The intended use of the AART Nasal Implant is for cosmetic augmentation and reconstruction of the nasal contour during rhinoplasty. They are intended for insertion via an intraoral or nasal sill incision.

Device Description

The AART Nasal Implants are manufactured from a medical grade silicone elastomer that has been molded into various "L" or straight shapes with concave convex dorsal aspects which reach from the alar cartilage to the radix. They are provided in seven styles with dimensions varying in length, width, and height. Titanium Oxide and Iron Oxide pigments may be added to the silicone to make the implant opaque if requested by the physician. These pigments are widely used in cosmetic surgery implant applications and will be lot tested for cvtotoxicity. The AART Nasal Implants are intended to be used for augmentation and reconstruction of the nasal contour during rhinoplasty. The surface characteristic of the implants is smooth. The AART Nasal Implants will be offered sterile and non-sterile.

AI/ML Overview

This 510(k) submission (K021418) for the AART Nasal Implant details its substantial equivalence to previously marketed predicate devices rather than providing a study demonstrating specific performance acceptance criteria for the device itself. Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set ground truth) are not applicable as they relate to performance studies, which are not present in this document.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material: Medical grade silicone elastomer	Material: Manufactured from medical grade silicone elastomer; Titanium Oxide and Iron Oxide pigments may be added (lot tested for cytotoxicity).
Design: Molded into various "L" or straight shapes with concave-convex dorsal aspects, reaching from alar cartilage to radix. Seven styles with varying length, width, and height. Smooth surface.	Design: Matches the description; seven styles with varying dimensions; smooth surface.
Function/Intended Use: Cosmetic augmentation and reconstruction of the nasal contour during rhinoplasty, intended for insertion via intraoral or nasal sill incision.	Function/Intended Use: Identical to predicate devices: "cosmetic augmentation and reconstruction of the nasal contour during rhinoplasty. They are intended for insertion via an intraoral or nasal sill incision."
Performance: Substantially equivalent to predicate devices in material, design, function, and performance.	Performance: "Substantially equivalent in function, design, performance and materials to the Duralastic Anatomical Nasal Implant marketed by Allied Biomedical Corporation of Ventura, CA and the Seare Biomedical Nasal Implant marketed by Seare Biomedical Corp. of Salt Lake City, Utah." All products have identical intended uses and are offered in similar shapes and sizes.
Sterilization: Sterilized by Gamma radiation, following ANSI/AAMI/ISO 11137-1994 standard.	Sterilization: "Will be sterilized by Gamma radiation. The sterilization cycle will be determined and validated following the ANSI/AAMI/ISO 11137-1994 standard 'Sterilization of health care products - Requirements for validation and routine control -Radiation sterilization'."

2. Sample size used for the test set and the data provenance

Not Applicable. This submission is based on substantial equivalence to predicate devices, not a new performance study requiring a test set of data.

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

Not Applicable. See point 2.

4. Adjudication method for the test set

Not Applicable. See point 2.

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

Not Applicable. This device is a physical nasal implant, not an AI or imaging device that would involve human readers or comparative effectiveness studies with AI assistance.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

Substantial Equivalence: The "ground truth" for this submission is the established safety and effectiveness record of existing, legally marketed predicate nasal implants (Duralastic Anatomical Nasal Implant and Seare Biomedical Nasal Implant). The AART Nasal Implant demonstrates that it is substantially equivalent in material, design, function, and performance to these predicates.

8. The sample size for the training set

Not Applicable. As this is not an AI or machine learning device, there is no training set in the conventional sense.

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

Not Applicable. See point 8.

Summary

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K021418

JUL - 2 2002

ATTACHMENT 5

510(k) Summary

April 29,2002

Contact Information:

Aesthetic and Reconstructive Technologies, Inc. (AART) 3545 Airway Drive, Suite 108 Reno, NV 89511 (775) 853-6800 / FAX (775) 853-6805 Winston A. Andrews

Proprietary Name: Common Name: Classification Name: AART Nasal Implant Silicone Elastomer Nasal Implant Prosthesis, Nose, Internal

Substantial Equivalence: The AART Nasal Implant is substantially equivalent in function, design, performance and materials to the Duralastic Anatomical Nasal Implant marketed by Allied Biomedical Corporation of Ventura, CA and the Seare Biomedical Nasal Implant marketed by Seare Biomedical Corp. of Salt Lake City, Utah.

Device Description: The AART Nasal Implants are manufactured from a medical grade silicone elastomer that has been molded into various "L" or straight shapes with concave convex dorsal aspects which reach from the alar cartilage to the radix. They are provided in seven styles with dimensions varying in length, width, and height. Titanium Oxide and Iron Oxide pigments may be added to the silicone to make the implant opaque if requested by the physician. These pigments are widely used in cosmetic surgery implant applications and will be lot tested for cvtotoxicity. The AART Nasal Implants are intended to be used for augmentation and reconstruction of the nasal contour during rhinoplasty. The surface characteristic of the implants is smooth. The AART Nasal Implants will be offered sterile and non-sterile.

The intended use for the AART Nasal Implant is augmentation and Intended Use: reconstruction of the nasal contour during thinoplasty. They are intended for insertion via an intraoral or nasal sill incision.

Predicate Device: The AART Nasal Implant is substantially equivalent in material, design, function, and performance to the Duralastic Anatomical Nasal Implant marketed by Allied Biomedical Corp. and the Seare Biomedical Nasal Implant marketed by Seare Biomedical Corp. All products have identical intended uses and are offered in similar shapes and sizes.

Sterilization Cycle: The AART Nasal Implant will be sterilized by Gamma radiation. The sterilization cycle will be determined and validated following the ANSI/AAMI/ISO 11137-1994 standard "Sterilization of health care products - Requirements for validation and routine control -Radiation sterilization".

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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 features the department's name in a circular arrangement around a stylized graphic. The graphic depicts three human profiles facing right, represented by curved lines. The profiles are stacked on top of each other, creating a sense of depth and unity.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesthetic and Reconstructive Technologies, Inc. c/o Ms. Catherine Riple 3545 Airway Drive, Suite 108 Reno, Nevada 89511

JUL = 2 2002

Re: K021418 Trade Name: AART Nasal Implant Regulation Number: 878.3680 Regulation Name: Prosthesis, Nasal Implant Regulatory Class: II Product Code: FZE Dated: April 29, 2002 Received: May 3, 2002

Dear Ms. Riple:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (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.

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Page 2 - Ms. Catherine Riple

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 HYPERLINK http://www.fda.gov/cdrh/dsma/dsmamain.html http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

L. Stipt. Clude

Célia 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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AMENDMENT 1

Page of

NUMBER (IF KNOWN) :	K021418
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AART Nasal Implant

DEVICE NAME:

510 (k)

INDICATIONS FOR USE:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Over-The-Counter-Use (Optional Format 1-2-96

Stypt Awode

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

510(k) Number K021418

Regulation Number and Section

§ 878.3680 Nose prosthesis.

(a)
Identification. A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.(b)
Classification. Class II.