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The FORA GW 9014/TD-9014 TeleHealth Gateway is for use by patients at home or at clinical settings. It is intended to be used in combination with a variety of patient monitors upon the prescription of a licensed physician or other authorized healthcare provider. It serves as the remote communication link between various FDA-cleared compatible monitors and the compatible healthcare facility at another location. The healthcare facility could be with the healthcare provider, or at a disease management center, or other out-of-hospital caregivers.

This device is intended to transmit selected medical information (i.e. blood glucose, blood pressure, body weight, body temperature, body fat, and body hydration) measured by FDA approved medical devices via RS232 or wireless connections over the internet or residential telephone line.

This device does not measure, interpret or make any decisions on the data that it conveys.

This device is not intended for emergency calls, and may not be used for transmission or indication of any real-time alarms or time critical data. This device is not for use in systems which substitute for medical care, or for patients requiring direct medical supervision.

This device is not intended for patients requiring direct medical supervision or emergency intervention. Clinical judgment and experience are required to check and interpret the measurements collected and transmitted.

FORA GW 9014/TD-9014 TeleHealth Gateway serves as the communication link between various compatible monitors and the compatible healthcare facility remotely. The healthcare facility may include healthcare providers, physicians, other caregivers, or a disease management center.

The proposed device uses either RS232 cable or Bluetooth connection to receive data from the monitors and then transmit the collected data to the server system through either Ethernet or modem. The healthcare providers can view the patient's test results through the web server at any time.

The provided text describes a 510(k) submission for the FORA GW 9014/TD-9014 TeleHealth Gateway, a device designed to transmit medical information. The document focuses on demonstrating substantial equivalence to a predicate device and outlining performance studies.

However, the provided text does not contain detailed information about specific quantitative acceptance criteria or a study with a test set, ground truth, or expert involvement as typically expected for evaluating AI/algorithm-driven medical devices.

Instead, the performance studies mentioned are:

1. Software validation: This indicates the device "meets the acceptable criteria," but details about these criteria and the specific performance metrics are not given.
2. Compliance with international standards: IEC/EN 60601-1, EN 300 328, EN 301 489-17 V1.2.1:2002, and EN 301 489-1 V1.8.1:2008, IEC 61000-4-2. This typically concerns electrical safety, electromagnetic compatibility, and radio equipment performance, not clinical performance metrics related to data accuracy or interpretation.
3. Consumer study: This evaluated the "understandability for lay users" of the instruction manual.

Given the nature of the device (a telehealth gateway for transmission, not analysis or interpretation), the type of performance studies conducted are appropriate for demonstrating its functionality and safety as a communication link. It explicitly states: "This device does not measure, interpret or make any decisions on the data that it conveys." Therefore, comprehensive studies involving ground truth from experts, multi-reader multi-case analyses, or standalone algorithm performance, as would be expected for diagnostic or AI-powered devices, are not applicable to this specific device.

Therefore, many sections of your requested table cannot be filled from the provided text.

Here's a summary of what can be extracted based on the provided document:

Acceptance Criteria and Reported Device Performance

Details on Studies (Based on available information and interpretations)

• Sample size used for the test set and the data provenance: Not applicable in the context of clinical performance evaluation for this device. The "consumer study" would have involved a sample size of "lay users," but the exact number and provenance are not specified.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The device transmits data and does not perform interpretation requiring expert ground truth in a clinical sense.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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: Not done. This device is purely a communication gateway and does not involve AI for interpretation or improvement of human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. The device's function is communication, not standalone diagnostic or predictive performance. Its "standalone" performance would be its ability to transmit data accurately and reliably, which would be covered by software validation and compliance testing.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance. For the software validation and compliance testing, the "ground truth" would be defined by the specified requirements of the standards and internal validation protocols (e.g., successful transmission, correct protocol implementation, immunity to interference).
• The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
• How the ground truth for the training set was established: Not applicable.

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