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MFM-CMS central monitoring system (hereinafter referred to as MFM-CMS) supports centralized management of patients' clinical data provided by EDAN medical devices. Clinicians can obtain patient clinical data via MFM-CMS. The indications for use of the MFM-CMS central monitoring system include:

• · Viewing patient real-time clinical data and alarms.
• · Storing and reviewing patient clinical data and alarms.
• · Printing real-time and history patient data.
• · Configuring local settings as well as synchronizing settings to a remote device through network.
• · Accessing patient clinical data between several departments.

MFM-CMS is intended to be used only in clinical or hospital environment by well-trained healthcare professionals.

MFM-CMS is indicated for use when monitoring adult and/or pediatric and/or neonate patients as indicated by labeling of the medical device providing the data.

MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded.

The provided text is a 510(k) summary for the Edan Instruments, Inc. MFM-CMS Central Monitoring System. It describes the device, its intended use, and a comparison to predicate devices, but does not contain information related to specific acceptance criteria, reported device performance in those criteria, sample sizes, expert qualifications, or ground truth establishment for a diagnostic AI device.

The submission is for a "Central Monitoring System" (MFM-CMS), which supports centralized management of patient clinical data from other EDAN medical devices. It is classified as an "Arrhythmia detector and alarm (including ST-segment measurement and alarm)" with product code MHX. However, the summary focuses on the system's ability to display, store, review, and print data, and manage settings, rather than its performance as an arrhythmia detector itself.

Therefore, many of the requested details cannot be extracted from this document, as they are typically found in the clinical validation studies of algorithms that perform diagnostic or interpretative tasks.

Here's an analysis based on the information available in the document:

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

This information is not provided in the document. The submission focuses on functional changes and comparison to predicates, not specific performance metrics like sensitivity, specificity, or accuracy for an arrhythmia detection algorithm. The "Performance" section within the comparison table refers to features like "Bi-directional Configuration" and "Data Review," not numerical performance criteria.

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

This information is not provided. The document states "Clinical testing: Not applicable. Clinical testing is not required to establish substantial equivalence to the predicate device." This indicates that no clinical test set was used to validate the device's performance in a diagnostic capacity.

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)

This information is not provided, as no clinical test set for diagnostic accuracy was utilized.

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

This information is not provided, as no clinical test set for diagnostic accuracy was utilized.

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

There is no indication that an MRMC study was done. The device is a "Central Monitoring System" and is not described as an AI-powered diagnostic tool that assists human readers.

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

This information is not provided, as the document does not describe the MFM-CMS as a standalone diagnostic algorithm. Its primary function is a central data management system. Although it is classified under "Arrhythmia detector and alarm," the detailed description of its updates and comparison to predicates emphasizes data handling and system functionality rather than algorithm performance for arrhythmia detection.

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

This information is not provided, as no clinical validation study is described.

8. The sample size for the training set

This information is not provided. As the submission focuses on software updates and functional equivalence, details about training sets for an AI algorithm are not relevant or discussed.

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

This information is not provided, as no clinical validation study or AI training is described.

Summary of what is available in the document:

The document describes the MFM-CMS as a central monitoring system that connects to other EDAN medical devices to manage patient clinical data. The submission is for an updated version (K232694) of an existing device (K120727), with the primary predicate being the BeneVision Central Monitoring System (K220058).

Key changes and comparisons:

The main changes to the software include:

• Add distributed function.
• Add license authorization.
• Support department management, device management, and user management.
• Support time synchronization function.
• Support data automatic dump function.
• Replace the software development platform.
• Supports simultaneous login of multiple clients.
• Support domain account to log in to the CMS client.

The comparison table highlights similarities and differences in intended use, operating system support, data review features, calculations, telemetry support, print capabilities, and network connectivity between the subject device and its predicate.

Performance Data (as per the document):
The document states:

• Non-clinical test: Biocompatibility testing and Electrical safety & electromagnetic compatibility (EMC) are "Not applicable."
• Software Verification and Validation Testing: Conducted in accordance with FDA guidance for software in medical devices.
• Bench Testing: Functional and system-level testing was conducted to validate performance, and results "show that the subject device meets relevant consensus standards" (e.g., IEC 60601-1-8:2006 + Am1:2012 for alarm systems).
• Clinical testing: "Not applicable. Clinical testing is not required to establish substantial equivalence to the predicate device."

Conclusion: The submission concludes that "The bench testing data and software verification and validation demonstrate that MFM-CMS Central Monitoring System is substantially equivalent to the predicate devices."

In essence, this FDA 510(k) summary focuses on demonstrating that the updated MFM-CMS system maintains the safety and effectiveness of its predicate devices through non-clinical testing and software verification, rather than providing a detailed performance study of a diagnostic algorithm against specific clinical acceptance criteria.

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