NUVANCE* Facial Rejuvenation System is intended to fixate subdermal tissue in an elevated position in plastic and reconstructive surgery. The device may be used in areas such as the forehead, midface, jowls and neck.

Device Description

NUVANCE For Face is a sterile implant typically used in minimally invasive face-lift and facial contouring procedures. It consists of a bi-directionally barbed polymer strand with a short and a long straight steel introducer attached at the ends. The device may be pigmented to enhance visibility.

The strand has barbed upper and lower anchoring sections with unbarbed smooth sections adjacent to the steel introducers. Upper and lower anchoring sections are barbed in opposite directions with a small unbarbed section between them. Two sizes and various lengths are available.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the NUVANCE* Facial Rejuvenation System, a nonabsorbable polypropylene surgical suture for fixating subdermal tissue. However, the document does not contain specific acceptance criteria, a detailed study report proving device performance against those criteria, or information on reader studies, ground truth establishment for a training set, or sample sizes for test and training sets in the context of AI/ML device evaluation.

The document states:

Performance Data: "Biological reactivity of the materials has been assessed using methods specified in ISO Standard 10993-1, and the material was found to be acceptable for its intended use. Results of functional performance testing (bench and animal testing) indicate that the proposed device meets or exceeds all functional requirements."

Based on the provided text, I cannot complete the requested tables and information fields as they pertain to detailed performance criteria and study methodologies, particularly in the context of AI/ML device evaluation. The document is a regulatory submission for a physical medical device (suture) and focuses on substantial equivalence to predicate devices, biological reactivity, and general functional performance, not on demonstrating performance against specific AI/ML metrics.

To directly answer your request based on the absence of the specific information you asked for:

Table of acceptance criteria and reported device performance: Not provided in the document. The document vaguely states "meets or exceeds all functional requirements" but does not define these requirements or provide specific quantitative performance metrics.
Sample sized used for the test set and the data provenance: Not provided. The document mentions "bench and animal testing" but no details on sample sizes or data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided. This device is a surgical suture, not an AI/ML diagnostic tool requiring expert ground truth for image interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/provided.
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/provided. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/provided. This is a physical surgical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/provided in the context of an AI/ML device. For material reactivity, ground truth would be established by ISO 10993-1 standards; for functional performance, it would be established by engineering specifications and physical test results from bench and animal studies.
The sample size for the training set: Not applicable/provided. The device is not an AI/ML model that requires a training set.
How the ground truth for the training set was established: Not applicable/provided.

In summary, the provided regulatory document for the NUVANCE Facial Rejuvenation System lacks the specific details regarding acceptance criteria, study methodologies, and data provenance as requested for an AI/ML device. The performance data mentioned relates to biological reactivity and functional testing, not to the types of studies typically conducted for AI/ML device evaluation.*

Summary

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Summary of Safety and Effectiveness

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below.

Submitted by:

Jennifer M. Paine Manager, Regulatory Affairs Ethicon, Inc., A Johnson & Johnson Company Route 22 West. PO Box 151 Somerville. NJ 08876

Name/Classification of Device:

Class II in 21 CFR § 878.5010, Nonabsorbable polypropylene surgical suture (GAW)

Trade Name:

NUVANCE* Facial Rejuvenation System or NUVANCE For Face

Predicate Devices:

PRONOVA* Suture ENDOTINE Midface Device FEATHERLIFT Threads CONTOUR Threads

Statement of Intended Use:

Device Description:

Summary of Technological Characteristics of New Device to Predicate Devices:

The modified device has similar technological characteristics as the predicate devices. Like currently marketed devices, it is a sterile, barbed implant intended for use in lifting and supporting soft tissue in the face and neck. Like several of the currently marketed devices, the proposed device is made

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JMP-2005-014

of nonabsorbable polymer. The polymer used is identical to that of PRONOVA* suture, currently marketed by Ethicon, Inc.

Performance Data:

Biological reactivity of the materials has been assessed using methods specified in ISO Standard 10993-1, and the material was found to be acceptable for its intended use. Results of functional performance testing (bench and animal testing) indicate that the proposed device meets or exceeds all functional requirements

Conclusions:

Based on the similarities to the predicate devices identified in this submission, we conclude that the modified device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.

Trademark of Ethicon, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (USA). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 6 2006

Ethicon, Inc. c/o Ms. Jennifer M. Paine, M.S. Manager, Regulatory Affairs Route 22 West P.O. Box 151

Somerville, New Jersey 08876

Re: K052953

Trade/Device Name: NUVANCE* Facial Rejuvenation System Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: MXW Dated: January 27, 2006 Received: January 30, 2006

Dear Ms. Paine:

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 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.

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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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

elmee

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

Enclosure

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JMP-2005-014

Indications for Use

510(k) Number (if known): Ko5295

Device Name: NUVANCE* Facial Rejuvenation System

Indications for Use:

*Trademark.

(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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: 15100 SION-1 vision of General, Restorative, ·i Neurological Devices

K052453 Ok) Number_

Regulation Number and Section

§ 878.5010 Nonabsorbable polypropylene surgical suture.

(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.