The LightStim for Pain LED Belt is an Over-The-Counter device intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.

Device Description

The LightStim for Pain LED Belt is a portable device that has between one and four separate LED pods, each of which has 52 LEDs and are attached to a elastic belt that stretches to encircle different sizes from as small as an ankle to as large as the torso, and attaches to itself with Velcro. Each pod has an LED array of 630nm, 865nm, and 940nm. The device is powered by a separate AC to DC 12-volt power supply and has an on/off switch, with a timer that shuts the device off automatically after 30 minutes of operation. Recommended treatment time is 5 to 30 minutes.

AI/ML Overview

Here's an analysis of the provided text regarding the LightStim for Pain LED Belt, focusing on the acceptance criteria and the study performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with quantitative benchmarks for efficacy. Instead, it describes performance testing related to safety and usability. The closest to performance efficacy is the temperature testing, but without pre-defined acceptance criteria, it's hard to classify it as such for clinical effectiveness.

Performance Metric	Acceptance Criteria (Implicit/Explicit)	Reported Device Performance
Safety
Electrical Safety	Compliance with 60601-1 and 60601-1-2 standards	Device tested according to 60601-1 and 60601-1-2. (Implicitly, it passed these standards, as it was cleared.)
Thermal Performance (Therapeutic Intent)	Elevation of tissue temperature to a level that provides "topical heating for the purpose of elevating tissue temperature". No specific target temperature or range for therapeutic effect is stated as an acceptance criterion.	Warmed skin to 40°C or more within 5 minutes on all 3 individuals. Fluctuated between 40.0°C and 41.8°C during the entire 30-minute test.
Usability	Ability of users to correctly self-select and understand/use the device based on the instruction manual. No specific percentage or pass/fail threshold is explicitly stated as an acceptance criterion.	100% of participants correctly self-selected. 97% (32 of 33) correctly answered all 19 questions and demonstrated understanding/use.

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

Temperature Testing:
- Sample Size: 3 individuals
- Data Provenance: Not specified, but likely prospective (performed for this submission). No country of origin is mentioned.
Usability Study:
- Sample Size: 33 male and female participants
- Data Provenance: Not specified, but likely prospective (performed for this submission). No country of origin is mentioned.

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

Temperature Testing: Ground truth is objective temperature measurement. No human expert interpretation is mentioned for establishing the truth of the temperature readings themselves.
Usability Study: The "ground truth" for the usability study would be the correct answers to the instruction manual questions and correct demonstration of device use. This wasn't established by external experts adjudicating subjective data, but rather by comparing participant responses/actions against the intended use and instruction manual.

4. Adjudication Method for the Test Set

Temperature Testing: No adjudication method mentioned as the data would be objective sensor readings.
Usability Study: No adjudication method mentioned. The evaluation seems to have been based on direct observation and participant responses to questions.

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, an MRMC comparative effectiveness study was not done.
This device, an LED belt for pain relief, is not an AI-powered diagnostic or interpretive device that would typically involve human "readers" or be subject to AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) study was not done. This device does not feature an AI algorithm.

7. The Type of Ground Truth Used

Temperature Testing: Objective physical measurement (temperature readings).
Usability Study: Compliance with the instruction manual and proper device operation (based on pre-defined correct actions/answers).

8. The Sample Size for the Training Set

There is no mention of a "training set" as this device does not utilize machine learning or AI algorithms requiring such a set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

August 21, 2015

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

LED Intellectual Properties LLC Mr. Steve Marchese Chief Executive Officer 16552 Von Karman Avenue Irvine, California 92606

Re: K151333

Trade/Device Name: LightStim for Pain LED Belt Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: May 17, 2015 Received: May 27, 2015

Dear Mr. Marchese:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

For

Sincerelv vours.

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K151333

Device Name LightStim for Pain LED Belt

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 806 Subpart C)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 806 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 806 Subpart C)

_ | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary of Safety and Effectiveness

LED Intellectual Properties, LLC.

Device: LightStim for Pain LED Belt K151333

1. General Information

Submitter: LED Intellectual Properties, LLC 16552 Von Karman Ave. Irvine, Ca. 92606

Contact Person: Steve Marchese & Chase Marchese Office: (949) 502-4088 Mobile: (714) 924-0492

Emails: Steve@lightstim.com & Chase@lightstim.com

2. Device name and code

Device Proprietary Name: LightStim for Pain LED Belt

Classification Code and name: ILY OTC Lamp Infrared Therapeutic Heating

3. Predicate Devices

LED Intellectual Properties LLC LightStim Professional 2-Panel Light System #2 (K150098), and LightStim for Pain (K083580)

4. Device Description

5. Indications for Use

{4}------------------------------------------------

6. Substantial Equivalency

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device(s). The LightStim for Pain LED Belt K151333 has the same intended use, is manufactured by the same LED Intellectual Properties, LLC, utilizes the exact same LEDs, has the same power output, and has a similar size treatment area as both predicates (see Summary of Safety & Effectiveness Table below).

Characteristic	LightStim for Pain LEDBelt K151333	LightStim for PainK083580	LightStim Professional2-Panel Light - (System#2 for the purposes ofthis submission) K150098
Manufacturer	LED IntellectualProperties, LLC	LED IntellectualProperties, LLC	LED IntellectualProperties, LLC
LED Wavelengths	630, 660, 855, 940	630, 660, 855, 940	630, 660, 855, 940
Output in Milliwatts	60mW cm2	60mW cm2	60mW cm2
Number of Pods ofLEDs	Minimum: 1 podMaximum: 4 pods	Minimum: 1 podMaximum: 1 pod	Minimum: 1 podMaximum: 2 pods
# of LEDs per Pod	52	72	565
Min./Max. TreatmentArea (sq. cm) andsize compatibility tovarious areas of thebody	Min:ട് 55Max: 2201-4 smaller podsallows user to adjustfor curved areas of thebody, e.g. legs,ankles, lower back.	Min: 42Treats only smallersingle areas of thebody.	Min 1 Pod:13Max 1 Pod:350Max: 2 Pods: 700Treats mostly largeflat areas of the body,e.g. the back or chest.

7. Performance Testing

The LightStim for Pain LED Belt results in patient contact with an electrically powered component therefore; it was tested according to 60601-1: Medical Electrical Equipment -Part 1: General requirements for basic safety and essential performance

The LightStim for Pain LED Belt includes an electronic component, and it was tested according to 60601-1-2 Medical Electrical Equipment – Part 1-2: General Requirements for Safety and Essential Performance.

Temperature testing was performed on 3 individuals. The LightStim for Pain LED Belt warmed the temperature of the skin to 40 degrees centigrade or more on all 3 individuals

{5}------------------------------------------------

in the first 5 minutes of the treatment. Temperatures were checked every 5 minutes and fluctuated between between 40.0 and 41.8 degrees during the entire 30-minutes test.

A Usability Study was conducted with 33 male and female participants of a variety of races, between the ages of 20 and 79, with education levels varying from 900 grade to 4year college degrees. 100% of the participants correctly self-selected. 97% (32 of the 33 participants) correctly answered all 19 questions relating to the Instruction Manual and correctly demonstrated their understanding and use of the device without any difficulties.

Therefore, taking into consideration the Table for Substantial Equivalence and the Summary of Safety & Effectiveness Table, an analysis of safety, indications, intended uses, performance, and technological properties, the LightStim for Pain LED Belt K151333 raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.