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The BW-X07HD Handheld VitalSigns Monitoring System is intended to be used in hospital, clinic, homecare, home and other medical settings where patient care is offered by qualified healthcare personnel who can use the device to monitor the patient's physical indexes, including ECG, SpO2, NIBP and TEMP as well as the pulse rate.

For measuring ECG, SpO2 the intended patient population is adult, for measuring NIBP the intended patient population is both adult and pediatric aged more than 3 years old, whereas for measuring TEMP the intent population is all types of people including newborn, pediatric and adult.

The device is used to collect, store, and transmit general patient health information and patient vital signs data between the patient and a health care professional.

The BW-X07HD Handheld VitalSigns Monitoring System is a handheld, smart and wireless connected medical device. The device can be easily used by healthcare professional personnel, ordinary users or patients, to monitor multiple physiological indexes, including TEMP, ECG, NIBP and SpO2 as well as the pulse rate. Medical data can be stored locally and can be sent through WiFi, 3G or 4G network.

The device incorporates an embedded system and an Android application. The embedded system integrates the Temp module, the ECG, NIBP, SpO2 module and the wireless module together. The device allows users to communicate through an HD video conferencing system but cannot be used as phone (only IP connection, Micro SIM card for data transmission).

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

Acceptance Criteria and Device Performance

The document describes the device, a Handheld Vital Signs Monitoring System, Model: BW-X07HD, and its performance characteristics compared to a predicate device (ViSi Mobile Monitoring System K150361). The acceptance criteria are largely defined by compliance with recognized international standards for medical electrical equipment and specific vital sign monitoring devices, as well as meeting performance specifications.

Due to the format of the provided text, a direct "acceptance criteria" column with explicit pass/fail values isn't present in a table. Instead, the document discusses compliance with standards and the device's technical specifications. The "Reported Device Performance" below is extracted from the "Subject Device BW-X07HD" column in the comparison table within the 510(k) summary. The "Acceptance Criteria" are implied by the standards the device complies with, which define the required performance levels.

Study Details

The document refers to "clinical tests" for NIBP, Oximeter (SpO2), and Thermometer, and states that their results meet the requirements of the respective ISO standards. It does not provide detailed descriptions of these clinical studies (e.g., protocols, specific methodologies, explicit sample sizes beyond "participants," or granular results).

1. Sample size used for the test set and the data provenance:

   • NIBP: "clinical test of NIBP was provided including both adult participants and pediatric participants aged more than 3 years old." (Specific number of participants not stated).
   • Thermometer: "clinical test of TEMP was provided including all types of people including newborn, pediatric and adult." (Specific number of participants not stated).
   • Oximeter: "clinical results of Oximeter Part of subject device meet the requirement as described in ISO 80601-2-61:2011." (Specific number of participants not stated, but this standard specifies that studies should be performed on at least 10 healthy adult volunteers, with a stable arterial oxygen saturation range between 70% and 100%).
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the reference to "clinical investigation" suggests prospective data collection for the purpose of the submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the document. For vital signs monitoring devices, ground truth is typically established by reference devices (e.g., invasive blood pressure monitoring for NIBP, blood gas analysis for SpO2, and calibrated thermometers for temperature) rather than expert consensus on interpretation. The document mentions compliance with standards that dictate how ground truth is established for these measurements.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not explicitly mentioned. For vital signs performance studies, expert adjudication methods like 2+1 or 3+1 are generally not applicable because the "ground truth" is measured instrumentally rather than being a subjective interpretation by experts.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This device is a vital signs monitor, not an AI-assisted diagnostic imaging or interpretation tool where human readers' performance with and without AI would be evaluated.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The clinical tests for NIBP, SpO2, and Thermometer evaluate the device's standalone performance in measuring these vital signs against reference methods. While a human is involved in applying the device and reading its output, the intrinsic measurement accuracy being evaluated is of the device itself (analogous to "algorithm only" in the context of a straightforward measurement device). The performance is assessed against recognized ISO standards without explicitly stating a human-in-the-loop component for improving diagnostic accuracy.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Reference Devices/Methods calibrated to medical standards:
     • For NIBP, the ground truth is established by a reference method as per ISO 81060-2:2013 (which generally involves simultaneous invasive or oscillometric reference measurements).
     • For SpO2, the ground truth is established by fractional oxygen saturation measurements from co-oximetry of arterial blood samples as per ISO 80601-2-61:2011.
     • For Temperature, the ground truth is established by a reference method as per ISO 80601-2-56:2009 (typically involving a highly accurate contact thermometer).

7. The sample size for the training set:

   • The document does not refer to a training set in the context of machine learning or AI. This is a conventional vital signs monitoring device, and its performance is validated through clinical testing against established standards, not via a machine learning training/testing paradigm.

8. How the ground truth for the training set was established:

   • As there is no mention of a training set for machine learning, this information is not applicable/provided.

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