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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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The Tablet Commander device is for use by patients to collect and transmit general health information, physiological measurements and other data between themselves and a caregiver.

The Tablet Commander makes no diagnosis. Clinical judgment and experience are required to check and interpret the information transmitted. The Tablet Commander is not intended as a substitute for medical care.

The Tablet Commander is a software application. Once installed on a commercially-available device, the Tablet Commander software uses standard communication protocols to exchange information with other medical devices (peripherals). Data collected from the medical devices is transmitted back to a database for review by a caregiver. The Tablet Commander software has a user interface which allows the patient and caregiver to communicate using methods which include questions and answers.

The provided text describes a 510(k) premarket notification for the "Tablet Commander" device, a software application for remote patient monitoring. The application focuses on functional and safety analysis rather than diagnostic accuracy. As such, acceptance criteria and performance metrics related to diagnostic accuracy (like sensitivity, specificity, or AUC) are not applicable or provided in this document.

Here's an analysis based on the information provided:

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

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or similar diagnostic measures. Instead, the acceptance is based on the device functioning according to its requirements and specifications, and demonstrating substantial equivalence to predicate devices in terms of intended use, technology, materials, and principles of operation, without introducing new hazards.

The key performance criterion is that the device "functioned according to its requirements and specifications." The validation activities supporting this are described as:

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

The document does not mention a specific "test set" in the context of clinical data or diagnostic performance. The validation appears to be primarily focused on software functionality and engineering verification and validation (V&V) activities. Therefore, details about the sample size for a test set, data provenance, or whether it was retrospective or prospective are not provided.

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)

Since there is no mention of a "test set" requiring ground truth establishment through expert review for diagnostic purposes, this information is not applicable and not provided in the document.

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

Similarly, as there is no diagnostic "test set" needing ground truth establishment, no adjudication method 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 MRMC comparative effectiveness study was conducted or is mentioned, as the device is a remote patient monitoring system and not an AI-assisted diagnostic tool.

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

The Tablet Commander is described as a "software application" that collects and transmits data for review by a caregiver. It explicitly states, "The Tablet Commander makes no diagnosis," and "Clinical judgment and experience are required to check and interpret the information transmitted." This indicates that the device is not intended for standalone diagnostic performance; it functions as a data collection and transmission tool within a human-in-the-loop system. Therefore, a standalone algorithm-only performance study (in a diagnostic sense) was not done, and would not be relevant to its intended use.

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

For the software validation, the "ground truth" implicitly refers to the device's functional requirements and specifications. The V&V testing confirms that the software behaves as designed and meets these predefined requirements, rather than validating against clinical ground truth like pathology or expert consensus on a diagnosis.

8. The sample size for the training set

The document does not describe the use of machine learning or AI models that would require a "training set" for diagnostic algorithm development. The device is a software application for data management and communication.

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

As there is no mention of a training set for machine learning, this information is not applicable and not provided.

Summary of the study and its purpose:

The study described is not a performance study in the typical sense of evaluating diagnostic accuracy using clinical data. Instead, it is a verification and validation (V&V) study of a software application for remote patient monitoring, conducted as part of a 510(k) premarket notification. The purpose was to demonstrate that the "Tablet Commander" software functions according to its requirements and specifications and that it is substantially equivalent to legally marketed predicate devices without raising new questions of safety or effectiveness.

The key study type conducted was risk-based verification and validation testing of the software, following FDA guidances ("Guidance for the Content of Premarket Submissions for software Contained in Medical Devices" and "General Principles of Software Validation") and using IEC 62304 as a model for software development. This type of study focuses on ensuring the software is correctly built (verification) and that it meets specified user needs (validation) within its intended technical scope, rather than clinical efficacy or diagnostic performance. No clinical tests were conducted because the device was considered to present no new hazards to safety or effectiveness compared to predicate devices.

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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.

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The Commander III is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site.

The Commander III is an FDA cleared device (K053303, K053304). It is similar to a simple personal computer with a modem that stores and transmits data to remote locations. The Commander III is cleared for use with a pulse oximeter, a weight scale, a glucose meter, a peak flow meter and a blood pressure cuff. This premarket submission seeks to add an additional pulse oximeter, the PO100, for use with the Commander III. The PO100 is a reusable pulse oximeter that connects to the Cardiocom Commander III via a cable in the same manner as the currently cleared pulse oximeter.

The provided text is a 510(k) summary for the Cardiocom Commander III, seeking to add an additional pulse oximeter (PO100) for use with the device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, much of the requested information cannot be extracted from this document, as it describes a regulatory submission focused on substantial equivalence rather than a detailed performance study with acceptance criteria.

However, based on the provided text, here's what can be gathered and what cannot:

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

This information is not provided in the document. The submission states: "To verify that device design met its functional and performance requirements, representative samples of the device underwent electrical, mechanical and clinical testing in accordance with applicable industry standards." However, it does not specify the numerical acceptance criteria or the quantitative results of these tests for the Commander III or the PO100.

2. Sample size 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 in the document. The text mentions "representative samples of the device" were tested, but no details on the sample size or the nature of the data are given.

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 in the document. The submission does not detail any expert-driven ground truth establishment.

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

This information is not provided in the document.

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

This information is not provided and is not applicable. The device described (Commander III with PO100) is a medical device for collecting and transmitting vital sign data, not an AI or imaging diagnostic tool that would typically involve human readers or MRMC studies.

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

This information is not explicitly detailed in the context of specific performance metrics. The submission focuses on the Commander III's ability to "store and transmit data to remote locations" and its use with various sensors, including the new PO100 pulse oximeter. The "functional and safety testing" mentioned implies testing the device's standalone performance in accordance with industry standards, but no specific results are given.

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

This information is not provided in the document. Given the nature of the device (a data collection and transmission system), ground truth would typically refer to the accuracy of the vital sign measurements provided by the connected sensors (like the pulse oximeter) compared to a gold standard, but this is not discussed in the summary.

8. The sample size for the training set

This information is not applicable/provided. The device is not an AI/machine learning algorithm requiring a "training set" in the conventional sense. Its functionality is to collect and transmit data from established medical sensors.

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

This information is not applicable/provided for the same reasons as point 8.

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The Commander III device is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site.
Contraindications, Precautions and Warnings: The Commander III device makes no interpretation, evaluation, medical judgments or recommendations for treatment. Clinical judgment and experience are required to check and interpret the information transmitted. The Commander III is not intended as a substitute for medical care.

Commander III is similar to a simple personal computer with a modem that stores and transmits data. Commander III connects to a user's telephone line at home. It has a display that asks health related questions to which the user can respond 'Yes', 'No', or select from a list. It also has inputs for devices such as weight scales, blood pressure meters, glucometers, peak flow meters and pulse oximeters. These devices download data through a RS232 connection. The functionality of these devices has not been modified; they are used as supplied from the manufacturer.

Here's an analysis of the provided text regarding the Cardiocom Commander III, broken down by your requested categories.

Important Note: The provided document is a 510(k) summary for a medical device seeking clearance based on substantial equivalence. This type of submission relies on showing that a new device is as safe and effective as a legally marketed predicate device (K982481 A&D Medical UA-767PC Digital Blood Pressure Monitor in this case), rather than requiring extensive de novo clinical trials to prove efficacy from scratch. Therefore, many of the typical acceptance criteria and study details for AI/ML devices, such as multi-reader multi-case studies or detailed ground truth establishment, are not present in this type of submission. The focus is on demonstrating comparability to the predicate device, particularly in areas like accuracy and safety standards.

Acceptance Criteria and Device Performance

Study Proving Acceptance Criteria:

The document states, "The results of bench, laboratory, and clinical testing indicates that the new device is as safe and effective as the predicate device." And in the conclusion: "After analyzing bench, test laboratory, and clinical testing data, it is the conclusion of Cardiocom that the Cardiocom Commander III is as safe and effective as the predicate device, has essentially no significant technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device."

This indicates that studies were performed to demonstrate that the Commander III meets the same performance and safety standards as the predicate device, specifically ANSI/AAMI SP10: 1992+A1 for blood pressure accuracy.

Additional Information Not Extensively Detailed in the Provided Text:

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

   • The document mentions "clinical testing data" but does not specify the sample size for a test set or the data provenance (e.g., country of origin, retrospective/prospective). As a 510(k) based on substantial equivalence, the clinical testing would likely be focused on demonstrating comparable performance to the predicate against established standards (like AAMI SP10), which often involves a specific number of subjects. However, these specifics are not in the provided summary.

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

   • Not applicable/Not specified in this type of submission. For blood pressure monitors, accuracy is typically assessed against a reference standard (e.g., a mercury sphygmomanometer used by trained clinicians) rather than "expert consensus" in the way it applies to diagnostic image interpretation. The AAMI SP10 standard outlines the methodology for such validation tests.

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

   • Not applicable/Not specified. "Adjudication" typically refers to resolving discrepancies in expert interpretations, which isn't the primary method for validating blood pressure device accuracy.

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:

   • No. This device is a measurement system, not an AI diagnostic tool that assists human readers/interpreters. There is no mention of AI or human-in-the-loop performance measurement in the provided text.

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

   • Yes, in the sense that the device's ability to measure blood pressure, pulse, etc., is evaluated as a standalone function primarily against established standards (like AAMI SP10). The device itself is a standalone measurement system for collecting vital signs.

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

   • For blood pressure accuracy, the ground truth would typically be established by a reference method, such as a mercury sphygmomanometer, performed by trained observers according to standard protocols (e.g., specified in AAMI SP10). The document refers to "clinical testing data" which would be based on this type of ground truth.

7. The sample size for the training set:

   • Not applicable/Not specified. This device is not described as using machine learning or AI that would require a distinct "training set." It is a hardware and software system for data collection and transmission.

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

   • Not applicable, as a training set, as typically understood for AI/ML, is not described for this device.

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The Commander III device is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site.

Commander III is similar to a simple personal computer with a modem that stores and transmits data. Commender III connects to a user's telephone line at home. It has a display that asks health related questions to which the user can respond 'Yes', 'No', or select from a list. It contains an integrated blood pressure meter. It also has inputs for devices such as weight scales, glucometers, peak flow meters and pulse oximeters. These devices download data through a RS232 connection. The functionality of these devices has not been modified; they are used as supplied from the manufacturer.

Here's the analysis of the provided text regarding the Cardiocom Commander III device, focusing on its acceptance criteria and the study used to prove it meets them:

Disclaimer: The provided document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It is not generally a detailed clinical study report and thus may not contain all the specific metrics and methodologies typically found in such a report. Many of the requested details (like specific statistical measures for performance, sample sizes for training data, expert qualifications, etc.) are not explicitly stated in this type of regulatory submission and would be found in the actual studies conducted by the manufacturer, which are summarized or referenced here.

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the Cardiocom Commander III does not define explicit, quantitative acceptance criteria for its performance. Instead, the core of this submission is a demonstration of substantial equivalence to a predicate device (Cardiocom LLC Commander II). This means the acceptance criterion is implicitly that the new device is "as safe and effective" as the predicate device.

The reported device performance, in this context, is that the new device maintains the same functionalities and performance characteristics as the predicate, especially regarding its core function of oscillometric automated blood pressure monitoring.

Study Details

The submission refers to "bench, laboratory, and clinical testing data" to support its claim of substantial equivalence. However, the details of these studies are very brief, which is typical for a 510(k) summary.

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

   • Test Set Sample Size: Not explicitly stated. The document simply mentions "clinical testing data."
   • Data Provenance: Not specified (e.g., country of origin). The document does not indicate if the data was retrospective or prospective.

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

   • Number of Experts: Not mentioned.
   • Qualifications of Experts: Not mentioned.

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

   • Not mentioned.

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:

   • This is not applicable to this device. The Cardiocom Commander III is a non-invasive automated blood pressure monitor and a data collection/transmission system. It does not involve human "readers" interpreting medical images or data in a way that an AI would assist.

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

   • Yes, for the blood pressure measurement component, the device would have undergone standalone performance testing against reference standards, as required for blood pressure devices. The submission states, "The Commander III has a built in NIBP meter," and this component's accuracy would have been validated. However, the specific results of this standalone performance (e.g., mean difference, standard deviation compared to a reference sphygmomanometer as per ISO standards) are not provided in this summary. The summary broadly states "bench, laboratory, and clinical testing data."

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

   • For the blood pressure meter component, the ground truth would typically be a simultaneous measurement by a trained observer using a calibrated mercury sphygmomanometer or an equivalent reference standard, adhering to recognized protocols for blood pressure device validation (e.g., ANSI/AAMI/ISO 81060-2). For the other vital sign inputs (glucometers, pulse oximeters, peak flow meters), the ground truth would be established by the respective reference devices' measurements, as the Commander III acts as a data collector and transmitter for these, not the primary measurement device (except for the built-in NIBP).

7. The sample size for the training set:

   • Not applicable/Not mentioned. This device does not appear to employ a machine learning or AI model that requires a "training set" in the conventional sense of AI algorithms that learn from data. It's a hardware device with embedded firmware for data collection and transmission.

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

   • Not applicable. As above, there's no indication of a machine learning "training set" being used for this device.

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The Commander II device is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site.

The Commander II is an automated device that connects to the user's telephone system at home. It has a display that asks the user health related questions and has inputs for devices such as weight scales, blood pressure meters, and other vital sign measurement devices.

The provided text is a 510(k) premarket notification for the Commander II device, which is an automated system for collecting and transmitting patient health data. This document does not contain the detailed study information or acceptance criteria typically found for studies evaluating the performance of a medical device against specific metrics, especially not for AI-enabled devices or clinical efficacy studies.

Instead, the document focuses on:

• Device Description and Intended Use: Explaining what the Commander II is and what it does.
• Substantial Equivalence to a Predicate Device: Arguing that the Commander II is similar enough to an already approved device (Home Care Monitoring System, AvidCare Corp., K010029) to be cleared for market.
• Safety and Functional Testing: Mentioning compliance with general electrical safety, emissions, and telephone network standards (EN60601-1-2, EN61000-3-2, FCC Part 68, UL/C-UL). It states "Verification and validation testing was conducted to establish performance and reliability characteristics of the device," but does not provide details of these tests, their acceptance criteria, or their results in a quantifiable manner.

Therefore, I cannot fulfill the request for a table of acceptance criteria, reported device performance, sample sizes, ground truth establishment, or specific study details like MRMC or standalone performance, as this information is not present in the provided text.

The document essentially states that the device was tested to general safety and operational standards and that these tests, along with the low-risk device type, led Cardiocom to conclude there are "no significant concerns about safety and effectiveness." It does not provide the kind of performance data (e.g., sensitivity, specificity, accuracy for a specific task) that would typically be associated with acceptance criteria for a diagnostic or AI-powered medical device.

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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 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.

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