The LUMINA Systems are intended to emit energy in the 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 promoting relaxation of muscle.

Device Description

The LUMINA 1600, 3300 and 6600 Systems are easy to use, non-invasive therapeutic device that provides continuous heat therapy. The Systems consist of a Console that houses the electronics and controls and a treatment probe applicators that deliver the infrared energy to the target area.

AI/ML Overview

The provided document is a 510(k) Premarket Notification Summary for the LUMINA Infrared Heat Lamp Therapy Systems. This type of submission is a regulatory pathway to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the document does not contain the detailed study information typically associated with establishing acceptance criteria and proving performance through a clinical trial with human subjects.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Functional Performance	Device provides continuous heat therapy.	The LUMINA Systems are described as "easy to use, non-invasive therapeutic devices that provide continuous heat therapy."
	Emits energy in the infrared spectrum.	Explicitly stated that the systems "emit energy in the infrared spectrum."
	Elevates tissue temperature for therapeutic purposes.	The systems are designed to "produce a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration" for the stated indications.
Electrical Safety	Complies with applicable electrical safety standards for medical devices.	Electrical safety testing was conducted "in accordance with all applicable standards for this type medical device."
Intended Use Equivalence	Intended uses are substantially equivalent to predicate devices.	The LUMINA Systems have "the same intended uses" as the predicate devices.
Technical Characteristic Equivalence	Similar functional and performance characteristics to predicate devices.	The LUMINA Systems have "similar functional and performance characteristics" to the predicate devices.

Explanation: The acceptance criteria here are primarily based on demonstrating substantial equivalence to predicate devices, focusing on functional performance, safety, and intended use, rather than specific quantitative clinical efficacy thresholds. The "reported device performance" reflects the general claims made about the device's capabilities and its alignment with predicate devices.

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

Not applicable. The document describes a 510(k) submission, which relies on demonstrating substantial equivalence to existing devices rather than a clinical study with a "test set" in the traditional sense. The testing mentioned (functional performance and electrical safety) is laboratory-based and doesn't involve human subjects as a "test set" for clinical efficacy.

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

Not applicable. This information is relevant for clinical studies where expert review is used to establish ground truth for a diagnostic or predictive device. This 510(k) premarket notification does not describe such a study.

4. Adjudication Method for the Test Set

Not applicable. (See explanation for point 3).

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 LUMINA Systems are infrared heat lamps, not AI-powered diagnostic or assistive devices that would involve human readers or an MRMC study.

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

Not applicable. The LUMINA Systems are therapeutic devices that physically deliver infrared energy, not standalone algorithms.

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

Not applicable for clinical efficacy. The "ground truth" for the 510(k) submission primarily revolved around:

Regulatory Standards: Compliance with 21 CFR 890.5500 for infrared lamps.
Literature: The device's ability to produce "a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration" for the indications. This implies that existing scientific and medical literature on infrared therapy serves as the basis for what constitutes an effective tissue temperature.
Predicate Device Characteristics: The functional and performance characteristics of legally marketed predicate devices served as a de facto "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device requiring a training set.

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

Not applicable. (See explanation for point 8).

Summary of the Study and Device Proof:

The "study" in this context is the 510(k) premarket notification process, not a clinical trial. The device, LUMINA Infrared Heat Lamp Therapy Systems, meets acceptance criteria by demonstrating substantial equivalence to already legally marketed predicate devices.

The proof relies on:

Functional Performance Testing: Confirming the device operates as intended (e.g., emits infrared energy, provides continuous heat).
Electrical Safety Testing: Ensuring compliance with all applicable safety standards.
Comparison to Predicate Devices: Explicitly stating that the LUMINA Systems have the "same intended uses, with similar functional and performance characteristics" as the predicate devices (Avicenna Laser Therapy, Inc. ALT Laser Model VTR 75, Light Force Therapy, Inc. Super Nova and Acubeam Systems, and Meditech International, Inc. BioFlex Professional Therapy System).
Compliance with Literature and FDA Acceptance: The systems are designed to produce tissue temperatures known to be therapeutically effective, as supported by existing literature and prior FDA acceptances for similar devices.

There is no mention of a human test set, experts establishing ground truth for a clinical study, or any form of AI involvement. The focus is on regulatory compliance and equivalence to established technology.

Summary

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2005

APPENDIX B

510(k) PREMARKET NOTIFICATION SUMMARY (per 21 CFR 807.92)

LUMINA Infrared Heat Lamp Therapy Systems Models 1600, 3300 and 6600

I. Applicant:

USA Laser Biotech Inc. 10115 Merrimac Road Richmond, VA 23235 Telephone: 804/320-4616

Key Contact: Nelson Marquina. PhD

II. Device Name

Proprietary Name: LUMINA 1600, 3300 and 6600 Systems Common / Usual Name: Infrared Lamp Classification Name: Infrared Lamp (21 CFR 890.5500) Product Code: ILY

III. Intended Use of the Device

IV. Predicate Devices

The LUMINA Systems are substantially equivalent to other infrared therapeutic lamps that are currently in commercial distribution. These predicate devices include, but are not limited to, the Avicenna Laser Therapy, Inc. ALT Laser Model VTR 75 (K031612), Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), and Meditech International, Inc. BioFlex Professional Therapy System (K023621).

V. Description of the Device

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K052814

Summary of the technical characteristics of the LUMINA Infrared Heat Lamp VI. Therapy Systems the referenced predicate devices

The LUMINA Systems 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.

VII. Testing

Testing of the LUMINA Systems include functional performance testing and electrical safety testing in accordance with all applicable standards for this type medical device.

VIII. Conclusions

Pursuant to the testing and comparison to the predicate devices, the LUMINA Systems have the same intended uses, with similar functional and performance characteristics. The Systems are designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 0 2005

USA Laser Biotech, Inc. c/o M. Joyce Heinrich Regulatory Consultant Texas Applied Biomedical Services 12101- A Cullen Boulevard Houston, Texas 77047-2951

Re: K052814

Trade/Device Name: Lumina 1600 System, Lumina 3300 and 6600 Systems Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: November 5, 2005 Received: November 9, 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- M. Joyce Heinrich

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your e FDA finding of substantial equivalence of your device to a legally premation on "Nesults in "Needassification 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 If you dosire 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/industry/support/index.html.

Sincerely yours,
Barbara Buchm

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 K052814

Device Name: Lumina 1600 System Lumina 3300 and 6600 Systems

Indications for Use:

The LUMINA Systems, as listed above, are intended to emit energy in the 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.

X Prescription Use: (Part 21 CFR 801 Subpart D) 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 (ODDE)

AND/OR

Barbore Buellmp

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neral. Restorative and Neurological Devices

510(k) Number K052614

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.