(98 days)
The NoTouch BreastScan system is intended to be used as an adjunctive screening device for the detection of breast cancer by measuring various temperature parameters from the surface of the breast.
The NoTouch BreastScan™ system is intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or an environment where patient care is provided by qualified healthcare personnel. The patient include adult. The device is for adjunctive diagnostic screening for the detection of breast cancer and diseases affecting blood perfusion of tissue or organs. This device is intended for use by a qualified healthcare professional trained in its use.
The NoTouch BreastScan consists of a group of hardware components. The hardware components consist of:
- Two digital infrared cameras
- . A computer system, with printer
- . An air conditioner unit
- . A specially designed mobile cart.
Software Components include:
- . NoTouch BreastScan Software
- . PDF Viewer
- . Drivers for Infrared imagers
- . ThermaCam Researcher Software
The provided text is a 510(k) summary for the NoTouch BreastScan device. While it states that "Testing of NoTouch BreastScan was performed as per the requirements" and "Complete validation and verification was performed on all software and hardware subsystems," it does not contain the detailed acceptance criteria or the specific study results proving the device meets these criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device (BREASTSCAN IR) and outlining the general intended use and technological characteristics. There is no information regarding 1. acceptance criteria, 2. sample size for test set and data provenance, 3. number and qualifications of experts for ground truth, 4. adjudication method, 5. comparative effectiveness study (MRMC), 6. standalone performance, 7. type of ground truth used, 8. sample size for training set, or 9. how ground truth for the training set was established.
Therefore, I cannot fulfill your request with the provided input because the necessary information about acceptance criteria and the detailed study results are absent.
§ 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.