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For in vitro diagnostic use only.
The VITROS Magnetic HDL-Cholesterol Reagent and VITROS CHOL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma.
VITROS Calibrator Kit 2
For in vitro diagnostic use only.
VITROS Calibrator Kit 2 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of CHOL, Cl-, ECO2, HDLC, K+, Na+, and TRIG.

The VITROS Chemistry Products Magnetic HDL-Cholesterol Reagent and VITROS CHOL Slides (modified) and VITROS Chemistry Products Calibrator Kit 2

The provided 510(k) summary describes a Special 510(k) submission for modifications to existing devices, specifically the VITROS Chemistry Products Magnetic HDL-Cholesterol Reagent and VITROS CHOL Slides, and VITROS Chemistry Products Calibrator Kit 2. The focus of this submission is to demonstrate substantial equivalence to the predicate device, not necessarily to establish new comprehensive performance criteria from scratch.

Therefore, the information available is primarily a comparison against the existing, cleared predicate device rather than presenting entirely new acceptance criteria and a standalone validation study that would typically be detailed for a novel device.

Here's an analysis based on the available text:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" for the modified device in terms of specific performance metrics (e.g., accuracy, precision targets). Instead, the demonstration of equivalence relies on showing that the modified device performs similarly to the predicate device across relevant characteristics and through comparative studies. The table presented focuses on the differences in device characteristics between the predicate and new device, rather than performance criteria.

However, the "Conclusions" section states: "Equivalence was demonstrated using magnetic HDL-Cholesterol Reagent and manufactured slides along with patient and quality control samples with measured HDL-cholesterol values spanning the assay range." This implies that the de facto acceptance criteria were that the performance characteristics (e.g., accuracy, precision) of the modified device, when measured with patient and QC samples across the assay range, were within acceptable limits of the predicate device's established performance, demonstrating "substantial equivalence."

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

The summary states: "Equivalence was demonstrated using magnetic HDL-Cholesterol Reagent and manufactured slides along with patient and quality control samples with measured HDL-cholesterol values spanning the assay range."

However, specific numerical sample sizes for the test set (number of patient samples, number of QC samples) are not reported in this 510(k) summary.

Data provenance (e.g., country of origin, retrospective/prospective) is not explicitly mentioned. Typically for IVDs, samples would be of human origin, and often from diverse populations to ensure generalizability, but this detail is absent. The study appears to be a laboratory validation study, likely prospective for the purpose of this submission if new lots were manufactured and tested.

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

This is an in vitro diagnostic (IVD) device designed to quantitatively measure a biomarker (HDL-Cholesterol). The "ground truth" for such devices is established by reference methods or comparison to a legally marketed predicate device, as opposed to expert human interpretation of images or clinical assessments.

Therefore, the concept of "experts used to establish ground truth" in the way it applies to imaging AI (e.g., radiologists) is not applicable here. The ground truth would be the actual HDL-Cholesterol concentration as determined by a highly accurate or reference method, against which the device's measurements are compared. The expertise involved would be in clinical chemistry and laboratory professionals performing the reference measurements and statistical analysis.

4. Adjudication Method for the Test Set

As this is an IVD device measuring a quantitative biomarker, an "adjudication method" in the sense of reconciling disagreements between multiple human readers (as in imaging studies) is not applicable. The "adjudication" of results would involve standard laboratory quality control procedures, statistical analysis of agreement between the modified device and the predicate/reference method, and assessment against predefined analytical performance specifications. No specific method beyond general "demonstration of equivalence" is detailed in this summary.

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 question is not applicable as this is an in vitro diagnostic (IVD) device for quantitative measurement of HDL-Cholesterol, not an AI-based imaging diagnostic device assisting human readers.

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

This question is not entirely applicable in the AI sense. This device is a reagent and slide system that, when used with an analyzer (VITROS 250, 550, 750, and 950 Series Analyzers), quantitatively measures HDL-Cholesterol. The "standalone" performance is the device's ability to accurately measure the analyte. The study demonstrated the performance of the modified reagent/slides with the analyzer systems, demonstrating equivalence to the predicate. There isn't a separate "human-in-the-loop" component in the direct measurement process of this type of IVD, beyond a laboratory technician operating the instrument and interpreting the numerical output.

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

For this IVD device, the "ground truth" would implicitly be the measured HDL-Cholesterol values obtained from the predicate device (K984303) or potentially a recognized reference method, as indicated by the statement: "Equivalence was demonstrated... along with patient and quality control samples with measured HDL-cholesterol values spanning the assay range." This implies a comparison against established, presumably accurate, values.

8. The Sample Size for the Training Set

This type of device (reagents and slides for chemical measurement) does not typically involve a "training set" in the machine learning/AI sense. Its performance is based on the chemical reactions and optical measurement principles. The development and optimization of the reagent formulation might involve experimental testing, but it's not a "training set" for an algorithm. Therefore, this information is not provided.

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

Since there is no "training set" in the AI sense for this IVD device, this question is not applicable.

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For in vitro diagnostic use only. The VITROS Magnetic HDL reagent and VITROS Cholesterol slides quantitatively measure HDL-cholesterol (HDLC) in serum and plasma.

Not Found

I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) clearance letter from the FDA for a medical device (VITROS Chemistry Products Magnetic HDL Cholesterol Reagents and VITROS Chemistry Products Calibrator Kit 2).

This type of document confirms that the FDA has found the device to be substantially equivalent to a legally marketed predicate device. It does not typically contain:

• Details about specific acceptance criteria and detailed device performance studies.
• Information on sample sizes for test sets, data provenance, number or qualifications of experts for ground truth, or adjudication methods.
• Results of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance studies.
• Specifics about the type of ground truth used or the sample size and ground truth establishment for a training set.

The document primarily focuses on the regulatory clearance for the device's market entry based on substantial equivalence, rather than a detailed technical report of the studies performed to validate its performance against specific acceptance criteria.

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