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The HeartCheck™ Cardi Beat ECG Monitor device with the GEMS Mobile software is an over-the-counter device to be used by patients 21 years of age or older. It is intended to record, store and transfer single channel Heart Rhythm signals and display Heart Rhythm waveforms. This 1-lead cardiac monitor allows remote users to display and transmit their ECG data to medical professionals via a communication device to a remote server.

The HeartCheck™ Cardi Beat ECG Monitor combined with GEMS Mobile software is indicated for users who are concerned about their heart rhythms and may have experienced symptoms that may suggest irregular or abnormal heart rhythms. Symptoms may include:

• · Skipped beats
• · Palpitations
• · Racing heart
• Fainting and lightheadedness
• · Irregular rate
• · History of any related heart abnormalities

The HeartCheck™ Cardi Beat ECG Monitor along with the GEMS Mobile software is not intended to substitute a hospital diagnostic ECG device. Users with an implanted pacemaker or are not recommended to use this device while the implanted device is operational. Users where their pacemaker is operational will not be able to record their ECG under normal sinus rhythm with the pacemaker on.

The HeartCheck™ CardiBeat ECG Monitor device model HC-WE-01 is an ambulatory and telemedicine based solution that is intended to enable uses to record, store, transfer, and display single channel ECG waveforms. The HeartCheck™ CardiBeat ECG Monitor combined with GEMS™ Mobile enables the user to send their ECG recordings to a medical service for review and interpretation by a qualified health service professional, such as a physician.

The 1 lead ECG Event Monitor is specifically designed to operate with GEMS™ Mobile software, a smartphone software configured to run on mobile devices such as smartphones and tablets. The device will record a pre-selected amount of user ECG activity, as directed by the user. Typical configuration is to record 30 seconds of ECG per event.

The HeartCheck™ CardiBeat ECG Monitor is activated through touch by the user whenever a recording is needed. The recorded data serves as a reliable heart rhythm record that may later be shown to physicians or other health care professionals for confirmation of the presence or absence of an arrhythmia. When a user feels that a cardiac event is occurring, the utilization of the HeartCheck™ CardiBeat ECG Monitor with GEMS™ Mobile has the feature of recording this real time data that would otherwise not be possible to capture.

While performing the recording, data is continuously sent to the smartphone or tablet by secure Bluetooth connection technology. Following an initial physician review, the ECG can be displayed for quality and observation purposes on the GEMS™ Mobile application. Users will not be able to view the waveform without a physician's pre-review from the SMART Monitoring system. This system used the HeartCheck™ ECG PEN and GEMS™ Home system (K11159) with an ECG reading service as a predicate device. The recorded data can be stored locally on the mobile device and/or not transmitted to CardioComm Solutions, Inc.'s SMART Monitoring ECG reading service (powered by GlobalCardio™ K111320) for analysis and assessment by qualified professionals.

The provided text is a 510(k) summary for the HeartCheck™ CardiBeat ECG Monitor with GEMS Mobile. It details the device's description, indications for use, and a comparison to predicate devices, but it explicitly states that no clinical testing was conducted to support this submission.

Therefore, I cannot provide a table of acceptance criteria and reported device performance (Point 1), nor can I answer questions regarding sample size for test sets (Point 2), number of experts (Point 3), adjudication methods (Point 4), MRMC studies (Point 5), standalone performance (Point 6), type of ground truth used (Point 7), sample size for training set (Point 8), or how ground truth was established for the training set (Point 9).

The document states:

• "1.3.2 Clinical Testing: No clinical testing was conducted to support this submission." (Page 7)

Instead, the submission for K181310 relies on:

• Nonclinical Testing: Performance evaluation leveraging hardware and software tests and validations, compliant with standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, IEC 62304, ISO 10933-1, ISO 10933-5, and ISO 10993-10. (Page 7)
• Substantial Equivalence (SE) Comparison: The device's indications for use, patient population, parameters measured, and other technical characteristics are compared to a primary predicate device (HeartCheck™ ECG PEN K111159) and a reference device (ECG Check K122184) to demonstrate substantial equivalence. (Pages 7-9)

In summary, the information requested regarding acceptance criteria and a study proving the device meets that criteria through clinical performance testing is not present in the provided document, as no clinical testing was performed for this submission. The device's acceptance was based on nonclinical testing and comparison to legally marketed predicate devices.

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Guava II is intended to be used by 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 multilead ECG devices. Guava II is intended to be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems. Guava II includes an algorithm that will analyze the 12 Lead ECG and produce measurements of the ECG recording as well as textual interpretation. The product also includes an automatic analysis and interpretation software library that provides ECG signal processing and analysis on a beat by beat basis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis for up to twelve (12) leads of historic ambulatory ECG data. The Guava II algorithm analysis can detect and classify arrhythmias and may be used to triage data, however, Guava II is not intended to offer independent diagnosis or provide medical alarms. Clinical judgment and experience are used to check and interpret the data as part of a diagnosis. Guava II is not for use in lifesupporting or sustaining systems or EGG monitoring devices. Guava II is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate.

The Guava II is a medical device software with a formal Application Programming Interface (API). The API can be invoked from Host Applications to provide services for capturing, storing, retrieving, viewing, editing, and analyzing ECGs (1-, 2-, 3-Channel and 12-Lead) and other Biosignals. Guava II may also be licensed to 3rd party organizations interested in embedding the capabilities within their own products. When the Guava II is used in other medical products, manufacturers will identify the indications for use depending on the application of their device.

The Guava II 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.

Here's an analysis of the acceptance criteria and study information for the Guava II device based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) nor provide detailed quantitative performance metrics for the Guava II device's algorithm. Instead, the performance testing section broadly states:

• "The device complies with AAMI EC11 and AAMI EC38 standards."
• "Verification and validation activities related to the device modification were performed on the applicant device, and the predetermined acceptance criteria were met in all cases."

Without specific numerical criteria or results, a table of acceptance criteria and reported performance cannot be generated in the traditional sense of metrics like sensitivity or accuracy. The "acceptance criteria" here are defined by compliance with AAMI standards and the successful outcome of the V&V activities.

If we were to infer the "reported performance" based on the conclusion, it would be "substantially equivalent to the predicate devices" and that its functions are "identical in function" to the QRS Algorithm in the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not specified in the provided document.
• Data Provenance: Not specified in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  • The Intended Use section states that "Clinical judgment and experience are used to check and interpret the data as part of a diagnosis," implying human expertise is involved in the clinical workflow, but this does not directly describe the establishment of a ground truth for a test set in a study.

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

• Not specified.

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 MRMC comparative effectiveness study involving human readers with and without AI assistance is mentioned. The study described focuses on the device's own performance and its equivalence to predicate devices, not on human reader improvement.

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

• Yes, a standalone performance assessment of the algorithm appears to have been conducted. The statement "The Guava II Louvain Data Processor performs automated ECG analysis and interpretation in the same manner as GlobalCardio. The two products use the identical machine code library (DLL) to perform the analysis, and testing demonstrates the QRS Algorithm embedded in the Guava II Louvain Data Processor is identical in function to the QRS Algorithm embedded in GlobalCardio" suggests a direct comparison of the algorithm's output.
• "Verification and validation activities related to the device modification were performed on the applicant device, and the predetermined acceptance criteria were met in all cases. The activities included scenario validations, algorithm confirmation testing, and device functional testing." This also points to standalone algorithm testing.

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

• The document does not explicitly state the type of ground truth used for performance testing. However, given the context of ECG analysis and comparison to a predicate device, it is common for the ground truth to be established by expert cardiologist review/consensus of the ECG waveforms, or by comparison to the established accuracy of the predicate's algorithm (implying the predicate’s ground truth method was implicitly used). The closest hint is the reference to "Clinical judgment and experience are used to check and interpret the data."

8. The sample size for the training set:

• Not specified. The document primarily discusses performance testing and equivalence to predicate devices, not the development or training of the algorithm.

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

• Not specified. As no training set information is provided, no details on its ground truth establishment are available.

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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 multilead ECG devices. GlobalCardio includes a QRS Algorithm that will analyze the 12 Lead ECG and produce measurements of the ECG recording as well as textual interpretation.

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 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, transtelephonic pacemaker follow-up, implantable cardioverter defibrillator (ICD) follow-up, in-clinic follow-up, 12 Lead ECG testing, 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.

The purpose of this submission is to include the 12 Lead ECG and Digital Device Integration modules.

The provided 510(k) summary for K111320 (GlobalCardio) describes performance testing as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Verification and validation activities related to the device modification were performed on the applicant device, and the predetermined acceptance criteria were met in all cases." It then lists the types of activities:

• Scenario validations
• Report viewing and customization testing
• Algorithm confirmation testing
• Device functional testing

However, specific acceptance criteria (e.g., numerical thresholds for accuracy, sensitivity, specificity, or specific functional requirements) and the quantitative results of these tests are not provided in this 510(k) summary. The summary only confirms that "predetermined acceptance criteria were met in all cases."

2. Sample Size Used for the Test Set and Data Provenance:

The 510(k) summary does not provide specific details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It broadly mentions "verification and validation activities."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The summary does not specify the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set:

The summary does not describe any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

There is no mention of an MRMC comparative effectiveness study being performed. The device is a data management tool and includes a QRS algorithm to produce measurements and textual interpretation, but it explicitly states: "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 suggests the device is not intended as a standalone diagnostic tool that would typically undergo an MRMC study to compare performance with human readers.

6. Standalone (Algorithm Only) Performance:

An "Algorithm confirmation testing" was performed, indicating that the QRS algorithm's performance was evaluated. However, specific metrics, results, or the methodology of this standalone evaluation are not disclosed in this summary. The device's intended use emphasizes human oversight, so while the algorithm was tested, its standalone performance isn't presented as a primary performance metric for regulatory purposes.

7. Type of Ground Truth Used:

The summary does not explicitly state the type of ground truth used for "Algorithm confirmation testing." Given the nature of a QRS algorithm, it would typically involve comparison against a gold standard derived from expert consensus or highly accurate, manually annotated ECG recordings.

8. Sample Size for the Training Set:

The 510(k) summary does not provide any information regarding the sample size used for the training set of the QRS algorithm.

9. How Ground Truth for the Training Set Was Established:

The 510(k) summary does not provide any information on how the ground truth for the training set was established.

Ask a specific question about this device

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)

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.

1. 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.
2. 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.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. 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.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there's no diagnostic performance being evaluated.
7. The sample size for the training set: Not applicable. This is not a machine learning or AI diagnostic device that requires a training set.
8. 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.

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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 qivers 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 djagnosis 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 version of GEMS includes the EASI algorithm for deriving an approximation to a 12-lead ECG from a 3-channel recording (using the lead placement specified in the EASITrak 12 Model 4100 / Zymed Model 4100 / EASI Arrhythmia Event Monitor user manual). If manual ST segment measurements will be made on the approximated 12-lead ECG, the patient population is limited to the following indications:

Ages: 33 to 82 years Heights: 147 to 185 cm (58 to 73 in) Weights: 53 to 118 kg (117 to 261 lb)

Height to Weight ratios: 1.41 to 2.99 cm/kq (0.25 to 0.54 in/lb)

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 text describes the Global ECG Management System (GEMS), focusing on a new feature: the EASI algorithm for deriving an approximated 12-lead ECG from a 3-channel recording.

However, the document does not contain a study that uses acceptance criteria to prove the device meets these criteria. Instead, it describes the device's functionality, its intended use, and its technological characteristics, particularly the EASI feature. There is a mention of the EASI system providing an "alternative source for 12-Lead ECGs, which are already supported by the approved (unmodified) device," implying a comparison to an existing, approved method rather than a full performance study against defined acceptance criteria.

The submission is a 510(k) for substantial equivalence, which means it likely relies on demonstrating that the new feature is as safe and effective as a legally marketed predicate device, rather than providing extensive performance data against predefined benchmarks for the new feature in isolation.

Therefore, I cannot populate the requested table or answer most of the questions because the necessary information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, etc.) is not present in the provided text.

Based on the provided text, the following can be inferred:

• Device: Global ECG Management System (GEMS)
• New Feature: EASI algorithm for deriving an approximation to a 12-Lead ECG from a 3-channel ECG.
• Context: This is a 510(k) submission for substantial equivalence.

Given the information provided, I cannot complete the table or thoroughly answer the questions about acceptance criteria and study details. The document is a 510(k) summary focused on demonstrating substantial equivalence rather than a detailed clinical validation study report for performance metrics.

Here's what can be extracted, emphasizing the lack of detailed study information:

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

   • No specific acceptance criteria or detailed performance metrics for the EASI algorithm are provided in this summary. The document states, "The EASI feature only supplies an alternative source for 12-Lead ECGs, which are already supported by the approved (unmodified) device. Thus the modification represents a minor change to the functionality of the product and does not change the indications for use." This implies the acceptance criterion was likely demonstrating that it functioned as an "alternative source" consistent with the predicate, rather than precise diagnostic performance targets.
   • The only performance-related information given is for a specific scenario: "If manual ST segment measurements will be made on the approximated 12-lead ECG, the patient population is limited to the following indications: Ages: 33 to 82 years, Heights: 147 to 185 cm (58 to 73 in), Weights: 53 to 118 kg (117 to 261 lb), Height to Weight ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb)". This is a limitation for use, not a performance metric or acceptance criterion.

2. Sample sizes used for the test set and the data provenance:

   • Not specified. The document does not describe a performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable / Not specified. No detailed performance study or ground truth establishment process is described.

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

   • Not applicable / Not specified. No detailed performance study is described.

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. The document does not describe an MRMC study. GEMS is described as a "data management tool" and "does not offer diagnosis or medical alarms," implying it's not an AI-assisted diagnostic tool for Human-in-the-loop performance improvement. Clinical judgment and experience are intended to be used to check and interpret the data.

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

   • Not explicitly described as a standalone performance study with metrics. The document frames the EASI algorithm as an "alternative source" for ECG data which GEMS then manages. There are no reported standalone performance metrics like sensitivity, specificity, or accuracy for the EASI algorithm itself.

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

   • Not applicable / Not specified. No detailed performance study is described that would require ground truth establishment.

8. The sample size for the training set:

   • Not specified. No mention of a training set as this is not a study report.

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

   • Not applicable / Not specified. No mention of a training set or ground truth establishment.

Ask a specific question about this device

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:

1. 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.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
5. 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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not available.
9. 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.

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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 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 using an Internet browser, Microsoft Internet Explorer. GlobalCardio operates as a client server application. GlobalCardio presents an interface to the user to 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, pacemaker follow-up, cardiac rehabilitation data, diagnosis, trans-telephonic monitoring, ECGs, ECG information, clinical history, physician notes, clinical history and associated reports and queries. GlobalCardio is a comprehensive ECG management system that is to be sold on a per-use or fee-for-service business and will not be shipped and installed, but rather, customer accounts which include user IDs and passwords will be created for each authorized client. All activity on GlobalCardio will be recorded by User ID: User IDs will be provided for each user to access their own secure, firewall protected, warehouse database(s). Databases may reside on the organizations computer network, managed by their own firewall. 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 other port, and stored to and retrieved from any computer media. Data 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.

The provided text is a 510(k) Summary for the GlobalCardio device (K013354). It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain the acceptance criteria, details of a study proving device performance against acceptance criteria, or any of the other requested information such as test set size, expert qualifications, or ground truth establishment.

The document states:

• Device Name: GlobalCardio
• Applicant: CardioComm Solutions Inc.
• Date: January 29, 2002
• Intended Use: "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 cardiac related data acquired from a variety of ECG sources including single and multi-lead ECG devices."
• Key Distinction: "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."

Since GlobalCardio is a data management tool and explicitly states it does not offer diagnosis or medical alarms, and requires competent human intervention for interpretation, it is highly unlikely that a study with "acceptance criteria" for diagnostic performance (such as sensitivity, specificity, or accuracy) was performed or would be required for its 510(k) clearance as a data management system.

The 510(k) clearance process for a device like GlobalCardio typically focuses on demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness. This often involves comparing features, data handling capabilities, security, and general functionality rather than clinical performance metrics for diagnosis.

To answer your specific questions, this document provides none of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. These are details often found in a separate clinical study report or a more detailed submission document, which is not included here.

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