GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X by IMPLANTECH ASSOCIATES INC.

The Gluteal Implants (Silicone Carving Blocks) are for augmentation and reconstructive surgery. The Implantech Gluteal Implants are carvable to allow the surgeon to shape the device should additional shaping be desired.

Device Description

Gluteal Implants (Silicone Carving Blocks)

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding a Gluteal Implant. This type of document, particularly one from 2005, is highly unlikely to contain the detailed study information, acceptance criteria, or performance metrics typically requested for AI/ML-based medical devices.

The information provided is primarily an FDA clearance letter for a physical medical device (gluteal implant made of silicone) and not an AI or software-as-a-medical-device (SaMD). Therefore, most of the requested fields are not applicable.

Here's a breakdown based on the provided text, highlighting what is not applicable (N/A):

Information Requested	Response
1. Table of Acceptance Criteria and Reported Performance	N/A. This document does not contain acceptance criteria for an AI/ML system or reported device performance metrics in that context. It's a clearance letter for a physical implant based on substantial equivalence.
2. Sample size and data provenance for test set	N/A. This is a physical gluteal implant, not an AI/ML device tested with data. The 510(k) clearance is based on substantial equivalence to a predicate device, not on clinical study performance data for an AI algorithm.
3. Number of experts and qualifications for ground truth	N/A. Ground truth establishment by experts is not relevant for a physical implant submission unless it involved an assessment of images for which the implant was used, which is not the case here. The ground truth for device safety and effectiveness is largely based on material properties, design, and clinical use of predicate devices for substantial equivalence.
4. Adjudication method for test set	N/A. Not applicable for a physical implant.
5. MRMC comparative effectiveness study	N/A. This applies to diagnostic devices or those involving human interpretation, not a physical implant.
6. Standalone (algorithm only) performance study	N/A. This is not an algorithm.
7. Type of ground truth used	N/A. While the safety and effectiveness of the implant would be supported by general medical knowledge, material science, and clinical experience with similar implants, the concept of "ground truth" as used in AI/ML performance evaluation does not apply directly.
8. Sample size for the training set	N/A. Not an AI/ML device with a training set.
9. How ground truth for the training set was established	N/A. Not an AI/ML device with training data.

Summary of the Document's Actual Content:

The document is an FDA 510(k) clearance letter dated November 4, 2005, for a device named "Gluteal Implant" (Trade/Device Name) under the product code MIB (Ear, nose, and throat synthetic polymer material, although the device is for gluteal augmentation, the regulation number 21 CFR 874.3620 typically covers synthetic polymer materials used in ENT, implying a material-based classification rather than anatomical region).

Indications for Use: The Gluteal Implants (Silicone Carving Blocks) are for augmentation and reconstructive surgery. They are carvable to allow the surgeon to shape the device.
Regulatory Status: The device was found substantially equivalent to legally marketed predicate devices, allowing it to proceed to market under general controls.
Applicant: Implantech Associates, Inc., submitted the 510(k) (K052504).
Classification: Class II device.

The information you are seeking about acceptance criteria for an AI/ML device is not present in this physical device clearance letter.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle with three lines representing its wings or feathers. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 4 2005

Stephen Meade Implantech Associates, Inc. 6025 Nicolle Street, Suite B Ventura, California 93003

Re: K052504

Trade/Device Name: Gluteal Implant Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: II Product Code: MIB Dated: September 9, 2005 Received: September 15, 2005

Dear Mr. Mcade:

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 agencics. 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 - Stephen Meade

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher with anow you to other maing of substantial equivalence of your device to a legally premaired 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 If you desire specific advice 10. Jour 2010) 276-0120. Also, please note the regulation entitled, Connact the Office of Commarket notification" (21CFR Part 807.97). You may obtain Missuranding Uy reference to prementonibilities under the Act from the Division of Small other general miormational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers; International and obress http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buehrn
fo

Mark N. Melkerson Acting 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 (if known):

K052504

Device Name:

Gluteal Implant

Indications For Use:

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

barbare Buehup
(Division Sign Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K052504

Page 1 of

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.