Search Results

The Podimetrics Remote Temperature Monitoring System™ (RTM System™) is intended to be used by a patient in conjunction with a healthcare professional or caretaker for periodic evaluation of the temperature over the soles of the feet for signs of inflammation. It will provide information indicating when the patient and healthcare provider should communicate for further evaluation and treatment regarding any persistent localized inflammation observed on the feet via the electronic sensing system and remote visualization of its data. The Podimetrics RTM System™ is intended to be used under the direction of a healthcare professional as an adjunct to, and not in replacement of, self-examination and periodic foot care and examination conducted by a healthcare professional and does not diagnose any specific disease state.

The Podimetrics RTM System™ is designed to help a patient and healthcare professional periodically evaluate the temperature over the soles of the feet for signs of inflammation. This evaluation may be helpful for determining when the patient and healthcare provider should communicate for physical examinations or care in addition to normally scheduled visits.

The system is comprised of the Podimetrics Mat and the Thermogram Explorer™ internet application. The Podimetrics Mat is about the same size and shape as a floor mat and placed on the floor of the patient's home. The patient stands on the mat once per day for about 20 seconds to collect a thermal scan of the soles of the feet. The thermal scan is recorded electronically via 2-dimensional array of temperature-sensitive resistors covering the top surface of the mat and the data is transmitted by an internal cellular modem to a remote server via cellular network.

The thermal scan data is processed and stored on the remote server and is displayed in Thermogram Explorer™, an internet application. The patient and healthcare professional can use Thermogram Explorer™ to access the thermograms and evaluate them for signs of inflammation. If any signs are observed, the patient can see the healthcare professional for a physical examination.

The Podimetrics Remote Temperature Monitoring System™ underwent a series of bench tests to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Human Factors Study (Mat Use): A "14-day in-home human factors study" was conducted. The document does not specify the exact number of participants, but it implies a sample of patients. No specific country of origin is mentioned, but "in-home" suggests users in typical environments. The study was prospective in nature.
• Other tests (Accuracy, Scan Time, Battery Life, Service Life, Electrical Safety, Wireless Data Transmission, Biocompatibility, Floor Safety, Shipping): These appear to be bench testing or laboratory-based tests. The document does not specify sample sizes for these tests, which is typical for engineering and material performance assessments rather than clinical trials. The data provenance is laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The document does not mention the use of experts to establish ground truth for the performance characteristics. Most of the tests are objective engineering or physical performance measurements (e.g., temperature accuracy, battery life, electrical safety standards).
• For the human factors studies, users themselves were the evaluators of their experience, not experts establishing a medical ground truth.

4. Adjudication method for the test set:

• No adjudication method is described, as the tests primarily involve objective measurements or user feedback rather than subjective interpretations requiring expert consensus.

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. The device is a monitoring system and not primarily an AI algorithm for diagnosis or interpretation that would typically require such a study to demonstrate improvement in human reader performance.

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

• The document describes the device as a "Remote Temperature Monitoring System™" and an "adjunct to, and not in replacement of, self-examination and periodic foot care and examination conducted by a healthcare professional." While the system processes and visualizes data, it is not presented as a standalone diagnostic AI algorithm. The performance characteristics focus on the accuracy and reliability of the physical device and its data transmission, not the diagnostic accuracy of an algorithm.

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

• The ground truth for most of the performance characteristics (e.g., accuracy, battery life, electrical safety) is based on established engineering and physical measurement standards.
• For the human factors studies, the "ground truth" was user experience and their ability to use the device as intended, reported directly by the users. There is no mention of medical ground truth (like pathology or clinical outcomes) being established for these specific performance tests, as the device's main function is data acquisition and presentation, not medical diagnosis.

8. The sample size for the training set:

• The document does not describe an AI algorithm or machine learning component that would require a distinct "training set" in the context of typical AI device development. The device's function is explained as an electronic sensing system that records and displays thermal scan data.

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

• As no training set for an AI algorithm is described, this question is not applicable based on the provided text.

Ask a specific question about this device