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The Daylink 112 Monitor ("DLM112") is for use in non-clinical settings (such as the home), as an accessory device that is intended to be a communication tool to enable health care providers to receive historical patient information. It is intended to be used in combination with a variety of external devices. The DLM112 serves as the remote communication link between compatible external devices, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management center or with the healthcare/wellness provider or other out of hospital caregivers. The purpose is to collect and transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line.

The DLM112 Monitor does not measure, interpret or make any decisions on the vital data that it conveys.

The DLM112 telemedicine device performs transmission of physiological patient information to and from wireless, infrared and cabled patient monitors, and a remote data server healthcare facility using standard digital communication technologies and protocols. The DLM112, with its build-in modem, transmits data using the public switched telephone network.

The DLM112 screen, displays the information or questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons

The DLM112 device is not used directly on a patient, and poses no significant risk to the patient or other people within the patient's home.

Here's an analysis of the provided 510(k) summary regarding the DLM112 Daylink Monitor, focusing on acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance for DLM112 Daylink Monitor

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "Based on the fact that the performance comparison of the predicate device and the submission device show that the differences are minor and causes no harm to the user, and the fact that the intended use and indication for use is the same, it was early in the project decided to focus on verification and internal validation instead of large scale validation in form of clinical investigation."

Therefore, there was no "test set" in the context of a clinical study or a dataset of patient information as would be used for evaluating an AI/algorithm-driven device. The validation focused on engineering verification and internal functional testing of the device against established technical standards.

• Sample Size: Not applicable in the context of patient data. The "sample" would be the device itself and its components undergoing engineering and functional tests.
• Data Provenance: Not applicable. The validation was based on testing the hardware and software against technical standards, not on patient data.

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

Not applicable. As there was no clinical test set involving patient data for which "ground truth" (e.g., disease presence, measurement accuracy) needed to be established by experts, this information is not provided. The "ground truth" here is the adherence to technical specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

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

No. This device is a communication hub, not an AI/algorithm that assists human readers in interpreting medical images or data. Therefore, an MRMC study is not relevant and was not performed.

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

Yes, in a conceptual sense, the "performance" described is standalone algorithm/device performance against technical specifications. However, it's crucial to understand that the DLM112 is a data transmission device, not an AI or diagnostic algorithm. Its "standalone performance" refers to its ability to reliably transmit data according to its design and industry standards, entirely without human intervention in the transmission process itself. The document states: "The DLM112 Monitor does not measure, interpret or make any decisions on the vital data that it conveys."

7. The Type of Ground Truth Used

The "ground truth" for the DLM112's performance is adherence to recognized engineering standards and regulatory requirements. This includes:

• IEC 60601-1 (general safety of medical electrical equipment)
• IEC 60601-1-2 (electromagnetic compatibility)
• FCC Part 15 (radio frequency emissions)
• FCC Part 68 (telecom network connections)
• ISO 14971:2000 (risk management processes)

The device's functionality (data transmission) was verified against these established technical benchmarks.

8. The Sample Size for the Training Set

Not applicable. The DLM112 is a hardware communication device with embedded software, not an AI model that requires a "training set" of data in the machine learning sense. Its functionality is based on programmed logic and communication protocols, not learned patterns from a dataset.

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

Not applicable. As there is no training set for an AI model, there is no ground truth established for it.

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