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The SYNCHRON Systems Thyroxine (T4) Reagent is intended for the quantitative determination of total thyroxine concentrations in serum on SYNCHRON Clinical Systems.

Device Description

The SYNCHRON Systems Thyroxine (T4) Reagent kit, which includes the T4 Reagent and the T4 Calibrators, in intended for use on Beckman's SYNCHRON Clinical Systems.

AI/ML Overview

Here's an analysis of the provided text regarding the SYNCHRON Systems Thyroxine (T4) Reagent, focusing on acceptance criteria and supporting studies:

This document is a 510(k) Summary of Safety & Effectiveness for an in vitro diagnostic device, not a medical imaging AI device. Therefore, many of the requested fields (like the number of experts, adjudication methods, MRMC studies, standalone performance for AI, training set details) are not applicable to this type of submission. The 'ground truth' in this context refers to the true concentration of T4 in a sample, which is established by comparison to a legally marketed predicate device.

Acceptance Criteria and Device Performance for SYNCHRON Systems Thyroxine (T4) Reagent

1. Table of Acceptance Criteria and Reported Device Performance

For in vitro diagnostic devices like this, the primary acceptance criteria revolve around demonstrating equivalence to a legally marketed predicate device through method comparison, imprecision, and stability. While explicit numerical acceptance criteria are often present in the full submission, this summary provides the performance results that are implicitly compared against such criteria to demonstrate equivalence.

Performance Metric	Acceptance Criteria (Implied for Equivalence)	Reported Device Performance
Method Comparison	Slope: Close to 1.0 Intercept: Close to 0 Correlation Coefficient (r): High (e.g., >0.95 or >0.98)	Slope: 1.018 Intercept: 0.12 µg/dL r: 0.992
Imprecision (Within-Run)	%C.V. should be within acceptable limits for diagnostic assays (e.g., typically <10% for many assays, especially at lower concentrations, and improving at higher concentrations).	Level 1: 4.3% C.V. Level 2: 2.4% C.V. Level 3: 1.7% C.V.
Imprecision (Total)	%C.V. should be within acceptable limits for diagnostic assays (slightly higher than within-run, but still demonstrating good reproducibility).	Level 1: 8.8% C.V. Level 2: 4.3% C.V. Level 3: 2.4% C.V.
On-Board Stability	Reagent performance (e.g., accuracy, precision) remains within specifications for the claimed stability period.	Study conducted, but specific quantitative results not provided in this summary. Stated simply as "Stablity Studies that folder round Casino CEDIA MAb Thyroxine Reagent with a SYNCHRON Application."

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

Method Comparison (Test Set):
- Sample Size: N = 97 samples
- Data Provenance: Not explicitly stated (e.g., country of origin). It's reasonable to infer these would be human serum samples collected for clinical testing purposes. The study is retrospective in the sense that the samples are tested by both methods simultaneously or sequentially to compare results.
Imprecision Study (Test Set):
- Sample Size: N = 80 replicates per level (Level 1, Level 2, Level 3). This is typically 2 replicates per run over 20 runs, or similar design.
- Data Provenance: Not explicitly stated. These would be control materials or pooled human serum samples at different T4 concentrations.

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

N/A. This is an in vitro diagnostic device. The "ground truth" for the test set is established by the predicate device (Boehringer Mannheim CEDIA MAb Thyroxine Reagent), which is a legally marketed and presumably well-validated T4 assay. There are no "experts" establishing ground truth in the sense of reviewing images or clinical cases.

4. Adjudication Method for the Test Set

N/A. This concept is not applicable to a chemical assay where results are quantitative values. The "adjudication" is essentially the comparison of the SYNCHRON T4 results to the predicate device's results.

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

N/A. This is an in vitro diagnostic device, not an AI software or imaging device. There are no human "readers" involved in interpreting the results beyond reading the numerical output.

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

Yes, effectively. The performance data presented (method comparison, imprecision) represents the standalone performance of the SYNCHRON Systems Thyroxine (T4) Reagent and SYNCHRON Clinical System. It is an automated assay; there is no "human-in-the-loop" once the sample is loaded and the assay initiated, beyond quality control monitoring and result review.

7. The Type of Ground Truth Used

Predicate Device Comparison. The "ground truth" for demonstrating equivalence is the results obtained from the Boehringer Mannheim CEDIA MAb Thyroxine Reagent, which is the legally marketed predicate device. This is a common strategy for 510(k) submissions of in vitro diagnostic tests.

8. The Sample Size for the Training Set

N/A. This document describes a chemical reagent for an automated assay. There is no concept of a "training set" in the context of machine learning, as this device does not utilize AI/ML. The product itself (reagent, calibrators) is developed and manufactured, then validated against predicate devices and performance specifications.

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

N/A. As above, there is no training set as this is not an AI/ML device.

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