The Quantum Light Therapy System is a non-heating lamp, infrared as described under the provisions of 21 CFR §890.5500 and is indicated for: Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin using the QS-2; QS-4; and/or the QS-L applicator heads.

Device Description

The Quantum Light Therapy System is a hand-held, non-invasive, pain therapy system which utilizes non-heating lamps consisting of both laser and light emitting diodes(LED) in three optional applicator heads. It combines the clinically accepted therapentic treatment of numerous predicate light therapy callor itsacs: It commercial distribution and 510(k) approved into one complete, compact, and costeffective system. The system consists of a basic hand-held, battery operated control unit and three optional (one-LED; two-laser) and interchangeable applicator heads which can only be used with the Quantum Light Therapy System control unit. The three distinct applicator heads produce wavelengths that range between 609-645mm which falls within the spectrum as defined by 21 CFR §890.5500. The two laser applicator heads produce an output power of <Smw prom-convergent beam and I he two laser apprication neads produced wavelength of 635mm 11% and ontinued of themse are classified as Class IIIa lastis. Bour operate and included on tortly in 21CFR Part 1040. Stargeton tional, Inc. has filed as a registered laser manufacturer with the Food and Drug Administration. The distinct LED applicator head produces a non coherent diffuse light source. This applicator head operates at a measured wavelength of 628mm ±3%.

AI/ML Overview

Here's an analysis of the provided text regarding the Quantum Light Therapy System, focusing on acceptance criteria and the study (or lack thereof) proving its performance.

It's important to note that this document is a 510(k) summary for a medical device. 510(k) clearances typically establish substantial equivalence to a predicate device, rather than requiring extensive clinical trials to prove efficacy against specific acceptance criteria. Therefore, the information provided focuses more on demonstrating equivalence and compliance with standards than on a detailed clinical study demonstrating specific performance metrics.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the typical sense of numerical thresholds for clinical performance (e.g., minimum sensitivity, specificity, accuracy, or reduction in a pain score). Instead, the "acceptance criteria" for a 510(k) device like this are primarily related to substantial equivalence to predicate devices, safety, and compliance with relevant technical standards.

The "reported device performance" is framed in terms of its intended use, similarity to predicate devices, and adherence to various electromagnetic and safety standards.

Here's a table summarizing what can be inferred as "acceptance criteria" from the document and the corresponding "performance" as stated:

Acceptance Criterion (Inferred from 510(k) Process)	Reported Device Performance (from text)
Intended Use Equivalence: Same intended use as predicate devices.	"The Quantum Light Therapy System has the same intended use... It combines the clinically accepted therapeutic uses of previously FDA 510(k) approved light therapy systems... into one complete, compact, and cost-effective system.""Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin..." (same as predicate indications).
Technological Characteristics Equivalence: Similar technological characteristics (wavelengths, power output) to predicate devices.	"The technological equivalence to the predicate devices is substantiated by the wavelengths and power outputs generated by the individual Quantum System applicator heads."The two laser applicator heads produce an output power of "<5mW" and wavelength of "635nm +/- 1%".The LED applicator head operates at "628nm ±3%".These fall within the spectrum as defined by "21 CFR §890.5500."
Safety and Functional Performance: Device is safe and performs functionally as expected.	"The testing of the Quantum Light Therapy System includes functional performance, software, firmware, electrical safety, and component specification.""The Quantum Light Therapy System does not raise any new regulatory, safety, and/or clinical efficacy issues."
Compliance with Standards: Adherence to relevant national and international standards.	"The Quantum Light Therapy System is manufactured, performs, is labeled, and is tested to comply with the following standards: FCC Standard 47CFR Part 15B, All Electrical Components Utilized Are UL® Approved, Class IIIa Laser 21CFR Part 1040, IEC60825-1, Amendment 2, IEC 60601-2-22, EMC: IEC 60601-1-2."
No New Safety/Efficacy Issues: Introduction of the device does not raise new questions about safety or efficacy.	"The Quantum Light Therapy System ... does not raise any new regulatory, safety, and/or clinical efficacy issues."

Study Information:

Based on the provided document, the "study" conducted for this 510(k) submission is primarily focused on bench testing and comparison to predicate device specifications, rather than a clinical trial measuring patient outcomes against specific performance criteria.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a clinical test set with patient data for performance evaluation. The "test set" here refers to the device itself and its components undergoing engineering and safety testing.
- Data Provenance: The data provenance is from internal testing by Stargate International, Inc. and testing by an outside independent laboratory to confirm compliance with various standards. The document does not mention human subject data or a clinical study. It's retrospective in the sense that it's comparing against existing predicate devices and established standards. The country of origin of the data would likely be the USA, where the company is based and the testing was presumably conducted, though not explicitly stated for the independent lab.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study involving expert assessment of clinical images or patient conditions to establish a ground truth. Ground truth, in this context, would be the established specifications of the device (e.g., wavelength, power output) and the requirements of the compliance standards.
Adjudication method for the test set:
- Not applicable. There's no clinical data or expert review that would require an adjudication method like 2+1 or 3+1. Adjudication was likely the process of confirming the device properties met the specified engineering and safety requirements.
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, a MRMC comparative effectiveness study was not done. This device is a therapeutic light system, not an AI-powered diagnostic tool, so such a study would be irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not a standalone algorithm. Its performance is inherent to its physical properties and operation.
The type of ground truth used:
- The "ground truth" for this 510(k) submission is based on:
  - Technical Specifications: Measured wavelengths and power outputs of the device compared against design specifications and regulatory requirements.
  - Predicate Device Characteristics: Comparison of the Quantum Light Therapy System's features, intended use, technological characteristics (e.g., non-heating lamp, specific wavelengths and power output range) to those of the legally marketed predicate devices.
  - Compliance Standards: Meeting the requirements of various FCC, UL, IEC, and CFR standards, as verified by testing.
The sample size for the training set:
- Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not applicable, as there is no training set involved.

In summary: The document describes a 510(k) submission focusing on demonstrating substantial equivalence to predicate devices and compliance with safety and performance standards. It does not present a clinical study with patient data, acceptance criteria for clinical outcomes, or expert-based ground truth establishment in the typical sense of a diagnostic or AI device study. The "study" here is primarily engineering and regulatory compliance testing.

Summary

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Image /page/0/Picture/0 description: The image shows the word "Stargate" in bold, black letters. Above the word is a thin, black oval shape. To the right of the oval is a black star shape.

MAR 2 6 2004

Final 510(k) Summary For Application #K032816 Dated March 23, 2004

(as required per 21CFR; §807.92)

Quantum Light Therapy System

The following modified 510k summary is in response to the issues indicated by the Food and Drug Administration in a phone conversation on March 22, 2004. This represents Stargate's Final Amended Summary.

I. Applicant	Stargate International, Inc.
	10235 South Progress Way #7
	Parker, CO 80134
	Phone: 303-840-8206
	Fax: 303-840-8320
II. Contact Name:	Robert H. Walker; CEO

III. Device Name

Proprietary Name	Quantum Light Therapy System
Common/Usual Name(s)	Low Level Laser Therapy (LLLT)Therapeutic Light System
Classification Name	Infrared Lamp; (21CFR; §890.5500)
Product Code(s)	NHN

rwalker@stargateinternational.com

IV. Predicate Device/Substantial Equivalency

The Quantum Light Therapy System is substantially equivalent to other pulsed low level therapeutic lasers and light therapy systems currently in commercial distribution. The Quantum Light Therapy System has the same intended use and similar technological characteristics to predicate devices. It combines the clinically accepted therapeutic uses of previously FDA 510(k) approved light therapy systems currently in commercial distribution into one complete, compact, and cost-effective system.

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The technological equivalence to the predicate devices is substantiated by the wavelengths and power outputs generated by the individual Quantum System applicator heads. Depending on the applicator head chosen by the clinician, the Quantum System will provide the same treatment benefits and regimens for conditions already approved by the Food and Drug Administration.

The predicate devices the Quantum System establishes equivalence to include the following:

Predicate Device	510(k) #	Manufacturer
Tuco Erchonia PL3000	K012580	Tuco Innovations
Super Nova; Accubeam	K001179	Light Force Therapy, Inc.
MedX 100 Series	K020017	MedX Electronics, Inc.

V. Intended Use of the Device

The Quantum Light Therapy System is a non-heating lamp, infrared as described under the provisions of 21 CFR §890.5500 and is indicated for:

A- Adjunctive use in providing temporary relief of minor chronic neck and shoulder paint of musculoskeletal origin using the QS-2; QS-4; and/or the QS-L applicator heads.

VI. Description of the Device

The system consists of a basic hand-held, battery operated control unit and three optional (one-LED; two-laser) and interchangeable applicator heads which can only be used with the Quantum Light Therapy System control unit.

The three distinct applicator heads produce wavelengths that range between 609-645mm which falls within the spectrum as defined by 21 CFR §890.5500.

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The two laser applicator heads produce an output power of <Smw prom-convergent beam and I he two laser apprication neads produced wavelength of 635mm 11% and ontinued of themse are classified as Class IIIa lastis. Bour operate and included on tortly in 21CFR Part 1040. Stargeton tional, Inc. has filed as a registered laser manufacturer with the Food and Drug Administration.

The distinct LED applicator head produces a non coherent diffuse light source. This applicator head operates at a measured wavelength of 628mm ±3%.

VII. Summary of Technical Characteristics of the Device To Referenced Predicate Devices

The Quantum Light Therapy System and the aforementioned predicate devices use diodes to emit I he Qualium Light Included in the intended use of the Quantum Light Therapy System is visible photomic energy to numal ussue. The Stargate applicator head chosen by the clinician.

VIII. System Testing

The testing of the Quantum Light Therapy System includes functional performance, software, firmware, electrical safety, and component specification. This includes four-staged manufactiffinate, electrical salety, and component specifications by an outside independent laboratory.

The Quantum Light Therapy System is manufactured, performs, is labeled, and is tested to comply with the following standards:

FCC Standard 47CFR Part 15B せ
All Electrical Components Utilized Are UL® Approved ◆
Class IIIa Laser 21CFR Part 1040. .
IEC60825-1, Amendment 2 해
IEC 60601-2-22 ャ
EMC: IEC 60601-1-2 .

IX. Conclusions

In accordance with testing and comparison to the predicate devices, and pursuant to 21CFR; 5890.500, the Quantum Light Therapy System has the same intended uses, with similar functional and performance characteristics.

The device meets or excceds the design, testing, and labeling standards required by law. The Quantum Light Therapy System is manufactured and performs as intended and does not raise any new regulatory, safety, and/or clinical efficacy issues.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.

Public Health Service

MAR 2 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert H. Walker CEO Stargate International, Inc. 10235 South Progress Way, #7 Parker, Colorado 80134

Re: K032816

Trade/Device Name: Quantum Light Therapy System Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, non-heating for adjunctive use in pain therapy Regulatory Class: II Product Code: NHN Dated: December 23, 2003 Received: December 29, 2003

Dear Mr. Walker:

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. Robert H. Walker

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 (301) 594-4659. 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,

Miriam C. Provost

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): K032816

Device Name: Quantum Light Therapy System

The Quantum Light Therapy System is a non-heating lamp, infrared as described Indications For Use: under the provisions of 21 CFR §890.5500 and is indicated for:

Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin using the QS-2; QS-4; and/or the QS-L applicator heads.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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 (ODE)

Miriam C. Provost

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

Page 1 of

510(k) Number K132816

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.