The intended use of the AART Silicone Carving Block is for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary. The rectangular blocks are designed for carving flatter devices for use in bone onlay for correction of surface defects resulting from skeletal anomalies such as depressions secondary to trauma or surgery. The contoured blocks are generally used for carving curved devices such as nasals or malars or used in body contouring to minimize muscular defects.

Device Description

The AART Silicone Carving Blocks are manufactured from a medical grade silicone elastomer that has been molded into various convex oval or rectangular shapes. They are provided in seven styles with dimensions varying in length, width, height and initial shape. Pigments may be added to the silicone to make the blocks opaque if requested by the physician. The AART Silicone Carving Block is intended to be used for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary.

AI/ML Overview

This submission for the AART Silicone Carving Block is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the same way one might for an AI/ML or diagnostic device. As such, the typical structure for reporting acceptance criteria and study data does not directly apply here.

The "study" in this context is the comparison made to predicate devices to establish substantial equivalence based on material, design, function, and performance, not a clinical trial with statistical endpoints.

Here's a breakdown of the information as it relates to this 510(k) submission, with an explanation of why some sections are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrated Substantial Equivalence)	Reported Device Performance (Claimed Equivalence)
Material: Medical grade silicone elastomer	Manufactured from medical grade silicone elastomer
Design: Various convex oval or rectangular shapes	Provided in seven styles with varying dimensions
Function: Used for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary; carving flatter devices for bone onlay; carving curved devices for nasals, malars, or body contouring	Intended for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary; rectangular blocks for bone onlay; contoured blocks for carving curved devices (nasals, malars) or body contouring
Performance: Safe and effective for intended use	Equivalent to predicate devices which are safe and effective

Explanation: The "acceptance criteria" for a 510(k) are implicitly the characteristics of the predicate devices. The "reported device performance" is the manufacturer's assertion that their device meets these characteristics, thereby demonstrating substantial equivalence. There are no explicit quantitative performance metrics or acceptance thresholds in this document because it's a materials/design equivalence submission.

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

Sample Size for Test Set: Not applicable. There was no specific "test set" in the sense of patient data or clinical samples for a performance study.
Data Provenance: Not applicable. The "data" here refers to the characteristics of the predicate devices and the new device. The provenance is from the manufacturing specifications and regulatory history of the predicate devices.

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

Not applicable. There was no "ground truth" to be established by experts in the context of a performance study. The ground truth, here, is the established safety and effectiveness of the predicate devices, which is generally accepted by regulatory bodies.

4. Adjudication method for the test set

Not applicable. No adjudications by experts were performed as part of a performance study.

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 is not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. This is not an AI/ML device, and no standalone algorithm performance was assessed.

7. The type of ground truth used

Not applicable in the typical sense of a diagnostic or AI device study. The "ground truth" implicitly relies on the established safety and efficacy of the predicate devices based on their historical use and regulatory clearances. This is a "comparison to predicate" ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, and no training set was used.

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

Not applicable. No training set was used.

Summary of the "Study" (Substantial Equivalence Justification):

The "study" in this 510(k) submission is a declaration and demonstration of substantial equivalence to existing, legally marketed predicate devices. The manufacturer, Aesthetic and Reconstructive Technologies, Inc. (AART), argued that their Silicone Carving Block is substantially equivalent to:

Silicone Carving Block marketed by Hanson Medical, Inc.
Spectrum Designs Pre-Form Contour Silicone Carving Block marketed by Spectrum Designs, Inc.

The basis for this substantial equivalence claim rests on the following points:

Identical Intended Uses: The AART device shares the same intended use for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary, and specific uses for rectangular and contoured blocks, as the predicate devices.
Similar Materials: The device is manufactured from a medical grade silicone elastomer, which is presented as equivalent to the materials of the predicate devices.
Similar Design and Performance: The devices are offered in similar shapes and sizes (various convex oval or rectangular shapes, seven styles) and are expected to perform comparably to the predicate devices.

The FDA reviewed this comparison and, finding the claims of equivalence sufficient, issued a determination of substantial equivalence, allowing the device to be marketed. No new clinical or performance data from a specific study with defined acceptance criteria were required or presented beyond the comparative analysis to the predicate devices.

Summary

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K021820

JUL 1 6 2002

ATTACHMENT 7

510(k) Summary

May 30, 2002

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

Substantial Equivalence: The AART Silicone Carving Block is substantially equivalent in function, design, performance and materials to the Silicone Carving Block marketed by Hanson Medical, Inc. of Kingston, WA and the Spectrum Designs Pre-Form Contour Silicone Carving Block marketed by Spectrum Designs, Inc. of Carpinteria, CA.

Device Description: The AART Silicone Carving Blocks are manufactured from a medical grade silicone elastomer that has been molded into various convex oval or rectangular shapes. They are provided in seven styles with dimensions varying in length, width, height and initial shape. Pigments may be added to the silicone to make the blocks opaque if requested by the physician. The AART Silicone Carving Block is intended to be used for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary.

Intended Use: The intended use for the AART Silicone Carving Block is for augmentation and reconstructive surgery where additional shaving by the surgeon may be necessary. The rectangular blocks are designed flatter devices for use in bone onlay for correction of surface defects resulting from skeletal anomalies such as depressions secondary to trauma or surgery. The contoured blocks are generally used for carving curved devices such as nasals or malars or used in body contouring to minimize muscular defects.

Predicate Device: The AART Silicone Carving Block is substantially equivalent in material. design, function, and performance to the Silicone Carving Block marketed by Hanson Medical. Inc. of Kingston, WA and the Spectrum Design Pre-Form Contour Silicone Carving Block marketed by Spectrum Designs. Inc. of Carpinteria. CA. All products have identical intended uses and are offered in similar shapes and sizes.

Packaging: The AART Silicone Carving Blocks will be offered non-sterile. The contoured carving blocks will be individually packaged in an autoclavable peel pouch and labeled on the plastic side with appropriate identification for traceability. They will then be boxed in a SSB

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ATTACHMENT 7 (cont'd.)

501(k) Summary

chipboard box along with a package insert and labeled for inventory and shipment. The rectangular blocks will be individually wrapped in a lint free tissue and then packaged in a plastic bag and labeled on one side with appropriate identification. The packaged block along with the package insert is then placed inside a second plastic bag for inventory and shipment.

Sterilization: The AART Silicone Carving Blocks are offered non-sterile. Recommended autoclave cycles are stated in the Package Insert which is included with each product.

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Image /page/2/Picture/1 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 a stylized caduceus or a series of human profiles.

Public Health Service

JUL 1 6 2002

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

Re: K021820 Trade Name: AART Silicone Carving Block Regulation Number: 874.3620 Regulation Name: Ear, nose and throat synthetic polymer material Regulatory Class: II Product Code: MIB Dated: May 30, 2002 Received: June 4, 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 (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 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,

Stupt Rhodes

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 of

510 (k) NUMBER (IF KNOWN) :	AART Silicone Carving Block	K021820
DEVICE NAME:	AART Silicone Carving Block

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) OR

Over - The - Counter - Use (Optional Format 1-2-5

Stupt Curdis

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

510(k) Number K021820

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.