830nm wave length : the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Device Description

SMARTLUX is light therapy system using two kinds of wave length light and infrared ray. It has four type of head which is including red, blue and IR respectively. Heads are chanqeable by user and assembled head is identified automatically after changing head and user interface is also changed according to each head. For the safety of device operation, there are emergency switch and key switch so operator can control by touch screen based on MEDMIX's software.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called SMARTLUX, which is a light therapy system. However, the document does not contain information about "acceptance criteria," "reported device performance" in a quantitative sense, "sample sizes" for test sets or training sets, "data provenance," "number of experts" for ground truth, "adjudication methods," "MRMC comparative effectiveness studies," or "standalone performance." The performance testing mentioned is generic (e.g., "Performance test is performed as per EN 60601-2-22: Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser Equipment" and "Performance Test Report for Temperature of therapeutic heat"). This suggests that the device's performance was evaluated against safety and general standards for medical electrical equipment and therapeutic heat, rather than clinical efficacy or diagnostic accuracy, which would typically involve the detailed criteria requested in your prompt.

Therefore,Based on the provided 510(k) summary (K120460) for the SMARTLUX device, I cannot fill out the requested information for acceptance criteria and a study proving device meets acceptance criteria. The document focuses on regulatory submission details, device description, intended use, and predicate devices, rather than a clinical performance study with the specific metrics you've requested.

Here's why and what information is available:

Type of Device: The SMARTLUX is a light therapy system, and its predicate devices are also light therapy systems (Omnilux Revive, Omnilux Blue, Omnilux Plus). These are generally cleared based on substantial equivalence to existing devices for specific therapeutic indications (e.g., dermatology, acne treatment, pain relief) and compliance with safety standards, rather than an AI-driven diagnostic or image analysis device that would typically involve the comprehensive performance metrics you've outlined.

Information NOT Found in the Document:

Table of acceptance criteria and reported device performance: This document does not specify quantitative clinical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or reported device performance against such criteria.
Sample size used for the test set and data provenance: No information on a test set (clinical or otherwise for performance evaluation) is provided, nor its sample size or data origin.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as there's no mention of a test set requiring expert-established ground truth.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: No mention of an MRMC study or any AI component that would be compared to human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as the device is a therapeutic light system, not an AI algorithm.
The type of ground truth used: Not discussed, as no performance study requiring ground truth is detailed.
The sample size for the training set: Not applicable, as this is not an AI learning system.
How the ground truth for the training set was established: Not applicable.

What is mentioned regarding "Performance Test":

The document states:

"Performance test is performed as per EN 60601-2-22: Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser Equipment."
"Performance Test Report for Temperature of therapeutic heat The test data is attached." (However, the "attached" data is not present in the provided text).

This indicates that the "performance tests" were related to safety and electrical standards conformance (EN 60601-2-22) and potentially thermal output/safety ("Temperature of therapeutic heat"), which are critical for light therapy devices but do not equate to clinical efficacy or diagnostic accuracy studies typically involving the metrics you requested. The acceptance criteria for these would be compliance with the specified standards and acceptable temperature ranges, respectively.

Summary

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K120460

ડ. 510(k) Summary

OCT
1

See 510(k) Summary, below. Medmix Co., Ltd.

1310, Hanla Sigma Valley Bldg, #345-90, Gasan-dong, Geumcheon-gu,Seoul,153-802 Korea TEL. +82 (2) 6443-4000 FAX. +82 (2) 6443-4001 Website: www.medmix.co.kr

Submission Correspondent: Peter Chunq

Tel 412-687-3976

Fax #: 412-687-3976 (Same with the home number)

Mobil phone #: 412-512-8802

Email address: pittcmi@hotmail.com

300 Atwood Street Pittsburgh, PA 15213 USA

Date: May 12th, 2012

2. Trade Name: . SMARTLUX

Common Name : Visible and Infrared Light Source Product Code: GEX Regulation: 878.4810 Class of device : ClassII.

3. Description of device:

SMARTLUX is light therapy system using two kinds of wave length light and infrared ray.

It has four type of head which is including red, blue and IR respectively.

Heads are chanqeable by user and assembled head is identified automatically

after changing head and user interface is also changed according to each head.

For the safety of device operation, there are emergency switch and key switch so operator can control by touch screen based on MEDMIX's software:

· Head type

SMARTLUX has ten type of heads for patient treatment. Below table shows the wave length of the light for each head.

Head Name	RED633nm	BLUE415nm	IR830nm
SMARTLUX – RED	°
SMARTLUX – BLUE		°
SMARTLUX – IR			°
SMARTLUX - FX	°		°

4. Predicate Devices

Wave length of red head in SmartLux are 633nm and pulse type is continuous which are . equal with Omnilux Revive(K030426)

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5. 510(k) Summary

Wave length of blue head in SmartLux are 415nm and pulse type is continuous which are . equal with Omnilux Blue (K030883)
Wave length of IR, FX head in SmartLux are 830 nm and pulse type is continuous which are equal with Omnilux Plus (K043317)

5. Intended use

633nm wave length : Dermatology for treatment of superficial, benign vascular, and pigmented lesions

415nm wave length : Dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris

6. Performance test

Performance test is performed as per EN 60601-2-22: Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser Equipment

. Performance Test Report for Temperature of therapeutic heat The test data is attached

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem. The logo is presented in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT

1
2012

Medmix Company, Limited % Mr. Peter Chung President 300 Atwood Pittsburgh, Pennsylvania 15213

Re: K120460

Trade/Device Name: SMARTLUX Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology

Regulatory Class: II Product Code: GEX Dated: September 18, 2012 Received: September 26, 2012

Dear Mr. Chung:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Peter Chung

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark M. Mulkerss

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use Statement

Indications for Use

510(k) Number (if known): K120460

Device Name: Visible and Infrared Light Source

Indications For Use:

633nm wave length : Dermatology for treatment of superficial, benign vascular, and pigmented lesions

415nm wave length : Dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris

Prescription Use X (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)

Neil R.P. Ogden for mxm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120460

Page 1 of 1

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.