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The Quantitative Sentinel (QS) System is a software application that is intended for use as clinical data management system (also referred to as a clinical information system - CIS). The primary function of the system is the management of clinical data (whether manually or automatically acquired) for the purpose of providing integrated, ready and organized access to patient and/or clinical data that would normally be provided on paper records and/or separate clinical systems/devices. The OS System serves as a decision support tool as well as an electronic medical record.

The Quantitative Sentinel (QS) System is a software application that is intended for use as clinical data management system (also referred to as a clinical information system - CIS). The primary function of the system is the management of clinical data (whether manually or automatically acquired) for the purpose of providing integrated, ready and organized access to patient and/or clinical data that would normally be provided on paper records and/or separate clinical systems/devices. The OS System serves as a decision support tool as well as an electronic medical record. The QS System operates on off-the-shelf software and hardware.

This document does not contain the requested information regarding acceptance criteria and a study proving the device meets those criteria.

Instead, the provided text is a 510(k) summary for the Quantitative Sentinel System 7.0, describing its intended use, comparison to predicate devices, and asserting that no clinical testing was necessary to demonstrate conformity to performance requirements.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment.

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