The medical device PHARAON LIPO is based on the use of a laser module allowing the emission of a beam of coherent light at 970nm ± 10 nm at a maximum power of 25W. The laser module consists of laser diodes assembled in series and optically aligned in order to focus in an optical fiber of 600um. The optical fiber is screwed onto the SMA 905 connector of the laser module. The apparatus PHARAON LIPO includes the whole of the supplies necessary to supply the laser (50A, 2V) and to ensure its thermalisation using a Peltier element built on a ventilated radiator.

In addition PHARAON LIPO includes the whole of electronics and the functions allowing the parameter setting of the laser and the safe functioning of the device. The adjustments of the parameters are done using a TFT screen and a tactile flagstone.

AI/ML Overview

The provided 510(k) K073617 for the PHARAON LIPO device is for a laser surgical instrument, not an AI/algorithm-driven device. Therefore, the information requested about acceptance criteria, study details, ground truth, and expert involvement (which are typically relevant for AI/algorithm performance evaluation) is not explicitly available in this type of submission.

510(k) submissions for devices like PHARAON LIPO primarily focus on demonstrating substantial equivalence to a legally marketed predicate device through engineering specifications, safety and performance testing against recognized standards, and functional comparison. They do not involve clinical studies with human readers, AI assistance, or the generation of ground truth in the same way an AI diagnostic or prognostic device would.

Based on the provided text, here’s what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

The document states that "Performance data demonstrate the safety and effectiveness of PHARAON LIPO for its intended use." However, it does not provide a table of specific quantitative acceptance criteria (e.g., power output tolerance, wavelength stability, thermal management metrics) nor detailed performance data against those criteria. It broadly states conformance to regulatory guidelines and standards.

Acceptance Criteria (Implicit/General):
- Conformance to Guidance on the content and organization of a premarket notification for a medical laser (June 1995).
- Conformance to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005).
- Conformance to 21CFR part 1040.10 and 1040.11 (Performance Standards for Laser Products).
- Demonstration of safety and effectiveness for laser-assisted lipolysis.
- Substantial equivalence to the predicate device SMARTLIPO (K062321) in terms of intended use, material design, and function.
Reported Device Performance: The document only makes a general statement: "Performance data demonstrate the safety and effectiveness of PHARAON LIPO for its intended use." No specific quantitative performance metrics are provided in the summary.

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

This information is not applicable/not provided in this 510(k) summary for a laser device. There is no "test set" in the context of an algorithm's performance on patient data. Performance evaluation for this type of device typically involves engineering tests, electrical safety tests, electromagnetic compatibility (EMC) tests, and biocompatibility tests, rather than clinical data sets.

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

This information is not applicable/not provided. Ground truth in the context of clinical images or patient data is not established for a laser device's mechanical or energy delivery performance.

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

This information is not applicable/not provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data, typically in AI performance studies.

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:

This information is not applicable/not provided. An MRMC study is designed for evaluating the impact of AI on human reader performance, which is not relevant for a standalone laser surgical instrument.

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

This information is not applicable/not provided. There is no "algorithm only" performance study relevant to this laser device in the context of AI. The device itself is the "standalone" entity whose physical and electrical performance is being evaluated.

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

This information is not applicable/not provided. "Ground truth" as understood in AI studies (e.g., pathology reports for image analysis) is not generated for evaluating the technical performance of a laser device. The "truth" for device performance lies in its adherence to engineering specifications and safety standards.

8. The sample size for the training set:

This information is not applicable/not provided. There is no "training set" for a laser surgical instrument in the context of machine learning.

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

This information is not applicable/not provided. As there is no training set, there is no ground truth established for it in this context.

Summary

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K073617

510k PHARAON LIPO

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

As required by section 807.92(c)

5 -1 GENERAL INFORMATION

Trade Name	PHARAON LIPO
Classification Name	LASER INSTRUMENT, SURGICAL, POWERED
Class	II
Product Code	GEX
CFR section	878.4810
Device panel	General & Plastic Surgery
Legally marketedpredicate devices	K062321: SMARTLIPO manufactured by CYNOSURE INC.
Submitter	OSYRIS121 Rue Chanzy, BP 9014059260 HELLEMMES FRANCE
Contacts	Pr JAOUAD ZEMMOURI CEOjaouad.zemmouri@osyris.comPhone : +33 (0)3 20 67 59 97Fax: +33 (0)3 20 04 46 24Regulatory contact: Dr Isabelle DRUBAIX (Idée Consulting)idrubaix@nordnet.fr

5 -2. DEVICE DESCRIPTION

5 - 3. INTENDED USE

PHARAON LIPO is intended for laser assisted lipolysis

5 - 4, PERFORMANCE DATA

PHARAON LIPO conforms to Guidance on the content and organization of a premarket notification for a medical laser (June 1995) and to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005).

PHARAON LIPO conforms to 21CFR part 1040.10 and 1040.11.

Performance data demonstrate the safety and effectiveness of PHARAON LIPO for its intended use.

5 - 5. SUBSTANTIAL EQUIVALENCE

PHARAON LIPO has the same intended use, material design and function as predicate device SMARTLIPO (K062321).

Summary preparation date: December 7, 2007

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Image /page/1/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 its wings spread, enclosed within 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

APR - 9 2008

Osyris % Pr Jaouad Zemmouri CEO 121, rue Chanzy, BP 90140 59260 Hellemmes France

Re: K073617

Trade/Device Name: Pharaon Lipo 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: March 26, 2008 Received: March 28, 2008

Dear Pr Jaouad Zemmouri:

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 comply 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

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Page 2 - Pr Jaouad Zemmouri

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.

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 N. Milliman

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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510k PHARAON LIPO

pg 1 of 1

INDICATIONS FOR USE

510(k) Number (if known): K073617

Device Name: PHARAON LIPO

Indications for Use: PHARAON LIPO is intended for laser assisted lipolysis

Prescription Use 14 (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number K073617

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.