(15 days)
The RTX3371 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 RTX3371 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) using standard wireless technologies.
The RTX3371 does not measure, interpret or make any decisions on the vital data that it conveys.
The RTX3371 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 RTX3371, with its build-in GSM/GPRS module, transmits data using public wireless networks.
The RTX3371 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 RTX3371 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 Tunstall Healthcare RTX3371 device is a physiological signal transmitter and receiver intended for use in non-clinical settings (e.g., home) as a communication tool. It enables healthcare providers to receive historical patient information by serving as a remote communication link between compatible external devices and a healthcare facility. The device collects and transmits selected medical information (e.g., weight, blood pressure, blood glucose) using standard wireless technologies. It does not measure, interpret, or make decisions on vital data.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standards and Regulations) | Reported Device Performance |
|---|---|
| IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | Testing successfully conducted to meet requirements. |
| IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests) | Testing successfully conducted to meet requirements. |
| EN980 (Symbols for use in the labelling of medical devices) | Testing successfully conducted to meet requirements. |
| FCC Part 15 (Radio Frequency Devices) | Testing successfully conducted to meet requirements. |
| FCC Part 24 (Personal Communications Services) | Testing successfully conducted to meet requirements. |
| ISO14971:2000 (Medical devices - Application of risk management to medical devices) | Risk management performed using FMEA. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes verification and internal validation testing activities. It explicitly states: "Based on the fact that the performance comparison of the predicate devices 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 are similar, it was early in the project decided to focus on verification and internal validation instead of large scale validation in form of clinical investigation."
This indicates that an external "test set" in the traditional sense of a clinical trial with human subjects for novel efficacy/performance testing was not performed. The primary testing focused on engineering verification and validation against specified standards. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) for clinical performance is not provided as a clinical study was deemed unnecessary for this device's 510(k) submission based on substantial equivalence to predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
As no large-scale clinical validation study with an independent test set was conducted (as per point 2), there is no information provided regarding the number or qualifications of experts used to establish ground truth for such a test set.
4. Adjudication Method for the Test Set:
Given the lack of a traditional clinical test set (as per point 2), there is no adjudication method mentioned as it would not be applicable in this context.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improving with AI vs without AI assistance:
The RTX3371 device is described as a communication tool for historical patient information and does not involve AI for interpretation or decision-making. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device's function is to transmit data; it does not involve an "algorithm only" performance for interpretation or diagnosis. Its performance is related to its ability to reliably transmit data and meet safety and electromagnetic compatibility standards. The verification and internal validation testing focused on these aspects, which can be considered "standalone" in the sense of the device functioning as intended.
7. The Type of Ground Truth Used:
For the technical performance of the device (communication, safety, EMC), the "ground truth" would be established by:
- Compliance with published international standards (IEC 60601-1, IEC 60601-1-2, EN980, FCC Part 15 & 24).
- Successful completion of risk management activities (ISO14971:2000 using FMEA).
- Verification and validation against internal design specifications and requirements.
There is no ground truth based on expert consensus, pathology, or outcomes data as this device does not perform diagnostic or interpretive functions.
8. The Sample Size for the Training Set:
The device is a communication hardware device, not an AI/ML algorithm that requires a "training set" in the conventional sense. Therefore, information regarding a training set sample size is not applicable and not provided.
9. How the Ground Truth for the Training Set was Established:
As there is no training set for an AI/ML algorithm, this question is not applicable.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).