Search Results

MiPal allows the user to collect vital signs data (including noninvasive blood pressure, pulse rate, weight and other data from optional add-on devices). The user can then transmit the data to a central database via a communication network. Use of the system allows retrospective review of certain physiological functions by qualified health care professionals. It is not intended for real-time, emergency, or critical care monitoring of patient vital signs. The MiPal is intended for use with adult and pediatric patients over twelve years of age.

SpO2 is to be used under the direction of licensed health care professionals, and is available only by or on the order of a physician.

The MiPal is a communication hub intended to receive and transmit patient information on a retrospective basis. The device is not intended for real-time monitoring or emergency use by patients or caregivers.

The MiPal is designed to optionally collect NiBP, pulse, and SpO2. It may also collect other vitals through the vitals acquisition process via Bluetooth medical peripherals. Peripherals will include:

• Scale
• o Glucose meter

The Watermark Medical MiPal is a communication hub intended to receive and transmit patient information on a retrospective basis. The device is not intended for real-time monitoring or emergency use by patients or caregivers. MiPal allows the user to collect vital signs data (including noninvasive blood pressure, pulse rate, weight and other data from optional add-on devices). The user can then transmit the data to a central database via a communication network. The system allows retrospective review of certain physiological functions by qualified health care professionals. The MiPal is intended for use with adult and pediatric patients over twelve years of age. SpO2 is to be used under the direction of licensed health care professionals, and is available only by or on the order of a physician.

The provided text only briefly discusses performance data by stating: "The verification and validation results demonstrated that the MiPal was in compliance with the guidelines and standards referenced in the FDA reviewer's guides and that it performed within its specifications and functional requirements."

Therefore, I cannot provide detailed information for all requested sections due to the limited information in the provided text.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

The document does not provide a table of acceptance criteria or specific reported device performance metrics. It only makes a general statement about compliance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not available in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not available in the provided text.

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

This information is not available in the provided text.

5. 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:

This information is not available in the provided text. The device is described as a "communication hub" to collect and transmit data for retrospective review, not as an AI-assisted diagnostic tool for human readers.

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

The device is not described as having an algorithm that performs interpretations or diagnostics independently. Its function is to collect and transmit data for review by healthcare professionals. Therefore, a standalone performance study in the sense of an algorithm's diagnostic accuracy is not relevant to the described function of this device, and no such study is mentioned.

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

This information is not available in the provided text.

8. The sample size for the training set:

This information is not available in the provided text. The device is a data collection and transmission hub, not a machine learning model that would require a training set in the conventional sense for its primary function.

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

This information is not available in the provided text for the reasons stated in point 8.

Ask a specific question about this device