The Maestro MDTL Laser System is intended to emit energy in the visible red & infrared spectrums 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 promoting relaxation of muscle.

Device Description

The Maestro MDTL Laser System is a non-invasive, portable therapeutic medical laser designed to deliver light energy to the target tissue. The System operates by AC power and can be used with a variety of laser probes.

The Maestro MDTL Laser System is comprised of a Base Unit and select Laser Probes. The Control Unit houses the electronics, circuits and controls to power the Laser Probes. The Laser Probes are connected to the Control Unit by a cable, which plugs into the rear of the Control Unit. The Laser Probes house the laser diode and circuitry to deliver the light energy to the designated treatment areas.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Maestro MDTL Laser System, which is an infrared lamp. This type of submission relies on demonstrating substantial equivalence to predicate devices rather than conducting extensive clinical studies with specific acceptance criteria and detailed performance reporting as might be expected for novel or high-risk devices.

Therefore, the information you've requested regarding specific acceptance criteria, a study proving the device meets them, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance does not apply to this 510(k) submission.

Here's an breakdown of the available information based on your request, highlighting what is not present in this document:

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

Acceptance Criteria (Not explicitly stated as such, but inferred from 510(k) process)	Reported Device Performance (as stated in the document)
Substantial Equivalence to Predicate Devices in intended use, technical, and performance characteristics	"The Maestro System and the named predicate devices have the same intended uses and similar technical and performance characteristics."
Compliance with International Standards	"ISO 9000:2000 EN46001 Directive 89/336 regarding electromagnetic compatibility"
Compliance with Applicable Performance Standards (e.g., 21 CFR 1010 and 1040)	"The System is designed to comply with applicable performance standards promulgated by Federal Food and Drug Administration, such as 21 CFR 1010 and 1040."
No new safety or efficacy issues raised	"The Maestro MDTL Laser System performs as intended and do not raise any new safety or efficacy issues."
Functional Performance Testing	"Testing of the System includes functional performance testing..."
Electrical Safety Testing	"...and electrical safety testing."

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

Not applicable. This 510(k) submission describes functional performance testing and electrical safety testing of the device itself, not a clinical study involving a "test set" of patients or data in the sense of a diagnostic or prognostic device. The testing described is against engineering and safety standards, and comparison to predicate devices, not clinical efficacy trials.

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):

Not applicable. As above, there is no "test set" requiring expert ground truth in the context of this 510(k) notification. The "ground truth" for this device's performance is compliance with electrical and functional standards and similarity to already cleared predicate devices.

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

Not applicable. No clinical test set or adjudication process is mentioned.

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:

Not applicable. The Maestro MDTL Laser System is a therapeutic laser for pain relief, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study, AI assistance, or effect size on human readers is relevant or performed.

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

Not applicable. This device is hardware, a therapeutic laser, not an algorithm.

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

The "ground truth" for this 510(k) relies on:
- Engineering and Safety Standards: Compliance with ISO 9000:2000, EN46001, Directive 89/336, 21 CFR 1010, and 1040.
- Functional Testing: The device performing as per its specifications (e.g., emitting light in the specified spectrum, maintaining power output).
- Comparison to Predicate Devices: Demonstrating the new device has "the same intended uses and similar technical and performance characteristics" to previously cleared predicate devices.

8. The sample size for the training set:

Not applicable. As this is not an AI/ML device, there is no "training set."

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

Not applicable. As this is not an AI/ML device, there is no "training set" ground truth to establish.

In summary, this 510(k) notification demonstrates substantial equivalence by comparing the Maestro MDTL Laser System to existing predicate devices based on intended use, performance (functional and electrical safety testing), and compliance with relevant standards. It does not involve clinical studies with patient test sets, AI algorithms, or expert ground truth adjudication in the way your questions imply for diagnostic AI systems.

Summary

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FEB 3 1005

Laser Therapeutics, Inc Maestro MDTL Laser System 510(k) Notification December 12, 2005

APPENDIX B

K053473

SUMMARY OF SAFETY AND EFFICACY

Maestro MDTL Therapeutic Laser System (as per 21 CFR Part 807.92)

I. GENERAL INFORMATION

Device Generic Name:	Infrared Lamp
Trade Name:	Maestro MDTL Laser System
Device Classification:	Class II, Performance Standards21CFR Part 890.5500 - Infrared Lamp,
Product Code:	ILY
Applicant Name and Address:	Advanced Medical Technologies, Inc.101 Waterside DriveCenterville, MA 02632508 / 790-9300Neil Camera, Presidentlasertherapeutics@hotmail.com

II. DEVICE DESCRIPTION

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III. INDICATIONS FOR USE

IV. Predicate Devices

The Maestro MDTL Laser System is substantially equivalent to other infrared therapeutic lamps that are currently in commercial distribution. Representative predicate devices to the Maestro MDTL Laser System include, but are not limited to, the Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), Medical Laser Therapeutics, LP MLT-1000 IR Laser System (K033986), the Meditech International Inc BioFlex Professional Therapy System (K023621), the Thor International DDII Laser System (K033923) and the Chattanooga Group Vectra Genisys Laser System (K040662).

V. Summary of the Technical Characteristics of the Maestro MDTL Laser System as Related to the Referenced Predicate Devices.

The Maestro MDTL Laser System and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices utilize infrared and visible laser diodes to generate topical heating for the purpose of elevating tissue temperatures for temporary relief of muscle and joint pain. The Maestro System and the named predicate devices have the same intended uses and similar technical and performance characteristics.

VI. Testing

Testing of the System includes functional performance testing and electrical safety testing. The Maestro MDTL Laser System is manufactured to comply with the following international standards:

ISO 9000:2000 EN46001 Directive 89/336 regarding electromagnetic compatibility

VII. Conclusions

Pursuant to the testing and comparison to the predicate devices, the Maestro MDTL Laser has the same intended uses, with similar functional and performance characteristics. The System is designed to comply with applicable performance standards promulgated by Federal Food and Drug Administration, such as 21 CFR 1010 and 1040. The Maestro MDTL Laser System performs as intended and do 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 Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 3 2006

Advanced Medical Technologies, Inc. c/o Ms. M. Joyce Heinrich Regulatory Consultant Texas Applied Biomedical Services, Inc. 12101-A Cullen Blvd. Houston, Texas 77047-2951

Re: K053473

Trade/Device Name: Maestro MDTL Laser System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: December 12, 2005 Received: December 14, 2005

Dear Ms. Heinrich:

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. Heinrich

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 vou 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" (21 CFR 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/industry/support/index.html.

Sincerely vours.

Barbare Ruelin
fox

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

Enclosure

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APPENDIX C

Indications for Use

510(k) Number (if known):

Pending K 653473

Device Name:

Maestro MDTL Laser System

Indications for Use:

The Maestro MDTL Laser System is intended to emit energy in the visible red & infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and ioint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.

AND/OR Over the Counter Use: Prescription Use: __ X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODDE)

Barbare method for MXM

Division of General, Restorative, and Neurological Devices

510(k) Number: K053473 18

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.