(17 days)
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.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.