(144 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 themally significant indications stemming from heat emitted from the human body. The significance of these thermal pariations 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 infrared and visual cameras and a touch-screen display. 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 is provided by a healthcare professional.
The provided text focuses on the 510(k) summary for the "ThermPix Thermovisual Camera" and its comparison to a predicate device. It details technical specifications and non-clinical testing performed to establish substantial equivalence. However, it explicitly states that clinical testing was not required and therefore does not contain information about a study proving the device meets acceptance criteria related to human performance, ground truth, expert adjudication, or MRMC studies.
I will extract the available information and highlight what is not present based on your request.
Here's the breakdown of the acceptance criteria and the study that was provided (non-clinical):
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct "acceptance criteria" but are implied through the comparison with the predicate device and the non-clinical performance testing. The "reported device performance" is the result of these non-clinical tests.
| Trait / Performance Metric | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (ThermPix Thermovisual Camera) |
|---|---|---|
| Indications for Use | To view, measure, and record heat patterns and variations as adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body. Not for sole screening/diagnosis, not a thermometry device. | Views, measures, and records heat patterns and variations. Intended for use as adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body. NOT for sole screening or diagnosis, NOT a thermometry device. (Identical to predicate) |
| Intended User | Healthcare Professionals | Healthcare Professionals (Identical) |
| Environment of Use | Clinical Environment | Clinical Environment (Identical) |
| Detector Type | Uncooled VOx microbolometer | Uncooled VOx microbolometer (Identical) |
| Spectral Range | Longwave infrared; 7.5 µm to 13.5 µm (Predicate) | Longwave infrared; 7.8 µm to 14 µm (Substantially Equivalent) |
| Frame Rate | 60 Hz (Predicate) | 9 Hz and 27 Hz (Substantially Equivalent - lower, but deemed acceptable for the intended use) |
| Thermal Sensitivity |
§ 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.