The THØR DDII 830CL3 Laser System is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

Device Description

THØR DDII 830CL3 Laser System is a handheld, non-invasive, low energy, nonheating infrared therapeutic medical laser that is intended for use as an adjunct treatment for managing the temporary relief of pain associated with Carpal Tunnel Syndrome. The THØR 830CL3 Laser System incorporates three 30 milliwatt (mW) Gallium Aluminum Arsenide (GaAlAs) laser diodes delivering a total output power of 90 milliwatts (mW) at 830 nanometer (nm) wavelength.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the THØR DDII 830CL3 Laser System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a medical device meets specific performance acceptance criteria through clinical studies directly. Therefore, much of the requested information regarding sample sizes, expert ground truth, adjudication, and clinical study details (MRMC, standalone performance, training sets) is not applicable or not found within this type of regulatory submission.

However, based on the provided text, we can extract details related to the device's technical characteristics, intended use, and the regulatory pathway.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria (as per regulatory compliance) and the Reported Device Performance:

Acceptance Criteria (Regulatory Compliance)	Reported Device Performance/Compliance
Intended Use: Adjunctive use in temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome	Substantially Equivalent: Same intended use as predicate devices. The system is designed to comply with generally accepted therapeutic laser performance specifications for this indication.
Technological Characteristics: Low energy, non-heating infrared therapeutic laser, 3 x 30mW GaAlAs laser diodes, 90mW total output power, 830nm wavelength.	Substantially Equivalent: Similar technological characteristics to predicate devices (e.g., MicroLight 830 Laser System, Acculaser Pro, MedX LCS System). Uses infrared diodes to emit invisible photonic energy to tissue.
Safety and Efficacy: No new safety or efficacy issues raised.	Substantially Equivalent: Performs as intended without raising new safety or efficacy issues, based on testing and comparison to predicate devices.
European Standards Compliance:	EN60601-1: 1993 (Medical Electrical Equipment)
	EN 60601-2-22:1996 (Medical Laser Equipment)
	EN60601-1-2: 1994 (EMC)
	IIb, Certificate No. C10151 issued by SGS (CE Marking Classification)
	93/42/EEC Annex II (Medical Device Directive)
Functional Performance Testing	Performed (details not provided on specific metrics)
Electrical Safety Testing	Performed (details not provided on specific metrics)

2. Sample size used for the test set and the data provenance:

Not applicable / Not found. This 510(k) submission does not describe a clinical study with a "test set" in the context of an AI/algorithm-driven device. The equivalence is based on technical characteristics and intended use compared to legally marketed predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not found. No ground truth establishment for a test set is described.

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

Not applicable / Not found. No test set or adjudication method 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 found. This device is a low-level laser system for pain relief, not an AI-driven diagnostic or assistive tool for human readers.

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

Not applicable / Not found. This device is a physical therapeutic laser system, not an algorithm.

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

Not applicable / Not found. The "ground truth" in this context is established through the regulatory acceptance of predicate devices and the demonstration of substantial equivalence based on technical specifications and safety/performance characteristics. There isn't a direct "ground truth" for a diagnostic outcome being evaluated.

8. The sample size for the training set:

Not applicable / Not found. This document does not describe a machine learning algorithm or a training set.

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

Not applicable / Not found. This document does not describe a machine learning algorithm or a training set.

Summary of the Study (as presented in the 510(k) notification):

The "study" described is a Premarket Notification (510(k)) which aims to demonstrate that the THØR DDII 830CL3 Laser System is substantially equivalent to legally marketed predicate devices. This is a regulatory pathway, not a clinical effectiveness study in the typical sense applied to diagnostic or AI devices.

The evidence presented for substantial equivalence consists of:

Comparison of Intended Use: The device shares the identical intended use (adjunctive use in temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome) with predicate devices.
Comparison of Technical Characteristics: The device utilizes similar physical principles (non-heating infrared lamps, infrared diodes emitting photonic energy) and specifications (e.g., 830nm wavelength, output power) to predicate devices.
Compliance with Recognized Standards: The device was tested and found to comply with relevant European standards for medical electrical equipment, medical laser equipment, EMC, and the Medical Device Directive. This includes functional performance testing and electrical safety testing.

The conclusion is that the device "has the same intended uses, with similar functional and performance characteristics" and "performs as intended and does not raise any new safety or efficacy issues," thus establishing substantial equivalence to the predicate devices.

Summary

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510(k) Notification THØR DDII 830CL3 System January 20, 2003

APPENDIX C SUMMARY OF SAFETY AND EFFICACY

510(k) PREMARKET NOTIFICATION SUMMARY

FEB 1 0 2003

(per 21 CFR 807.92)

THØR DDII 830CL3 Laser System

I. Applicant:

THØR International Ltd. Caer Sidhe Chiltern Road Amersham HP6 5PH United Kingdom Telephone: +44 1494 433 736 +44 1494 431 481 Facsimile: James Carroll Contact: james@thorlaser.com e-mail M. Joyce Heinrich Contact Person: Texas Applied Biomedical Services, Inc. 12101 Cullen Blvd., # A Houston, Texas 77047 713 / 734-4433 telephone 713 / 734-5671 facsimile

II. Device Name:

Proprietary Name:	THØR DDII 830CL3 Laser System
Common / Usual Name:	Low Level Laser System
Classification Name:	Infrared Lamp (21 CFR 890.5500)
Product Code:	NHN

tabs1@tabs.net e-mail

III. Predicate Device

THØR DDII 830CL3 Laser System is substantially equivalent to other low level therapeutic lasers currently in commercial distribution. These predicate devices include the MicroLight Corporation of America, Inc. MicroLight 830 Laser System (K010175), Acculaser, Inc. Acculaser Pro Low Level Laser System (K020657) and the MedX LCS System (K021985). These devices were cleared for introduction into interstate commerce via the FDA's 510(k) Notification process. The Therapeutic Laser System has the same intended use as and similar technological characteristics to these predicate devices.

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IV. Intended Use of the Device

The THØR DDII 830CL3 Laser System is a non-heating infrared lamp and is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

V. Description of the Device

Summary of the technical characteristics of the THØR DDII 830CL3 Laser VI. System to the referenced predicate device.

The THØR DDII 830CL3 Laser System and the aforementioned predicate devices are non-heating infrared lamps as defined in 21 CFR 890.5500. These devices use infrared diodes to emit invisible photonic energy to tissue. The intended use is identical for all devices.

VII. Testing

Testing of the THØR DDII 830CL3 Laser System included functional performance testing and electrical safety testing.

The THØR DDII 830CL3 Laser System is manufactured to comply with the following European standards:

Medical Electrical Equipment Medical Laser Equipment EMC CE Marking Classification Medical Device Directive

EN60601-1: 1993 EN 60601-2-22:1996 EN60601-1-2: 1994 IIb, Certificate No. C10151 issued by SGS 93/42/EEC Annex II

VIII. Conclusions

Pursuant to the testing and comparison to the predicate devices, the THØR DDII 830CL3 Laser System has the same intended uses, with similar functional and performance characteristics. The System is designed to comply with the generally accepted therapeutic laser performance specifications as an adjunctive treatment for the relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

THØR DDII 830CL3 Laser System performs as intended and does not raise any new safety or efficacy issues.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

FEB 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

THOR International Ltd. c/o M. Joyce Heinrich Regulatory Consultant Texas Applied Biomedical Services, Inc. 12101 A Cullen Boulevard Houston, Texas 77047

Re: K030226

Trade Name: THOR DDII 830CL3 Laser 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: January 17, 2003 Received: January 22, 2003

Dear Ms. Heinrich:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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) 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 vours.

Sincerely yours,

Mark A. Milliman

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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APPENDIX B

STATEMENT OF INDICATIONS FOR USE

STATEMENT FOR INDICATIONS FOR USE

Pending KO30226 510(k) Number (if known):

THØR DDII 830CL3 Laser System Device Name:

Indications for Use:

The THØR DDII 830CL3 Laser System is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over the Counter Use Prescription Use: (Optional Format 1-2-96) (per 21 CFR801.109) (Division Sign-Off) 510(k) Number _ េរោ Sivision of General Dosto Juve Jugical Devices 10(k) Number _________________________________________________________________________________________________________________________________________________________________

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.