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510(k) Data Aggregation
(219 days)
The TMC Health Monitor is intended to facilitate monitoring and transmission to a remote server of certain physiological parameters relevant to the remote management of health status and chronic disease conditions.
The TMC Health Monitor is a system that provides:
- Monitoring and display of vital signs/health parameters.
- Management and scheduling of clinical measurements and questionnaires.
- A web connection to patient health information.
- Reporting to clinicians and allied health workers.
The device has been designed to provide the user with information to assist with an appropriate treatment program or further investigation.
The TeleMedCare Health Monitor is designed to be used in the home or community setting to enable remote care management of patients with chronic illness.
The TeleMedCare Health Monitor is an ergonomic design table top device with a touch screen and associated measurement components that may be integral or connected to it wirelessly or by cable. After measurements are recorded, the data is viewed and stored on the device then automatically transmitted via telephone modem or local area network (LAN) to a secure remote server. This data is then able to be viewed remotely over the web by the user's health care professional to assist them with chronic care management. Access to information stored and processed by the device is by means of password protection, encryption and use of collocated secure servers.
The device also provides a means of messaging and video teleconferencing between the patient and carer to discuss their health and treatment. Questionnaires may also be configured by the carer to gauge other aspects of a patients well being.
TeleMedCare software, captures, stores and transmits health data and access controlled carer's may set upper and lower limits to allow notification to them when these limits are exceeded to review health care management. The device however does not offer critical care or emergency support and requires professional medical interpretation for treatment of prescribed users.
The System has functionality and devices to record, store and transmit data for body blood pressure, glucose and oximetry, heart rate (ECG), lung function (Spirometry), body temperature and weight.
Power to the device is supplied by a medical grade power supply delivering 12 volts D.C to the system via a cable plugged into the back of the unit along with connection to tethered external measurement modules and the internet. The TeleMedCare Health Monitor has been tested and complies with international standards for electrical and electrocardiograph safety, electromagnetic compatibility and telecommunication standards.
The TeleMedCare Health Monitor is a patient monitoring system designed for remote care management of patients with chronic illnesses. The provided summary states that the device has undergone extensive internal bench testing, independent clinical trials, and product evaluations. It has been cleared for use in Australia, New Zealand, and Europe and is CE marked. The submission focuses on substantial equivalence to predicate devices rather than providing specific detailed acceptance criteria and a dedicated study report proving those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not include an explicit table of acceptance criteria with corresponding performance metrics from a specific study. Instead, it relies on substantial equivalence to predicate devices and general compliance with recognized standards. The acceptance criteria are implicitly met through:
| Acceptance Criteria Category | Implicit Criteria (Based on information provided) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Monitor and display vital signs/health parameters. | The device provides "Monitoring and display of vital signs/health parameters." |
| Manage and schedule clinical measurements and questionnaires. | The device provides "Management and scheduling of clinical measurements and questionnaires." | |
| Provide web connection to patient health information. | The device provides "A web connection to patient health information." | |
| Report to clinicians and allied health workers. | The device provides "Reporting to clinicians and allied health workers." | |
| Data Handling & Transmission | Capture, store, and transmit health data reliably via telephone modem or LAN to a secure remote server. | "Hundreds of thousands of measurements have reliably been accumulated and reported to professional health providers without a single device recall." |
| Security & Privacy | Access to information must be password protected, encrypted, and use collocated secure servers. | "Access to information stored and processed by the device is by means of password protection, encryption and use of collocated secure servers." |
| Safety & Efficacy | Compliance with FDA recognized standards, electrical and electrocardiograph safety, electromagnetic compatibility, and telecommunication standards. | "Tested and complies with international standards for electrical and electrocardiograph safety, electromagnetic compatibility and telecommunication standards." "Test criteria... established by reference and compliance with FDA recognized standards." |
| Risk Management | Application of risk management in accordance with EN ISO 14971:2007. | "Outcome of risk assessments... in accordance with EN ISO 14971:2007." |
| No New Questions of Safety/Efficacy | Should not raise new questions concerning the safety and efficacy compared to predicate devices. | "A comparative analysis has established that the TeleMedCare Health Monitor... raise no new questions concerning the safety and efficacy of the device." |
2. Sample Size for the Test Set and Data Provenance
The 510(k) summary does not specify a distinct "test set" and its sample size or data provenance in the context of a formal clinical validation study for the US submission. The emphasis is on:
- "Extensive internal bench testing": No details provided on sample size or how this relates to a test set.
- "Independent clinical trials and product evaluations by various health institutions and government and nongovernment organizations": These are reported to have been conducted since 2001 in Australia, New Zealand, and Europe. The specific sample sizes and detailed data provenance (e.g., country, retrospective/prospective nature) for these trials are not provided in this summary. However, it is stated that "hundreds of thousands of measurements have reliably been accumulated."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The 510(k) summary does not provide any information regarding the number or qualifications of experts used to establish ground truth for a discrete test set. The device itself is designed for "professional medical interpretation for treatment of prescribed users." The focus of the submission is on the device's technical and safety performance, and its substantial equivalence to other patient monitors.
4. Adjudication Method for the Test Set
No information is provided about an adjudication method for a test set, as a specific, detailed performance study with a test set and associated ground truth is not elaborated upon in this 510(k) summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided 510(k) summary. The document does not describe the device as an AI-powered diagnostic tool where human reader performance would be enhanced with AI assistance. It is a data collection and transmission system.
6. Standalone Performance Study
No specific standalone performance study (algorithm only without human-in-the-loop performance) is described in the provided summary. The device's performance is gauged by its reliability in data collection, storage, and transmission, and its compliance with relevant safety and technical standards as demonstrated over years of use in other markets and through general testing.
7. Type of Ground Truth Used
The concept of "ground truth" as typically used in AI/diagnostic device validation (e.g., pathology, outcomes data) is not directly applicable or discussed in this 510(k) summary. The device's function is to monitor and transmit physiological parameters, not to provide diagnostic interpretations. The "truth" for its claims would relate to the accuracy of its measurements and the reliability of its data transmission, which are addressed by compliance with standards and a history of reliable operation.
8. Sample Size for the Training Set
No information regarding a "training set" or its sample size is provided. The device described is a hardware and software system for data collection and transmission, not an AI/machine learning model that typically undergoes a training phase.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned (since this is not an AI/ML device in the context of the summary), there is no information on how ground truth for such a set would have been established.
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