Search Results
Found 2 results
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.
Ask a specific question about this device
(21 days)
The purpose of the TCx-I Remote Care Management System is to collect and transmit medical information such as weight, blood pressure and pulse rate, and blood glucose from the patients on completion of their testing and transmit these results to their healthcare provider at another facility. The system supports videoconferencing, multimedia education and messages. This system is installed by or with support from trained professionals. This device is not intended to provide time sensitive data or alarms. This system may not be used as a substitute for direct medical intervention or emergency care. Interpretation of the information collected and transmitted requires clinical judgment by an experienced medical professional.
TCx-I Remote Care Management system collects and transmits measurement information such as weight, blood pressure and pulse rate, and Blood Glucose data from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.
The BL Healthcare Inc. TCx-I Remote Care Management System (RCMS) is a telemedicine system designed to collect and transmit medical information (weight, blood pressure, pulse rate, blood glucose) from patients to healthcare providers. The provided document is a 510(k) summary and submission acceptance letter, which details its regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than a full clinical study with specific acceptance criteria and performance metrics for an AI algorithm.
Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment methods, expert qualifications, adjudication methods, MRMC studies, and standalone performance for an AI-powered device is not applicable or not provided in this document. The device described here is a data collection and transmission system, not an AI diagnostic or assistive tool in the way current AI medical devices are typically evaluated.
Here's what can be extracted from the document based on your questions:
1. Table of acceptance criteria and the reported device performance
Based on the document, there are no specific numeric acceptance criteria or reported device performance metrics in terms of accuracy, sensitivity, specificity, etc., as typically associated with AI performance. The "acceptance criteria" here relate to regulatory compliance and the system's ability to correctly transmit data.
| Acceptance Criteria Category | Specific Criteria (as inferred) | Reported Device Performance (as inferred) |
|---|---|---|
| Data Collection & Transmission | Ensure data is collected and transmitted correctly to the server. | Non-clinical substantial equivalency testing and Risk-based verification testing performed per FDA guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" demonstrated correct data collection and transmission. |
| Safety and Effectiveness | Device is as safe and effective as predicate devices. | Non-clinical testing met required objectives, demonstrating safety and effectiveness comparable to predicate devices. |
| Regulatory Compliance | Conforms to relevant FDA recognized standards. | Conforms to IEC60601-1-1 and IEC60601-1-2. Labeling conforms to FDA guidance "Guidance on Medical Device Patient labeling" April 19, 2001. |
| Technological Characteristics | Same fundamental technology as predicate devices. | The TCx-I Remote Care Management system has the same fundamental technology as the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable/Not provided. The evaluation was based on non-clinical software validation and risk-based verification testing, not a clinical "test set" of patient data in the context of an AI algorithm.
- Data provenance: Not applicable/Not provided in the context of an AI algorithm's test data. The testing focused on the system's functional integrity.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the sense of expert-labeled data for algorithm evaluation, was not established for this type of system validation. The "ground truth" implicitly was whether the system correctly collected and transmitted the input data.
4. Adjudication method for the test set
Not applicable. No adjudication method for a test set was mentioned, as it was not a study evaluating human interpretation or AI performance on medical images/signals.
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 MRMC comparative effectiveness study was done. This device is a data transmission system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone performance evaluation (in the context of an AI algorithm's diagnostic or predictive capabilities) was done. The focus was on the reliability of data transmission.
7. The type of ground truth used
The "ground truth" for this system's validation would be the accurate transmission and display of the measured physiological parameters (weight, BP, pulse, blood glucose). This is established through engineering and software testing protocols, verifying that what is measured at the patient end is accurately reflected at the healthcare provider end. It does not involve expert consensus, pathology, or outcomes data in the typical sense of AI evaluation.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that undergoes "training" on a dataset. Its primary function is data acquisition and transmission.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1