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1. For in vitro diagnostic use only. VITROS Chemistry Products CAFFN Reagent Kit is used on the VITROS 5,1 FS Chemistry System to quantitatively measure caffeine (CAFFN) concentration in human serum and plasma of subjects undergoing therapy with caffeine, especially for cases of neonatal apnea.
2. For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assayed control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and CAFFN on VITROS 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. The VITROS 5,1 FS Chemistry 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 range of MicroTip assays, in this case the VITROS Chemistry Products CAFFN Reagent Kit (Reagents 1 and 2, Buffer and Calibrators) and the VITROS Chemistry Products TDM Performance Verifiers, which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS CAFFN assay.
3. The VITROS Chemistry Products Thin Film range of products, which are dry, multilavered, 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 3).

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

This document describes a 510(k) premarket notification for the VITROS Chemistry Products CAFFN Reagent Kit and VITROS Chemistry Products TDM Performance Verifiers I, II, and III.

The primary study establishing substantial equivalence for the CAFFN Reagent Kit is a correlation study comparing its performance to a legally marketed predicate device, the SYVA® Emit® Caffeine Assay.

While the document confirms the device meets the acceptance criteria for substantial equivalence, it does not provide detailed acceptance criteria values or specific performance results in a structured table as requested. However, it does state the key finding of the correlation study.

Here's the information extracted from the provided text, structured to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a numerical format. Instead, it demonstrates substantial equivalence through a correlation study and other supporting studies (precision, expected values, linearity, and specificity summaries are referenced but not detailed). The primary performance metric presented is the correlation between the new device and the predicate device.

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

• Sample Size for Test Set: The document mentions "patient samples" were used in the equivalence study but does not specify the exact number or sample size of patients or samples.
• Data Provenance: Not specified. It's implied to be retrospective or a controlled clinical sample collection, but the country of origin is not mentioned.

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

• Number of Experts: Not applicable. The ground truth (or reference standard in this context) for the test set was established by the predicate device's measurements, not by human expert interpretation.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The comparison is directly between the new device's readings and the predicate device's readings. There is no human adjudication process involved as it's a quantitative chemical assay.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. This is a chemical assay, not an imaging or diagnostic interpretation device that would typically involve human readers.

6. Standalone Performance Study (Algorithm only without Human-in-the-loop performance)

• Standalone Study Done: Yes. The correlation study and other tests (precision, linearity, specificity) represent the standalone performance of the VITROS Chemistry Products CAFFN Reagent Kit on the VITROS 5,1 FS Chemistry System. The results are compared against the predicate device, which also operates in a standalone manner.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the comparison study was the measurements obtained from the legally marketed predicate device (SYVA® Emit® Caffeine Assay). It can also be considered an "established reference method" for comparing new devices.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a chemical reagent kit for an immunoassay, not a machine learning or AI algorithm that typically has a "training set" in the conventional sense. The development of such assays involves analytical validation, not statistical model training.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set in the AI/ML context for this type of device. The development and optimization of the assay would involve various laboratory methods and reference materials, but these are not referred to as "training sets" with associated "ground truth" in this context.

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