The LCT 101 low level laser accessory is a non-heating infrared lamp powered by the MBM 1010 console, as per 21 CFR 890.550. It emits energy in the infrared spectrum, with an auxiliary visible red guide light. It is indicated for adjunctive use in the temporary relief of the hand and wrist pain associated with carpal tunnel syndrome.

Device Description

NMA 100 Laser Accessory primarily consists of a hand held laser cluster accessory powered by the NMA 1052 Console. The hand held laser cluster contains the laser diodes and assembly, circuit board, electronics and labels. The hand piece is controlled from the console. The console automatically times the 33-second cycles of treatment.

The NMA 100 Laser Accessory is an 830 nm infrared laser indicated for adjunctive use in the temporary management of hand and wrist pain associated with carpal tunnel syndrome. The NMA 100 Laser utilizes three semiconductor laser diodes each emitting approximately 30 milliwatts (maximum 35 mW) continuous wave light at 830 nm. It utilizes 830 nm gallium-aluminum-arsenide laser diodes. The console automatically turns itself off after three joules of energy has been delivered.

AI/ML Overview

The provided text describes a medical device, the NMA 1052 Console with NMA 100 Laser Accessory (also referred to as MBM 1010 Console System and LCT 101 Laser in later sections), and its 510(k) submission to the FDA. However, the text does not contain information about acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The document is primarily a summary of the device's specifications, its classification, predicate device, and the FDA's 510(k) clearance letter. It focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The response below will indicate where information is Not Found (NF).

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
NF	NF

Study Information

Sample size used for the test set and the data provenance: NF
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: NF
Adjudication method (e.g., 2+1, 3+1, none) for the test set: NF
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: NF (This device is a laser accessory for pain management, not an AI imaging analysis tool, so an MRMC study is not applicable in the traditional sense.)
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: NF (This device is a physical therapy device; "standalone performance" in the context of an algorithm is not applicable.)
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): NF
The sample size for the training set: NF
How the ground truth for the training set was established: NF

Additional Device Information from the Text:

Device Name: NMA 1052 Console with NMA 100 Laser Accessory (also MBM 1010 Console System and LCT 101 Laser)
Classification: Class II, Lamp, non-heating, for adjunctive use in pain therapy (21 CFR 890.5500)
Predicate Device: MedX LCS Laser Series - K021985
Intended Use: Adjunctive use in the temporary management of hand and wrist pain associated with carpal tunnel syndrome.
Technical Specifications:
- Hand-held laser cluster accessory powered by the NMA 1052 Console.
- Emits 830 nm infrared laser light.
- Utilizes three semiconductor laser diodes, each emitting approximately 30 milliwatts (max 35 mW) continuous wave.
- Uses 830 nm gallium-aluminum-arsenide laser diodes.
- Console automatically times 33-second treatment cycles.
- Console automatically turns off after three joules of energy have been delivered.
Regulatory Compliance:
- Meets requirements of UL2606 standards in United Sates.
- Health Canada - Medical Therapeutic Device approved.
- UL Entela field evaluated and labeled (file FE-32134-1).
- Underwriters Laboratories of Canada field evaluated (file FE:32505-2).

Summary

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MAR 2 4 2003

DISCUSSION OF SAFETY AND EFFECTIVENESS 3.

A. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA

Model No./Name:	NMA 1052 Console with NMA 100 Laser Accessory
Classification:	Lamp Non-heating - Section B – NHNPhysical Medicine Device, 21 CFR 89.5500 (Class II)
Predicate Device:	MedX LCS Laser Series - K021985

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

DEVICE SPECIFICATIONS B.

The device meets the requirements of the UL2606 standards in United States.

The product has been:

Health Canada - Medical Therapeutic Device approved (Canada)
UL Entela field evaluated and labeled (file FE-32134-1) .
Underwriters Laboratories of Canada field evaluated . (file FE:32505-2)

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, arranged in a diagonal line. The profiles are connected and appear to be emerging from a single point. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Anita Saltmarche, RN, BScN, MHSc Vice President of Clinical and Scientific Affairs MedX Electronics, Inc. 3535 Laird Road, Unit 2 Mississauga, Ontario Canada L5L 5Y7

MAR 2 4 2003

Re: K024310

Trade/Device Name: MBM 1010 Console System and LCT 101 Laser 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 17, 2002 Received: December 24, 2002

Dear Ms. Saltmarche:

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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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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,

Muriam C. Provost

for 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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510(k) Number (if known):	K024310
Device Name:	MBM 1010 and LCT 101

Indications For Use:

iriam C. Provost

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

510(k) Number K024316

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	OR Over-the-Counter Use ______
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(Optional Format 1-2-96)

MedX Electronics Inc.

NMA 1052/100 Laser System - 510(k) Notification

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.