(265 days)
The Thermidas IR System is for adjunctive use in addition to other clinical diagnostic procedures for diagnostic imaging for thermally significant indications of all skin regions of the human body. The system is for reviewing and reporting of temperature patterns and changes. The significance of the value of these thermal patterns is determined by professional investigation. The system is not intended for absolute temperature measurements. The Thermidas IR system is intended for use by trained technical personnel.
The Thermidas IR System consists of an off-the-shelf thermal imaging camera, a mount for the camera and a Windows workstation running the Thermidas Imager software. The Thermidas IR System is a non-invasive medical device which uses infrared radiation naturally emitted by the patient, which senses variations in temperature. The captured data is processed by software producing a quantitative image on the computer screen. The medical professional can use the image to review, analyze, investigate, and quantify the temperature of the objects that are imaged.
The Thermidas IR System (ThIR-A615) is a Class I, reserved telethermographic system. Since it is a Class I device, clinical studies were not required and were not performed. Therefore, information regarding acceptance criteria based on clinical performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, adjudication methods, or multi-reader multi-case studies is not available in the provided text.
The substantial equivalence determination was based on non-clinical performance testing against several international and national standards.
1. A table of acceptance criteria and the reported device performance
Since clinical performance testing was not required or performed, the "reported device performance" in terms of clinical metrics (e.g., sensitivity, specificity) is not available. The acceptance criteria were met by demonstrating compliance with the following non-clinical testing standards:
| Acceptance Criteria (Standard Compliance) | Reported Device Performance (Compliance Statement) |
|---|---|
| EN ISO 13485:2016 | Compliance with this standard for Medical devices - Quality management systems |
| EN IS 14971:2012 | Compliance with this standard for Medical devices - Application of risk management to medical devices |
| IEC 62304:2015 (Ed 1.1) | Compliance with this standard for Medical device software - Software life cycle processes |
| EN 62366-1:2015 | Compliance with this standard for Medical devices - Application of usability engineering to medical devices |
| EN 60601-1:2006+A1:2013 | Compliance with this standard for Medical electrical equipment - General requirements for basic safety and essential performance |
| EN 606001-1-2:2015 | Compliance with this standard for Medical electrical equipment - Electromagnetic disturbances - Requirements and tests |
| IEC 60601-1-2:2014 | Compliance with this standard for Medical electrical equipment - Electromagnetic disturbances - Requirements and tests |
| ANSI/AAMI ES60601-1:2005/(R)2012 | Compliance with this standard for Medical electrical equipment - General requirements for basic safety and essential performance |
| Directive 93/42/EEC on Medical Devices | Compliance with Annex II for infrared imaging devices for medical diagnostic purposes |
Discussion on Device Features Compared to Predicate (Found in the "Predicate Device Comparison" Table):
While not formal performance metrics, the device's technical specifications and features were compared to the predicate to establish substantial equivalence. These comparisons highlight attributes that contribute to the device's functional performance:
- Resolution: Both the predicate and proposed device support high resolution (e.g., 640x480). The proposed device explicitly states it uses a "640 x 480 pixel microbolometer that detects temperature differences as small as 50 mK, for accuracy at longer distances."
- Image Frequency: Both devices offer high image frequency (e.g., 50-60 Hz) for real-time viewing. The proposed device specifies "Stream full-frame 16-bit images at 50 Hz, or in windowed mode as high as 200 Hz, for high-speed processes."
- Focus: Both offer automatic focus.
- Connectivity: Both use Gigabit Ethernet.
- Calibration: Both are factory calibrated.
- Lens: Both use a 25-degree standard lens.
- Software Features: Both provide software for capturing, displaying, and analyzing thermal patterns (e.g., patient records, image capture, visualization, ROI analysis, reporting).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. Clinical studies were not required or performed for this Class I device. The testing involved compliance with non-clinical engineering and quality standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Clinical studies were not required or performed. There was no clinical ground truth established for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set requiring adjudication was used.
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
- Not Applicable. No MRMC study was conducted. The device is a telethermographic system for adjunctive diagnostic imaging, and the provided documentation does not indicate it uses AI for image interpretation or for assisting human readers in a comparative effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. Clinical studies were not performed. The device is a system for reviewing and reporting temperature patterns, with the interpretation by trained technical personnel. The software itself "makes no determination regarding what the thermal patterns or relative temperature values mean" and "The decision making is not based on the software itself."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No clinical ground truth was established as clinical studies were not performed. For the non-clinical testing, compliance with standards served as the "ground truth" for safety and performance according to those standards.
8. The sample size for the training set
- Not Applicable. As clinical studies were not performed, there was no clinical training set.
9. How the ground truth for the training set was established
- Not Applicable. As clinical studies were not performed, there was no clinical training set or associated ground truth establishment.
§ 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.