(85 days)
GEMS 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, including diagnostic 12-lead devices. Users will be able to purchase specific modules for managing other patient cardiac related data such as pacemaker and rehabilitation data that fit their patients' needs. The ECG module may be licensed to other software developers as an ECG viewer for their products. GEMS is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate. GEMS 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.
GEMS is a software product designed for Microsoft Windows 98, Windows NT, and Windows 2000 operating systems running on an IBM compatible platform. GEMS is compatible with industry standard client server database management systems and as such will operate standalone or on a local or wide area networks. GEMS consists of a user interface that enables health care professionals to input, store, and output data from a relational database. The product consists of a set of modules that can be installed as required to customize the application to individual users' needs. Modular design has the benefit of encapsulating changes within the overall application. If a module changes, then in most cases the change will affect only that module and will not affect the rest of the program. This permits more efficient and controlled development and testing, and prevents new and unknown safety issues and anomalies from being introduced. This stability contributes to the safety and reliability of the product. GEMS is capable of multi-tasking and supports the linking and embedding of related information objects in the ECG. The software stores all aspects of a patient's cardiology record including: arrhythmia diagnosis, pathological diagnosis, ECGs, ECG information, physician notes, clinical history, pacemaker/ICD data and associated reports. Data can be entered via keyboard, mouse, bar code reader, serial port, or IrDA port, and stored to and retrieved from any computer media. Information can be displayed on the computer monitor or printed. GEMS 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.
The provided document describes the Global ECG Management System II (GEMS), a software product designed for managing ECG and patient cardiology data.
However, the document does not contain information about acceptance criteria, a study proving device performance against these criteria, or specific performance metrics (like sensitivity, specificity, or accuracy) derived from such studies.
The 510(k) summary focuses on establishing substantial equivalence to a predicate device (Brentwood PC-ECG K955023) by detailing its intended use, description, and technological characteristics. The only specific performance testing mentioned is for the heart rate calculation feature, which was "completed and submitted according to the relevant sections of AAMI EC38." However, no results from this testing are provided in the document.
Therefore, I cannot populate the requested table or answer most of the questions because the information is not present in the provided text.
Here's a breakdown of what CANNOT be answered based on the provided text:
- A table of acceptance criteria and the reported device performance: Not available. The document states that testing for heart rate calculation was done according to AAMI EC38, but no specific criteria or performance results are disclosed.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not available. The device is described as a data management tool and specifically states it "does not offer diagnosis or medical alarms," and "It is intended that competent human intervention be involved before any impact on health occurs." This suggests it's not an AI-assisted diagnostic tool that would typically undergo MRMC studies for improved reader performance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available.
- The type of ground truth used: Not available.
- The sample size for the training set: Not available.
- How the ground truth for the training set was established: Not available.
The document primarily focuses on regulatory submission (510(k) summary and FDA clearance letter) and establishing substantial equivalence rather than detailing performance studies.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).