The Excalibur IV Light Therapy System is a non-heating lamp, infrared as described under the provisions of 21 CFR §890.5500 and is clinically indicated for: -- Adjunctive use in providing temporary relief of minor chronic neck and shoulder pair of musculoskeletal origin.

Device Description

The Excalibur IV Light Therapy System is a hand-held, non-invasive, pain therapy system which utilizes non-heating lamps consisting of four laser diodes in one applicator head. It combines the clinically accepted therapeutic treatment of numerous predicate light therapy systems currently in commercial distribution and 510(k) approved. The system consists of a basic hand-held, battery operated control unit and a permanently attached applicator head. The laser operates at a measured wavelength of 635nm (±1%) and complies with all performance, labeling, and manufacturing standards set forth in 21CFR Part 1040. Stargate International Inc. is a registered laser manufacturer with the Food and Drug Administration. The laser applicator head produces an output power of ≤4.5mw2 measured, per non-convergent beam and is classified as a Class IIIa laser.

AI/ML Overview

The provided document describes the Excalibur IV Light Therapy System, a Class II medical device, and its submission for 510(k) clearance by Stargate International, Inc. The core of the submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical efficacy through a direct comparative study with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes (test, training), number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types cannot be fully provided from the given text because the 510(k) summary for this device does not include such a clinical performance study. The device's clearance is based on its similarity to existing approved devices.

Here's an attempt to answer the questions based on the available information, noting the limitations:

Acceptance Criteria and Device Performance:

The document does not detail specific quantitative acceptance criteria or a dedicated study designed to prove the device meets such criteria in terms of clinical efficacy. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device in terms of intended use and technological characteristics.

Acceptance Criteria Category (Implicit from 510(k) Process)	Reported Device Performance (as per submission)
Intended Use Equivalence	The Excalibur IV Light Therapy System has the "same intended use" as the predicate device (Quantum System, K032816). - Excalibur IV Indication: Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin. - Predicate Device Indication: Assumed to be the same, allowing for pain therapy treatment for the specified clinical presentation.
Technological Characteristics Equivalence	The Excalibur IV Light Therapy System has "similar technological characteristics" to the predicate device. - Wavelength: Measured at 635nm (±1%). - Power Output: ≤4.5mW per non-convergent beam. - Technology: Uses Gallium Aluminum Arsenide (GaAlAs) diodes with non-convergent beam output. - Treatment Variables: Conforms to performance specifications of predicate devices in frequency, wavelength, time, and power output. - Classification: Class IIIa laser, in compliance with 21 CFR Part 1040. - Standards Compliance: FCC Standard 47CFR Part 15B, UL® approved electrical components, Class IIIa Laser - 21CFR Part 1040.
Safety & Performance Standards Compliance	Manufactured, performs, is labeled, and tested to comply with FCC Standard 47CFR Part 15B, UL® approved electrical components, and Class IIIa Laser - 21CFR Part 1040. Includes functional performance, electrical safety, and component specification testing during manufacturing.
No New Regulatory/Safety/Efficacy Issues	The submission concludes that the device "does not raise any new regulatory, safety, and/or clinical efficacy issues."

Detailed Study Information (Not applicable for this 510(k) submission):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. The submission does not describe a clinical performance study with a distinct test set of patient data to assess the device's efficacy. The substantial equivalence argument relies on the inherent characteristics and intended use being similar to an already approved device.
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):
- N/A. Since there's no clinical performance study with a test set requiring ground truth establishment for patient outcomes, this information is not relevant to this submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No clinical study involving expert adjudication of a test set is described.
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:
- N/A. This device is a light therapy system, not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. The device is a physical light therapy system, not an algorithm. The submission explicitly states, "There is no software incorporated into the operation of the Excalibur IV Light Therapy System."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. For this 510(k) summary, the "ground truth" for clearance is essentially the established safety and efficacy of the predicate device (Quantum System, K032816) for its specified indications, which the Excalibur IV aims to mirror. No new clinical ground truth from patient outcomes was established or required for this submission.
The sample size for the training set:
- N/A. This device does not use machine learning or AI that would require a "training set" in the computational sense.
How the ground truth for the training set was established:
- N/A. As no training set for an algorithm is involved, this question does not apply.

Summary of Device Substantiation:

The Excalibur IV Light Therapy System obtained 510(k) clearance by demonstrating "substantial equivalence" to a predicate device (Quantum System, K032816) based on same intended use (adjunctive relief of minor chronic neck and shoulder pain of musculoskeletal origin) and similar technological characteristics (wavelength, power output, diode technology, conformance to clinical parameters). The submission focused on compliance with relevant electrical, laser, and manufacturing standards, as well as functional performance and component specifications, rather than new clinical efficacy trials with acceptance criteria.

Summary

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JUL 2 7 2005

Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters, specifically 'K051631'. The characters are written in a bold, slightly irregular font, giving them a distinct and somewhat informal appearance. The numbers are clearly distinguishable, and the overall impression is that of a label or identifier. The image is simple, focusing solely on the legibility and presentation of the alphanumeric sequence.

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510(k) Summary

(as required per 21CFR; §807.92)

Excalibur IV Light Therapy System

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; CEOrwalker@stargateinternational.com
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III. Device Name

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

IV. Predicate Device/Substantial Equivalency

The Excalibur IV Light Therapy System is substantially equivalent to other pulsed low level therapeutic lasers and light therapy systems currently in commercial distribution. The Excalibur IV 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 theracy. systems currently in commercial distribution into one compact and cost-effective system.

The technological equivalence to the predicate devices is substantiated by the wavelength and power output generated by the one Excalibur IV System applicator head permanently attached to the basic unit. The Excalibur IV System will provide the same treatment benefits and regimens for clinical presentations already approved by the Food and Drug Administration for the predicate devices.

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K051631 2 of 3

The predicate device the Excalibur IV System establishes equivalence to is the following:

Predicate Device	510(k) #	Manufacturer
Quantum System ..................................	K032816	Stargate International

V. Intended Use of the Device

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

-- Adjunctive use in providing temporary relief of minor chronic neck and shoulder pair of musculoskeletal origin.
As with the predicate device, pain therapy treatment can be prescribed for pain associated with with the clinical presentation specified above by having the beams pulsed or continuous with time consid erations. The Excalibur IV Light Therapy System's variables conform to the performance specification of the clinical parameters used by the predicate devices in frequency, wavelength, time, and power outpul

VI. Description of the Device

The system consists of a basic hand-held, battery operated control unit and a permanently attacher applicator head. The laser operates at a measured wavelength of 635nm (±1%) and complies with al performance, labeling, and manufacturing standards set forth in 21CFR Part 1040. Stargate International Inc. is a registered laser manufacturer with the Food and Drug Administration.

The laser applicator head produces an output power of ≤4.5mw2 measured, per non-convergen beam and is classified as a Class IIIa laser.

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

The Excalibur IV Light Therapy System and the aforementioned predicate devices use Gallium Aluminum Arsenide (GaAlAs) diodes with non-convergent beam output to emit visible photonic energy to human tissue. The technology is dependent on the laws of physics in that the variables are free wency wavelength, power output, and time.

The performance parameters and intended use of the Excalibur IV Light Therapy System are identical to all predicate devices.

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VIII. System Testing

The testing of the Excalibur IV Light Therapy System includes functional performance, electrica safety, and component specification. This includes four-staged manufacturing esticularly, esticulu verification.

There is no software incorporated into the operation of the Excalibur IV Light Therapy System.

The Excalibur IV 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.

IX. Conclusions

In accordance with testing and comparison to the predicate devices, and pursuant to 21CFR; §890.500, the Excalibur IV Light Therapy System has the same intended use, with similar functional and performance characteristics.

The device meets or exceeds the design, testing, and labeling standards required by law. The Excalibur IV 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 a black and white logo. The logo is circular in shape and features an abstract image of an eagle in the center. The eagle is composed of three curved lines that suggest the shape of the bird's head, body, and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 27 2005

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

Re: K051631

Trade/Device Name: Excalibur IV 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: June 15, 2005 Received: June 20, 2005

Dear Mr. Walker:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations to toges and the Medical Device Amendments, or to conninered province to May 20, 1978, the eccordance with the provisions of the Federal Food, Drug. de vices martie 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 r ou may, merers, mains of the Act include requirements for annual registration, listing of general controls provision 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 If your device to such additional controls. Existing major regulations affecting your device can may oc subject to sublications, 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 1 toase be determination that your device complies with other requirements of the Act that 1127 has made a and regulations administered by other Federal agencies. You must or any I each statutes and regainents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fat 607); adoming (21 CFR Part 820); and if applicable, the electronic form in the quant) 35 real 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) Fins lotter will and my your e FDA finding of substantial equivalence of your device to a legally premarked predicated 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 If you acono 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 other general 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.himl.

Sincerely yours,

Stypk Curles
Mark N. Mellecker

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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Indications For Use

510(k) Number (if known):	K05/63
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Device Name: Excalibur IV Light Therapy System

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

Adjunctive use in providing temporary relief of minor chroni‹ neck and shoulder pain of musculoskeletal origin.

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)

Division Sign Off

Division of General, Restorative and No rological Devices

510(k) Number K051631
Page 10 - Excalibur IV 510(k) dated June 15, 2005

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.