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VITROS Free T3 Reagent Pack For in vitro diagnostic use only. The VITROS Free T3 Reagent Pack quantitatively measures free triodothyronine (FT3) concentration in serum and plasma (EDTA or heparin) to aid in the differential diagnosis of thyroid disease.

VITROS Free T3 Calibrators - For in virro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of Free T3 in serum and plasma (EDTA or heparin)

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:

1. The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products Free T3 Reagent Pack, VITROS Immunodiagnostic Products Free T3 Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS Free T3 assay.
2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
3. Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

The provided text describes a 510(k) submission for a new formulation of the VITROS Immunodiagnostic Products Free T3 Reagent Pack and Free T3 Calibrators. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device.

Here's an analysis of the acceptance criteria and the study as described, specifically addressing the points requested and noting where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in terms of performance metrics (e.g., specific thresholds for accuracy, precision, correlation). Instead, it relies on demonstrating "substantial equivalence" to a predicate device. The study's reported performance is a comparison of characteristics and the overall conclusion of equivalence.

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

The document states: "Equivalence was demonstrated using manufactured reagents along with patient samples with measured Free T3 values spanning the assay range." However, the specific sample size used for the test set is not provided.

The data provenance (e.g., country of origin, retrospective or prospective) is not explicitly stated. It can be inferred that the samples are human given the intended use "in human body fluids."

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

This type of information is generally not applicable or discussed for in vitro diagnostic (IVD) assays, particularly those measuring analytes like Free T3. The "ground truth" for an IVD device is typically established by laboratory reference methods or comparison to a predicate device's established values, not by human expert interpretation of images or clinical assessments in the same way as an AI-powered diagnostic imaging tool. Therefore, this information is not present in the document.

4. Adjudication Method for the Test Set

As explained in point 3, the concept of expert adjudication in the context of diagnostic performance for an assay like Free T3 is not typically relevant. The comparison is based on quantitative measurements. Therefore, no adjudication method is described or applicable.

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 done. This type of study is relevant for diagnostic imaging interpretation where human readers are involved. For an automated in vitro diagnostic assay, an MRMC study is not applicable.

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

This device is an in vitro diagnostic assay, which by its nature operates "standalone" in the sense that it performs a chemical analysis to produce a quantitative result without direct human interpretation of the underlying signal in the way an imaging algorithm does. The "algorithm" here is the chemical reaction and detection process. The documentation describes the performance of this system.

While a human clinician interprets the final numerical result, the device itself provides the measurement without human-in-the-loop performance during the assay execution. Therefore, the performance described is inherently "standalone" for the assay's function.

7. The Type of Ground Truth Used

The "ground truth" for this study is essentially the results obtained from the predicate device (VITROS Immunodiagnostic Products Free T3 assay, original formulation).

The document states: "Equivalence was demonstrated using manufactured reagents along with patient samples with measured Free T3 values spanning the assay range." This implies that the new formulation's readings on these patient samples were compared against the established readings of the predicate device on the same samples.

8. The Sample Size for the Training Set

The document does not specify a training set size or mention a distinct "training set" in the context of device development or validation. For chemical assays like this, performance is validated through analytical studies (precision, accuracy, linearity, interference, etc.) rather than "training" an AI model.

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

As there is no mention of a training set in the context of machine learning or AI, this information is not applicable and not provided. The "ground truth" for the predicate device's original establishment would have been through its own rigorous validation studies against reference methods, but this is not detailed for the new formulation's submission which focuses on substantial equivalence.

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