The Luminex Infrared Lamp System is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.

Device Description

The Luminex Infrared Lamp System is an AC operated, non-invasive, therapeutic medical device that provides continuous heat therapy through the use of infrared and visible laser diodes. The system consists of a Control Unit that houses the electronics and controls, and treatment probes that contain the infrared and visible laser diodes. The probes are intended to be placed directly on the skin to provide topical heating.

AI/ML Overview

The provided text describes the Luminex Infrared Lamp System, a therapeutic medical device, and its 510(k) premarket notification. However, it does not contain a detailed study report with specific acceptance criteria and performance data in the format requested.

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. The "Testing" section broadly mentions "functional performance testing and electrical safety testing in accordance with all applicable standards for Infrared Lamp Systems of this type," but it does not elaborate on what these tests entailed, what the acceptance criteria were, or the performance results.

Therefore, much of the requested information regarding sample sizes, ground truth establishment, expert adjudication, or MRMC studies cannot be extracted from this document as these types of detailed studies were not presented.

Here's an attempt to answer the questions based on the available information, with many points noted as "Not Provided" due to the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Functional Performance	Product produces a level of tissue temperature reported in the literature and accepted by the FDA for therapeutic heat.	Performs as intended, producing a level of tissue temperature reported in the literature and accepted by the Federal Food and Drug Administration.
Electrical Safety	In accordance with all applicable standards for Infrared Lamp Systems of this type.	Tested in accordance with all applicable standards.
Intended Use	Equivalent to predicate devices (Thor DDII IR Lamp System, Maestro MDTL Laser System, Vectra Genisys Laser System).	Has the equivalent intended uses.
Technical & Performance Characteristics	Similar to predicate devices.	Has similar technical and performance characteristics.
Safety & Efficacy Issues	Device does not raise any new safety or efficacy issues.	Does not raise any new safety or efficacy issues.

2. Sample size used for the test set and the data provenance

Sample size: Not Provided (The document mentions "functional performance testing" and "electrical safety testing" but does not specify the number of devices tested or any patient/subject data if applicable).
Data provenance: Not Provided (No patient data or human subject studies are detailed. The testing appears to be primarily device-centric and in-house.)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Provided (No human subject test set is described where expert ground truth would be established.)

4. Adjudication method for the test set

Not Provided (No human subject test set is described requiring adjudication.)

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

No. This device is an infrared lamp for therapeutic heating, not an AI-assisted diagnostic or interpretive device that would involve human readers or MRMC studies.

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

Yes, in a sense. The testing described (functional performance and electrical safety) assesses the device's inherent operation without human interpretation. However, it's not an "algorithm-only" performance in the context of AI, but rather the performance of the physical medical device.

7. The type of ground truth used

Functional Performance: Implicitly, "a level of tissue temperature reported in the literature and accepted by the Federal Food and Drug Administration." This refers to established physiological effects of heat therapy.
Electrical Safety: Compliance with national/international electrical safety standards.
Intended Use & Characteristics: Comparison to legally marketed predicate devices.

8. The sample size for the training set

Not Applicable/Not Provided. This device is a physical therapeutic device, not an AI model that requires a training set in the conventional sense.

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

Not Applicable/Not Provided.

Summary

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f082969

APPENDIX C

OCT 2 3 2008

SUMMARY OF SAFETY AND EFFICACY

(Per 21 CFR Part 807.92)

I. GENERAL INFORMATION

Device Generic Name:	Infrared Lamp
Trade Name:	Luminex Infrared Lamp System
Device Classification:	Class II, Performance Standards21CFR Part 890.5500 - Lamp, Infrared,Therapeutic Heating
Product Code:	ILY
Applicant Name and Address:	Medical Laser Systems, Inc.20 Baldwin DriveBranford, CT 60405203 / 481-2395Brian D. Richardson, President
Key Contact:	Miki Kolton, Regulatory ConsultantGreenberq, Traurig, LLP800 Connecticut Ave NW Suite 500Washington, DC 20006202-331-3100
510(k) Number:	Pending

II. DEVICE DESCRIPTION

III. INDICATIONS FOR USE

The Luminex Infrared Lamp System is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating

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tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.

IV. Predicate Devices

Predicate devices to the Luminex Infrared Lamp System include, but are not limited to, the Thor DDII IR Lamp System (K033923), the Maestro MDTL Laser System (K053473), and the Vectra Genisys Laser System (K040662).

V. Summary of the Technical Characteristics of the Luminex System as Related to the Referenced Predicate Devices.

The Luminex Infrared Lamp System and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices utilize infrared and visible diodes to generate topical heating for the purpose of elevating tissue temperatures for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local circulation and the temporary relaxation of muscle. The Luminex Infrared Lamp System and the aforementioned predicate devices have the same intended uses and similar technical and performance characteristics.

VI. Testing

Testing of the Luminex Infrared Lamp System includes functional performance testing and electrical safety testing in accordance with all applicable standards for Infrared Lamp Systems of this type.

VII. Conclusions

Pursuant to the testing and comparison to the predicate devices, the Luminex Infrared Lamp System has the equivalent intended uses, with similar technical and performance characteristics. The Luminex Infrared Lamp System complies with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in the literature and accepted by the Federal Food and Druq Administration.

The Luminex Infrared Lamp System performs as intended and does not raise any new safety or efficacy issues.

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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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 3 2008

Medical Laser Systems, Inc. % Greenberg, Traurig, LLP Ms. Miki Kolton 800 Connecticut Avenue NW. Suite 500 Washington, District of Columbia 20006

Re: K082969

Trade/Device Name: Luminex Infrared Lamp System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: September 22, 2008 Received: October 8, 2008

Dear Ms. Kolton:

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 such 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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Page 2 - Ms. Miki Kolton

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 to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Protmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events, (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/industry/support/index.html.

Sincerely yours.

Mark M. Mikkelson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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APPENDIX A

Indications for Use Statement

510(k) Number (if known):

Pending

Device Name:

Luminex Infrared Lamp System

Indications for Use:

Prescription Use: X AND/OR Over the Counter Use: (Part 21 CFR 801 Subpart D) (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 (ODpE)

Nitrogen for men

(Division Sign-Off)" Division of General, Restorative, and Neurological Devices

510(k) Number K082969

Regulation Number and Section

N/A