Search Results

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.

Ask a specific question about this device

Ask a specific question about this device

Use of the MultiView WorkStation Infinity 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 device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The MultiView WorkStation Infinity Telemetry System, 510(k) K972714, has been modified to enable the Pause, Bradycardia, and Tachycardia Arrhythmia calls.

The provided document is incomplete and only describes a 510(k) submission for a device modification, but it does not contain the actual study or acceptance criteria. The information provided here focuses on the administrative aspects of a 510(k) application, such as the device's trade name, common name, classification, and intended use. It also mentions that the modification enables "Pause, Bradycardia, and Tachycardia Arrhythmia calls."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the given text.

To answer your request, I would need a document specifically detailing the verification and validation (V&V) testing performed for the device modification, which would include:

• Acceptance Criteria: Specific thresholds or performance metrics that the device must meet.
• Study Design: How the test was conducted.
• Device Performance: The results observed during the study.
• Sample Size and Data Provenance: Details about the dataset used.
• Ground Truth: How the reference standard was established.
• Expert Details: Qualifications and number of experts involved.
• Adjudication Method: If applicable.
• MRMC or Standalone Studies: If such studies were performed.
• Training Set Details: If applicable for an AI/algorithm.

Without this information, I cannot complete the table or answer the specific questions about the study.

Ask a specific question about this device