AART SILICONE SHEETING by AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC.

Nasal septal repair
Orbital floor reconstruction
Tympanic membrane repair
Dialysis shunt anchoring
Durameter repair
Staged repair of omphalocoel
Lengthening of extraocular muscles
As a protective sheathing to help facilitate neural regeneration and tendon anastomosis
As a protective sheathing to help facilitate osteogenesis
Other uses deemed appropriate by the using surgeon

Caution: The American Academy of Oral Maxillofacial Surgeons recommends against the use of silicone products for permanent treatment of Temporo Mandibular Joint Disease.

Device Description

The AART Silicone Sheeting is manufactured from a medical grade silicone elastomer intended for long term implantation. The sheeting will be provided reinforced or non-reinforced in three sizes of varying thicknesses. The AART Silicone Sheeting is intended to be used for various surgical and non-surgical applications and may be trimmed by scalpel or scissors where additional shaping by the surgeon may be necessary.

AI/ML Overview

The provided document is a 510(k) summary for the "AART Silicone Sheeting." It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria for the new device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment cannot be fully extracted from this document as it does not contain the specifics of a performance study in the way you've outlined for AI/medical device performance evaluation.

Here's a breakdown of what can be inferred or what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

None provided. This document is a 510(k) summary demonstrating substantial equivalence, not a detailed performance study with quantitative acceptance criteria and results for the AART Silicone Sheeting itself. The substantial equivalence argument is based on the material, design, function, and performance being similar to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable / Not provided. No specific "test set" or clinical study data for the AART Silicone Sheeting is described in this document. The submission is a comparison to a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable / Not provided. No ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set

Not applicable / Not provided. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

Not applicable / Not provided. This document does not describe an MRMC study or any study involving human readers with or without AI assistance. The device is a silicone sheeting for physical applications, not an AI diagnostic tool.

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

Not applicable / Not provided. This device is a physical medical implant/sheeting, not an algorithm or AI product.

7. The Type of Ground Truth Used

Not applicable / Not provided. No performance data requiring ground truth is presented for the AART Silicone Sheeting. The substantial equivalence argument relies on the properties and intended use being similar to a legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable / Not provided. As this is not an AI/algorithm-based device, there is no concept of a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable / Not provided. No training set data or ground truth establishment is mentioned.

Summary of what the document does provide regarding the device and its regulatory pathway:

Device Name: AART Silicone Sheeting
Intended Use: Various surgical and non-surgical applications (short term and long term), including nasal splinting, wound dressing, management of scarring, nasal septal repair, orbital floor reconstruction, etc. (See Attachment 1 for full list).
Predicate Device: Seare Biomedical Silicone Sheeting
Substantial Equivalence Claim: Based on similar function, design, performance, materials, intended uses, sizes, thicknesses, and options of reinforcement/non-reinforcement as the predicate device.
Sterilization: Gamma Radiation (minimum 25kGy) to a sterility assurance level (SAL) of 10⁻⁶.
Regulatory Decision: The FDA found the device substantially equivalent to the predicate (K022223 letter). This means it can be marketed under general controls.

Summary

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022223

AUG 0 8 2002

ATTACHMENT 7

510(k) Summary

July 2, 2002

Applicant:	Aesthetic and Reconstructive Technologies, Inc. (AART)
	3545 Airway Drive, Suite 108
	Reno, NV 89511
	(775) 853-6800 / FAX (775) 853-6805
Contact Person:	Catherine Riple
	Consultant for AART, Inc.
	(805) 239-1059
Proprietary Name:	AART Silicone Sheeting
Common Name:	Silicone Carving Block
Classification Name:	Elastomer, Silicone Block

Substantial Equivalence: The AART Silicone Sheeting is substantially equivalent in function, design, performance and materials to the Seare Biomedical Silicone Sheeting marketed by Seare Biomedical Corporation of Salt Lake City, Utah.

Device Description: The AART Silicone Sheeting is manufactured from a medical grade silicone elastomer intended for long term implantation. The sheeting will be provided reinforced or non-reinforced in three sizes of varying thicknesses. The AART Silicone Sheeting is intended to be used for various surgical and non-surgical applications and may be trimmed by scalpel or scissors where additional shaping by the surgeon may be necessary.

The intended use for the AART Silicone Sheeting is for various surgical and non-Intended Use: surgical applications. The silicone sheeting is intended for short term and long term applications.

Predicate Device: The AART Silicone Sheeting is substantially equivalent in material, design, function, and performance to the Seare Biomedical Silicone Sheeting marketed by Seare Biomedical Corporation of Salt Lake City, Utah. All products have virtually identical intended uses and are offered in similar sizes, thicknesses, and options of reinforcement or nonreinforcement.

Packaging: The AART Silicone Sheeting will be offered sterile. The sheeting will be packaged individually in a double Tyvek® pouch configuration. One size of sheeting will be offered both individually or in boxes of ten. Once steallized the individual sheeting will then be packaged in a protective plastic bag along with a package insert for inventory and shipping. Sheeting sold in boxes of ten will be boxed after sterilization along with a package insert.

Sterilization: The AART Silicone Sheeting is offered sterile. Sheeting will be sterilized by Gamma Radiation. The radiation dose level will be a minimum of 25kGy or as determined by the validation studies. The sterility assurance level (SAL) for the AART Silicone Sheeting will be 10 - .

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring three overlapping profiles of human faces, creating a sense of depth and connection.

AUG 0 8 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesthetic and Reconstructive Technologies, Inc. c/o Catherine Riple 5871 Lone Pine Place Paso Robles, California 93446

Re: K022223

Trade/Device Name: AART Silicone Sheeting Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, and Throat Synthetic Polymer Material Regulatory Class: Class II Product Code: MIB Dated: July 2, 2002 Received: July 9, 2002

Dear Ms. Riple:

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 mav 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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Page 2 -- Ms. Catherine Ripple

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" (21 CFR 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 http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Stypt Elwrdn
LNSulie M. Witte, Ph.D., M.D.

Celia 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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ATTACHMENT 1

Page 1 of 1

510 (k) NUMBER (IF KNOWN): K022223.

DEVICE NAME:

AART Silicone Sheeting

INDICATIONS FOR USE:

The AART Silicone Sheeting has a variety of intended uses. The silicone sheeting is intended for short term and long term applications.

Short term indications for use:

Nasal splinting ●
Wound dressing ●
Management of keloid or hypertrophic scarring �
Temporary use in TMJ disease .
Temporary joint shims .
Laboratory-uses ●

Long term indications for use:

Nasal septal repair ●
Orbital floor reconstruction ●
Tympanic membrane repair ●
Dialysis shunt anchoring ●
Durameter repair ●
Staged repair of omphalocoel .
Lengthening of extraocular muscles
As a protective sheathing to help facilitate neural regeneration and tendon anastomosis .
As a protective sheathing to help facilitate osteogenesis .
Other uses deemed appropriate by the using surgeon ●

Caution: The American Academy of Oral Maxillofacial Surgeons recommends against the use of silicone products for permanent treatment of Temporo Mandibular Joint Disease.

(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)

Hyt Purdu

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

KOZZZZZ3 510(k) Number -

Regulation Number and Section

§ 874.3620 Ear, nose, and throat synthetic polymer material.

(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.