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The MYO TestPak used on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic product for the measurement of myoglobin in heparinized plasma. Measurements of myoglobin are used as aids in the rapid diagnosis of renal or heart disease, e.g. acute myocardial infarction.

This myoglobin assay is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. The enzymatic rate of the bound fraction increases directly with the concentration of myoglobin in the sample. The reaction rate is measured by an optical system that monitors the reaction rate via front surface fluorescence.

The information provided describes the Stratus® CS MYO TestPak, an in vitro diagnostic device for measuring myoglobin. The submission focuses on demonstrating substantial equivalence to a previously cleared device, the myoglobin assay performed on the Dade Stratus® analyzer, rather than meeting specific performance acceptance criteria against a defined clinical gold standard.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: 203 unique samples (n=203).
   • Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. It describes a "split sample comparison study," implying prospective collection where each sample was split and analyzed on both devices simultaneously, but this is not explicitly confirmed.

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

   • Not Applicable. For this particular submission, the "ground truth" for the test set was not established by human experts in the classical sense. Instead, the predicate device (Dade Stratus® analyzer) served as the reference method against which the new device's performance was compared for analytical equivalence.

3. Adjudication method for the test set:

   • Not Applicable. Since the "ground truth" was derived from the predicate device's analytical results, there was no expert adjudication process.

4. 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 is an in vitro diagnostic device for measuring a biomarker (myoglobin) and does not involve human readers interpreting images or data where AI assistance would be relevant. The study focuses on analytical performance.

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

   • Yes, in essence. The performance presented is for the Stratus® CS MYO TestPak acting independently to measure myoglobin concentrations. While a human initiates the test and interprets the final numerical result, the "performance" described here (correlation, slope, intercept) is purely analytical and automated by the device. It's a "standalone" analytical performance against a predicate device.

6. The type of ground truth used:

   • The "ground truth" for this substantial equivalence study was the analytical results obtained from the predicate device (Dade Stratus® analyzer). This is a common approach for IVD devices seeking equivalence where an established method exists.

7. The sample size for the training set:

   • Not Applicable / Not Explicitly Stated. This submission does not describe a machine learning algorithm that requires a distinct "training set." The device is a "two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology," which relies on biochemical reactions and an optical system, not on "training" in the AI sense.

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

   • Not Applicable. As there is no described training set for an AI/ML algorithm, this question is not relevant to the provided documentation.

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