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The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations.

The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.

The physiological parameters monitored include ECG, non-invasive blood pressure and SpO2. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro is also intended to provide physiologic data over the Unity network to clinical information systems for display.

The ApexPro Telemetry System is composed of six major components:
• The patient worn data acquisition transmitters
• The receiver antenna system infrastructure
• The receivers
• The receiver subsystem
• A computer platform running the ApexPro Telemetry Application
• A computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application)

The provided text is a 510(k) summary for the ApexPro Telemetry System. While it states that the device complies with voluntary standards and mentions quality assurance measures, it does not include detailed acceptance criteria or a study proving that the device meets specific performance metrics.

Here's what can be extracted based on the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: The document states that the ApexPro "complies with the voluntary standards as detailed in The following quality assurance Section 9 of this submission." However, Section 9 is not provided in this document, so the specific voluntary standards and their associated acceptance criteria are unknown. No quantitative performance metrics for the device (e.g., accuracy of arrhythmia detection, sensitivity, specificity) are given in this summary.

2. Sample Size Used for the Test Set and Data Provenance:

Missing Information: The document does not specify any sample size used for a test set, nor does it mention the data provenance (country of origin, retrospective/prospective). The study described is a general "test summary" of quality assurance measures, not a clinical trial with a defined test set of patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Missing Information: Since no specific clinical test set is described, there is no information about experts used to establish ground truth.

4. Adjudication Method for the Test Set:

Missing Information: No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

Missing Information: No MRMC study is mentioned. The document primarily focuses on demonstrating substantial equivalence to a predicate device through technological similarity and quality assurance, rather than a comparative effectiveness study with human readers.

6. If a Standalone (algorithm only without human-in-the-loop performance) was Done:

The document describes the device as processing "physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations." This implies an algorithmic component. However, no standalone performance study details (e.g., sensitivity, specificity of the algorithm itself) are provided in this summary. The "Test Summary" section refers to "Software and hardware testing," which might include standalone performance, but no results are detailed.

7. The Type of Ground Truth Used:

Ground truth for "software and hardware testing" and "safety testing" would likely refer to internal verification and validation against known standards and simulated or real-world scenarios. However, the exact type of ground truth (e.g., expert consensus, pathology, outcomes data) for specific physiological data detection claims is not stated.

8. The Sample Size for the Training Set:

Missing Information: No training set or its sample size is mentioned, as this document is not describing a machine learning model training process in detail.

9. How the Ground Truth for the Training Set was Established:

Missing Information: Since no training set is described, there is no information on how its ground truth was established.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through system description, intended use, and a high-level overview of quality assurance measures, rather than a detailed performance study with specific acceptance criteria and outcome metrics.

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