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The INFINITY MultiView WorkStation, INFINTY Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Draeger Patient Monitoring Systems and recorders.

The INFINITY MultiView WorkStation with Rest ECG is intended to provide interpretive diagnostic statements and reports when connected to an ECG monitor.

Use of the INFINITY MultiView WorkStation Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters:

• Heart rate
• . ECG Arrhythmia Analysis
• . Arterial oxygen saturation
• . Pulse rate
• ST segment analysis .

The INFINITY MultiView WorkStation (MVWS) Telemetry System with TruST is indicated for use when 12-Lead ECG monitoring with a reduced set of electrodes is desired. Reconstructed leads are intended for real-time assessment of ST segment changes.

With the release of software version VF4, the Infinity MultiView WorkStation can receive ECG data sent from a Reynolds CardioCollect and process Rest ECG reports (K980625) when a CardioCollect is interfaced to a MultiView WorkStation via an RS232 connection. Additionally, when a 12-lead Rest ECG for a TruST monitored patient is successfully acquired and uploaded, the MultiView WorkStation calculates a set of baseline coefficients specific to each patient.

This 510(k) submission (K033305) is for modifications to the INFINITY MultiView WorkStation, specifically with the release of software version VF4 and its integration with the TruST system. This submission primarily focuses on the device's ability to process Rest ECG reports and reconstruct 12-lead ECGs from a reduced electrode set for ST segment analysis.

The document states that a clinical performance study was performed to demonstrate substantial equivalence, but the details of the study, including acceptance criteria and reported device performance metrics, are not provided in the extracted text. The text explicitly says: "Assessment of non-clinical performance data for equivalence: Section J" and "Assessment of clinical performance data for equivalence: Section J", indicating that these details are elaborated in Section J of the full 510(k) submission, which is not included here.

Therefore,Based on the provided text, it's not possible to describe the acceptance criteria and the study that proves the device meets those criteria comprehensively. The document states that testing was performed in accordance with internal design control procedures and indicates no affect on the safety or efficacy of the MultiView WorkStation, but no specific performance data or acceptance criteria are detailed.

Here's what can be inferred and what cannot be from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not provided in the extract. The document mentions "Assessment of clinical performance data for equivalence: Section J," implying this information is elsewhere in the submission. Without Section J, specific acceptance criteria (e.g., sensitivity, specificity, accuracy for ST segment changes, or interpretive diagnostic statements) and the reported performance metrics are unknown.

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

• Not provided in the extract. The document does not specify the number of patients or ECGs used in any test set, nor the country of origin of the data, or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not provided in the extract. The document does not mention the involvement of experts for establishing ground truth, their number, or their qualifications.

4. Adjudication Method:

• Not provided in the extract. There is no information regarding any adjudication method used for the test set.

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

• Not provided in the extract. The document does not mention any MRMC study or the effect size of human readers improving with or without AI assistance. The device is described as providing "interpretive diagnostic statements" and "reconstructed leads intended for real-time assessment of ST segment changes," suggesting an algorithmic function rather than direct human assistance for interpretation.

6. Standalone Performance Study:

• Implied but not detailed. The device is stated to "calculate a set of baseline coefficients specific to each patient" and "provide interpretive diagnostic statements and reports." This suggests standalone algorithmic performance for these functions. However, no specific standalone performance study results (e.g., sensitivity, specificity, or accuracy compared to a gold standard) are provided in the extract.

7. Type of Ground Truth Used:

• Not explicitly stated for performance evaluation. For the interpretive diagnostic statements and ST segment analysis, the ground truth would typically be established by expert cardiologists reviewing full 12-lead ECGs or potentially correlated with clinical outcomes or pathology, but the document does not specify which was used.

8. Sample Size for the Training Set:

• Not provided in the extract. The document does not mention any training set or its size.

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

• Not provided in the extract. As no training set is mentioned, the method for establishing its ground truth is also not specified.

In summary, the provided text from the 510(k) summary (K033305) indicates that a clinical performance assessment was conducted (referenced in Section J), but it does not contain the specific details required to answer the questions regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement. The focus of this specific summary is on the modifications to the software for existing functionalities related to ECG processing and ST segment analysis.

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INFINITY MegaCare is a software application for viewing, manual editing, printing, and archiving of digitized electrocardiograph records from Rest ECG devices, Exercise ECG devices, Ambulance ECG devices, Holter ECG devices and the Infinity Monitoring System.

INFINITY MegaCare is intended to provide analysis of Rest ECG's and to provide preliminary data for editing and confirmation by a physician. INFINITY MegaCare can provide a serial comparison of Rest ECG data to facilitate the review of current and previous Rest ECG's.

INFINITY MegaCare is designed for network compatibility to facilitate retrieval of data and to interface with other hospital information systems though HL7 protocols.

INFINITY MegaCare is a computer software program that allows viewing, manual editing, printing and archiving of digitized electrocardiograph records from Rest ECG devices, Exercise ECG devices, ambulance ECG devices, Holter ECG devices and the INFINITY Monitoring System.

INFINITY MegaCare uses the Microsoft Windows 2000 server operating system, Microsoft IIS Web server, and Microsoft SOL Server 2000 relational database. The system consists of a software application, which is installed on a user provided IBM compatible server running the Microsoft Windows 2000 Server operation system. MegaCare utilizes the ECG analysis algorithm developed under the direction of Dr. Peter MacFarlane at the University of Glasgow and used for the INFINITY MVWS Rest ECG (K980625) and Burdick's Eclipse 4 Electrocardiograph (K946281).

Here's an analysis of the provided text, focusing on acceptance criteria, study details, and ground truth establishment:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria in a quantitative or pass/fail manner. It claims "substantially equivalent" for both non-clinical and clinical performance.

However, the "Device Description" and "Intended Use" sections imply general performance expectations related to analysis of Rest ECGs, serial comparison, viewing, editing, printing, and archiving. The text also mentions that the device "utilizes the ECG analysis algorithm developed under the direction of Dr. Peter MacFarlane at the University of Glasgow and used for the INFINITY MVWS Rest ECG (K980625) and Burdick's Eclipse 4 Electrocardiograph (K946281)." This suggests that the performance of those predicate devices effectively sets the "acceptance criteria" for the analysis algorithm within INFINITY MegaCare.

Given this, the table would primarily reflect the reliance on the predicate device's performance rather than independently stated criteria for INFINITY MegaCare's analysis algorithm.

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

The provided text does not explicitly state a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The submission relies on demonstrating substantial equivalence to predicate devices for which the ECG analysis algorithm was already validated.

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

The document does not provide this information. It mentions that the ECG analysis algorithm was "developed under the direction of Dr. Peter MacFarlane at the University of Glasgow," implying expert involvement in the algorithm's initial development and validation for the predicate devices. However, it does not specify how ground truth was established for the INFINITY MegaCare's own assessment.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The focus is on the device's standalone performance and its equivalence to predicate devices, not on human readers' improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study of the algorithm was implicitly done for the predicate devices, and that performance is leveraged for INFINITY MegaCare. The filing states: "MegaCare utilizes the ECG analysis algorithm developed under the direction of Dr. Peter MacFarlane at the University of Glasgow and used for the INFINITY MVWS Rest ECG (K980625) and Burdick's Eclipse 4 Electrocardiograph (K946281)." This indicates that the core analytical capabilities of INFINITY MegaCare are based on an already validated standalone algorithm. The submission itself then claims "Assessment of non-clinical performance data for equivalence: Substantially equivalent (Section S)" and "Assessment of clinical performance data for equivalence: Substantially equivalent (Section T)," further implying that the standalone performance of the algorithm (inherited from the predicate) was deemed sufficient.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the algorithm's original validation or for INFINITY MegaCare's assessment. Given it's an ECG analysis algorithm intended "to provide preliminary data for editing and confirmation by a physician," it is highly probable that the ground truth for an ECG analysis algorithm would involve a consensus of expert cardiologists or electrophysiologists, meticulously reviewing and annotating ECG waveforms and clinical outcomes.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set of the ECG analysis algorithm. This information would typically be tied to the initial development and validation of the algorithm by Dr. MacFarlane.

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

The document does not detail how the ground truth for the training set was established. As inferred in point 7, it's highly likely that it involved expert review and consensus of ECGs, possibly correlated with patient outcomes, for the development of Dr. MacFarlane's algorithm.

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Use of the INFINITY MultiView WorkStation Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters:

• . Heart rate
• ECG Arrhythmia Analysis ●
• Arterial oxygen saturation ●
• Pulse rate
• ST segment analysis .

The INFINITY MultiView WorkStation (MVWS) Telemetry System with TruST is indicated for use when 12-Lead ECG monitoring with a reduced set of electrodes is desired. Reconstructed leads are intended for real-time assessment of ST segment changes.

Siemens' INFINITY MultiView WorkStation Telemetry with TruST enables continuous 12-lead ECG monitoring with a reduced number of electrodes. With TruST only 6 lead wires are required to acquire 12 leads of ECG. TruST relies on conventional lead placement and the INFINITY TruST telemetry transmitters. The TruST matrix uses general reconstruction coefficients to compute 4 precordial leads.

Here's a breakdown of the acceptance criteria and study information for the Siemens Infinity MultiView WorkStation Telemetry System with TruST, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical performance acceptance criteria (e.g., specific sensitivity, specificity, accuracy thresholds) or precise reported device performance metrics for the TruST feature. Instead, it relies on substantial equivalence to predicate devices and describes the intended functionality. However, we can infer the acceptance criteria are met if the device demonstrates equivalent performance to the predicate devices in terms of its ability to monitor 12-lead ECG with a reduced set of electrodes and reconstruct leads for real-time ST segment assessment.

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

The document does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "Assessment of clinical performance data for equivalence: Section J," implying that clinical data was submitted in that section, but the summary document itself does not contain those details.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it provide an effect size for human readers with vs. without AI assistance. The focus of this 510(k) is on the device's technical capability to reconstruct leads and monitor ST segments, implying a standalone performance assessment or equivalence claim rather than a human-in-the-loop improvement study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The description of the TruST system, specifically that "The TruST matrix uses general reconstruction coefficients to compute 4 precordial leads" and that "Reconstructed leads are intended for real-time assessment of ST segment changes," strongly suggests that a standalone (algorithm-only) performance assessment would have been done to validate the accuracy of these reconstructed leads against a conventionally acquired 12-lead ECG. However, the summary document does not explicitly describe this study or its results in detail. The focus is on establishing substantial equivalence.

7. Type of Ground Truth Used (Test Set)

The document does not explicitly state the type of ground truth used for the test set. Given the nature of ECG monitoring and ST segment analysis, it's highly probable that the ground truth would have been established by:

• Comparison to conventionally acquired 12-lead ECGs (e.g., a full 12-lead ECG from the same patient at the same time, reviewed by experts).
• Expert consensus based on interpretation of conventional 12-lead ECGs.
• Potentially, correlation with clinical outcomes or pathology if the clinical study was designed to assess diagnostic accuracy for specific conditions (though this is less likely for a 510(k) summary focused on technical equivalence for monitoring).

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set.

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

The document does not describe how the ground truth for any potential training set was established. Since the TruST system involves "general reconstruction coefficients," it implies a model or algorithm was developed. For such a model, a training set would typically have ground truth established by:

• Conventionally acquired 12-lead ECGs that are considered the gold standard for full 12-lead information.
• Expert cardiologists or electrophysiologists who interpret these full 12-lead ECGs and potentially correlate them with patient data or outcomes to develop the "ground truth" for ST segment morphology and deviation.

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