(32 days)
GlobalCardio is intended to be used as a data management tool for cardiologists, general practitioners, cardiac or ECG technicians, nurses. monitoring service technicians, and other cardiac related institutions or care givers to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multi-lead ECG devices. GlobalCardio will be accessed over the Internet and data will be stored at either the client site or at the central GlobalCardio data warehouse. Data will be secure, and with separate data stores for each client. Users will be able to access specific modules for managing patient cardiac related data such as arrhythmia and implantable pulse generator (such as pacemakers, and implantable cardioverter defibrillators) data that fit their patients' needs. GlobalCardio is intended for use in clinics. hospitals, physician's offices, or anywhere a medical doctor deems appropriate. GlobalCardio does not offer diagnosis or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.
GlobalCardio is a cardiology software product, delivered over the web using the Application Service Provider (ASP) model. GlobalCardio operates on IBM compatible PCs and runs within an Internet browser, Microsoft Internet Explorer. GlobalCardio operates as a client server application. GlobalCardio presents an interface for health care professionals to input, store, query and output data from a centrally hosted, or client based relational database. The product is a web-based database system for the secure storage of all aspects of a patient's cardiology record including: arrhythmia follow-up and diagnosis, trans-telephonic pacemaker follow-up, implantable cardioverter defibrillator (ICD) follow-up, in-clinic follow-up, cardiac rehabilitation data, stress test data pathological diagnosis, ECGs, ECG information, clinical history, physician notes, clinical history and associated reports and queries. GlobalCardio is a comprehensive ECG management system. GlobalCardio is sold in two ways: Per-use or fee-for-service. Software is not shipped and installed, but instead . customer accounts are set up for access and record management from the centrally hosted web application. Login IDs and passwords are created for each authorized client. Databases reside in the secure, firewall protected, warehouse at the application host site. Technology licensing. GlobalCardio technology is licensed to another . company which then hosts a complete service, as described above, including secure data warehousing. All activity on GlobalCardio is recorded by User ID. User IDs are provided for each customer to access their own secure database(s). GlobalCardio is designed as a multi-user system capable of supporting large volumes of simultaneous users. Data can be entered via keyboard, mouse, bar code reader, sound card, serial port, or IrDA port, and stored to and retrieved from any computer media. Information can be displayed on the computer monitor or printed. GlobalCardio is not a life-supporting or life-sustaining system. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.
This 510(k) summary describes a software product, GlobalCardio, which is a data management tool for cardiology records. It explicitly states that GlobalCardio does not offer diagnosis or medical alarms, and that "competent human intervention" and "clinical judgment and experience are used to check and interpret the data."
Therefore, the device itself is not performing any diagnostic or classification tasks that would typically require acceptance criteria based on performance metrics like sensitivity, specificity, or AUC. As a data management tool, its performance is related to its ability to store, retrieve, communicate, and report data reliably and securely.
Given the provided text, there is no study described that establishes acceptance criteria for diagnostic performance or measures the device's accuracy in making medical decisions. The document is a 510(k) submission for a modification to an existing device, adding new data management modules (in-clinic pacing follow-up and ICD follow-up). The focus of the submission is on demonstrating substantial equivalence to the predicate device for its intended use as a data management tool, rather than proving diagnostic accuracy.
Therefore, many of the requested elements (acceptance criteria, reported device performance, sample sizes for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable or not provided in this specific document because they pertain to a different type of device (e.g., an AI-powered diagnostic tool).
However, based on the information provided, we can infer some general "acceptance criteria" related to its functionality as a data management system, even if not explicitly stated with quantitative metrics in this summary:
Table of Acceptance Criteria and Reported Device Performance (Inferred/Not Applicable for Diagnostic Performance)
| Acceptance Criteria (Inferred for a Data Management Tool) | Reported Device Performance (Inferred/Stated Functionality) |
|---|---|
| Data Storage and Retrieval: | |
| Ability to store and retrieve all aspects of a patient's cardiology record. Ability to store data from new in-clinic pacing and ICD follow-up modules. | The product "presents an interface for health care professionals to input, store, query and output data from a centrally hosted, or client based relational database." It manages "all aspects of a patient's cardiology record including: arrhythmia follow-up and diagnosis, trans-telephonic pacemaker follow-up, implantable cardioverter defibrillator (ICD) follow-up, in-clinic follow-up, cardiac rehabilitation data, stress test data pathological diagnosis, ECGs, ECG information, clinical history, physician notes, clinical history and associated reports and queries." New modules allow physicians "to store data and generate additional reports based on that data specific to these encounter types." |
| Data Security: | |
| Secure storage and access of patient data. | Databases reside in a "secure, firewall protected, warehouse at the application host site." "Data will be secure, and with separate data stores for each client." Access relies on "Login IDs and passwords." |
| Accessibility and Communication: | |
| Web-based access for multiple users. | "Delivered over the web using the Application Service Provider (ASP) model." "Operates on IBM compatible PCs and runs within an Internet browser, Microsoft Internet Explorer." "Designed as a multi-user system capable of supporting large volumes of simultaneous users." "Accessed over the Internet." Users "will be able to access specific modules." |
| Reporting Capabilities: | |
| Generation of various reports. | "Generate additional reports" for in-clinic pacing and ICD follow-up. Existing modules already support "associated reports and queries." |
| Data Input Methods: | |
| Support for various input methods. | "Data can be entered via keyboard, mouse, bar code reader, sound card, serial port, or IrDA port." |
| Non-Diagnostic Nature: | |
| Does not provide diagnosis or medical alarms; requires human intervention. | "GlobalCardio does not offer diagnosis or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data." This statement clarifies the device's role and its reliance on human expertise, effectively setting a boundary for its "performance" claims. |
Since this product is a data management tool and explicitly states it does not offer diagnosis or medical alarms, and that "competent human intervention" is required, the following points are largely not provided or not applicable in this 510(k) summary for a diagnostic AI device.
- Sample size used for the test set and the data provenance: Not applicable. While the system manages patient data, the 510(k) is about the software's functionality, not its diagnostic performance on a test set of medical cases.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set for diagnostic accuracy is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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. The device is not an AI diagnostic assistant.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device's function is purely data management, and it explicitly states it requires human interpretation.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there's no diagnostic performance being evaluated.
- The sample size for the training set: Not applicable. This is not a machine learning or AI diagnostic device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the document describes a software system for managing cardiology data, akin to an electronic health record system focusing on a specific medical domain, with added specific modules for pacing and ICD follow-up. Its "performance" and "acceptance criteria" are therefore centered on its functionality as a secure, accessible, and comprehensive data storage and retrieval system, rather than on diagnostic accuracy or AI-driven insights.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).