(72 days)
The MHS 5000 thermal imaging system is a thermal based imaging device intended for viewing and digitally storing thermal patterns generated by the human body in the settings, surgery, healthcare practitioner facilities or in any environment where healthcare is provided by a qualified healthcare professional. The MHS 5000 provides for use with both laptop and desktop computers. The computer provides the user interface, image storage and display. Use of this device is determined by the healthcare professional and is based upon his or her assessment of the patient's medical condition and requirements. The patient population is not limited to pediatric and neonatal. The device is for providing thermal images of the human body.
The MHS 5000 thermal imaging system is a thermal based imaging device intended for viewing and digitally storing thermal patterns generated by the human body. The MHS 5000 provides for use with both laptop and desktop computers. The computer provides the user interface, image storage and display.
I am sorry, but the provided text does not contain detailed information about the acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter for the MHS 5000 Thermal Imaging System, indicating that the device has been found substantially equivalent to a predicate device.
The clearance letter primarily addresses regulatory aspects, such as:
- Device identification: MHS 5000 Thermal Imaging System.
- Intended Use: "a thermal based imaging device intended for viewing and digitally storing thermal patterns generated by the human body... for providing thermal images of the human body."
- Regulatory classification: Class I.
- General controls: Acknowledgment of general controls provisions of the Act, including annual registration, misbranding, and adulteration rules.
- Marketing permission: Granting permission to market the device.
There is no information within this document regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used in studies.
- Training set sample size.
- Ground truth establishment method for the training set.
To obtain this type of detailed performance data, one would typically need to refer to the premarket notification (510(k)) submission document itself, which details the studies and evidence provided to the FDA to demonstrate substantial equivalence, or publicly available literature related to the device's validation. This clearance letter is merely the FDA's decision based on that submission.
§ 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.