(83 days)
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.
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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. -
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the document.
- Data Provenance: Not specified in the document.
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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.
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Adjudication Method:
- Not specified in the document.
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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.
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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.
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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.
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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.
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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.
§ 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.