The model CG-4000 Cell Gen laser emits energy in the infrared spectrum to provide topical heating to elevate tissue temperature for temporary relief of muscle and joint pain, muscle spasm and stiffness associated with arthritis. It also increases blood circulation and relaxes muscle tissue.

Device Description

The Cell Gen CG-4000 laser is a non-invasive, diode laser system consisting of an enclosure which contains the control unit and a treatment probe connected by an optic fiber.

AI/ML Overview

The provided text is a 510(k) summary for the Cell Gen Laser, Model CG-4000. It focuses on establishing substantial equivalence to a predicate device, not on presenting a detailed study proving the device meets specific acceptance criteria in terms of clinical performance or effectiveness.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth cannot be extracted from this document because such a study is not described.

Here's a breakdown of what can be inferred and what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: The document implies the overarching acceptance criterion is substantial equivalence to the predicate device (Neurolase150, K032787) in terms of function, performance, energy source, and intended uses. Specifically, it aims to comply with "generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Food and Drug Administration." No specific numerical thresholds or performance metrics are provided as acceptance criteria for clinical efficacy.
Reported Device Performance: The document states that the device "has similar function, performance, energy source and intended uses" to the predicate. It also mentions "producing a level of tissue temperature reported in literature." However, no specific performance data from a clinical study (e.g., pain reduction scores, range of motion improvements, objective temperature measurements in a clinical setting) are reported to demonstrate effectiveness against stated acceptance criteria.

Acceptance Criteria (Inferred/Implied)	Reported Device Performance (from text)
Substantial Equivalence to Predicate Device (Neurolase150, K032787)	"The CG-4000 and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices use infrared laser diodes to generate topical heating for temporary relief of muscle and joint pain. The overall safety and effectiveness of the CG-4000 is not affected by differences in design from the predicate devices.""In consideration of the testing and comparison to the predicate devices, the CG-4000 has similar function, performance, energy source and intended uses to these devices."
Compliance with accepted therapeutic heat performance specifications	"This laser is designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Food and Drug Administration." (No specific temperature range or data provided from the device's own testing in the summary).
Safety	"Testing of the CG-4000 will include performance testing and electrical safety testing in accordance with all applicable standards for this type of medical device." (No specific safety incident rates or data are reported in the summary.)

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

Not Applicable / Not Provided. The document describes "performance testing and electrical safety testing" but does not mention a clinical "test set" or study involving human subjects to assess the device's efficacy for pain relief or other intended uses. The focus is on technical compliance and comparison to a predicate device.

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

Not Applicable / Not Provided. No clinical ground truth or experts for such a purpose are mentioned, as no clinical efficacy study is detailed.

4. Adjudication method for the test set:

Not Applicable / Not Provided.

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. This device is an infrared lamp for therapeutic heat, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance are irrelevant to this product submission.

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

Not Applicable. See point 5.

7. The type of ground truth used:

The "ground truth" for the submission is primarily the predicate device (Neurolase150), which was previously cleared by the FDA. The submission's "truth" is that the new device is substantially equivalent to this already-approved device, and therefore can be considered safe and effective for the stated indications.
Additionally, "generally accepted therapeutic heat performance specifications" and "literature" are cited as a basis for understanding effective tissue temperature.

8. The sample size for the training set:

Not Applicable / Not Provided. No machine learning or AI component that would require a training set is mentioned.

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

Not Applicable / Not Provided.

Summary

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510(k) Summarv

APR 2 1 2008

I. Applicant: Cell Gen Therapeutics, LLC 17734 Preston Road Suite 204 Dallas, TX 75252 Phone (214)914-2762 Fax (972)380-0999 Date 12/14/2007
II. Device name: Cell Gen Laser, model CG-4000 Common name: Infrared Lamp Classification: Infrared Lamp (21 CFR 890-5500) Product Code: ILY

III. Intended Use:

IV. Predicate Device:

a. Neurolase150 cleared under K032787 dated November 20, 2003

V. Device Description:

The Cell Gen CG-4000 laser is a non-invasive, diode laser system consisting of an enclosure which contains the control unit and a treatment probe connected by an optic fiber.

VI. Substantial Equivalency:

The CG-4000 and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices use infrared laser diodes to generate topical heating for temporary relief of muscle and joint pain. The overall safety and effectiveness of the CG-4000 is not affected by differences in design from the predicate devices.

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20800854 r. 204

VII. Testing:

Testing of the CG-4000 will include performance testing and electrical safety testing in accordance with all applicable standards for this type of medical device.

VIII. Conclusions:

In consideration of the testing and comparison to the predicate devices, the CG-4000 has similar function, performance, energy source and intended uses to these devices. This laser is designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Food and Drug Administration.

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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 with three tail feathers, representing the department's commitment to promoting health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 2008

Cell Gen Therapeutics, LLC % Mr. Dick Rivera President 17734 Preston Road, Suite 204 Dallas, Texas 75252

Re: K080084

Trade/Device Name: Cell Gen Laser, Model CG 4000 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Codc: ILY Dated: March 24, 2008 Received: March 25, 2008

Dear Mr. Rivera:

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 or carry 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 Orth 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 - Mr. Dick Rivera

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millican

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

Enclosure

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K080084
f. I of

Indications for Use

510(k) Number (if known): K080084

Device Name: Cell Gen Laser, Model CG 4000

Indications For Use:

Prescription Use X (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)

Neil Rt Ol for mkn

Division of General, Restorative, and Neurological Devices

Page 1 of

510(k) Number K080084

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.