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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

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.

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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

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.

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