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The VITROS 5,1 FS Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)

For in vitro diagnostic use only. The VITROS dHDL Reagent Pack quantitatively measures HDL cholesterol (HDLC) concentration in serum and plasma. High Density Lipoprotein (HDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with lower HDL cholesterol concentrations.

For in vitro diagnostic use only. VITROS Chemistry 2. Products Calibrator Kit 19 is used on the VITROS 5,1 FS Chemistry System in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate dHDL.

For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is a saline solution used on the VITROS 5,1 FS Chemistry System in conjunction with VITROS Calibrator Kit 19 to calibrate dHDL.

The VITROS 5,1 FS Chemistry System is a fully automated, computer controlled, clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, drugs of abuse, proteins and other chemistries of clinical interest in biological fluids such as serum, plasma, urine and cerebral spinal fluid (sample type is chemistry dependent). The system has been designed for high volume clinical in-vitro diagnostics applications. The analyzer operates in conjunction with reagents, calibrators and controls designed for use with the system. The instrument provides automatic dilution capability for all assays on board the system. The system analyzes up to 845 tests per hour with up to 40 analytes per sample. Major hardware components include a command center/operator interface, a sampling center, a disposable tip processing center, the VITROS Chemistry Slide General Chemistry center, and the VITROS MicroTip Special Chemistry processing center.

The VITROS Chemistry MicroTip range of products (in this case VITROS Chemistry Products dHDL Reagent Pack, VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1), are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS dHDL assay for HDL cholesterol.

The provided text describes the VITROS 5,1 FS Chemistry System and the VITROS Chemistry Products dHDL assay, including their intended use, device descriptions, and comparison to predicate devices, but it does not explicitly state acceptance criteria or provide a detailed study plan with methodologies typically used to "prove" a device meets acceptance criteria in the way a clinical study would for efficacy.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices through performance characteristics such as precision, correlation, and linearity, which are common for in vitro diagnostic (IVD) devices.

However, I can extract the relevant performance data presented that implicitly serves as evidence for the device's acceptable performance in comparison to its predicates.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The submission demonstrates the performance of the VITROS 5,1 FS Chemistry System and the VITROS Chemistry Products dHDL assay by comparing their characteristics to legally marketed predicate devices. For IVD devices like this, the "acceptance criteria" are generally met by demonstrating that the new device performs equivalently or comparably to existing, approved devices for the intended use. This is primarily shown through method comparison studies, precision assessments, and linearity studies.

1. Table of Acceptance Criteria and the Reported Device Performance

Implicit Acceptance Criteria: The performance (slope, intercept, correlation coefficient, precision, and linearity) of the new device should be comparable to or within acceptable limits relative to the predicate devices. The study aims to show substantial equivalence.

2. Sample size used for the test set and the data provenance

• dHDL Correlation Study Test Set Sample Size: 107 patient samples.
• Other Assays Method Comparison (AST, CREA, PHYT, Na+, URIC): Sample size for these individual method correlations is not explicitly stated, but the 'R' values are provided, implying a comparison was done.
• Data Provenance: The document does not specify the country of origin for the patient samples. It mentions "patient samples," which typically implies prospective collection for such studies, but it is not explicitly stated if they were prospective or retrospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable to this type of device submission. For IVD devices, the "ground truth" is typically established by comparing the new device's measurements against a predicate device or a reference method, rather than expert interpretation of images or clinical findings.

4. Adjudication method for the test set

• This information is not applicable to this type of device submission. Adjudication methods (like 2+1) are typically used for subjective assessments (e.g., image interpretation), not for quantitative measurements by a chemistry analyzer. The "adjudication" here is the mathematical comparison to the predicate device's quantitative 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 information is not applicable to this type of device submission. MRMC studies are relevant for imaging devices that involve human interpretation, often with AI assistance. This device is a chemistry analyzer for quantitative measurements.

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

• The performance data presented (precision, linearity, method correlation) are inherently standalone performance of the analyzer and its assay reagents. As an automated IVD device, its primary function is to provide quantitative results without real-time human intervention in the measurement process itself, beyond loading samples and reagents.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for the new device's performance was established by comparing its quantitative measurements against the results obtained from legally marketed predicate devices. Specifically for dHDL, the predicate was the Bayer Direct HDL Cholesterol II assay. For other assays, the VITROS 950 Chemistry System with its corresponding assays served as the predicate.

8. The sample size for the training set

• The document does not specify a separate "training set" sample size. For IVD devices, method development usually involves internal studies, but the submission focuses on verification and validation studies using patient samples and controls, which are analogous to a test set. There isn't typically an "AI training set" in the context of this type of analyzer.

9. How the ground truth for the training set was established

• As a training set is not explicitly mentioned in the context of AI model development, this question is not applicable. For the development and validation of an IVD assay, ground truth is established through rigorous chemical and biological validation methods, often comparing results against established reference methods or highly characterized control materials, before performance against a predicate is assessed. This is an analytical validation, not an AI model training and ground truth establishment.

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