The Clini-Lase System is an infrared lamp that is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperture for the temporary relief of minor muscle and joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the Clini-Lase System may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Device Description

The Clini-Lase System consists of a clinical and portable control base unit, and seperate attachment infrared heat lamp probes. The control base unit houses the electronics, LCD display and system controls and is powered by 12 Volts DC suplied by an AC-DC Power Adapter. The attachment probes produce infrared radiation to provide topical heating. Various single and cluster probes are available for the base units. The probes are conected by a readily replacable independent cable assembly.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Clini-Lase System, and it does not include detailed performance data from a clinical study to establish acceptance criteria or device performance in the way typically expected for an AI/ML device.

Instead, this document is a summary demonstrating substantial equivalence to legally marketed predicate devices, which is a common regulatory pathway for medical devices that are not novel. The key takeaway is that the Clini-Lase System is an infrared lamp, and its regulatory clearance is based on its similarity to existing infrared lamps, not on new clinical performance studies establishing specific efficacy outcomes with acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not available in this document because a formal clinical study to prove new performance claims was not conducted or required for this type of submission.

Here's an analysis based on the information provided, addressing what can be answered and noting what cannot:

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

Not applicable/Not provided. The document states: "The differences in the specifications of the Clini-Lase System and the predicate devices do not result in different performance or raise new questions of safety or efficacy." This indicates that the device's performance is assumed to be similar to legally marketed predicate devices, and no new performance claims with specific acceptance criteria are being established or reported.

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

Not applicable/Not provided. No clinical performance study with a test set was conducted or reported in this 510(k) summary.

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/Not provided. No test set or ground truth establishment by experts is described, as no new performance study was reported.

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

Not applicable/Not provided. No test set involved in a clinical study for new performance claims 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

Not applicable/Not provided. This is an infrared lamp, not an AI/ML diagnostic or assistive device. No MRMC study or AI assistance is relevant here.

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

Not applicable/Not provided. This is an infrared lamp, not an algorithm.

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

Not applicable/Not provided. No new ground truth was established for the purpose of this 510(k) submission, as it relies on substantial equivalence to existing devices.

8. The sample size for the training set

Not applicable/Not provided. This is an infrared lamp, not an AI/ML device requiring a training set.

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

Not applicable/Not provided. Not an AI/ML device.

Summary of what is known from the provided document:

Device: Clini-Lase System (infrared lamp)
Intended Use: To emit energy in the infrared spectrum to provide topical heating for the temporary relief of minor muscle and joint pain/stiffness, minor joint pain associated with arthritis, temporary increase in local circulation, relaxation of muscles, and to help muscle spasms, minor sprains/strains, and minor muscular back pain.
Basis of Approval: Predicate Device (substantial equivalence).
Predicate Devices: MedX LCT100 & MedX LCS Portable Laser, Thor DDII IR Lamp Systems, Vectra Genisis Laser System, Laser Sys*Stim 540 Model ME 540, Palomar LuxIR Handpiece.
Performance Data: The submission explicitly states, "The differences in the specifications of the Clini-Lase System and the predicate devices do not result in different performance or raise new questions of safety or efficacy." This is the core "performance data" relied upon for substantial equivalence, implying performance is equivalent to the predicates.
Non-clinical Data: Potential hazards identified and mitigated by design and labeling.
Conclusion: The device is substantially equivalent to legally-marketed predicate devices.

In essence, this document is a regulatory submission for substantial equivalence based on the device's physical characteristics and intended use being similar to already cleared devices, rather than a report on a clinical study establishing new performance metrics against specific acceptance criteria.

Summary

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510(k) Premarket Notification for the Clini-Lase

510(k) Summary of Saftey and Effectiveness

1. Submitter's Name and Address

American Spine Center, Ltd. 100 Mascoutah Avenue Belleville, IL 62220-3801 Phone: 618-233-6824 Fax: 618-233-6825

Key Contact: James J. White, President

Date Prepared: 09/22/2005

2. Device Name

Proprietary Name: Clini-Lase Laser System Common / Usual Name: Infrared Lamp Classification Name: Infrared Lamp (21 CFR 890.5500) Product Code: ILY

Model #: CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-Base, CLP-275 and CLP-55.

3. Legally-Marketed Predicate Devices

The Clini-Lase System are substantially equivalent to other infrared sources (product code ILY) currently in commercial distribution such as:

K032231 MedX LCT100 & MedX LCS Portable Laser K033923 Thor DDII IR Lamp Systems K040662 Vectra Genisis Laser System

K043586 Laser Sys*Stim 540, Model ME 540

K050370 Palomar LuxIR Handpiece

Description of the Device

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052647 2 of 2

510(k) Premarket Notification for the Clini-Lase System

4. Intended Use of the Device

5. Performance Data

The differences in the specifications of the Clini-Lase System and the predicate devices do not result in different performance or raise new questions of safety or efficacy.

6. Non-clinical Data

Potentail hazards are identified and have been mitigated by design and labeling.

7. Conclusion

Based on the foregoing, the Clini-Lase System is substantially equivalent to the legally-marketed predicate devices.

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Name of Manufacturer: American Spine Center, LTD. Laser Model Name and Number: Clini-Lase System CL-2000, CL-1200, CL-155, CL-500. CL-300, CL-275, CL-55

Laser Type: (Circle all that apply)

Alexandrite, Argon, CO2, Copper-Vapor, Diode, Dye, Nd:YAG, Erbium, Hol: YAG, Krypton, Ruby, KTP/532, Excimer, HENE, Accessory, Other

CED's ________________________________________________________________________________________________________________________________________________________________________

Indications in this application: The Clini-Lase System is an infrared lamp that is 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 associated with arthritis, for the temporary increase in local circulation where applied, and the relaxation of muscles, minor sprains and strains, and minor muscular back pain.

FDA Document Control Number: K052647

FDA Product Code: 79GEX

Reviewer Computer Initials: CYH

Date of Clearance Letter: 11/04/05

Basis of Approval: (Circle all that apply)

Predicate Device (PD), Clinical Data (CD), Animal Data (AD), Specifications (SPECS), Bench Test Data (BTD), Historical Information (HI), Other

Description of Laser: Operation Modes: (Circle all that apply) CW, Pulsed Q-Switched, Mode Locked, Contact, Free Beam, Other ________________________________________________________________________________________________________________

Wavelength in Nanometers: 808, 650, 785

Power/Energy Range (Watts/Joules): 25 mW - 500 mW

Pulse Width: n/a

Repitition Rate: n/a

Delivery System: hand held probes Comments:

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 2005

James J. White President American Spine Center, LTD. Clini-Lase 100 Mascoutah Avenue Belleville, Illinois 6220-3801

Re: K052647

Trade/Device Name: Clini-Lase Systems, with Models: CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, and CL-55 CLP-Base, CLP-275 and CLP-55

Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: October 31, 2005 Received: October 31, 2005

Dear Mr. White:

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- James J. White

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and w your e FDA finding of substantial equivalence of your device to a legally prematted 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 If you attire 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/industry/support/index.html

Sincerely vours.

Sincerely yours,

Barbaze Buehup

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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K092647/5

510(k) Premarket Notification for the Clini-Lase System

Indication for Use:

K052647

510(k) Number (if known):

Device Name:

Clini-Lase System, with Models:

CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, and CL-55.

CLP-Base, CLP-275 and CLP-55.

Indication For Use:

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-the Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, OFFICE of Device Evaluation (ODE)

Tarbayemohmd

Division of General, Restorative, and Neurological Devices

510(k) Number K052647

Page 1 of 1

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.