(30 days)
The ThermPix Thermovisual Camera is intended to view, measure, and record heat patterns and variations. It is intended for use as adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body. The significance of these thermal patterns and variations is determined by professional investigation. This device is intended for use by qualified technical personnel. Clinical judgement and experience are required to review and interpret the information transmitted.
The ThermPix Thermovisual Camera is only for use in addition to other diagnostic medical devices. It does not provide any absolute measurement of temperature and should not be used for sole screening or diagnosis for any disease or condition.
The system is not intended to be used as a thermometry device.
The ThermPix Thermovisual Camera is a Telethermographic system which consists of an infrared camera embedded in a Tablet case and a Commercial Off the Shelf Tablet (WIFF only). It is a non-contact, non-invasive, and non-radiating infrared system capable of imaging and storing thermal patterns generated by the human body. These images along with other patient-specific data are uploaded via WIFI to the ThermPix Cloud, a secure repository where clinicians can access and augment data from a 3rd party device or computer.
It employs passive infrared emission sensing technology to capture the thermal data and uses proprietary software to display the temperature distribution pattern as an image. It is suitable for imaging adult human targets and can be used in hospitals, acute and sub-acute healthcare settings, clinics, and any environment where healthcare is provided by a healthcare professional.
Here's a breakdown of the acceptance criteria and study information for the ThermPix Thermovisual Camera, based on the provided document:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Temperature Difference Accuracy: Ability to distinguish temperature differences | With 99% confidence, temperature differences of 1°C or more are discernible by a trained user. |
| Electrical Safety and EMC: Compliance with relevant standards | Passed IEC 60601-1-2 Ed 4.1, IEC 60601-1 Ed 3.2, IEC 60601-1-6 Ed 3.2. |
| Software Verification and Validation: Compliance with relevant standards | Compliant with IEC 62304 Ed 1.1 and FDA Guidance for Software in Medical Devices. |
2. Sample Size for Test Set and Data Provenance
The document mentions that for the Performance Validation Testing, image data was collected from 2 cameras.
The temperatures ranged from 20°C to 40°C in increments of 2°C.
The provenance of this data (e.g., country of origin, retrospective/prospective) is not explicitly stated in the provided text.
3. Number of Experts and Qualifications for Ground Truth Establishment
The document states: "Results indicate that with 99% confidence temperature differences in 1 °C or more are discernible by a trained user."
The number of such "trained users" and their specific qualifications (e.g., radiologist with X years of experience) are not specified.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method used for the test set.
5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. The study focuses on the device's ability to discern temperature differences by a "trained user" rather than comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
The device is described as a "Thermovisual Camera" intended to "view, measure, and record heat patterns." The performance validation assesses its ability to allow users to distinguish temperature differences. This indicates a device-only performance test, where the device itself is producing the thermal images, and a human user then interprets them. The study focuses on how well the device enables a trained user, implying a standalone performance in terms of image quality and accuracy for interpretation. However, there isn't a direct "algorithm-only" performance metric separate from human observation.
7. Type of Ground Truth Used
The ground truth for the "Temperature Difference Accuracy" appears to be based on known temperature differences created using a "traceable certified reference black body calibrator and thermocouples." This represents a highly controlled and objective physical measurement.
8. Sample Size for the Training Set
The document does not provide information about a specific training set or its sample size. The performance validation describes testing the device's ability to allow users to distinguish temperature differences, not the training of an AI algorithm from a specific dataset.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set for an AI algorithm, there is no information on how its ground truth was established. The focus of the provided document is on the device's physical and functional performance, rather than an AI/ML component that requires a training set.
§ 884.2980 Telethermographic system.
(a)
Telethermographic system intended for adjunctive diagnostic screening for detection of breast cancer or other uses —(1)Identification. A telethermographic system for adjunctive diagnostic screening for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(2)
Classification. Class I (general controls).(b)
Telethermographic system intended for use alone in diagnostic screening for detection of breast cancer or other uses —(1)Identification. A telethermographic system for use as the sole diagnostic screening tool for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 884.3.