(283 days)
Transtelephonic monitoring of arrhythmia and/or pacemaker implant patients that do not require emergency medical intervention.
In-office acquisition and display of single and/or multi-lead ECG. Collection, storing, reporting, transfer, and management of patient(s) health information.
CardioMagic® 2000 Cardiac Monitoring System Software (CMS) is a productivity enhancing, office automation product. The intended users of CMS are physicians, clinics, and hospitals with cardiac patient follow-up and monitoring practices. CMS is a database software product, intended to involve competent intervention before any impact on health occurs. The software does not analyze the information. Clinical judgment and experience are required to check and interpret the printed reports, as part of the process of evaluating pacemaker performance, or patient ECG rhythms. There are no known contraindications for use of this device.
CardioMagic software is installed on an IBM compatible personal computer, which may also be networked to other PC's. An Instromedix LifeSigns Receiving Center™ (LRC) may be attached to the PC, to acquire transmitted data and waveforms from transtelephonic pacemaker monitors and ECG event recorders.
CardioMagic provides remote control of the LRC, presents the received waveforms and data on the computer screen, assists in editing, viewing, and organizing the received data, and provides database support for patient and device information, and provide reports.
The CardioMagic® 2000 Software is not a device that performs any analysis or provides diagnostic output. It is described as a "productivity enhancing, office automation product" that assists in editing, viewing, and organizing received data, and provides database support. The document explicitly states: "The software does not analyze the information. Clinical judgment and experience are required to check and interpret the printed reports, as part of the process of evaluating pacemaker performance, or patient ECG rhythms."
Therefore, the typical acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, accuracy) are not applicable to this software. The "study" described in the document is a substantial equivalence comparison to predicate devices rather than a performance study in the traditional sense for AI/ML devices.
Here's an analysis based on the provided text, focusing on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Given that the device is a data management and display tool and not a diagnostic AI/ML algorithm, there are no specific performance metrics like sensitivity, specificity, or AUC mentioned. The acceptance criteria relate to its functionality and equivalence to existing systems. The table below summarizes the comparison features, which serve as the "acceptance criteria" for functionality, and the device's reported capabilities.
| Acceptance Feature/Spec (Criteria) | CardioMagic® 2000 Performance |
|---|---|
| Emphasis | |
| MINUETT™ Arrhythmia | YES |
| CONCERTO™ Pacer Follow-up | YES |
| SYMPHONY™ Both | YES |
| Compatibility | |
| Single User | YES |
| Network Compatible | YES |
| IBM Compatible Computers | YES |
| Operating System | WIN 95 |
| Transtelephonic Reception | YES |
| In-Office ECG Reception | YES |
| Screen Tools | |
| ECG Strips Viewing | YES |
| Screen Calipers | YES |
| Edit Transmissions | YES |
| Context Sensitive Help Support | YES |
| Receiver Control | YES |
| Software ECG Filters | YES |
| Pacer F/U | |
| Display/Record ECG and Pacemaker Pulse Events | YES |
| Magnet Mode Markers | YES |
| Non-Magnet and Magnet Mode ECG Collection | YES |
| Manual Entry of Magnet Rate | YES |
| Automatically Measures Pacer Pulsewidth | NO (stated as NO for Symphony) |
| Manual Pacer Pulse Data Entry | YES |
| Records Pacer Pulse Data from Transmitter | YES |
| Measures Pacer Pulse Width | YES |
| ECG F/U | |
| Support of IMX 3X Formats | YES |
| Support of M, IMX 1X Formats | YES |
| Automatically Determines Heart Rate | YES (stated as YES for Symphony) |
| On-Screen Editing of ECG | YES |
| Interfaces | |
| Interfaces to External ECG Transtelephonic Receiver | YES |
| Receives Digitized ECG Signals via Serial Port | YES |
| Implant Interrogator Connection Interface | YES |
| Printer Interface | YES |
| Remote User Support | YES |
| Autodialer | YES |
| Outputs | |
| Hardcopy Report Generation | YES |
| File Transfer | YES |
| Fax Reports | YES |
| Mailing List/Data Merge | YES |
| Electronic Data Transfer/Merge | YES |
| Database | |
| Database Storage and Retrieval | YES |
| Database Search & Filters | YES |
| Relational Database of Patient Demographics, Lead/Electrode, Insurance, Referring Physician Info | YES |
| Relational Database of Implant Info, Programming Parameters, Thresholds | YES |
| Device Dictionary | YES |
| Scheduler | |
| Telephone Calling Schedule | YES |
| Office Call Scheduling | YES |
| Security | |
| Security Key | YES |
| Security Code | YES |
| Net Security (via network) | YES |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as there was no "test set" in the context of proving diagnostic performance. The submission is a substantial equivalence claim based on comparing functionalities of the CardioMagic® 2000 Software to legally marketed predicate devices (previous CardioMagic products, PaceArt CPTS, and PaceBase). The data provenance would refer to the features of these predicate devices and the new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable. There was no ground truth establishment for a diagnostic test set. The review focused on functional equivalence.
4. Adjudication Method for the Test Set
This is not applicable. No test set requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or mentioned. The device does not involve human readers interpreting AI output to improve performance. It is a data management tool.
6. Standalone Performance Study
No standalone performance study (i.e., algorithm only without human-in-the-loop performance) was conducted or mentioned. The software's purpose is to manage and display data, not to perform automated analysis or provide diagnostic outputs independently. The document explicitly states: "The software does not analyze the information."
7. Type of Ground Truth Used
This is not applicable as there was no ground truth for diagnostic or analytical performance. The basis for acceptance was the functional equivalence of the software's features to those of predicate devices.
8. Sample Size for the Training Set
This is not applicable. The CardioMagic® 2000 Software is not an AI/ML model that requires a training set. It's a software application with predefined functionalities.
9. How the Ground Truth for the Training Set Was Established
This is not applicable.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).