The EMD Thermography System, Model RTM-02-RES is an infrared spectrum thermography system used to measure, record and view thermal patterns generated by the human body. It is intended for use as an adjunct to other clinical diagnostic procedures in the screening and diagnosis of abnormalities where a physician chooses to use thermography.

Device Description

The EMD Thermography System is an infrared frequency thermography system, designed to provide non-invasive temperature measurements of sites on the human body. The device includes an infrared sensor for measuring temperatures at specific areas on the skin surface. This sensor are placed in contact with the skin to perform measurements. A personal computer and software is for analysis of the temperature measurements and display of the temperature distributions.

AI/ML Overview

The provided document is a 510(k) summary for the EMD Thermography System, Model RTM-02-RES. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain detailed information about acceptance criteria or a specific study that proves the device meets those criteria in a quantitative sense.

The "Performance Testing" section broadly states: "Information submitted in this premarket notification for the EMD Thermography System includes results of testing for electrical safety, EMI/EMC, temperature measurement accuracy and results of clinical testing." This indicates that some form of testing was done, but the specifics requested in your prompt (acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, etc.) are not present in the provided text.

Therefore, I cannot populate the table or answer most of your questions based solely on the provided input. I will indicate where information is missing.

Here's an attempt to answer based on the available information, noting the significant gaps:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Clinical Performance: Not specified in the document.	The document broadly states "results of clinical testing" were submitted, but no specific performance metrics (e.g., sensitivity, specificity, accuracy) or reference to a clinical study's outcome are provided.
Temperature Measurement Accuracy: Not specified in the document.	The document broadly states "results of testing for... temperature measurement accuracy" were submitted, but no specific accuracy thresholds (e.g., ±X degrees Celsius) or the measured accuracy are provided.
Electrical Safety: Not specified in the document.	The document broadly states "results of testing for electrical safety" were submitted, but no specific standards (e.g., IEC 60601-1) or compliance results are detailed.
EMI/EMC (Electromagnetic Interference/Compatibility): Not specified in the document.	The document broadly states "results of testing for EMI/EMC" were submitted, but no specific standards or compliance results are detailed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the document.
Data Provenance: Not specified in the document. (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document mentions "clinical diagnostic procedures" and physician choice, but no details on expert panels or ground truth establishment for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study is not mentioned in the document. The device is described as an "infrared frequency thermography system" and an "adjunct," suggesting it's a diagnostic tool, but not necessarily an AI-assisted interpretation system in the modern sense. The document does not describe human reader improvement with or without AI.

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

The document describes the device as being "used to measure, record and view thermal patterns" and "intended for use as an adjunct to other clinical diagnostic procedures in the screening and diagnosis of abnormalities where a physician chooses to use thermography." This implies a human-in-the-loop scenario.
No specific standalone algorithm performance is discussed, as the system includes a "personal computer and software for analysis of the temperature measurements and display of the temperature distributions," but it doesn't clearly delineate an "AI algorithm" separate from the overall system for standalone performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided in the document. "Clinical testing" is mentioned, but the method for establishing ultimate ground truth for abnormalities is not detailed.

8. The sample size for the training set

This information is not provided in the document. The concept of a "training set" in the context of machine learning is not explicitly discussed, though software is mentioned for analysis and display.

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

This information is not provided in the document, as a training set and its ground truth establishment are not discussed.

Conclusion:

The provided 510(k) summary is a high-level overview for regulatory clearance based on substantial equivalence. It confirms that performance testing (electrical safety, EMI/EMC, temperature measurement accuracy, and clinical testing) was submitted to the FDA, but it does not include the detailed results, acceptance criteria, methodologies, or study specifics that would be necessary to answer most of your questions. Regulatory summaries often omit such granular details, which would typically be found in the full submission documents.

Summary

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K050239

Image /page/0/Picture/1 description: The image shows the logo for EM Diagnostics Breastscan Technologies. The logo features a stick figure with outstretched arms and legs on the left. To the right of the figure is the text "EM Diagnostics" in a serif font, and below that is the text "BREASTSCAN TECHNOLOGIES" in a smaller, sans-serif font.

MAP 16 %0

510(k) Summary EM Diagnostics, Inc., EMD Thermography System, Model RTM-02-RES

Date Prepared: 20 February 2006

Sponsor	Consultant
Mr. Orest Lozynsky	Mr. Richard Keen
EM Diagnostics, Inc.	Compliance Consultants
111 Center St., Suite 1200	1151 Hope Street
Little Rock, AR 72201	Stamford, CT 06907-1659
501-907-7744 F 907 7745	203 329 2700 F 203 329 2345
orest@emdlr.com	rkeen@fda-complianceconsultants.com
Device Name	Predicate Devices
Proprietary Name:
EMD thermography system, Model RTM-01-RES	KO03130
	Regutherrn 952
Common Name
Thermography System	K971956, CRT 2000
	Thermographic System
	Wemer Eidam.
	Medizin-Technologie GmbH
Class I device	Regulation Number	Product Code
Telethermographic systems	21 CFR 884.2980	LHQ
liquid crystal thermographic systems	21 CFR 884.2982	IYM

Obstetrical and Gynecological DevicePanel

Device Description

Intended Use

The EMD Thermography System is an infrared spectrum thermography system used to measure, record and view thermal patterns generated by the human body. It is intended for use as an adjunct to other clinical diagnostic procedures in the screening and diagnosis of abnormalities where a physician chooses to use thermography.

Di zuosni dri. 111 Center Street, Suite 1200 Little Rock. AR 72201 Tcl: 501.907.7744 Fax: 801.907.7745

Image /page/0/Picture/12 description: The image contains a handwritten number, "293". The number is written in a simple, slightly rounded style. The digits are clearly separated and legible, with the "2" and "9" being slightly taller than the "3".

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Image /page/1/Picture/0 description: The image shows the logo for EM Diagnostics Breastscan Technologies. The logo features a stylized human figure on the left, followed by the text "EM Diagnostics" in a bold, sans-serif font. Below "Diagnostics" is the text "BREASTSCAN TECHNOLOGIES" in a smaller, sans-serif font.

Technological Characteristics And Substantial Equivalence

The EMD Thermography System is substantially equivalent to predicate direct contact the mography systems. The EMD Thermography System and the predicate devices have fundamentally the same indications for use. All of these devices are designed to be used to measure temperature.

Performance Testing

I efromation submitted in this promarket notification for the EMD Thermography System includes results of testing for electrical safety, EMI/EMC, temperature measurement accuracy and results of clinical testing.

20 February 2006

Mr. Orest Lozynsky

Date

E di Diagnogrics Inc. 111 Center Street, Suite 1200 Little Rock, AR 72201 Tel: 501.907.7744 Fax: 501.907.7745

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle or bird-like figure, with its head facing to the right and its wings forming a flowing, abstract shape.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 9 - 2008

EM Diagnostics, Inc. % Mr. James R. Veal Vice President, Strategic and Technical Assistance Medical Device Consultant 49 Plain Street NORTH ATTLEBORO MA 02760

Re: K050239

Trade/Device Name: EMD Thermography System, Model RTM-02-RES Regulation Number: 21 CFR 884.2980 Regulation Name: Telethermographic system Regulatory Class: I Product Code: LHQ Dated: February 20, 2006 Received: February 22, 2006

Dear Mr. Veal:

This letter corrects our substantially equivalent letter of March 16, 2006.

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 (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

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CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act): 21 CFR 1000-1050.

This letter will allow you to continue 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 to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. 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 from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

forni M. Whay

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): _K050239

Device Name: EMD-Thermography System, Model-RTM-02-RES

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Segner

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

304

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.