(333 days)
Non-invasive measurement of systolic pressure (SYS), diastolic pressure (DIA), heart rate (HR), heart rate variability (HRV), and irregular heartbeats (IrrHB) for professionals at home. The device is not intended for ambulatory use. The device has not been tested and it is not intended for pediatric use. The device provides a HRV parameter which is only mathematical analysis and is not intended to produce any interpretation of those measurements or any kind of diagnosis.
The non-invasive blood pressure measuring system HRVWatch-Mini Wrist Monitor is a smaller size variation of the HRVWatch Wrist Monitor (K123130) previously cleared by FDA in 2013. Identical to its larger-size predecessor in terms of device main functions, the Mini monitor measures blood pressures (BP) (systolic pressure SYS and diastolic pressure DIA) and heart rate (HR), using the oscillometric method commonly employed by electronic blood pressure meters. In addition, the device utilizes piezo-electrical sensors embedded in the cuff (wrist band) to obtain detailed radial arterial waveforms. The 5-minute continuous waveform recording allows the device to detect and report irregular heartbeats. Heart rate variability (HRV) parameters are also obtained by time- and frequency-domain statistical analyses of pulse peak intervals. The main body of the device with its biosensors and electrical circuit boards has the full function of signal acquisition, analysis, and data storage. The testing by the device is controlled by a software programs (app) installed in a smart phone or tablet (the collateral device) via two-way blue-tooth communication. The display of the collateral device (phone or tablet) is used to show live test data plots during test, or post-test data reports and plots. Test data can be uploaded to cloud using the collateral device's internet connectivity. HRVWatch-Mini Wrist Monitor is intended to provide only patient parameter measurements and associated rankings based upon established standard values, and is not intended to produce any clinical interpretation of those measurements or any kind of diagnosis.
The provided text describes the HRVWatch-Mini Wrist Monitor and its acceptance criteria, particularly in the context of its 510(k) submission to the FDA. However, it does not contain a detailed table of acceptance criteria with reported device performance or the specific results of a comparative effectiveness study (MRMC). It primarily focuses on the substantial equivalence argument, the study design for equivalency, and general compliance with standards.
Here's a breakdown of the information that is available and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Missing Information: The document states that the device complies with ANSI/AAMI SP10-1992 for Electronic or Automatic Sphygmomanometers, which sets accuracy standards for blood pressure devices. However, a table explicitly listing the acceptance criteria (e.g., mean difference and standard deviation for BP measurements) from this standard and directly comparing them to the HRVWatch-Mini's specific numerical performance is not provided. The document only makes a general statement about compliance and substantial equivalence to a predicate device.
2. Sample Size for the Test Set and Data Provenance
| Feature | Description |
|---|---|
| Sample Size (Test Set) | 10 subjects |
| Data Provenance | Retrospective (data collected for a prior cleared device, HRVWatch-Full-Size, and then compared to the new Mini version) and Prospective (new data collected on the 10 subjects using the HRVWatch-Mini and HRVWatch-Full-Size for comparison). The study involved company employees and family members. |
| Country of Origin of Data | Taiwan |
3. Number of Experts and Qualifications for Ground Truth (Test Set)
Missing Information: The document describes a comparative study between two devices (HRVWatch-Mini and HRVWatch-Full-Size), where the "ground truth" for the Mini was established by comparison to the Full-Size device. The Full-Size device was previously FDA-cleared.
It does not mention the use of external experts to establish a "ground truth" for the test set in the traditional sense of medical image analysis where expert consensus defines the 'correct' answer. Instead, the "ground truth" or reference for the HRVWatch-Mini's performance (for BP, HR, HRV, and IrrHB) was the performance of the HRVWatch-Full-Size wrist monitor (K123130), which was already FDA-cleared. The study aimed to show substantial equivalence between the two devices.
4. Adjudication Method for the Test Set
Missing Information: Given that the study was a device performance comparison against a predicate, and not a diagnostic interpretation task requiring human experts to establish ground truth from raw data, an "adjudication method" in the sense of resolving discrepancies among multiple experts (e.g., 2+1, 3+1) is not applicable and therefore not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Missing Information: No MRMC comparative effectiveness study was done. The study conducted was a technical comparison of the new device to its predicate, not a study evaluating human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Partial Information: The document states, "HRVWatch-Mini Wrist Monitor is intended to provide only patient parameter measurements and associated rankings based upon established standard values, and is not intended to produce any clinical interpretation of those measurements or any kind of diagnosis." This implies a standalone algorithm only approach for the device's outputs (SYS, DIA, HR, HRV, IrrHB), as it specifically states it does not provide clinical interpretation or diagnosis. The intent of the study was to show the algorithm-derived measurements of the Mini were equivalent to the algorithm-derived measurements of the Full-Size.
7. Type of Ground Truth Used (Test Set)
The "ground truth" for the HRVWatch-Mini's performance in the comparative study was based on the measurements obtained from the FDA-cleared HRVWatch-Full-Size Wrist Monitor (K123130). This functions as a reference device or established standard for the purpose of demonstrating substantial equivalence.
8. Sample Size for the Training Set
Missing Information: The document does not explicitly state the sample size used for training any internal algorithms or models within the HRVWatch-Mini. It focuses on the validation of the device's measurements against a predicate. Given that the Mini is described as a "smaller size variation" with "identical key parts" and "analytical firmware" to a previously cleared device (K123130), it's possible that the training (if any was needed for the specific algorithms) occurred during the development of the original HRVWatch Wrist Monitor.
9. How the Ground Truth for the Training Set Was Established
Missing Information: This information is not provided in the document. As noted above, the document describes the substantial equivalence of the new device to a predicate, not the original development and training of algorithms for the predicate device or the new device.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).