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The Infinity CentralStation (ICS) is intended for use by trained healthcare professionals for the purpose of centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation. Infinity CentralStation with Rest ECG is intended for the production and interpretation of diagnostic electrocardiograms for adult and pediatric patients when connected to a monitor with diagnostic 12-Lead ECG monitoring enabled.

Infinity CentralStation (ICS) Wide (MS26800) consists of medical grade software installed and configured on an information technology platform available in one model with configurable software options and optional touch and/or non-touch widescreen displays.
The Infinity CentralStation (ICS) Wide with proposed VG2 modifications is a Central monitoring station capable of real-time display and storage of multi-parameter physiological patient data and alarm annunciation for patient monitors including but not limited to ambulatory and non-ambulatory wireless telemetry monitoring.

The provided text describes a medical device, the Infinity CentralStation Wide, and its regulatory clearance (K151860). However, it does not contain a detailed study proving the device meets specific performance acceptance criteria for an AI or physiological monitoring algorithm.

The document states that the primary modification (VG2 release) is a change in the operating system for enhanced cybersecurity and that "additional proposed modifications do not significantly alter technological characteristics and do not impact the safety or effectiveness of the device." This suggests the focus was on regulatory compliance related to software updates and overall functionality, rather than a new AI-driven feature requiring a specific performance study.

Here's a breakdown of what is and is not provided, based on your requested information:

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

• Not provided in the document. The document mentions "user acceptance criteria was established and assessed based on user feedback obtained in the form of surveys with pre-determined assessment questions and user ratings for the various functionality tested." This refers to user satisfaction and acceptance, not quantitative performance metrics for a specific algorithm.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not provided. The document mentions "Validation testing was performed in a hospital environment" but does not specify the sample size of patients, data, or source for any performance evaluation. Given the focus on cybersecurity and general functionality updates, it's unlikely a specific "test set" for an algorithm's performance was used in the way implied by your question.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not provided. There is no mention of expert-established ground truth for an algorithm's performance, as no such algorithm performance study is detailed.

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

• Not provided. 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:

• No, an MRMC study was not done or reported. The device is a central monitoring station, not an AI diagnostic aid that assists human readers.

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

• Not applicable/Not provided. The device is a display and management system for patient physiological data and alarms, not a standalone algorithm. While it handles "arrhythmia detection or alarms" (as per the product code MHX), the document focuses on the system's software update and general functionality rather than detailed performance metrics of these detection algorithms. The primary modification mentioned (VG2) is an operating system change for cybersecurity.

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

• Not provided. No ground truth for an algorithm's performance is detailed.

8. The sample size for the training set:

• Not applicable/Not provided. No AI model training or associated training set details are mentioned.

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

• Not applicable/Not provided. No AI model training or associated ground truth establishment for a training set is mentioned.

Summary of Device Performance and Acceptance Criteria (as reported in the document, albeit for general functionality and user acceptance):

Acceptance Criteria Mentioned:

• Performance/Functional Testing: To confirm effective implementation of proposed modifications and that design outputs satisfy design inputs.
• User Acceptance: Established
• User Satisfaction: Assessed
• User Observations: Obtained

Reported Device Performance / Outcome:

Key Takeaway:

This document is a 510(k) summary for a software update (VG2) to an existing central monitoring station (Infinity CentralStation Wide). The primary focus of the regulatory filing and the "performance data" section is on ensuring that the software modifications (mainly operating system update for cybersecurity) do not negatively impact the device's established safety and effectiveness. It does not detail a study rigorously evaluating the performance of a specific AI or physiological monitoring algorithm against quantitative clinical acceptance criteria, as one might expect for a novel AI diagnostic or classification tool. The "acceptance criteria" and "performance" discussed are largely related to confirming the general functionality, safety, and user acceptance of the updated system.

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