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The Centra View patient monitor is intended for monitoring, and recording of multiple physiological parameters. The device is indicated for use in health care facilities by health care professionals whenever there is a need for monitoring of physiological parameters of adult, neonatal, and pediatric patients. CentraView is indicated for use in data collection and clinical information management through cable connections with independent bedside devices. Centra View is not intended for monitoring purposes, nor is it intended to control any of the independent bedside devices it is connected to.

The CentraView System:

• Is intended for use on neonatal, pediatric and adult patients.
• Is intended for use in critical care environments by trained healthcare providers.
• Does not require direct patient contact.
• Is a prescription device which restricts its sale and/or use except by the order of a physician.

The Centra View ™ Device Link System receives digital data produced by external devices through device specific cables, and displays and stores this information for review by health care professionals. When connected to a bedside device, the Centra View™ Device Link System is intended for electronic data collection and clinical information management. Centra View ™ Device Link System is neither patient connected, nor does it remotely control the attached source device.

The provided text focuses on regulatory approval (510(k)) for the Centra View™ Device Link System, a device for electronic data collection and clinical information management. It details the device's purpose, classification, and substantial equivalence to a predicate device, as well as general safety standards and validation studies performed.

However, the document does not contain the specific information requested regarding detailed acceptance criteria, reported device performance metrics against those criteria, or the methodology of a study that would demonstrate such performance. The "validation studies" mentioned ("Device Drive Unit Test" and "Integration Test Analysis") are indicated as performed but no results or specifics about these tests are provided.

Therefore, I cannot populate the requested tables and sections with data from the given text. The information required for a performance study (like sample sizes, ground truth establishment, expert qualifications, etc.) is not present in this 510(k) summary and FDA clearance letter.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:

1. A table of acceptance criteria and the reported device performance:

• Missing: The document mentions "Additional testing and validation studies were performed" (Device Drive Unit Test, Integration Test Analysis) but does not provide any specific acceptance criteria or the performance metrics achieved by the device in these tests.

2. Sample sized used for the test set and the data provenance:

• Missing: The text does not specify any sample sizes for test sets or data provenance.

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

• Missing: No information regarding experts or ground truth establishment is provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Missing: No adjudication method is mentioned.

5. 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 / Missing: This device is a data collection and management system, not described as an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study as typically understood for AI in diagnostics would not be relevant, and no such study is mentioned.

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

• Clarification Needed: The device's function is to collect and display data for health care professionals, not to perform independent diagnostic decisions. Its "performance" would likely relate to data accuracy, integrity, and reliable transmission, not standalone diagnostic performance. No specific details on standalone performance testing are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Missing: No "ground truth" for clinical performance is mentioned, as the device's primary function is data handling, not diagnosis.

8. The sample size for the training set:

• Missing: No training set or machine learning aspects are described for this device.

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

• Missing: No training set is mentioned.

Summary of Device and its Intended Use (from the text):

• Device Name: CentraView™ Device Link System
• Manufacturer: ICU DataSystems, Inc.
• Purpose: Receives digital data from external bedside devices (e.g., blood pressure monitors, cardiac monitors, ventilators, oximeters, CO2 gas analyzers, IV infusion pumps), displays, and stores this information for review by healthcare professionals.
• Indications for Use: Intended for electronic data collection and clinical information management in healthcare facilities. It monitors and records multiple physiological parameters for adult, neonatal, and pediatric patients. It is not intended for monitoring purposes directly, nor does it control connected devices.
• Patient Contact: Does not require direct patient contact.
• Regulatory Status: Cleared under 510(k) as substantially equivalent to a predicate device (Cardiac Monitor, 21 CFR 870.2300, Product Code MWI).
• Standards: Complies with UL and IEEE Safety Standards.
• Validation Studies Mentioned:
  • Device Drive Unit Test
  • Integration Test Analysis
    (Details, acceptance criteria, and results of these tests are not provided in the given text.)

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