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The LifeSign MI® Myoglobin/Troponin I Rapid Test is intended for use as an in vitro diagnostic product for the rapid qualitative determination of myoglobin and troponin I in serum, human whole blood, or plasma as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care or hospital settings.

LifeSign MI® Myoglobin/Troponin I is simple one step immunochromatographic test for the rapid, qualitative detection of myoglobin and Troponin I.

I am sorry, but the provided text only contains a 510(k) summary for a medical device called "LifeSign MI® Myoglobin/Troponin I Rapid Test." This summary focuses on establishing substantial equivalence to a predicate device and does not include details about acceptance criteria, study results, or other information typically found in a clinical study report.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and the reported device performance. The document does not describe specific performance metrics or acceptance criteria for the device itself. It mainly compares its features to a predicate device.
• Sample sized used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
• If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

The document is a regulatory submission for substantial equivalence, not a clinical performance study report. It focuses on demonstrating that the new device is "exactly the same" as a previously approved predicate device, with the only change being the removal of specific antibodies.

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