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For in vitro diagnostic use only. VITROS Chemistry Products TRFRN Reagent is used to quantitatively measure transferrin (TRFRN) concentration in human serum and plasma.

For in vitro diagnostic use. VITROS Chemistry Products Calibrator Kit 20 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM.

For in vitro diagnostic use only. VITROS Chemistry Products Protein Performance Verifiers are assayed controls used to monitor the performance of TRFRN, C3, C4, IgA, IgG and IgM Reagents on VITROS 5,1 FS Chemistry Systems.

The VITROS 5.1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS System is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.

The system is comprised of four main elements:

1 The VITROS 5,1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. The VITROS 5,1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
2 The VITROS Chemistry Products MicroTip range of liquid reagent products (in this case VITROS Chemistry Products TRFRN Reagent, VITROS Chemistry Products Calibrator Kit 20 and VITROS Chemistry Products Protein Performance Verifiers I. II and III), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS TRFRN assay.
3 The VITROS Chemistry Products Thin Film range of dry products, which are dry, multilayered, analytical elements, coated on polyester supports. The thin film products each have their own 510(k) clearance numbers and were cleared for market for use on the VITROS 5,1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers". The required information was provided in the VITROS 5,1 FS Chemistry System premarket notification (K031924).
4 Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2).

The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.

The provided text describes the substantial equivalence of the VITROS Chemistry Products TRFRN Reagent, Calibrator Kit 20, and Protein Performance Verifiers to predicate devices. It does not contain information about acceptance criteria and a study design in the way one would typically describe a clinical validation for a medical imaging AI device. Instead, it focuses on demonstrating equivalence through comparison of assay characteristics and a correlation study.

Here's an attempt to extract relevant information and note the absence of others, aligning with your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pre-defined manner for the performance of the new device relative to a gold standard. Instead, it demonstrates performance by showing correlation and similarity to a legally marketed predicate device.

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

• Sample Size: The document states that "patient samples" were used, but does not specify the exact sample size for the correlation study or other performance studies (precision, sensitivity, specificity, expected values).
• Data Provenance: The document states that "commercially available reagents along with patient samples" were used. There is no information provided regarding the country of origin of the data or whether it was retrospective or prospective.

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

This type of information is not applicable to this submission. The "ground truth" for a quantitative diagnostic assay like transferrin measurement is typically the result obtained from a reference method or another validated diagnostic device (in this case, the predicate device). There is no mention of human experts establishing a ground truth for individual cases in this context, unlike a qualitative diagnostic device (e.g., an AI imaging algorithm).

4. Adjudication Method for the Test Set

This type of information is not applicable to this submission. Adjudication methods (like 2+1 or 3+1) are typically used for qualitative assessments where multiple human readers might disagree, and a consensus needs to be formed to establish ground truth or interpret results. For a quantitative assay, the comparison is directly between numerical 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

This type of information is not applicable to this submission. An MRMC study is relevant for AI-assisted diagnostic tools that interpret images or other qualitative data, showing how AI impacts human reader performance. This submission is for a fully automated in vitro diagnostic assay with no human interpretation component in the direct measurement of transferrin.

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

Yes, this describes a standalone performance study. The VITROS Chemistry Products TRFRN Reagent is designed to quantitatively measure transferrin concentration on the VITROS 5,1 FS Chemistry System. The correlation study compares the results generated by this new automated system (algorithm/device only) directly with the results from the predicate automated system. There is no human intervention in the result generation itself that would constitute a "human-in-the-loop" component.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is the quantitative measurement of transferrin by the predicate device, the IMMAGE® Immunochemistry System TRF Transferrin Reagent on the Beckman IMMAGE® Immunochemistry System (K963427). This is a common approach for demonstrating substantial equivalence for new in vitro diagnostic devices, where the predicate device's established performance serves as the benchmark.

8. The Sample Size for the Training Set

The document does not provide information on a "training set" in the context of an AI/machine learning model. This submission is for a conventional chemical reagent and assay system, not an AI algorithm that undergoes a distinct training phase with a dedicated dataset. The correlation study mentioned uses "patient samples" which would typically be a test set for assessing performance.

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

As there is no mention of a "training set" in the context of AI/machine learning, this question is not applicable. For the performance evaluation, the predicate device results served as the reference for comparison.

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