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The intended use of the Zyter RPM is to provide an interface with physiological patient monitoring systems to forward recorded device information to the patient's healthcare provider.

Zyter RPM does not alter the behavior of the primary medical devices and associated alert annunciations.

Zyter RPM is not intended to be used for diagnostic purposes. Zyter RPM is intended for use by professional clinical personnel and relies on proper use and operation of both the communication infrastructure in place at the use environment (e.g., healthcare facility or home setting) and the display interface used. Zyter RPM is a software product and cannot come into physical contact with patients.

Zyter RPM is a Software as a Medical Device (SaMD) intended to provide healthcare professionals with supplemental information about events and alerts originating from medical devices, or other event or alert producing systems within a clinical or home setting. This device can route notifications including all or a subset of the event or alert information along with related contextual information to selected end points such as but not limited to mobile phones, or other computing or communications end points.

Zyter RPM is intended to provide remote central monitoring and display of information as recorded by multiple specifically compatible FDA cleared devices on a central screen and to provider alert and alert notifications on the screen and to other provider devices.

The Zyter RPM software application will receive, aggregate, process, distribute and display parameters, alerts, and events at locations other than at the patient for multiple patients.

Information provided by the Zyter RPM software is not intended for diagnosis or active patient monitoring where immediate action is required.

Receipt of notifications by the end point is not confirmed, and delivery to the end point is not guaranteed. The primary alert notification is the device or system producing the alert or event.

Zyter RPM is not intended to directly diagnose or treat patients or to be used in the prevention of a disease or condition, nor does Zyter RPM come into direct contact with patients.

Zyter RPM serves as a convenient user interface to integrate data and provide health care professionals the ability to access and monitor parameters of devices and data that have been cleared by the FDA. Zyter RPM does not affect the intended use, or alter the indications for use, for the cleared devices with which it is intended to function.

The Zyter RPM has two separate user interfaces: one is the provider web application and the second is the patient mobile application. The patient mobile application is used by patient-users along with their assigned medical devices to see their own health data and send device readings to their provider. The web application is used by healthcare providers to manage their patients, receive alerts and view their patient's medical data.

Zyter RPM is comprised of two main components:

• Mobile App (for patient users)
• Web App (for healthcare provider users)

The patient mobile application is used by patient-users along with their assigned medical devices to see their own health data and send device readings to their provider. The web application is used by healthcare providers to manage their patients, receive alerts and view their patient's medical data.

The patient-user is provided with a pre-configured Zyter Tablet for remote health monitoring. The patientuser may also choose to use their own smartphone and download the Zyter Mobile App. The patient is also assigned a number of health devices by their healthcare provider. The patient-user is responsible for connecting the health devices to the Zyter Tablet (or mobile phone). Pairing of the health devices with the tablet (or mobile phone) ensures wireless communication between both devices. Instructions for connecting health devices to the patient mobile app are included in the patient app guide. Zyter RPM mobile application also has a functionality that allows the patient to schedule a tele-visit with their healthcare provider. The patient may choose to take a self-assessment questionnaire found in the Zyter RPM prior to scheduling a visit.

Zyter RPM is a digital healthcare platform that automatically collects and routes data from the patient's pre-configured, compatible, at-home medical devices (blood pressure cuffs, glucometers, thermometers, digital weight scales, and smart watches) to the hospital office via a 4G cellular or Wireless connection.

The health devices are configured to a user in the Zyter user management using the Device Mac address. Zyter validation algorithm doesn't allow the duplicate Mac address entries. Zyter RPM provides patients with Tablets pre-installed with Zyter mobile application. Users connect with the wireless health devices through the mobile app. Zyter also supports BYOD model where patients use their own mobile devices to install the Zyter app from the App store and Google Play store to connect with the wireless devices.

Zyter RPM supports two transmission protocols, device data transmission through Bluetooth technology where the Bluetooth device needs to be paired with the mobile app and the 4G/LTE devices where the device data is transmitted to Zyter via device cloud via APIs and no device pairing required.

Zyter RPM achieves EMR connectivity using on-prem or on-cloud solutions.

The vitals reading from the health devices are securely processed through device SDKs/APIs and they are accessed through the patient and provider RPM dashboard. The Zyter RPM Dashboard enables the monitoring of multiple patients with an information tab for each patient. All physiological patient data, plus alerts and notifications from each patient's RPM devices, go directly to the dashboard for physician review, as well as intervention via a telehealth virtual visit if a patient's readings are out of the normal range.

Physicians can also configure alerts for custom parameters of device readings for individual patients. Zyter RPM devices also send alerts to the physician dashboard, email and SMS, and a reminder to the patient's Zyter RPM app, if a device has been dormant for a pre-determined amount of time.

Physicians can set a Zyter RPM alert based on any patient device reading that is out of range. Depending on the device(s) the patient receives, alert ranges can be set to measure the following values:

• BP (Systolic), mmHg
• BP (Diastolic), mmHg
• Pulse Oximeter, % Sp02
• Temperature, Fº or Cº
• Weight Scale, lbs
• Blood Glucose, mmoI/L

Zyter RPM is compatible with the following medical devices and accessories:
BodyTrace Blood Pressure Monitor K131395
iHealth BP Monitor - iHealth Track (KN550BT) K160014
BodyTrace Weighing Scale N/A - Wellness device
iHealth Weighing Scale N/A - Wellness device
Smart Meter iGlucose Blood Glucose Monitor Starter Kit K161790
iHealth Blood Glucose - iHealth Gluco + (BG5s): K181070
iHealth Thermometer PT3 K202753
iHealth Air Pulse Oximeter - iHealth Air (PO3M): K131111
Nonin Pulse Oximeter K131021
Apple Health Kit N/A - Apple Health System
Samsung Android Tablet

Here's a breakdown of the acceptance criteria and study information for the Zyter RPM device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific pass/fail acceptance criteria in terms of numerical thresholds for device performance. Instead, it indicates that performance testing was conducted to demonstrate substantial equivalence through software verification and validation, and human factors testing.

The document discusses the types of performance testing performed. Here's a table summarizing those and the general reported outcome:

• ANSI/AAMI/IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes
• FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
• FDA Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices
• FDA Guidance for Industry and Food and Drug Administration Staff, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
• FDA Guidance for Industry and Food and Drug Administration Staff Postmarket Management of Cybersecurity in Medical Devices
  Conclusion: Demonstrated substantial equivalence. |
  | Performance Bench Testing (Server Capacity) | Testing conducted on the number of concurrent transactions (readings/alerts) APIs can handle within a stipulated interval. Transactions stimulated through auto scripts to test server capacity and identify when application performance begins to degrade.
  Implied successful performance within expected loads. |
  | Human Factors Testing | A summative human factors study was conducted to evaluate the usability of the subject device by the intended users, in compliance with ANSI/AAMI/EC 62366-1:2015/A1:2020 and FDA Guidance for Industry and Food and Drug Administration Staff Applying Human Factors and Usability Engineering to Medical Devices.
  Implied successful usability for intended users. |
  | Risk Analysis | Performed (listed under performance testing).
  Implied acceptable risk profile. |

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

The document does not specify a sample size for any "test set" in the traditional sense of a clinical or imaging study. The testing described is primarily focused on software verification/validation, performance bench testing (server capacity), and human factors.

• Software Verification and Validation: This typically involves testing various modules, functionalities, and integration points. A "sample size" isn't directly applicable in the same way as a clinical trial.
• Performance Bench Testing: This involves simulating transactions. The document doesn't provide the number of simulated transactions or specific data provenance beyond general "auto scripts."
• Human Factors Testing: While a summative study was conducted, the document does not state the number of participants (the "test set" for human factors) or their demographics.
• Data Provenance: Not applicable as there is no mention of patient data being used for a test set to evaluate diagnostic or clinical performance.

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

This information is not provided as the study described is not a diagnostic performance study requiring expert ground truth.

4. Adjudication Method for the Test Set

This information is not provided as the study described is not a diagnostic performance study requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The Zyter RPM is a remote patient monitoring software that provides an interface for physiological data and alerts; it is not intended for diagnostic purposes and does not involve human readers interpreting medical images or data in a diagnostic context where AI assistance would be measured for improving diagnostic accuracy. The device's purpose is to aggregate and route data and alerts.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The performance testing described (Software V&V, Performance Bench Testing) can be considered "standalone" in the sense that it evaluates the software's functionality, reliability, and capacity on its own. However, the device's intended use is inherently connected to human users (healthcare providers and patients), and human factors testing was conducted to assess usability with human interaction. The device itself is an "algorithm only" software from the perspective that it processes and presents data, but its utility is in its interaction with connected devices and human users. There isn't a "diagnostic algorithm" performance being measured in isolation.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically used in diagnostic performance studies (e.g., pathology, outcomes data) is not applicable here. The Zyter RPM is not a diagnostic device. The "truth" being verified in its testing relates to:

• Software Functionality: Does the software perform its coded tasks correctly? (Verified through V&V).
• Data Aggregation and Routing Accuracy: Does it correctly receive, process, distribute, and display parameters/alerts as intended? (Verified through V&V and bench testing).
• System Capacity: Can it handle the expected load? (Verified through performance bench testing).
• Usability: Is it intuitive and safe for its intended users? (Verified through human factors testing).

8. The Sample Size for the Training Set

The document does not mention a training set. This is expected because the Zyter RPM appears to be a rule-based or conventional software system for data aggregation and alert management, rather than an AI/Machine Learning model that would require a "training set" of data for learning patterns to make predictions or classifications.

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

Since there is no mention of a training set, this information is not applicable.

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