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The MHS 7000 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, acute care settings, surgery, healthcare practitioner facilities or in any environment where healthcare is provided by a qualified healthcare professional. The MHS 7000 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 age groups from adult to pediatric and neonatal. The device is for providing thermal images of the human body. This device is intended for use by qualified healthcare personnel who are trained in its use.

The MHS 7000 thermal imaging system is a thermal based imaging device intended for viewing and digitally storing thermal patterns generated by the human body. The MHS 7000 provides for use with both laptop and desktop computers. The computer provides the user interface, image storage and display.

Here's an analysis of the provided text regarding the MHS 7000 Thermal Imaging System, focusing on acceptance criteria and study details.

Based on the provided documents (FDA 510(k) summary), there is NO information about acceptance criteria or a study proving the device meets specific performance criteria beyond substantial equivalence to a predicate device.

The document is an FDA 510(k) clearance letter, which determines substantial equivalence to a previously legally marketed device, not necessarily performance against specific acceptance criteria. This type of clearance often relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as a predicate device. It does not typically detail the specific performance studies that a modern AI/ML device submission would necessitate.

Therefore, most of the requested information cannot be extracted from this particular document.

However, I can provide the structure and explain why certain sections cannot be filled based on the provided text.

Summary of Acceptance Criteria and Study Details (Based on available information)

Given that this is an FDA 510(k) clearance for a "Telethermographic system" from 2003, the primary "acceptance criterion" met for regulatory clearance was substantial equivalence to a predicate device, rather than specific quantitative performance metrics against a defined ground truth. The document does not provide details of a performance study in the way a modern AI/ML device would be assessed.

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion	Reported Device Performance
   Substantial Equivalence to Predicate Device (as per 510(k) process requirements)	The FDA determined the MHS 7000 Thermal Imaging System is substantially equivalent to legally marketed predicate devices, based on its intended use as a thermal-based imaging device for viewing and digitally storing thermal patterns generated by the human body in various healthcare settings.
   Specific Performance Metrics (e.g., sensitivity, specificity, accuracy, precision, etc.)	Not provided in this document. The document does not detail specific performance thresholds or how the device met them.

2. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not specified in the document.
   • Data Provenance: Not specified in the document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Not specified in the document. For a 510(k) clearance based on substantial equivalence for this type of device in 2003, a formal "ground truth" establishment using multiple experts for performance evaluation (as would be done for an AI/ML device) was likely not the primary method of demonstration.

4. Adjudication Method:

   • Not specified in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No evidence of an MRMC study is provided in this document. The clearance is for the device itself as a telethermographic system, not for an AI-assisted diagnostic tool. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable to the information given.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No evidence of a standalone performance study (in the context of an AI/ML algorithm) is provided in this document. The MHS 7000 is described as an "imaging device" that provides thermal images, with the "computer providing the user interface, image storage and display." It functions as an imaging system, not an autonomous diagnostic algorithm.

7. The type of ground truth used:

   • Not specified in the document. For the purpose of 510(k) clearance for a basic imaging device, the "ground truth" might have implicitly referred to the known physical thermal properties being captured and displayed accurately, or clinical utility demonstrated by predicate devices, rather than a diagnostic "ground truth" in terms of disease presence/absence.

8. The sample size for the training set:

   • Not applicable as this document does not describe the development of an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established:

   • Not applicable as this document does not describe the development of an AI/ML algorithm requiring a training set.

Crucial Takeaway:

This 2003 FDA 510(k) clearance letter for the MHS 7000 Thermal Imaging System is for a conventional medical imaging device (telethermographic system) and does not contain the type of performance study details, acceptance criteria, or AI/ML specific information often requested for contemporary AI-powered medical devices. The clearance is based on substantial equivalence to predicate devices.

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The Micro Health Systems, MHS MED LIGHT 1000 is a device which helps to temporarily increase local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains through the use of heat applied in a non-contact manner.

The Micro Health Systems, MHS MED LIGHT 1000 is a device which helps to temporarily increase local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains through the use of heat applied in a non-contact manner. Aiming means adjustable by users from the heat ceramic filament in which there is no hazard for contacting high temperature lamps. An adjustable timer control for safety functions is also incorporated into the MHS MED LIGHT 1000. The Micro Health System MHS MED LIGHT 1000 cooling method is related to temperature of the enclosure, and the enclosure, and the enclosure temperatures of the three devices listed in the comparison table are assured. According to the different wattages and the maximum temperatures, we also know the ceramic type lamp of the AP-2018 is more efficient that the other two lamps. The maximum temperatures for these three devices listed in the comparison table are above 100 degrees Fahrenheit, and can reach the intended results. The timer controls and the continuous intensity controls exist on the MHS MED LIGHT 1000. The user can control the timer function and intensity control the receiving heat amount, thus assuming the safety level.

This document is a 510(k) clearance letter from the FDA for a device called "MHS Med Light 1000". It states that the device is substantially equivalent to legally marketed predicate devices. This type of document, particularly one from 2002, does not typically contain detailed information about acceptance criteria or specific study designs in the way that currently submitted AI/ML device clearances do.

Therefore, for this specific document, I cannot provide the requested information because it is not present. The letter primarily focuses on regulatory clearance based on substantial equivalence to existing predicate devices, rather than presenting a performance study against predefined acceptance criteria.

Based on the provided document, the following information is not available:

1. A table of acceptance criteria and the reported device performance: This document does not specify acceptance criteria for quantitative performance metrics or report specific device performance data.
2. Sample sizes used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not relevant as this is not an AI/ML device and human reader studies are not discussed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
8. The sample size for the training set: Not relevant.
9. How the ground truth for the training set was established: Not relevant.

What the document does state regarding device function and comparison:

• Indications For Use: The device temporarily increases local blood circulation and temporarily relieves minor muscle and joint aches and pains through non-contact heat application.
• Safety Features: Adjustable aiming, adjustable timer control for safety, and an enclosed ceramic filament to prevent contact with high-temperature lamps.
• Comparison Point: It mentions a "comparison table" (not provided in the document) which presumably compared the MHS Med Light 1000 to predicate devices.
• Temperature: It states that the maximum temperatures for the three devices listed in the comparison table are "above 100 degrees Fahrenheit, and can reach the intended results." It also notes the ceramic type lamp of a device called "AP-2018" is "more efficient than the other two lamps."
• User Control: Users can control the timer and intensity to manage the received heat amount, implying a safety level.

The document's primary purpose is to grant K021956 clearance based on substantial equivalence, not to detail a rigorous performance study.

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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:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance studies.
7. Type of ground truth used in studies.
8. Training set sample size.
9. 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.

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