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For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System, when used for the measurement of immunoassays which include Cortisol.

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: 1. The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Reagent Pack, VITROS Immunodiagnostic Products Calibrators, which are combined by the VITROS Immunodiagnostic System to perform a VITROS assay). 2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. 3. Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K984310). The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products. The VITROS Immunodiagnostic Products Cortisol Range Verifiers are a base matrix of freeze-dried human plasma spiked with analyte (Cortisol) at low and high levels.

The provided text describes a 510(k) summary for the VITROS Immunodiagnostic Products Cortisol Range Verifiers. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving device performance.

The document focuses on demonstrating substantial equivalence to a predicate device, as required for a 510(k) submission, rather than presenting a detailed performance study with acceptance criteria.

Here's what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The text compares the intended use and matrix of the subject device to its predicate, but it does not specify any quantitative acceptance criteria or performance metrics for the VITROS Cortisol Range Verifiers themselves.

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

This information is not provided in the document. The 510(k) summary focuses on substantial equivalence based on device characteristics rather than a new performance study with a test set.

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 provided in the document. As no detailed performance study with a test set is described, there's no mention of ground truth establishment or experts involved.

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

This information is not provided in the document.

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 and not provided in the document. This device (range verifiers for an immunoassay system) is an in vitro diagnostic product, not an AI-assisted diagnostic tool that would involve human readers and MRMC studies.

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

This information is not applicable and not provided in the document. This is not an algorithm, but a physical diagnostic product. The document describes the "VITROS Immunodiagnostic System" as the instrumentation, but the subject device is the "Cortisol Range Verifiers" used with that system.

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

This information is not provided in the document.

8. The sample size for the training set:

This information is not provided in the document.

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

This information is not provided in the document.

Summary of the Study (as described in the document):

The document does not describe a clinical performance study with defined acceptance criteria and detailed quantitative results. Instead, it discusses a substantial equivalence comparison study to a predicate device (VITROS Immunodiagnostic Products FSH Range Verifiers, K973517).

• Study Goal: To demonstrate that the VITROS Immunodiagnostic Products Cortisol Range Verifiers are substantially equivalent to the predicate device.
• Methodology: Equivalence was demonstrated by comparing the physical properties and intended uses of the subject device with the predicate device and other commercially available reagents.
• Key Comparisons (from Table 1):
  • Intended Use: Both devices are for verifying the calibration range of the VITROS Immunodiagnostic System for the measurement of a particular analyte (Cortisol for the subject device, FSH for the predicate).
  • Matrix of Range Verifiers: Both use a base matrix of freeze-dried human plasma spiked with the respective analyte.
  • Range Verifier Levels: Both have "Low and high" levels.
• Conclusion: The information presented in the pre-market notification (including these comparisons) was deemed sufficient to provide reasonable assurance that the VITROS Cortisol Range Verifiers are safe and effective for their stated intended use and are substantially equivalent to the predicate device.

In essence, the "study" described here is primarily a comparative analysis for regulatory clearance (510(k)) rather than a detailed performance validation study with specific acceptance criteria beyond demonstrating equivalence.

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