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Intended for qualified healthcare personnel who are trained in its use, the MedHot MTI 2000 is a non-contact, non-invasive, non-radiating, thermographic imaging device for use as an adjunct to other clinical diagnostic procedures in the capture, quantification, and screening, of differences in skin surface temperature changes.

The device can digitally render quantitative images of thermal data via the capture and algorithmic interpretation of relative infrared information from the imaging camera in collaborative use with a compatible computer system which provides a user interface and image storage.

Patient populations and environmental use includes all age groups from adult to pediatric and neonatal in hospital, sub acute and public areas i.e. airports.

The MedHot MTI 2000 thermal imaging system is a non-invasive system that provides the user a visual representation of thermal temperature data in the form of a quantitative image on the users computer screen. The process begins by the cameras' capture of a data array representative of infrared radiation naturally emitted by the object being imaged; the data array is converted to a temperature data array using an algorithmic derivative. Once the infrared data is in the form of temperature data, software on the user's computer is used to generate an image from the rendered temperature data. The user can use this image in a number of ways to quantify the temperature of objects imaged.

The provided text describes the MedHot MTI 2000 Thermal Imaging System, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a 510(k) summary (K063047) for the MedHot MTI 2000, which focuses on demonstrating substantial equivalence to a predicate device. This type of submission generally relies on comparing the new device's technological characteristics and intended use to a device already cleared by the FDA, rather than presenting new clinical performance studies with acceptance criteria.

Here's a breakdown of why the requested information cannot be provided from the given text:

• No Acceptance Criteria: The document does not define any specific performance metrics (e.g., sensitivity, specificity, accuracy, thermal resolution, etc.) as "acceptance criteria."
• No Study Proving Acceptance Criteria Met: Since no acceptance criteria are stated, there is no study described that demonstrates the device meets them.

The "Non-Clinical Testing" section explicitly states:

• "Camera unit was successfully tested for EMC and EMI compliance as per IEC 60601-1-2 requirements." (This is about safety and electrical compatibility, not diagnostic performance.)
• "Clinical Testing: Not applicable" This clearly indicates that no clinical performance study was conducted or presented in this 510(k) submission.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, ground truth, expert qualifications, or MRMC studies for a performance study, as such a study is not detailed in the provided text.

The document determines substantial equivalence based on:

• Technological Characteristics Comparison: A comparison table is provided (Exhibit C, {1} of the input) between the MedHot MTI 2000 and a predicate device (A20M) across various parameters like detector type, spectral response, thermal sensitivity, array resolution, etc. This comparison aims to show that the differences do not raise new questions of safety or effectiveness.
• Intended Use: The intended use of the MedHot MTI 2000 is defined as an "adjunct to other clinical diagnostic procedures in the capture, quantification, and screening, of differences in skin surface temperature changes." This aligns with the predicate device's intended use, which is typical for substantial equivalence.

Without a performance study being described, the other requested details such as sample size, ground truth, number of experts, adjudication methods, MRMC studies, or standalone performance are not present in this document.

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