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The Meditherm med2000 thermal imaging system is a thermal based imaging device intended for viewing and digitally storing thermal patterns generated by the human body in the clinical, hospital, healthcare practitioner facilities or in any environment when healthcares were with acute care settings, surgery, healthcare applications. The Meditherm med2000 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 populations and many of the populations include all ages of the human body and internal images of the human body. This device is intended for use by qualified healthcare personnel who are trained in its use.

The Meditherm med2000 thermal imaging system is a thermal based imaging device intended for viewing and digitally storing thermal patterns generated by the human body. It provides for use with both laptop and desktop computers. The computer provides the user interface, image storage and display.

This is a 510(k) clearance letter and an Indications for Use statement, not a study report or clinical trial summary. Therefore, the detailed information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and study methodologies (MRMC, standalone) is not available in the provided text.

The documents indicate regulatory clearance for the Meditherm Med2000 thermal imaging system based on its substantial equivalence to predicate devices, but they do not describe a specific study proving the device meets particular acceptance criteria in the way a clinical trial report would.

Here's a breakdown of what can be extracted and what cannot:

What Can Be Extracted from the Provided Text:

• Device Name: Meditherm Med2000
• Regulatory Class: I (21 CFR §884.2980/Procode: 90 LHQ)
• Intended Use: "The Meditherm med2000 thermal imaging system is a thermal based imaging device intended for viewing and digitally storing thermal patterns generated by the human body in the clinical, hospital, healthcare practitioner facilities or in any environment where healthcare is provided. The Meditherm med2000 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 populations include all ages of the human body for both external and internal images of the human body. This device is intended for use by qualified healthcare personnel who are trained in its use."

Information NOT Available in the Provided Text:

• A table of acceptance criteria and the reported device performance: The clearance letter states the device was found "substantially equivalent to legally marketed predicate devices," which is the regulatory acceptance criterion for 510(k) clearance, but it does not detail specific performance metrics (e.g., sensitivity, specificity, accuracy) or numerical thresholds.
• Sample size used for the test set and the data provenance: No information on a specific test set.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set study is detailed.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: No information on such a study.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is described as a "thermal based imaging device" with a "computer provides the user interface, image storage and display," implying human interaction. No standalone algorithm performance is mentioned.
• The type of ground truth used: Not applicable, as no study is detailed.
• The sample size for the training set: Not applicable, as this is a 510(k) submission, not a machine learning algorithm development document.
• How the ground truth for the training set was established: Not applicable.

Summary:

The provided documents are a regulatory clearance for a medical device. They affirm its substantial equivalence to existing devices for its stated intended use. However, they do not contain the details of a clinical study or performance evaluation that would specify acceptance criteria and report device performance in the manner requested for an AI/device performance study. The 510(k) process primarily assesses substantial equivalence, not necessarily de novo clinical effectiveness against pre-defined performance metrics through a clinical trial.

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