thyroxine (T4) kit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with specific acceptance criteria and ground truth for disease diagnosis in the same way an AI/ML powered device might.

Therefore, the requested information regarding "acceptance criteria" for an AI device, "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," and "ground truth for training/testing" in the context of an AI/ML study does not directly apply to this submission.

However, I can extract the closest analogous information available within this document, focusing on the performance characteristics presented to demonstrate equivalence.

Here's an attempt to answer the questions based on the provided document, interpreting "acceptance criteria" as performance metrics for this diagnostic kit.

1. Table of Acceptance Criteria and Reported Device Performance

For an in-vitro diagnostic kit like this, "acceptance criteria" are typically defined by demonstrating that the new device performs comparably to or within acceptable ranges relative to a predicate device and established analytical performance specifications. The document provides a comparison of various features and performance characteristics between the new GSP Neonatal T4 kit and its predicate device, AutoDELFIA Neonatal T4 Kit.

• Intra-assay variation 14.9 %
• Inter-assay variation 10.0 %
• Total variation 18.0 %
  Control 2; 8.08 µg/dL serum
• Intra-assay variation 10.6 %
• Inter-assay variation 7.1 %
• Total variation 12.7 %
  Control 3; 18.2 µg/dL serum
• Intra-assay variation 8.2%
• Inter-assay variation 4.3%
• Total variation 9.3 % | Sample 1; 2.0 µg/dL
• Within run 1.0%
• Within lot 15.5%
• Total variation 15.8%
  Sample 2; 4.8 µg/dL
• Within run 7.3%
• Within lot 10.7%
• Total variation 11.4%
  Sample 3; 7.5 µg/dL
• Within run 6.5%
• Within lot 8.4%
• Total variation 8.6%
  Sample 4; 16.6 µg/dL
• Within run 4.5%
• Within lot 7.8%
• Total variation 8.5%
  Sample 5; 19.8 µg/dL
• Within run 7.2%
• Within lot 9.9%
• Total variation 10.3%
  Sample 6; 21.4 µg/dL
• Within run 7.1%
• Within lot 9.8%
• Total variation 10.1% |
  | Measuring Range | 1.5 µg/dL to the highest level calibrator | 1.6 to 30 µg/dL serum |
  | Limit of Blank (LoB) |

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