(90 days)
The CoolTouch Nd:YAG Laser Systems are indicated for the treatment of periorbital and perioral wrinkles.
The CoolTouch Nd:YAG Laser Systems are ND:YAG lasers producing laser emission at 1320 nm. The lasers consist of three interconnected sections: The cabinet, which houses the power supply, cooling system, microcontroller and the laser, the fiber optics, and the handpiece.
Here's an analysis of the provided text regarding the CoolTouch Nd:YAG Laser System's acceptance criteria and study information:
Based on the provided documents, there's no detailed information available about specific acceptance criteria or a comprehensive study report that would typically include the requested metrics for an AI/device performance evaluation. The document is a 510(k) premarket notification summary for a medical device (laser system), not an AI algorithm.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, as required for medical device clearance in the US. It mentions "Clinical Performance Data," but only as a general statement: "Clinical trials produced results that indicate that that CoolTouch Nd:YAG Laser System is effective in the treatment of periorbital and perioral wrinkles." This is a summary and does not contain the specifics of a clinical study report.
Therefore, many of the requested details about acceptance criteria, study design for AI, sample sizes, ground truth, and expert involvement are not present in the provided text.
However, I can extract the available relevant information and present it in the requested format, clearly indicating where information is absent.
Acceptance Criteria and Device Performance
| Acceptance Criteria (If specified) | Reported Device Performance |
|---|---|
| Not specified in the document. | "Clinical trials produced results that indicate that that CoolTouch Nd:YAG Laser System is effective in the treatment of periorbital and perioral wrinkles." |
Study Details (Based on available information)
-
Sample size used for the test set and the data provenance:
This information is not provided in the given document. The document only states that "Clinical trials produced results," implying a test set was used, but details on size and provenance are absent. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the given document. The context of a physical laser device for wrinkle treatment suggests that "ground truth" would likely be clinical assessments of wrinkle reduction, possibly by physicians, but no specifics are given. -
Adjudication method for the test set:
This information is not provided in the given document. -
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:
This information is not applicable to the described device. The CoolTouch Nd:YAG Laser System is a physical laser device for treatment, not an AI algorithm, and therefore an MRMC study comparing human readers with and without AI assistance is not relevant to its function. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable to the described device, as it is a physical laser system, not a standalone algorithm. -
The type of ground truth used:
The document implicitly suggests the ground truth was based on clinical assessment of wrinkle reduction, as it states the device is "effective in the treatment of periorbital and perioral wrinkles." More specific details (e.g., objective measurements, subjective ratings, standardized scales) are not provided. -
The sample size for the training set:
This information is not provided in the given document. For a clinical trial of a laser device, there would be participants, but the term "training set" is typically used for machine learning models and is not directly applicable here. -
How the ground truth for the training set was established:
This information is not provided in the given document. Similar to point 7, the concept of a "training set" with established ground truth is more relevant to AI. For a medical device trial, the "ground truth" (i.e., the outcome measure of wrinkle reduction) would be established through clinical protocols, but the specifics are not detailed.
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| MAR 7 2002 | CoolTouch CorporationCoolTouch Nd:YAG Laser System510(k) Premarket Notification |
|---|---|
| 510(k) SUMMARY | |
| Submitter: | CoolTouch Corporation |
| Address: | 9085 Foothills BoulevardRoseville, CA 95747 |
| Contact Person: | Donald V. JohnsonDirector of Regulatory and Quality Affairs |
| Telephone: | (916) 677-1900 |
| Facsimile: | (916) 677-1901 |
| Date Prepared: | December 6, 2001 |
| Device Trade Name: | CoolTouch Nd:YAG Laser SystemCoolTouch-II Nd:YAG Laser System |
| Common Name: | Nd: YAG Pulsed Surgical Laser |
| Classification Name: | Laser Surgical Instrument.21 C.F.R. § 878.4810 |
| Legally Marketed Predicate Device: | New Star Lasers, Inc. Model 130 Nd:YAG SurgicalLaser System (K962791). |
| Description of the CoolTouchNd:YAG Laser Systems: | The CoolTouch Nd:YAG Laser Systems are ND:YAGlasers producing laser emission at 1320 nm. The lasersconsist of three interconnected sections: The cabinet,which houses the power supply, cooling system,microcontroller and the laser, the fiber optics, and thehandpiece. |
| Intended use of CoolTouchNd:YAG Laser Systems: | The CoolTouch Nd:YAG Laser Systems are indicatedfor the treatment of periorbital and perioral wrinkles. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | Clinical trials produced results that indicate that thatCoolTouch Nd:YAG Laser System is effective in thetreatment of periorbital and perioral wrinkles. |
| Conclusion: | The CoolTouch Nd:YAG Laser Systems are indicatedfor the treatment of periorbital and perioral wrinkles. |
| Additional Information: | None requested at this time |
:
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 7 2002
Mr. Donald V. Johnson Director of Regulatory and Quality Affairs CoolTouch Corporation 9085 Foothills Boulevard Roseville, CA 95747
Re: K014035
Trade/Device Name: Cooltouch Nd: YAG Laser System CoolTouch-II Nd:YAG Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 6, 2001 Received: December 7, 2001
Dear Mr. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becaren on the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass suated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered proc to may 20, 1978, are cance with the provisions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I va may, therefere, mains of the Act include requirements for annual registration, listing of general controll provision 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 If your device is olassified (600 wor of ols. Existing major regulations affecting your device can may be subject to such additions, 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 r lease or admissed a determination that your device complies with other requirements of the Act that I Dr Has made a statutes and regulations administered by other Federal agencies. You must of any I oderal bather act's requirements, including, but not limited to: registration and listing (21 compry with an the riev 61 CFR Part 801); good manufacturing practice requirements as set Of It Fat 607), accems (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by sichine (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Mr. Donald V. Johnson
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,
Miriam C. Provost
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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INDICATION FOR USE STATEMENT
K 014035 510(k) Number: __
Device Name: CoolTouch Corporation "CoolTouch"and "CoolTouch-II" Nd:YAG Laser Systems
Indications for Use:
The CoolTouch Nd:YAG Laser Systems are indicated for the treatment of periorbital and perioral wrinkles.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ V (per 21 CFR 801.109)
OR
Over-the-Counter Use_
Miriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number K6/4035
§ 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.