AFFIRM DO DIODE LASER by CYNOSURE, INC.

The Affirm DO Diode laser device is indicated for use in general surgery and dermatology for the coagulation of soft tissue. It is also indicated for the treatment of perioral wrinkles, and pigmented lesions.

Device Description

Affirm DO is a diode laser. It is a laser with a wavelength of 1440 nm. Laser activation is by footswitch. Overall weight of the laser is 15 Kg, and the size is 25 x 9 x 18 cm (HxWxD). Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.

AI/ML Overview

The provided document does not describe acceptance criteria or a study that proves a device meets such criteria.

Instead, it is a 510(k) summary for the "Affirm DO Diode Laser" and the corresponding FDA clearance letter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study.

Here's why the requested information cannot be extracted and what the document does state:

No Acceptance Criteria or Performance Data: The "Nonclinical Performance Data" and "Clinical Performance Data" sections explicitly state "none." This means no studies were submitted to demonstrate performance against pre-defined criteria.
Substantial Equivalence: The basis for clearance is "comparison" to a predicate device (Cynosure YAG MIR Family Laser) based on having "the same indication for uses, the same principle of operation, the same wavelength and similar pulse energy range."

Therefore, I cannot provide the requested table or detailed study information because it is not present in the provided text.

Specifically, for each point requested:

A table of acceptance criteria and the reported device performance: Not available. No acceptance criteria or performance data are reported.
Sample size used for the test set and the data provenance: Not applicable. No test set or clinical data was used for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established as no clinical data was used.
Adjudication method for the test set: Not applicable. No adjudication was performed as no clinical data was used.
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 is a laser device, not an AI diagnostic tool, and no MRMC study was done.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a laser device, not an algorithm.
The type of ground truth used: Not applicable. No ground truth was used.
The sample size for the training set: Not applicable. No training set was used.
How the ground truth for the training set was established: Not applicable. No training set or ground truth for it was established.

Summary

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区101601

510(K) Summary

SEP 2 3 2010

Submitter:	Cynosure, Inc.5 Carlisle RoadWestford, MA 01886
Contact:	Anthony BurnsDirector of Regulatory Affairs
Date Summary Prepared:	June 2, 2010
Device Trade Name:	Affirm DO Diode Laser
Common Name:	Medical Laser System
Classification Name:	Instrument, Surgical, Powered, Laser79-GEX21 CFR 878.4810
Equivalent Device:	Cynosure YAG MIR Family Laser
Device Description:	Affirm DO is a diode laser. It is a laser with a wavelength of 1440 nm.
	Laser activation is by footswitch. Overall weight of the laser is 15 Kg,and the size is 25 x 9 x 18 cm (HxWxD).
	Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.
Intended Use:	The Affirm DO is indicated for use in general surgery and dermatologyfor the coagulation of soft tissue. It is also indicated for the treatmentof periorbital and perioral wrinkles, and pigmented lesions.
Comparison:	TheAffirm DO Diode laser has the same indication for uses, the sameprinciple of operation, the same wavelength and similar pulse energyrange as the predicate devices.
Nonclinical Performance Data:	none
Clinical Performance Data:	none
Conclusion:	The Affirm DO Diode laser is a safe and effective device for theintended uses.
Additional Information:	none

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

Cynosure, Inc. % Mr. Anthony Burns Director of Regulatory Affairs 5 Carlisle Road Westford, Massachusetts 01886

SEP 2 3 2010

Re: K101601

Trade/Device Name: Affirm DO Diode Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: September 09, 2010 Received: September 20, 2010

Dear Mr. Burns:

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 mav publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Anthony Burns

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); 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 vours. 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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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

SEP 2 3 2010

Device Name: | Affirm DO Diode Laser

Indications For Use:

ಗ Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 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 R.P. Andersen Forman

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

510(k) Number K101601

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.