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The Ambio Remote Health Monitoring System ("System") consists of Ambio Wireless Connectors to send readings from off-the-shelf blood pressure and blood glucose meters; the Ambio Scale with built in wireless connectivity to send readings through the Ambio Gateway to the Ambio Care Portal. The Care Portal is used by patients and their caregivers ("Users") to view readings, set reminders to take meter readings and pills, set reading thresholds which will trigger alert messages and set who will get reminder and alert messages. Reading history can be printed or exported. Users can maintain an exercise log, food log and records of doctor visits and lab tests. Users can set goals and rewards for taking readings and for keeping readings in target ranges. A patient survey tool can be used to gather qualitative health information. The System also has a shared calendar and message board to coordinate among Users. General health information from accredited sources is also available.

The Ambio Remote Health Monitoring 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 does not alter the indicated use of the described blood pressure or blood glucose monitors.

The System consists of:

(1) Ambio Wireless Connectors (Wireless Connectors):
The Wireless Connector is an electronic device that plugs into the USB port of compatible Blood Pressure Monitors and Blood Glucose Monitors to read the log, encrypt the data, and wirelessly transmit the data to the Ambio Gateway. Readings are sent automatically based on a schedule stored in the Wireless Connector or, the User can push the button on the Wireless Connector to initiate reading the Monitor log and transferring the data.

(2) Ambio Scale
The Ambio Scale is a stand on digital weight scale with an embedded Ambio Wireless Connector. When the User takes a weight reading, it is then encrypted by the Ambio Wireless Connector and wirelessly transmitted to the Ambio Gateway.

(3) Ambio Gateway
The Ambio Gateway is an electronic device that connects to the Patient's existing home Internet router using an Ethernet cable. The Ambio Gateway wirelessly receives encrypted data from the Ambio Wireless Connector and transmits it through the user's home broadband internet router to the Ambio Care Portal.

(4) Ambio Care Portal
The Ambio Care Portal is a secure, web based data base and software application that allows Users to review patient data collected from the described health devices using the Ambio Wireless Connector and Ambio Gateway.

The Care Portal is used by patients and their authorized caregivers ("Users") to view readings, set reminders, set personalized thresholds which will trigger alert messages. Reading history can be printed or exported. Users can set goals and rewards for taking readings per their schedule and achieving readings target. Users can maintain an exercise log, food log and records of doctor visits and lab tests. Users can create patient surveys to gather qualitative information. Users can coordinate using a shared calendar and message board. Health information from accredited sources can also be displayed.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Ambio Remote Health Monitoring System:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document (K130676) is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific, quantitative acceptance criteria for device performance in terms of diagnostic accuracy or clinical outcomes. The "acceptance criteria" presented are related to compliance with electrical safety and electromagnetic compatibility (EMC) standards, and the general functionality of the system components.

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

The document does not specify a sample size for an external "test set" in the context of clinical performance or diagnostic accuracy. The testing described is primarily non-clinical engineering and software verification/validation.

• Test Set Sample Size: Not applicable/not provided for clinical performance testing.
• Data Provenance: Not applicable for clinical performance testing, as no such data is described. The non-clinical testing was performed by Intertek Testing Services.

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

Not applicable. The described testing is technical (electrical safety, EMC, software functionality) not clinical. Therefore, there is no mention of experts establishing a clinical "ground truth."

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication is described.

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

No. An MRMC comparative effectiveness study was not done or reported. This device is a remote monitoring system, not a diagnostic imaging or interpretation aid where MRMC studies are typically employed to assess human reader performance with and without AI assistance.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance):

No. This device is a system for data collection and display, not an AI or algorithm with standalone diagnostic performance metrics (e.g., sensitivity, specificity). The "algorithm" here refers to the software for data transfer, storage, and display, which was tested for functionality.

7. Type of Ground Truth Used:

For the non-clinical performance data, the "ground truth" would be established by the specifications of the standards (e.g., IEC 60601-1) and the internal design specifications of the Ambio Health System. For example, for EMC testing, the "ground truth" is whether measured emissions/immunity levels fall within the limits defined by IEC/EN 60601-1-2.

• Expert Consensus: Not applicable.
• Pathology: Not applicable.
• Outcomes Data: Not applicable.
• Other: Compliance with established engineering and safety standards, and adherence to internal design specifications.

8. Sample Size for the Training Set:

Not applicable/not provided. This device is not an AI/ML system that would require a "training set" in the typical sense for learning patterns from data to make predictions or classifications. The software is deterministic and performs predefined functions (data transfer, encryption, storage, display, alerts based on thresholds).

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

Not applicable, as there is no "training set."

Summary of the Study:

The "study" described in the 510(k) Summary is a non-clinical evaluation focusing on:

• Compliance with Recognized Standards: The primary evidence provided is that the system components (Wireless Connectors, Scale, Gateway, Care Portal) comply with relevant electrical safety (IEC 60601-1 series) and electromagnetic compatibility (IEC/EN 60601-1-2) standards. These tests were performed by Intertek Testing Services.
• Internal Design Control Verification and Validation: This involved testing of all executable code and functionality, confirming that identified risks (including human factors for usability) were addressed, and verifying that the system interfaces correctly with various accessory medical devices (glucose meters, blood pressure monitors, scales). This "study" ensures that the product meets its own design specifications and is suitable for its intended use, which is remote monitoring and data display, not diagnostic interpretation.

The conclusion is that based on these non-clinical tests and a comparison of technological characteristics and intended use with predicate devices, the Ambio Remote Health Monitoring System is as safe and effective as the predicates. The FDA concurred with this assessment, leading to the 510(k) clearance.

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