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The Fusion™ System and accessories blood pressure measurement system is intended to be used on patients with wrist circumference of 11 cm - 22 cm by trained medical personnel to continually monitor systolic, diastolic and mean blood pressure and pulse rate.

The Fusion System module option of Nellcor OxiMAX Option (K012891), is indicated for the continuous non-invasive monitoring of a patient's functional oxygen saturation of arterial hemoglobin (SpO2) by trained medical personnel.

The Fusion System module option of Kendall Genius Thermometer (K920713) is indicated for the measuring of a patient's body temperature.

This device is prescription use only.

The Fusion™ System is a non-invasive blood pressure monitor that uses a pressure sensor placed directly on top of the radial artery. This sensor is noninvasive and eliminates the need for an occlusive inflatable cuff. This device is intended to be used on patients by trained medical personnel to continually monitor systolic, diastolic and mean blood pressure, and pulse rate.

The Fusion™ System uses a patented "sweep technique" which applies a varying force on the radial artery. The counterpressure in the artery produces a signal which is digitized and used to calculate blood pressure parameters.

The sensor measures the pulse at the point of maximum energy transfer; the wave shapes are analyzed by Medwave's proprietary algorithms. Parameters are extracted from the waveforms and a set of coefficients are applied to them yielding systolic, mean, and diastolic pressures approximately every 15 heart beats. These algorithms have been tested and validated in clinical studies by synchronized comparisons to arterial line pressure waveforms.

Patient pressures can be monitored visually by viewing the screen and audibly entering limits into the Fusion™ System alarm menu. Patient measurements above or below the limits will be automatically brought to the attention of the caregiver through these visual and audible alarms. A Start/Stop key provides the operator with an option to cancel operation at anytime.

The Fusion™ System can be ordered with additional module options:

• · Tyco Healthcare Nellcor OxiMax Pulse Oximetry System (K012891) provides monitoring of a patient's functional oxygen saturation of arterial hemoglobin.
• · Kendall Genius Thermometer (K920713) provides patient's body temperature readings.
• · Seiko Thermal Printer SII providing hardcopy of readings selected to print.

The Medwave, Inc. Fusion™ System is a non-invasive blood pressure monitor. Here's an analysis of its acceptance criteria and the supporting study:

1. Acceptance Criteria and Reported Device Performance

The device's performance claims are based on meeting industry standards for non-invasive blood pressure monitors.

2. Sample Size and Data Provenance

The document indicates that clinical data supporting the performance claims is "on file at Medwave, Inc." However, it does not specify the sample size used for the test set or the country of origin. It also doesn't explicitly state whether the data was retrospective or prospective.

3. Number of Experts and Qualifications

The document does not provide information on the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method

The document does not specify an adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not conducted as this is a medical device for automated measurements, not an AI diagnostic imaging system that would typically involve human readers. The device is intended to provide automated measurements.

6. Standalone Performance Study

Yes, a standalone study was performed. The device's algorithms were "tested and validated in clinical studies by synchronized comparisons to arterial line pressure waveforms." This indicates that the algorithm's performance was evaluated independently against a gold standard.

7. Type of Ground Truth Used

The ground truth used for validating the blood pressure measurements was the intra-arterial line pressure waveforms. This is considered a highly accurate and invasive "gold standard" for blood pressure measurement.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set of the proprietary algorithms.

9. How Ground Truth for the Training Set Was Established

The document states that "Parameters are extracted from the waveforms and a set of coefficients is applied to them, yielding systolic, mean and diastolic pressures. The algorithms have been tested against intra arterial line pressure waveforms and proven to meet industry standards..." This implies that the ground truth for training (or at least for validation) was established using intra-arterial line pressure waveforms.

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The Primo™ Noninvasive Blood Pressure Measurement System is a hand held non-invasive blood pressure measurement system intended to be used on adult patients with wrist circumferences of 11 cm - 22 cm by trained medical personnel to measure systolic, diastolic blood pressure and pulse rate.

The Primo™ Noninvasive Blood Pressure Measurement System is a hand-held non-invasive blood pressure measurement system that measure systolic, diastolic blood pressure and pulse rate from the user's wrist. The system is contained in hard plastic housings that contain a user interface panel and a wrist sensor. The characteristics of the arterial waveforms are recorded with a unique pressure sensor that is placed over the radial artery. This system provides a single reading of blood pressure, using a pressure sensor placed on the wrist over the radial artery. This sensor is noninvasive.

Here's a breakdown of the acceptance criteria and study information for the Medwave, Inc. Primo™ Noninvasive Blood Pressure Measurement System, based on the provided text:

Acceptance Criteria and Device Performance

Note: Many acceptance criteria listed in the table (e.g., Device Labeling, Storage Conditions, Vibration and Shock, Software Testing, etc.) refer to various standards (ANSI/AAMI SP10-2002, IEC60601, CDRH Guidance Document, NSTA, Medwave internal documents) and are stated as "X" or "Tested and successfully completed," indicating compliance. The table above focuses on the quantitative performance metrics explicitly stated.

Study Information

Here's the detailed information about the study that proves the device meets the acceptance criteria:

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated in the provided text. The text mentions "an extensive collection of tests" and "study results in the supporting Clinical Data on file at Medwave, Inc." (for pulse accuracy) and "study results in Appendix H" (for blood pressure accuracy against intra-arterial lines), but does not give specific numbers for the test set.
   • Data Provenance: Not explicitly stated. The document does not specify the country of origin of the data or whether it was retrospective or prospective.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

   • Not explicitly stated. The document mentions that the algorithms were "tested against intra arterial line pressure waveforms," which implies a direct physiological measurement as ground truth rather than expert interpretation of images or other data.

3. Adjudication Method for the Test Set:

   • Not applicable/Not stated. Since the ground truth primarily relies on intra-arterial line pressure waveforms, an adjudication method for expert consensus is not described.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Was it done? No. The document does not mention any MRMC study or comparison of human readers with and without AI assistance for this device. This is a standalone device measuring physiological parameters directly.
   • Effect size of human readers improving with AI vs without AI assistance: Not applicable, as no such study was described.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

   • Was it done? Yes. The entire description of the performance testing focuses on the device's accuracy in measuring blood pressure and pulse rate (algorithm only performance). The device is a "hand-held non-invasive blood pressure measurement system" that provides "a single reading." The algorithms' performance is directly assessed against intra-arterial line pressure waveforms.

6. Type of Ground Truth Used:

   • Intra-arterial line pressure waveforms. The document explicitly states: "The algorithms have been tested against intra arterial line pressure waveforms and proven to meet industry standards..."

7. Sample Size for the Training Set:

   • Not explicitly stated. The document refers to "Medwave's proprietary algorithms" and states they have been "tested against intra arterial line pressure waveforms," but does not provide information about the training set size for these algorithms.

8. How the Ground Truth for the Training Set Was Established:

   • Not explicitly stated for the training set. However, given that the algorithms were tested against intra-arterial line pressure waveforms, it is highly probable that similar intra-arterial line pressure data would have been used as ground truth for establishing and refining these proprietary algorithms during their development/training phase. The document does not detail this process explicitly.

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