The Perma Facial Implants are solid silicone implants that are intended for use in plastic and reconstructive surgery. The devices can be used for cosmetic augmentation and corrections in the face, including areas such as the nose, chin, and cheeks.

Device Description

The SurgiSil™ Perma Facial Implants are injection-molded (pre-formed) silicone implants with a hardness of 40 on the shore "00" scale. The SurgiSil™ Perma Facial Implants have a cylindrical shape with tapered ends. The implants will be provided in various sizes, with diameters of 2-6 mm and lengths of 50-75 mm. The Perma Facial Implants are individually packaged and sterilized by gamma irradiation and are labeled for single use. The Perma Facial Implants are designed with tapered ends to reduce visibility of the implant ends following implantation. The smooth surface of the implant prevents tissue ingrowth permitting easy removal and/or exchange of the implant. The Perma Facial Implants are ideal for use in soft tissue augmentation anywhere in the face where, in the physician's experience, use of a soft silicone elastomer is appropriate.

AI/ML Overview

Here's an analysis of the provided text regarding the SurgiSil™ Perma Facial Implants, focusing on acceptance criteria and study details.

Based on the provided 510(k) summary, typical "acceptance criteria" and "study" details like those associated with performance testing for AI/software devices are not present. This document is a 510(k) summary for a physical implant, not a software device, and therefore the evaluation process is fundamentally different.

The 510(k) pathway focuses on demonstrating substantial equivalence to a predicate device, primarily through material composition, intended use, and technological characteristics, rather than establishing specific performance metrics for the device itself.

Here's a breakdown of the information that is available and why certain criteria typically asked for AI/software studies are not applicable:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Expected for AI/Software)	Reported Device Performance in Document	Rationale for Absence (for this type of device)
Performance Goals	Sensitivity, Specificity, Accuracy, FROC curves	Not Applicable	This is a physical implant, not a diagnostic or prognostic device that has "performance" in terms of measurement accuracy or diagnostic capability. Its "performance" is assessed through biocompatibility and material characteristics.
Safety Endpoints	Adverse event rates	Implied Safety based on Material and Predicate. The document states: "Testing was conducted that confirms that the Perma Facial Implants are biocompatible and safe for the intended use."	Specific rates or types of adverse events from a clinical study are not provided in this summary, as is common for 510(k) submissions where safety is often inferred from predicate devices and material testing.
Device Functionality	Hardness, Shape, Sterilization	Hardness: 40 on the shore "00" scale. Shape: Cylindrical with tapered ends. Sterilization: Gamma irradiation.	These are descriptive specifications and are met by the manufacturing process. They aren't "acceptance criteria" in the sense of a test against a threshold, but rather descriptions of the product as designed.
Biocompatibility	ISO 10993 compliance (e.g., cytotoxicity, sensitization, irritation)	"Testing was conducted that confirms that the Perma Facial Implants are biocompatible and safe for the intended use."	While testing was done, the specific results against ISO 10993 standards (e.g., passed cytotoxicity, passed sensitization) are not detailed in this summary.
Interoperability	N/A (for physical implant)	Not Applicable	This is not a software device that interfaces with other systems.
Usability	N/A (for physical implant)	Not Applicable	Usability is generally assessed differently for implants (e.g., surgeon ease of placement) and not typically with quantitative metrics like those for AI software.

Study Details (As applicable to this type of device)

Given that this is a 510(k) for a physical implant, many of the requested study details (especially those related to AI/software performance) are not relevant or are not found in this type of submission.

Sample size used for the test set and the data provenance:
- Not explicitly stated in terms of a "test set" for performance. The document mentions "Testing was conducted that confirms that the Perma Facial Implants are biocompatible and safe for the intended use." This likely refers to material testing (e.g., mechanical properties, biocompatibility per ISO standards) rather than a clinical "test set" of patients.
- Data provenance: Not mentioned. It's likely laboratory testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the context of diagnostic accuracy is not relevant for this physical implant. Biocompatibility testing is assessed by laboratory analysis against standards, not expert consensus on an output.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication process is described as there isn't a diagnostic outcome being evaluated.
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:
- No. 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. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the AI/diagnostic sense. The "truth" for this device relates to material properties meeting specifications and biocompatibility standards.
The sample size for the training set:
- Not applicable. There is no "training set" for a physical implant.
How the ground truth for the training set was established:
- Not applicable. There is no "training set" for a physical implant.

Summary of the Device's "Proof" of Meeting "Acceptance Criteria" (Substantial Equivalence):

The "study" presented in this 510(k) summary is primarily a demonstration of substantial equivalence to legally marketed predicate devices, not a performance study in the way one would analyze an AI or imaging device.

The key arguments for meeting acceptance criteria (which, in this context, are the requirements for 510(k) clearance based on substantial equivalence) are:

Identical Intended Use: The Perma Facial Implants are intended for use in plastic and reconstructive surgery for cosmetic augmentation and corrections in the face, which is stated to be similar to the predicate devices.
Similar Material Composition: Both the proposed device and the predicate devices are manufactured from medical grade silicone elastomer.
Technological Characteristics: While there are design differences (sizes and shapes), the core technology (silicone implant for facial augmentation) is considered similar.
Biocompatibility Testing: The document states that "Testing was conducted that confirms that the Perma Facial Implants are biocompatible and safe for the intended use." While details aren't provided, this implies that the device passed relevant biocompatibility tests (e.g., ISO 10993 series) typical for implantable materials.
Sterilization Method: Gamma irradiation, a common and accepted method.

In essence, the "study" that proves the device meets the "acceptance criteria" (of substantial equivalence) is the comparison to established predicate devices combined with implicit or explicitly mentioned (but not detailed) biocompatibility and material testing. The FDA's clearance (K071823) confirms that the agency agreed with this assessment of substantial equivalence.

Summary

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510(k) Summary for the SurgiSiI™ Perma Facial Implants

SEP 1 9 2007

SUBMITTER/510(K) HOLDER 1.

SurgiSil™ 3801 West 15th Street Suite 150 Plano, TX 75075

Contact Person: Peter Raphael, M.D. 972-543-2477 Telephone:

September 10, 2007 Date Prepared:

2. DEVICE NAME

Proprietary Name: Perma Facial Implants Common/Usual Name: Silicone block Classification Name: Ear, nose, and throat synthetic polymer material

3. PREDICATE DEVICES

Spectrum Designs Pre-Form Contour Silicone Carving Block, Spectrum Designs . (K982688)
. AART Silicone Carving Block, Aesthetic and Reconstructive Technologies, Inc. (K021820)
Seare Biomedical Silicone Sheeting, Seare Biomedical Corporation (K983041)
AART Silicone Sheeting, Aesthetic and Reconstructive Technologies, Inc. . (K022223)

4. DEVICE DESCRIPTION

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The Perma Facial Implants are individually packaged and sterilized by gamma irradiation and are labeled for single use.

The Perma Facial Implants are designed with tapered ends to reduce visibility of the implant ends following implantation. The smooth surface of the implant prevents tissue ingrowth permitting easy removal and/or exchange of the implant. The Perma Facial Implants are ideal for use in soft tissue augmentation anywhere in the face where, in the physician's experience, use of a soft silicone elastomer is appropriate.

ട്. INTENDED USE

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The proposed Perma Facial Implants and the predicate devices are manufactured from medical grade silicone elastomer and are indicated for implantation in the facial region for various surgical applications. Differences between the proposed Perma Facial Implants and the predicate silicone implants are limited to design differences, including the range of sizes and shapes available. Testing was conducted that confirms that the Perma Facial Implants are biocompatible and safe for the intended use.

The similarities in intended use and material composition between the proposed Perma Facial Implants and the predicate Spectrum Designs Pre-Form Contour Silicone Carving Block, AART Silicone Carving Block, Seare Biomedical Silicone Sheeting, and AART Silicone Sheeting, leads to a conclusion of substantial equivalence between the proposed and predicate devices.

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Surgisil % Medical Device Consultants, Inc. Cynthia J.M. Nolte, Ph.D., RAC Senior Regulatory Consultant 49 Plain Street North Attleboro, Massachusetts 02760

SEP 1 9 2007

Re: K071823

Trade/Device Name: Perma Facial Implants Regulation Number: 21 CFR 878.3500 Regulation Name: Polytetrafluoroethylene with carbon fibers composite implant material Regulatory Class: II Product Code: ODU Dated: August 28, 2007 Received: August 29, 2007

Dear Dr. Nolte:

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 - Cynthia J.M. Nolte, Ph.D., RAC

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark A. Mulhern

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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Indications for Use

510(k) Number: K071823

Device Name: Perma Facial Implants

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millhurn

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

510(k) Number K071823

Regulation Number and Section

§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.

(a)
Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.(b)
Classification. Class II.