(504 days)
The Vital Signs Patch (VSP) system is intended to be used on patients in a clinical environment for the continuous, non-invasive monitoring of ECG, Heart Rate (HR), respiration rate, surface temperature, and arterial blood oxygen saturation (intended use group adults 21 and above), when prescribed by a physician or other qualified healthcare professional.
The Vital Signs Patch (VSP) system is designed to monitor vital signs of patients. The internal LifeWatch Technologies Ltd. (LWT in short) Part Number of the VSP is CG-1101B. The VSP system consists of the following components: Vital Signs Patch, VSP transmitter ("Brain"), Gateway, Clinical Backend.
Here's a breakdown of the acceptance criteria and study information for the Vital Signs Patch system, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it states that the device was subjected to extensive verification/validation testing to ensure it meets all functional and performance requirements and is fit for its intended use. The performance details are primarily linked to the adherence to voluntary performance standards and a specific clinical trial for SpO2.
Here's an attempt to infer and summarize based on the provided text, linking performance to the mentioned standards:
| Parameter Monitored | Acceptance Criteria (Inferred from Standards) | Reported Device Performance |
|---|---|---|
| ECG, Heart Rate | ANSI/AAMI/ISO EC57:1998 (R) 2008: Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms | "Software Functional Unit Verification", "System Level Software Validation", "Arrhythmia Detection Algorithm Performance Validation" all performed to ensure the device meets functional and performance requirements and is fit for its intended use, conforming to EC57 and EC38 standards. |
| Respiration Rate | Implicitly covered by general functional and performance requirements for vital signs monitoring. | "Software Functional Unit Verification", "System Level Software Validation" to ensure the device meets functional and performance requirements and is fit for its intended use. ECG electrodes used for impedance measurement. |
| Surface Temperature | ISO 80601-2-56:2009: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature | "Software Functional Unit Verification", "System Level Software Validation" to ensure the device meets functional and performance requirements and is fit for its intended use, conforming to ISO 80601-2-56. |
| SpO2 | ISO 80601-2-61:2011: Particular requirements for basic safety and essential performance of pulse oximeter equipment | "Clinical trial of the SPO2 function" was performed. Conforms to ISO 80601-2-61. Specific results are not provided in this summary. The device's SpO2 function is stated to be substantially equivalent to the cleared MD300W4 Beijing Wrist Pulse Oximeter. |
| General Safety | IEC 60601-1:2005 (Safety), IEC 60601-1-2:2007 (EMC), ISO 14971:2007 (Risk Mgt), ISO 10993-1:2009 (Biocompatibility) | Electrical Safety, EMC, and FCC testing by an independent, certified, external test laboratory. Conforms to IEC 60601-1, IEC 60601-1-2, ISO 14971, and ISO 10993-1. |
| Software | IEC 62304:2006: Medical Device Software Software Lifecycle Processes, FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11 2005" | "Software Verification and Validation", "Software Functional Unit Verification", "System Level Software Validation", "Arrhythmia Detection Algorithm Performance Validation". Conforms to IEC 62304 and FDA software guidance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document explicitly mentions a "Clinical trial of the SPO2 function." However, it does not specify the sample size for this clinical trial or for any other performance test.
- Data Provenance: The document does not specify the country of origin of the data. It also does not specify if the studies were retrospective or prospective, although "Clinical trial of the SpO2 function" typically implies a prospective study.
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 for any of the tests, including the SpO2 clinical trial.
4. Adjudication Method
The document does not specify any adjudication methods (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed, nor any effect size of human readers improving with or without AI assistance. The device is for monitoring vital signs, not for assisting human interpretation of complex medical images or data that would typically involve a MRMC study.
6. Standalone Performance Study
The document indicates that studies were performed on the device's functional and performance requirements. The Arrhythmia Detection Algorithm Performance Validation and the Clinical trial of the SPO2 function suggest standalone performance evaluations of these specific features, focusing on the algorithm's accuracy in detecting arrhythmias and the SpO2 sensor's performance against a reference. While not explicitly termed "standalone performance study," the objective of these tests, especially against recognized standards, inherently assesses the algorithm/device performance without constant human intervention in data collection during the measurement phase. The device then presents data to a human for diagnosis.
7. Type of Ground Truth Used
- For SpO2: A "Clinical trial" was conducted. In such trials for pulse oximetry, the ground truth is typically established by comparing the device's readings against arterial blood gas (ABG) measurements from a co-oximeter, which is considered the gold standard for SpO2. This is implied by the nature of such a clinical trial conforming to ISO 80601-2-61.
- For ECG/Arrhythmia Detection: The ground truth for algorithm performance validation against standards like ANSI/AAMI/ISO EC57 often involves using truth-labeled ECG databases (e.g., MIT-BIH Arrhythmia Database) or synchronously recorded and extensively reviewed ECGs by expert cardiologists.
- For other vital signs (HR, Respiration, Temperature): Ground truth would typically be established by comparing the device's readings against established reference methods or calibrated medical devices known for their accuracy.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size used for the training set for any of the algorithms or features.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for the training set was established.
§ 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.