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For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of selected analytes.

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 range of 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 System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products. The VITROS Oncology Controls are intended for in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of selected analytes.

The provided text describes a 510(k) summary for the "VITROS Immunodiagnostic Products Oncology Controls." However, it focuses on demonstrating substantial equivalence to a predicate device rather than detailing a study with specific acceptance criteria and performance metrics of the new device itself.

Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes for test and training sets, ground truth establishment, and details of clinical studies (like MRMC or standalone) is not present in the provided document.

Here's the information that can be extracted or inferred based on the text:

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

This information is not explicitly stated in terms of numerical acceptance criteria or performance metrics for the VITROS Oncology Controls. The document focuses on demonstrating substantial equivalence to the predicate device. The performance is implied to be acceptable if it is "substantially equivalent" to a legally marketed device.

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

• Sample Size for Test Set: Not specified. The document mentions "a minimum of 10 assays" for deriving expected values, but this refers to internal characterization, not a formal test set for demonstrating performance against external ground truth.
• Data Provenance: Not specified. It mentions "different laboratories using different reagent batches" for deriving expected values, suggesting multi-site involvement, but no specific countries or retrospective/prospective nature are detailed for a formal study.

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):

Not applicable/Not specified. This device is a quality control material, not a diagnostic device that requires expert interpretation for establishing ground truth on patient samples. The "ground truth" for a control material would be its reliably characterized concentration of analytes.

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

Not applicable/Not specified. Adjudication methods are typically used in clinical studies where multiple readers interpret images or data, which is not relevant for a quality control material.

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:

Not applicable. This device is a quality control material for an immunodiagnostic system, not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

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

Not applicable. This device is a quality control material, not an algorithm.

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

For this type of device (quality control material), the "ground truth" is the analytically determined, characterized concentration of the target analytes within the control material itself. This is established through rigorous laboratory testing (e.g., replicate analyses, use of reference methods, and statistical determination of mean and standard deviation). The document states, "Each control has quoted, for each specific analyte, a mean value derived from a minimum of 10 assays and a standard deviation anticipated for singleton determinations of each control in a number of different laboratories using different reagent batches. Values are lot specific."

8. The sample size for the training set:

Not applicable/Not specified. This device is a physical quality control material and not an AI algorithm requiring a training set in the conventional sense. The "training" in this context would be the internal characterization of the control material (see point 7).

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

Not applicable/Not specified, as it's not an AI algorithm. For the characterization of the control material (its "ground truth"), it was established by "a mean value derived from a minimum of 10 assays and a standard deviation anticipated for singleton determinations of each control in a number of different laboratories using different reagent batches."

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