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Infinity Explorer software enables the Patient Vicinity Workstation (PVW) to function as the secondary display for physiological parameters received from the primary Infinity modular monitors. Infinity Explorer displays only visual parameter alarm data for the connected modular monitor and does not generate audible alarms. Audible and visual alarms are available at the primary Infinity modular monitors.

The device is intended to be used in an environment where patient care is provided by healthcare professionals such as physicians, nurses, and technicians trained on the use of the device, who will determine when use of the device is indicated based upon their professional assessment of the patient's medical condition.

The device is intended for use with adult, pediatric, and neonatal populations.

The Infinity Explorer software runs on a specialized medical grade Patient Vicinity Workstation (PVW) and allows the user to extend the viewing capability of the bedside monitor and integrate additional patient information originating from various sources throughout the hospital on a single display. Additional patient information can reside remotely on a clinical information system, HIS, Web, Lab Department, etc.

Specifically, the Infinity Explorer software extends the real-time viewing capabilities of the primary patient monitors that are part of the Infinity modular monitoring series. Infinity Explorer software runs on a dedicated Infinity C700 for IT patient vicinity workstation. The workstation monitors are touch screen computer workstations that allow you to interact with menu functions. However, a keyboard and mouse may also be used to interact with the display. The patient connected bedside monitor is the primary monitoring device and the workstation monitor with Infinity Explorer software is the secondary display monitor. All data to and from the bedside patient monitor is transmitted to or received from Infinity Explorer software over the Infinity Network. Infinity Explorer software can also provide control back to the connected bedside patient monitor. There are no audible alarms on the patient vicinity workstation running Infinity Explorer software. However, there are visual alarms initiated at the primary monitor that present on the workstation display running Infinity Explorer software.

The provided text describes the regulatory clearance for the "Infinity Explorer" software, which functions as a secondary display for physiological parameters from primary Infinity modular monitors. The document focuses on establishing substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific performance acceptance criteria in terms of clinical accuracy or diagnostic efficacy.

Therefore, many of the requested elements regarding acceptance criteria for device performance, sample sizes for test sets, expert involvement, and ground truth establishment are not present in this regulatory document. The performance data section primarily addresses safety, compatibility, and software verification/validation, rather than clinical efficacy.

However, I can extract the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not detail specific sample sizes for test sets in the context of clinical performance or accuracy. The "test sets" referenced are related to engineering and software validation (e.g., electrical safety, EMC, mechanical, software verification).
• Data provenance (country of origin, retrospective/prospective) is not applicable or specified for the types of testing described.

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

• Not applicable. The document describes engineering and software validation tests, not clinical performance studies requiring expert ground truth establishment.

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

• Not applicable. This is not a clinical study involving adjudication of results.

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:

• No MRMC comparative effectiveness study was done. This device is a display software for physiological parameters, not an AI-assisted diagnostic tool.

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

• The document implies standalone performance for the software's functionality and displays visual alarm data independently, but this is assessed through software verification and validation, not as a standalone clinical diagnostic algorithm. It functions as a "secondary display" to a human-monitored primary device.

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

• For the software verification and validation, the "ground truth" would be the expected functional behavior and output as defined by the software requirements and design specifications, and the established standards (e.g., IEC 60601-1-8 for alarms). It does not involve clinical ground truth from expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that would typically involve a "training set" for model development. The verification and validation applies to the pre-programmed software.

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

• Not applicable, as there is no training set mentioned for this type of software device.

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