(78 days)
Thermal Imaging is a medical imaging modality for use as an adjunctive procedure to support other diagnostic modalities. For example, thermal imaging of breasts can demonstrate a temperature variance as a method to help clarify findings indicated by mammography or some other diagnostic procedure.
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This document is an FDA 510(k) clearance letter for a medical device called the "Mark I Thermal Imager." It primarily discusses regulatory approval and does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria. The letter confirms that the device is substantially equivalent to a legally marketed predicate device, but it does not provide the specifics of the performance testing or clinical studies.
Therefore, I cannot fulfill your request for the information outlined in your prompt using only the provided text. The document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Information on experts used to establish ground truth.
- Adjudication method for a test set.
- Details of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on a standalone algorithm performance study.
- The type of ground truth used.
- Sample size for a training set.
- How ground truth for the training set was established.
The "Indications for Use" section (page 2 of the input) briefly describes the purpose of thermal imaging as an "adjunctive procedure to support other diagnostic modalities" and its ability to "demonstrate a temperature variance as a method to help clarify findings indicated by mammography or some other diagnostic procedure." However, this is a statement of intended use, not a report of study results or acceptance criteria.
To obtain the information you are looking for, you would typically need to consult the 510(k) premarket notification submission itself, which would contain the detailed study results and performance data.
§ 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.