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Cardiac STATus™ Controls (CK-MB/Myoglobin/Troponin I) are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of the Spectral Diagnostics Inc. Cardiac STATus™ CK-MB, Myoglobin, and Troponin I Rapid Tests. These external controls compliment the monitoring of the test performance by the internal control provided in each test device.

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This document is an FDA 510(k) clearance letter for an in vitro diagnostic device, specifically quality control materials for cardiac markers. It does not contain information about a study that assesses a device's performance against detailed acceptance criteria in the way described in the prompt.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, ground truth details, expert qualifications, adjudication methods, MRMC studies, or standalone performance) from this document. This letter primarily confirms that the device is substantially equivalent to a previously marketed device and outlines regulatory obligations.

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Cardiac STATus™ Troponin I Controls are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of the Spectral Diagnostics Inc. Cardiac STATus™ Troponin I Rapid Test. These external controls compliment the monitoring of the test performance by the internal control provided in each test device.

Cardiac STATus™ Controls /Troponin I

The provided document is a 510(k) clearance letter from the FDA for a device called "Cardiac STATus™ Controls/Troponin I". This letter approves the marketing of the device, stating it is substantially equivalent to legally marketed predicate devices. However, the document does not contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details.

The document states the "Cardiac STATus™ Troponin I Controls are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of the Spectral Diagnostics Inc. Cardiac STATus™ Troponin I Rapid Test." This indicates the device is a control material, not the diagnostic test itself.

Therefore, I cannot provide the requested information from this document. The 510(k) summary submitted by the manufacturer (which is not provided here) would likely contain some of these details, particularly regarding the performance data that supported the substantial equivalence claim.

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Cardiac STATus™ Controls are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of the Spectral Diagnostics Inc. Cardiac STATus™ CKMB/Myoglobin Rapid Test. These external controls complement the monitoring of the test performance by the internal control provided in each test device.

Cardiac STATus™ Controls /CK-MB/Myoglobin

I am unable to extract specific acceptance criteria and study details from the provided text to fulfill your request. The document is a 1997 FDA 510(k) clearance letter for "Cardiac STATus™ Controls," which are quality control materials for an in-vitro diagnostic test, not a medical device that performs a diagnosis or algorithm.

The text primarily details:

• The FDA's decision of substantial equivalence for the Cardiac STATus™ Controls.
• Regulatory classifications and requirements for the device.
• Instructions for the manufacturer regarding labeling, promotion, and other regulatory obligations.
• The intended use of the Cardiac STATus™ Controls as "assayed quality control materials in quality assurance programs to monitor the performance of the Spectral Diagnostics Inc. Cardiac STATus™ CKMB/Myoglobin Rapid Test."

There is no mention of a study involving algorithmic performance, human readers, or detailed acceptance criteria for a diagnostic device's accuracy. Thus, I cannot construct the table or answer the specific questions about sample sizes, ground truth, experts, or comparative effectiveness studies that you've asked for.

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