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The VITROS Chemistry Products dHDL assay is intended for the in vitro quantitative measurement of HDL cholesterol in human serum or plasma. The VITROS 5,1 FS Chemistry System with enGen™ Laboratory Automation 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.) The VITROS Chemistry Products dHDL Reagent Pack, VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1 are used for the quantitative measurement of HDL cholesterol in serum or plasma.

The modified device is the VITROS Chemistry Products dHDL Reagent Pack, VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1 which are combined by the VITROS 5,1 FS Chemistry System with enGen Laboratory Automation System to perform the VITROS dHDL assay for HDL cholesterol. The VITROS HDL assay has not been changed. The VITROS 5.1 FS Chemistry System (instrumentation, which provides automated use of chemistry reagents) is interfaced to a Laboratory Automation System, which conducts pre-analytical and post-analytical sample and data management.

The provided text is a 510(k) summary for a medical device and does not contain the detailed study information required to answer all parts of your request. This document is a regulatory submission, not a scientific study report.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided 510(k) summary. A 510(k) often asserts substantial equivalence to a predicate device rather than providing extensive performance data against specific acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the provided 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not present in the provided 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not present in the provided 510(k) 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

A multi-reader multi-case (MRMC) study is typically performed for imaging devices where human interpretation is involved. This device is a clinical chemistry system (in vitro diagnostic device) for measuring HDL cholesterol. Therefore, an MRMC study is not applicable and was not performed. The device is an automated system, not one that assists human readers in interpreting images.

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

The device is an automated clinical chemistry system. Its performance is inherently "standalone" in the sense that it performs quantitative measurements without human intervention in the measurement process itself, beyond loading samples and reagents. The 510(k) claims substantial equivalence for the "VITROS dHDL assay performed on the VITROS® 5,1 FS Chemistry System with enGen™ Laboratory Automation System" to "the VITROS dHDL assay performed on the VITROS® 5,1 FS Chemistry System." This implies performance was assessed for the automated system. However, specific details of this assessment are not provided.

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

For a quantitative clinical chemistry assay, the "ground truth" would typically be established by a reference method or a highly accurate laboratory method for measuring HDL cholesterol. However, the specific method used as ground truth for the equivalence study is not mentioned in this summary.

8. The sample size for the training set

This information is not present in the provided 510(k) summary. This document is for a traditional IVD device, not an AI/ML medical device as commonly understood for "training sets." The device is a reagent pack and calibrators used with a chemistry system.

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

Not applicable as this is an IVD device, not an AI/ML medical device with "training sets" in the conventional sense.

Summary of what is available from the text:

• Device: VITROS Chemistry Products dHDL Reagent Pack, Calibrator Kit 19, FS Calibrator 1, used with VITROS 5,1 FS Chemistry System and enGen Laboratory Automation System.
• Intended Use: In vitro quantitative measurement of HDL cholesterol in human serum or plasma.
• Study described (implicitly): A substantial equivalence study comparing the modified system (with enGen Automation) to the predicate system (without enGen Automation) for the dHDL assay.
• Claim of equivalence: The modified device has the same intended use, fundamental scientific technology, and operating principle as the predicate device. The dHDL assay performed on the modified system is substantially equivalent to the dHDL assay performed on the predicate system. This suggests that the study aimed to show performance comparability rather than meeting specific performance criteria against a clinical gold standard.

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