(348 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 office or patients at home under the supervision of a trained professional. The device is not intended for ambulatory use. The device is designed for wearing on the left wrist only. 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 Wrist 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 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 analyses of peak-to-peak intervals. The main body of the device has the full functions of testing, display, and data storage. A mini-USB port is provided for connection and data download to a PC. A device-specific software, HRVWatch Manager, is included in the product package for database management and report printing running on a Windows-based PC. HRVWatch Wrist Monitor is intended to provide only patient parameter measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis.
The provided text describes the HRVWatch Wrist Monitor and its performance evaluation, but it does not specify explicit acceptance criteria in a table format with reported device performance against those criteria. Instead, it states compliance with international standards and substantial equivalence to predicate devices.
However, based on the information provided, I can infer the "acceptance criteria" through the standards the device claims to meet, particularly ANSI/AAMI SP10 for blood pressure measurements and the 1996 HRV International Standard for heart rate variability and irregular heartbeats. The study's results are then presented as demonstrating compliance with these standards and substantial equivalence.
Here's an attempt to structure the information based on your request, with inferred acceptance criteria based on the cited standards:
Acceptance Criteria and Study for HRVWatch Wrist Monitor
1. Table of Acceptance Criteria and Reported Device Performance
| Measurement/Parameter | Inferred Acceptance Criteria (Based on Cited Standards) | Reported Device Performance (as stated in submission) |
|---|---|---|
| Blood Pressure (SYS, DIA) | Compliance with ANSI/AAMI SP10-1992 Electronic or Automatic Sphygmomanometers standard. | "HRVWatch conforms to ANSI/AAMI SP10" and demonstrated "substantially equivalent to the predicate devices of manual mercury sphygmomanometers for the measurement of systolic and diastolic pressures." |
| Heart Rate (HR) | Substantial equivalence to predicate ECG devices. | "substantially equivalent to the predicate devices of electrocardiograph HRV analyzers for the measurements of HRV and irregular heartbeats." (HR is part of this overall assessment) |
| Heart Rate Variability (HRV) | Compliance with 1996 HRV International Standard. | "The data acquisition and analytical steps follow the guideline listed in 1996 HRV International Standard." and "substantially equivalent to the predicate devices of electrocardiograph HRV analyzers for the measurements of HRV and irregular heartbeats." |
| Irregular Heartbeats (IrrHB) | Detection of peak intervals > 4 standard deviations; substantial equivalence to predicate ECG devices. | "Peak intervals greater than 4 standard deviations are reported as irregular heartbeats." and "substantially equivalent to the predicate devices of electrocardiograph HRV analyzers for the measurements of HRV and irregular heartbeats." |
| Safety | Compliance with EN60601-1, IEC 60601-1, ISO 13485 (general medical device safety standards). | "The clinical test results showed HRVWatch to be safe for its intended use" |
Note: The document states that the "clinical test results showed HRVWatch to be safe for its intended use and substantially equivalent to the predicate devices for technical designs, functions, and data accuracy," and that it "conforms to ANSI/AAMI SP10." Specific numerical deviations or ranges for BP accuracy are not provided in this summary, but are typically required for ANSI/AAMI SP10 compliance.
2. Sample Size Used for the Test Set and the Data Provenance
- Total Subjects for Human Clinical Study: 88 subjects.
- Subjects for Intra-device variability test: 10 subjects (subset of total).
- Subjects for SP10 BP test: All 88 subjects (stated as "all in the SP10 BP test").
- Subjects for Heart Rate, Heart Rate Variability, and Irregular Heartbeats test: 50 subjects (subset of total).
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. Given the applicant is from Taiwan, it is plausible the study was conducted there. It is a "human clinical study," implying a prospective design for data collection, although not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not explicitly state the number or qualifications of experts used to establish ground truth.
- Blood Pressure Ground Truth: The device was compared to a "manual mercury sphygmomanometer," which serves as the reference standard. The operation of such a device typically relies on a trained observer, but their specific qualifications are not mentioned.
- Heart Rate, HRV, and Irregular Heartbeats Ground Truth: The device was compared to an "ECG" (Electrocardiogram), which serves as the reference standard. Similarly, the interpretation of ECGs for ground truth would be performed by qualified personnel (e.g., cardiologists or trained technicians), but their specific number or qualifications are not mentioned.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for resolving discrepancies or establishing ground truth based on multiple expert opinions. The ground truth was established by direct comparison to predicate devices/reference standards (manual mercury sphygmomanometer for BP, ECG for HR/HRV/IrrHB).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a measurement system and not an AI-assisted diagnostic tool designed to augment human reader performance. The study focused on the device's accuracy compared to reference standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are essentially "standalone" performance evaluations of the device's measurements (SYS, DIA, HR, HRV, IrrHB) against established reference standards. The device itself is intended to provide measurements ("patient parameter measurements") and is "not intended to produce any interpretation of those measurements or any kind of diagnosis." Therefore, its performance is assessed directly, without considering a human-in-the-loop scenario for diagnostic improvement.
7. The Type of Ground Truth Used
- Blood Pressure (SYS, DIA): The ground truth was established using a manual mercury sphygmomanometer, which is considered a traditional clinical reference standard for blood pressure measurement.
- Heart Rate (HR), Heart Rate Variability (HRV), and Irregular Heartbeats (IrrHB): The ground truth was established using an ECG (Electrocardiogram), which is the clinical gold standard for cardiac rhythm and heart rate analysis.
8. The Sample Size for the Training Set
The document does not provide information about a separate training set or its sample size. The description of the clinical study appears to be a single test set used for performance evaluation. Device development and algorithm 'training' (if any, for the oscillometric method or HRV analysis) would typically occur prior to this validation study.
9. How the Ground Truth for the Training Set Was Established
As no training set is described in the provided text, information on how its ground truth was established is not available.
§ 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).