(101 days)
The Sentinel BreastScan II 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 in an environment where patient care is provided by qualified healthcare personnel. The patient populations include adult. The device is for adjunctive diagnostic screening for detection of breast cancer and diseases affecting blood perfusion or reperfusion of tissue or organs. This device is intended for use by qualified healthcare personnel trained in its use.
The Sentinel BreastScan II System consists of a portable device that captures and records thermal infrared energy (heat) emitting from a person's body. There is no compression of the breast or patient contact with the device and the test emits no radiation to the patient. The device consists of a thermal camera, a metal enclosure to secure and protect components, a motor and electronics to raise and lower the tester to adjust the camera for various sized patients, a chair with attached armrests, adjustable special heat reflecting mirrors, a computer with a touchscreen monitor, data storage, software, and Wi-Fi communication. The tester includes an air cooling unit that blows cool air during part of the test cycle.
The provided text describes the Sentinel BreastScan II System, which is a telethermographic system for adjunctive diagnostic screening for breast cancer. However, the document primarily focuses on demonstrating substantial equivalence to a predicate device (Infrared Sciences Corp., BreastScan IR) based on technological characteristics and adherence to safety standards.
Crucially, the provided text DOES NOT contain information regarding a study that proves the device meets specific performance-based acceptance criteria for its diagnostic claims (e.g., sensitivity, specificity, accuracy for breast cancer detection).
The "Performance Data" section only mentions compliance with electrical safety standards (ANSI/AAMI ES60601-1, IEC 60601-1-2) and claims that the device "meets all Sentinel BreastScan II requirements and specifications as provided in the verification and validation testing results reports." It does not provide any specific quantitative performance metrics related to diagnostic accuracy, nor does it detail any clinical studies (such as MRMC or standalone performance studies) that would typically be used to demonstrate such performance.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and reported device performance specific to diagnostic accuracy, as this data is not present.
- Sample size and data provenance for a diagnostic test set.
- Number of experts and their qualifications for establishing ground truth, adjudication methods, MRMC study details, or standalone performance study details, as these studies are not described.
- Type of ground truth used for diagnostic claims.
- Sample size for the training set or how ground truth was established for it.
The document indicates that the device's 510(k) clearance was based on demonstrating "substantial equivalence" to a predicate device, which often relies on demonstrating similar technological characteristics and adherence to general safety standards rather than new clinical performance studies for diagnostic accuracy, especially for Class I or II devices where a predicate exists with established performance.
In summary, the provided document does not contain the information requested about a study proving the device meets performance-based acceptance criteria for its diagnostic function.
§ 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.