The MB System is a device that emits energy in the infrared spectrum to provide temporary increase in local blood circulation, temporary relief of muscle pain, spasms and stiffness, temporary relief of minor pain and joint aches associated with arthritis, and relaxation of muscles.

Device Description

The MB BioEnergy Light Therapy System provides easy to use front pancl controls and display for the operation of an array of infrared light emitting diodes that can apply topical heat to areas of the patient body. The user can set the frequency of oscillation, intensity level, and time of operation to control delivery of the radiation.

AI/ML Overview

The provided text is a 510(k) Summary for the MB BioEnergy Light Therapy System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through a standalone study with specific acceptance criteria and performance metrics.

Therefore, the study design elements typically associated with acceptance criteria and a detailed clinical study (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training/test sets) are not present in this document.

The document primarily states that the device: "has been tested to support compliance with industry standards, and therefore raises no new issues of safety or efficacy." This indicates compliance with general safety and performance standards for similar devices, rather than specific performance metrics against clinical acceptance criteria.

Here's an attempt to answer the request based on the absence of this information in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified as clinical performance metrics. The submission focuses on substantial equivalence to predicate devices and compliance with industry standards.	The device provides "temporary increase in local blood circulation, temporary relief of muscle pain, spasms and stiffness, temporary relief of minor pain and joint aches associated with arthritis, and relaxation of muscles" which aligns with the intended use and performance of predicate devices. Compliance with "industry standards" is also stated.

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

Sample Size (Test Set): Not applicable for this type of submission. There is no specific test set data provided for clinical performance evaluation.
Data Provenance: Not applicable. The document does not describe a clinical study with a test set of data.

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

Number of Experts: Not applicable. No ground truth establishment for a test set is described.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. No test set or adjudication process is described.

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

MRMC Study: No. This device is a light therapy system, not an AI-assisted diagnostic or therapeutic tool that would involve human readers.

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

Standalone Performance: Not applicable. This device is a physical light therapy system, not an algorithm.

7. The type of ground truth used

Type of Ground Truth: Not applicable. Clinical ground truth for performance metrics is not described in this 510(k) summary. The "ground truth" for this submission is based on the established safety and efficacy of the predicate devices.

8. The sample size for the training set

Sample Size (Training Set): Not applicable. There is no mention of a training set as this is not an AI/algorithm device requiring one.

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

Ground Truth Establishment (Training Set): Not applicable.

Summary

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030275 1/2

NOV 2 9 2004

510(k) Summary

1. Applicant

Amest Corporation 30394 Esperanza Rancho Santa Margarita, CA 92688 Contact person: John Iest Amest Corporation 30394 Esperanza Rancho Santa Margarita. CA 92688 949-766-9692 ext 11 Date prepared: August 31, 2004

2. Device name

Proprietary name:	MB BioEnergy Light Therapy System
Common name:	Light Therapy System
Classification:	Infrared lamp (21 CFR 890.5500)
Product Code:	ILY

3. Substantially Equivalent Devices

1. K020017 -	MedX Health Corp. MedX 1000 Series Infrared Lamp
2. K014208	Russian American Technology Associates, Inc., SSIR Lamp

4, Device Description:

5. Intended use:

The MB System is a device that emits energy in the infrared spectrum to provide temporary increase in local blood circulation, temporary relief of muscle pain. spasms and stiffness, temporary relief of minor pain and joint aches associated with arthritis, and relaxation of muscles.

6. Comparison of technological characteristics with predicate device:

The MB BioEnergy Light Therapy System and the MedX 1000 Series and the SSIR System all use LEDs to provide IR energy to generate topical heating to clevate temperature. The treatment from all of these devices is designed to provide relief of muscle pain and strains. All devices have the same method of treatment, have similar indications for use, and provide the same general controls for administration of topical heating.

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7. Conclusion

The MB BioEnergy Light Therapy System is substantially equivalent to the predicate devices, has been tested to support compliance with industry standards, and therefore raises no new issues of safety or efficacy.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle-like emblem with three stylized lines representing the bird's body and wings. The emblem is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 2004

Mr. John Iest President Amest Corporation 30394 Esperanza Ranch Santa Margarita, California 92688

Re: K030275

Trade/Device Name: MB BioEnergy Light Therapy System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: ILY Dated: August 30, 2004 Received: August 31, 2004

Dear Mr. lest:

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 - Mr. John Iest

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 Office of Compliance at (240) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Muriam C. Provost
C.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K030275

Device Name: MB BioEnergy Light Therapy System

Indications for Use:

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

Division of General, Restorative, and Neurological Devices

510(k) Number K036275

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.