MHS 7000 by MICRO HEALTH SYSTEMS INC.

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.

Device Description

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.

AI/ML Overview

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.

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.
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.
Adjudication Method:
- Not specified in the document.
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.
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.
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.
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.
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.

Summary

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 26 2003

Mr. Robert Barnes President Micro Health Systems, Inc. 7407 Dover Lane PARKLAND FL 33067

Re: K030018

Trade/Device Name: MHS 7000 Thermal Imaging System Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: 90 LHQ Dated: December 28, 2002 Received: January 2, 2003

Dear Mr. Barnes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

to proceed to the market.

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510(K) Number (if known):

Devise Name: MHS 7000

Indications For Use:

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.

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDHR of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
And Radiological Devices

510(k) Number __

Prescription Use _ or Over-the-Counter Use _

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030018

Regulation Number and Section

§ 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.