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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.

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TempStat" is a daily activity assist device that is intended to assist a patient to visualize the image and condition of the soles of their feet in connection with a daily self-examination for signs of inflammation on the sole of the foot. TempStat" will assist the patient in determining when they should contact their healthcare provider for further diagnosis and treatment regarding any skin changes seen by a mirror and/or highlighted by the liquid crystal foot pads. TempStat™ is intended to be used as an adjunct to, and not in replacement of, periodic foot care and examinations conducted by a health care professional and used under the direction of a health care professional and does not diagnose any specific disease state.

The Visual Footcare Technologies TempStat® device is a daily activity assist designed to make the examination of the plantar surface of the foot simple and easy to accomplish. It consists of a plastic pancl that has a 2X convex mirror in the center third scction, with two polycarbonate plastic pads on either side of the mirror. The plastic pads are contructed primarily of liquid crystallinc cholesteric esters that react to skin surface temperature and change to a specific color relative to that level of temperature. With this device, the patient can visually examine his foot and also see a graphical representation of the heat pattern on the plantar solc of his foot. The device is designed to sit on the floor in front of the patient, who is seated in a chair. The patient leans over and raises his foot to see the bottom of his foot in the mirror, and then places them on the polycarbonate pads. After 60 seconds, the patient can remove his feet and can visualize the pattern of skin tempcrature from the plantar surface of his foot.

The Visual Footcare Technologies, LLC TempStat™ device, as described in the 510(k) summary, includes performance testing centered on the accuracy of its liquid crystal pads and its ability to assist patients in visualizing their foot's plantar surface. Here's a breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

Detailed Study Information

The provided 510(k) summary offers limited detail on the specific study methodologies for each criterion. Based on the available information:

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

   • Temperature Accuracy Study: Not explicitly stated. The study references ASTM E 1061-01 Standard, which might specify sample sizes for such tests, but this detail is not present in the 510(k).
   • Patient Preference Study: Not explicitly stated. The text says "All study subjects felt...", which implies a sample was used, but the number is not provided.
   • Data Provenance: Not explicitly stated, but given it's for a US regulatory submission, it's highly likely to be US data, and given the nature of the device, likely prospective studies (i.e., experiments designed to test the device).

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

   • Temperature Accuracy Study: No experts were mentioned for establishing ground truth for the temperature accuracy. The ground truth would likely be established by a calibrated reference thermometer or laboratory equipment against which the device's color changes are compared, as per ASTM E 1061-01.
   • Patient Preference Study: No experts were described as establishing ground truth. This type of study relies on direct feedback from the "study subjects" themselves regarding their perception of the device's utility in visualization, rather than an expert's assessment of their visualization ability.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not specified for either study.

4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The studies focused on functional accuracy and user preference rather than reader performance.

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

   • Temperature Accuracy Study: This would be considered a standalone performance test of the device's physical components (liquid crystal pads) to accurately reflect temperature. It assesses the intrinsic accuracy of the temperature display mechanism.
   • Patient Preference Study: This involved human interaction ("study subjects" viewing their feet), so it was not standalone in the sense of "algorithm only."

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

   • Temperature Accuracy Study: The ground truth was likely established by reference to a calibrated temperature standard (e.g., a precise thermometer) as implied by the ASTM E 1061-01 standard.
   • Patient Preference Study: The "ground truth" was the self-reported perception of the study subjects regarding the device's assistance in visualization.

7. The sample size for the training set: Not applicable, as this device does not use machine learning algorithms that would require a training set. Its functionality is based on physical properties of liquid crystals and mirror optics.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for this device.

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