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The RTX3370 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 RTX3370 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 centre 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 RTX3370 does not measure, interpret or make any decisions on the vital data that it conveys.

The RTX3370 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 RTX3370, with its build-in modem, transmits data using the public switched telephone network.

The RTX3370 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 RTX3370 device is not used directly on a patient, and poses no significant risk to the patient or other people within the patient's home.

The provided text describes a 510(k) submission for the RTX3370 telemedicine device and its substantial equivalence to a predicate device (DLM112 Daylink Monitor, K062304). The submission focuses on demonstrating that the new device meets the same safety and effectiveness criteria as the predicate device, primarily through verification and validation activities guided by relevant standards, rather than a clinical trial with specific performance metrics.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not detail specific sample sizes for a "test set" in the context of a clinical performance study. The evaluation focused on verification and internal validation in contrast to "large scale validation in form of clinical investigation." Therefore, it's highly likely that the testing involved laboratory-based verification of compliance with established standards and internal validation protocols conducted by the manufacturer.

• Sample size: Not specified, as it was not a traditional clinical study but rather engineering verification and validation.
• Data provenance: Not explicitly stated, but given it's manufacturer-conducted verification and validation, it would be internal data from the company (RTX Healthcare, Denmark). The tests would be prospective in nature, as they are conducted on the device to prove compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable and not provided in the document. The device is a physiological signal transmitter and receiver, a communication tool, and not a diagnostic device that interprets medical data or requires expert-established ground truth for its performance assessment in the way a diagnostic AI would. Its "performance" is assessed against technical standards and its ability to accurately transmit data, not against clinical expert interpretations of medical conditions.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This type of adjudication method is used in clinical studies, particularly in radiology or pathology, where human expert disagreement needs to be resolved for ground truth establishment. This is not relevant for the type of device and testing described.

5. 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:

No, an MRMC comparative effectiveness study was not performed. This type of study would be relevant for AI-powered diagnostic or assistive tools where human performance is being evaluated and potentially augmented by AI. The RTX3370 is a communication device and does not involve "human readers" or "AI assistance" in the diagnostic sense.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device itself is a "standalone" communication device in the sense that its primary function (data transmission) does not involve a human-in-the-loop for its direct operation. However, its purpose is to transmit data to healthcare providers. The performance data discussed relates to its compliance with technical standards (e.g., electrical safety, EMC, radio frequency emissions, telephone network connectivity) and internal validation of its communication functions. It's not an algorithm that performs a diagnostic task, so the concept of "standalone" performance for an algorithm isn't directly applicable in the same way as for AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The concept of "ground truth" for this device's performance relies on compliance with established technical and safety standards (e.g., IEC 60601-1, FCC Part 15, etc.) and successful execution of its intended communication functions as verified by internal testing. There is no biological or clinical "ground truth" (like pathology or outcomes data) involved for this specific type of device, as it does not make diagnostic or treatment decisions.

8. The sample size for the training set:

Not applicable. The RTX3370 is not an AI/ML device, so there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set.

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