The Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength is further indicated for laser assisted lipolysis.

Device Description

The Cynosure Smartlipo Multiwavelength laser with 1440nm wavelength is a Nd:YAG laser, having a ND:YAG crystal rod as a lasing medium. It is a laser with wavelengths of 1064 nm, 1320 nm, and 1440 nm.

Laser activation is by footswitch. Overall weight of the laser is 285lbs, and the size is 41"x18"x32" (HxWxD).

Electrical requirement is 220 VAC, 20A, 50-60 Hz, single phase.

AI/ML Overview

This document is a 510(k) summary for a medical laser system. The information provided does not describe a study involving acceptance criteria for device performance based on clinical metrics, nor does it detail a clinical study with human readers or an AI component. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the provided text, highlighting the absence of the requested information:

Analysis of the Provided Text:

The document is a 510(k) Summary for the Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength. This type of submission to the FDA focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a detailed clinical study with performance metrics in the way your request implies.

The core of this submission is a comparison to a predicate device, not a clinical trial with specific performance metrics and acceptance criteria for the new device itself.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and AI performance are not present in this type of regulatory document.

Here's how each of your requested points relates to the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not Applicable	Not Applicable
(This document does not specify quantitative acceptance criteria for device performance in a clinical study. Instead, it relies on demonstrating substantial equivalence to a predicate device.)	(No specific performance metrics or patient outcomes are reported in this summary beyond the statement of safety and effectiveness.)

Reasoning: The 510(k) summary states: "The Cynosure Smartlipo Mutliwavelength Laser with 1440nm wavelength is a safe and effective device for the 'indications for use' specified." This is a conclusion of equivalence, not a report against specific clinical performance criteria. The document lists "Nonclinical Performance Data: None" and "Clinical Performance Data: none," indicating that the submission did not rely on new performance data to establish safety and effectiveness, but rather on the equivalence to an existing device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable. No test set (in the context of clinical performance evaluation) is mentioned.
Data Provenance: Not applicable. No clinical data is presented.

Reasoning: The document explicitly states "Clinical Performance Data: none." This means no clinical study data with test sets was used for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

Reasoning: Since no clinical data or test set was used, there was no need for experts to establish ground truth for performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable.

Reasoning: No clinical test set or performance evaluation requiring adjudication was conducted or presented.

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

MRMC Study Done: No.
Effect Size: Not applicable.

Reasoning: This is a laser device, not an AI-assisted diagnostic or imaging device. Therefore, a multi-reader, multi-case study, particularly one involving AI, is entirely irrelevant to this submission.

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

Standalone Performance Study: No.

Reasoning: This is a physical laser device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Not applicable.

Reasoning: As no clinical studies or performance evaluations were conducted for this submission, no ground truth data was generated or used.

8. The sample size for the training set

Sample Size for Training Set: Not applicable.

Reasoning: This device does not involve machine learning or AI, so there is no training set in the context of algorithm development.

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

Ground Truth Establishment for Training Set: Not applicable.

Reasoning: As there is no training set for an algorithm, the establishment of its ground truth is also not applicable.

Conclusion based on the provided document:

The Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength received 510(k) clearance (K091537) based on demonstrating substantial equivalence to a predicate device (also the Cynosure Smartlipo Multiwavelength Laser, but presumably without the 1440nm wavelength or with a different history). The key arguments for substantial equivalence were:

Identical indications for use: Surgical incision, excision, vaporization, ablation, and coagulation of soft tissue, and laser-assisted lipolysis.
Same principle of operation: Nd:YAG laser with 1064 nm, 1320 nm, and 1440 nm wavelengths.
Similar laser parameters to the predicate device.

The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: none," indicating that the clearance was achieved without new performance studies or data evaluating specific acceptance criteria for the new device's functions as described in your request. Instead, it relies on the established safety and effectiveness of the existing predicate device.

Summary

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K 091537

Submitter:

Contact:

Date Summary Prepared: Device Trade Name:

Common Name:

Classification Name:

Equivalent Device: Device Description:

Intended Use:

Comparison:

Nonclinical Performance Data: Clinical Performance Data: Conclusion:

Additional Information:

510(K) Summary Cynosure, Inc. 5 Carlisle Road SEP - 3 2009 Westford, MA 01886 Anthony Burns Regulatory Affairs Manager May 22, 2009 Cynosure Smartlipo Multiwavelength Laser with 1440mm wavelength

Medical Laser System

Instrument, surgical, powered, laser 79-GEX 21 CFR 878.4810

Cynosure Smartlipo Multiwavelength Laser

The Cynosure Smartlipo Multiwavelength laser with 1440nm wavelength is a Nd:YAG laser, having a ND:YAG crystal rod as a lasing medium. It is a laser with wavelengths of 1064 nm, 1320 nm, and 1440 nm.

Laser activation is by footswitch. Overall weight of the laser is 285lbs, and the size is 41"x18"x32" (HxWxD).

Electrical requirement is 220 VAC, 20A, 50-60 Hz, single phase.

The SmartLipo Multiwavelength Laser with 1440nm wavelength is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The SmartLipo Multiwavelength with 1440nm wavelength is further indicated for laser assisted lipolysis.

The Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength has the identical indications for use, the same principle of operation, and similar laser parameters as the predicate device.

None

none

The Cynosure Smartlipo Mutliwavelength Laser with 1440nm wavelength is a safe and effective device for the 'indications for use' specified.

none

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with stylized lines representing its wings and body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

SEP - 8 2009

Re: K091537

Trade/Device Name: Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength 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: July 2, 2009 Received: July 6, 2009

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.

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 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

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Page 2 - Mr. Anthony Burns

forth in the quality systems (OS) 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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sturman P. Chapman

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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510(k) Number (if known):

K 091537

Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength Device Name:

Indications For Use:

OR Prescriptive Use X (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)

Milke P. Oglin formkn

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

510(k) Number K091537

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.