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The Waldo Patient Monitor is a remote patient monitor device available by prescription. The Waldo Patient Monitor is designed to be used in the home of a patient undergoing remote monitoring for maintenance of chronic disease. The Waldo Patient Monitor provides guidance in operating medical sensor devices, reminders for medication compliance and connectivity to healthcare professionals through text messaging and real-time video conferencing technology.

The Waldo Patient Monitor connects to commercially available wireless and tethered glucose meters, weight scales, blood pressure monitors and pulse oximeters. The Waldo Patient Monitor stores and displays the information on the LCD screen and transmits the information to the Waldo Health secure host server using connectivity including, but not limited to, FCC approved Wi-Fi, Cellular Wireless Internet or Ethernet.

Healthcare professionals can review the transmitted information utilizing the Waldo Health Clinician Access System and set thresholds to trigger alerts based on specific thresholds being exceeded.

The Waldo Health System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when time-critical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention. The system is intended for patients who are willing and capable of managing its use. Judgment and experience by a caregiver or by a family member are required to check and interpret the information delivered.

A list of devices that are compatible with the Waldo Patient Monitor will be available in the user's manual and the Waldo Health website.

The Waldo Patient Monitor is a remote patient monitoring device available via prescription.

The Waldo Patient Monitor connects to commercially available wireless and tethered glucose meters, weight scales, blood pressure monitors and pulse oximeters, stores and displays the information on the LCD screen and transmits the information to the Waldo Health secure server. Healthcare professionals can review the transmitted information utilizing the Waldo Health Clinician Access System.

The Waldo Health System consists of:

1. Waldo Health System Hardware:
   The physical component of Waldo Health System is the Waldo Patient Monitor. which is an electronic device contained in an acrylonitrile butadiene styrene (ABS) thermoplastic enclosure with a touch screen, built-in video camera. microphone, speaker, and a reminder light ("light bar") mounted on top of the case. The Waldo Patient Monitor contains front and back panels that provide standard USB 2.0 connectors, Ethernet connector, power connector and power button, as well as volume controls.

2. Waldo Patient Monitor Software Application:
   The Waldo Patient Monitor executes the Waldo Patient Monitor Software Application, which connects to commercially available wireless and tethered glucose meters, weight scales, blood pressure monitors and pulse oximeters. stores and displays the information on the LCD screen and transmits the information to the Waldo Health secure server.

3. Waldo Health Clinician Access System (CAS) Software Application:
   The Waldo Health Clinician Access System (CAS), which is associated with and manages multiple Waldo Patient Monitor devices, is designed to allow doctors and nurses to create and access electronic health records as well as provide a user-friendly interface into a patient's health condition.

The Waldo Health System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required. The system is contraindicated for patients requiring direct medical supervision or emergency intervention. The system is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.

The Waldo Health Patient Monitor (K110334) is a remote patient monitoring device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Unfortunately, the provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed reported device performance metrics in a table format for its core functions. The document outlines the device's functionality and indicates that testing was performed, but it lacks the specific performance targets typically found in acceptance criteria.

However, based on the Discussion of Non-Clinical Testing section, we can infer general categories for which the device met requirements:

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not specify a sample size for the test set or the provenance (country of origin, retrospective/prospective) of any data used for non-clinical testing. It broadly mentions "bench testing using Waldo Health procedures and specifications" and "usability testing under duplicated operating conditions."

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided information does not mention the use of experts to establish ground truth for a test set. The testing described is primarily non-clinical (bench, usability, performance standards) rather than clinical validation against expert interpretations of patient data.

4. Adjudication Method for the Test Set

As there's no mention of experts or a specific test set requiring adjudication in the context of diagnostic or interpretive performance, no adjudication method (e.g., 2+1, 3+1) is described.

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

A Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The device is a remote patient monitor for collecting and transmitting data, not for interpreting medical images or making diagnoses that would typically involve a human-in-the-loop AI assistance study. Therefore, there is no effect size reported for human readers improving with AI assistance.

6. Standalone (Algorithm Only) Performance

The concept of "standalone performance" as it relates to an algorithm making a diagnosis or interpretation without human intervention is not applicable to this device in the context of the provided documentation. The Waldo Patient Monitor's primary function is data collection and transmission. While it "stores and displays the information" and allows for "thresholds to trigger alerts," it "is not intended for diagnosis or as a substitute for medical care" and "Clinical judgment and experience by a caregiver are required to check and interpret the information delivered." This indicates that the device is a data conduit and an alerting system, always requiring human interpretation and not functioning as a standalone diagnostic algorithm.

7. Type of Ground Truth Used

The ground truth used for the testing described is based on engineering specifications, performance standards (IEC 60601-1, IEC 60601-1-2), and internal design requirements. For example, ground truth for data collection would be the actual readings from the connected medical sensors, and the device's accuracy would be compared against these readings. For usability, the ground truth would be the defined usability goals and task completion rates. There is no mention of ground truth based on expert consensus, pathology, or outcomes data, as this is a non-diagnostic data collection and transmission device.

8. Sample Size for the Training Set

The 510(k) summary does not mention a training set sample size. This is expected as the device's software primarily handles data transmission and user interface, rather than complex machine learning algorithms that require extensive training data.

9. How the Ground Truth for the Training Set Was Established

Since no training set is discussed in the context of machine learning, the question of how its ground truth was established is not applicable. The software development would have followed standard software engineering practices and testing against functional specifications.

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