(47 days)
The InfraCAM-MED is a non-contact, non-invasive, non-radiating, thermal (infrared) imaging video camera intended as an adjunctive diagnostic device for viewing heat patterns generated by the relative surface temperature of human heart tissue and vessels during coronary artery bypass graft surgery. Images of the exposed heart may be captured as a black/white video image using VHS/SVHS videotape, or a black/white still image using a thermal image printer. The InfraCAM-MED Thermal Coronary Angiography imaging camera may be used to perform the following:
- Viewing and documenting temperature differences between myocardium, graft . and vessels distal to the anastomotic site generated by the injection of cold or warm fluid into the proximal end of a vein graft.
- Viewing and documenting temperature differences between myocardium, graft . and vessels distal to the anastomotic site generated by blood flow after release of the cross clamp(s) on a arterial graft.
- Viewing and documenting temperature changes to the myocardium during the . retrograde or antegrade perfusion of warm or cold cardioplegia.
The InfraCAM-MED is a small infrared camera with integral high-resolution CRT viewfinder. It is a battery operated thermal imaging system that is completely self contained with integral TV compatible display. The InfraCAM-MED is qualified to MIL STD 810E. The camera head houses the thermal image camera. During surgery, the camera is situated outside the sterile field therefore it is not covered by a sterile drape.
The provided text does not contain specific acceptance criteria or detailed results from a study that a medical device (Inframetrics InfraCAM-MED) needs to meet. It mentions that "both animal and clinical testing were performed using the InfraCAM-MED which showed that the InfraCAM-MED performs as intended," but it does not elaborate on what "performs as intended" quantitatively means or provide any performance metrics.
Therefore, I cannot populate the requested table or answer most of the questions because the necessary information is not present in the given document.
Here's what I can extract and what is missing:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Performs as intended" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified.
- Data Provenance: Not specified (animal and clinical testing mentioned, but no details on location or study design type).
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 specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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. The device described (InfraCAM-MED) is a thermal imaging system, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an algorithm. The device itself is a standalone imaging system for viewing and documenting thermal patterns.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified.
8. The sample size for the training set:
- Not applicable. This is typically relevant for machine learning models, which is not the primary function of this thermal imaging device.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.