MEDPOR Customized Surgical Implants. are prescription devices tailored to a patient's same hiocompatible nure nown his his mized Surgical Implants are made from the same biocompatible pure porous high-density polyethylene (pHDPE) material as all MEDPOR Surgical Implants. An advantage of (pHDPE) is that the surrounding body tissue grows into the porous matrix, so the implant becomes integrated with and stabilized in the host tissues.

AI/ML Overview

This 510(k) premarket notification describes a medical device, the MEDPOR® Customized Surgical Implant, and seeks to demonstrate its substantial equivalence to a predicate device, the MEDPOR Surgical Implant Material; Preformed Cranial & Facial Implants.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic device, or specific strength/durability for an implant). Instead, the acceptance criteria in this context are primarily focused on demonstrating substantial equivalence to a predicate device. This is a common approach for 510(k) submissions.

The table presented in the document itself serves as the core of this comparison:

Characteristic	MEDPOR Surgical Implant (Predicate)	MEDPOR Customized Surgical Implant (New Device)	SE (Substantial Equivalence) Y/N
Intended Use	For augmentation or restoration of bony contour in craniofacial defects.	For augmentation or restoration of bony contour in craniofacial defects.	Y
Materials	A linear, high-density polyethylene biomaterial	A linear, high-density polyethylene biomaterial	Y
Manufacturing Process	Preformed Shapes	Patient Specific Preformed Shapes	Y
Size Ranges/Specifications	Refer to Product Catalog	Customized according to a signed prescription form	Y
Shapes	Refer to Product Catalog	Customized according to a signed prescription form	Y
Packaging	Double peel pouched and put in a Clamshell or shelf box	Double peel pouched and put in a Clamshell or shelf box	Y
Sterile/Non-Sterile	Sterile	Sterile	Y
Sterilization Method	EO Gas	EO Gas	Y
Non-Pyrogenic Claim	YES	NO	N
Shelf-Life	10 years	10 years	Y
Biocompatibility	Yes	Yes	Y
Prescription Device	Yes - Sale by or on the order of a physician	Yes - Sale by or on the order of a physician	Y
Labeling	MEDPOR Surgical Implants including TITAN!™ and BARRIER™ Implant Instructions For Use	MEDPOR CUSTOMIZED Surgical Implants	Y - Different only in that the labeling removes NON-PYROGENIC claim and has the statement "not tested for endotoxin".

Reported Device Performance:
The document doesn't report specific quantitative performance metrics for the customized implant that would be typically seen in a study evaluating a device's effectiveness or safety against numerical criteria. Instead, the performance is implicitly demonstrated by showing that the customized implant shares fundamental characteristics (material, intended use, sterilization, biocompatibility, etc.) with a legally marketed device known to be safe and effective. The key difference noted is the customization aspect (patient-specific shapes) and the associated absence of a "Non-Pyrogenic Claim" and a specific labeling change reflecting "not tested for endotoxin."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The provided documentation does not describe a clinical study or a test set in the traditional sense that would involve a sample size of patients or data for evaluation. The "study" here is a comparison of characteristics between the new device and the predicate device, not an empirical performance trial with a patient cohort. Therefore, concepts like sample size, country of origin, retrospective/prospective do not directly apply to this type of regulatory submission. The data provenance is primarily the design specifications and manufacturing information of the device itself and the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This regulatory submission (510(k)) does not involve the establishment of a "ground truth" by experts in the context of a clinical study or algorithm evaluation. The "ground truth" for demonstrating substantial equivalence is the predicate device's known characteristics and regulatory clearance. The experts involved are primarily the manufacturer's R&D, regulatory, and quality assurance teams who have compiled the technical specifications and performed the comparison, and subsequently, the FDA reviewers who evaluate the submission. Their qualifications are not detailed here, but they would be regulatory and scientific experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

As there is no clinical or performance test set described that requires expert review and adjudication, this information is not applicable to this document. The "adjudication" is the FDA's regulatory review process.

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

This is not applicable. The device is an implant for craniofacial defects, not a diagnostic imaging device involving human readers or AI assistance.

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

This is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As explained above, the "ground truth" in this context is the established characteristics and regulatory clearance of the predicate device. The manufacturer demonstrated that their new customized implant has substantially equivalent characteristics for safety and effectiveness.

8. The sample size for the training set

This is not applicable. The device is a physical implant, not an AI model that requires a training set.

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

This is not applicable as there is no training set for an AI model.

Summary

{0}------------------------------------------------

083621

Image /page/0/Picture/1 description: The image shows the logo for POREX Surgical Products Group. The word "POREX" is in large, bold, sans-serif font. Below the word "POREX" is the text "SURGICAL PRODUCTS GROUP" in a smaller, sans-serif font. The logo is black and white.

-3 2009

510(k) SUMMARY

Date of Summary: January 30, 2009

Manufacturer and Submitter:

Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265

Tel: (678) 479-1610 Fax: (678) 479-4495

Contact: Mrs. Jerri Mann E-mail: jerri.mann@porex.com

Trade Name: MEDPOR® Customized Surgical Implant

Class: II 21 CFR 874.3620 Ear, nose, and throat synthetic polymer material.

Product Code: JOF

Subsequent Product Code: GWO

Substantially equivalent to: MEDPOR Surgical Implant Material; Preformed Cranial &
Facial Implants, K022480 Facial Implants, K922489

Device Description:

Indications for Use:

The MEDPOR Customized Surgical Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for Porex Surgical Products Group. The word "POREX" is in large, bold, black letters. Below the word "POREX" is the text "SURGICAL PRODUCTS GROUP" in smaller, thinner letters. The logo is simple and professional.

Technological Characteristics:

MEDPOR Customized Surgical Implant shapes can be created from CT scan data, a physical model, drawing or other information provided by a physician. MEDPOR Customized Surgical Implant shapes have the same intended use, are manufactured from the same material, can be trimmed with a blace in the sterile field, will accept plates and screws and are packaged the same as other MEDPOR Preformed Cranial and Facial Implants. MEDPOR Customized Surgical Implants are sterilized with Ethylene Oxide.

Substantial Equivalence:

MEDPOR Customized Surgical Implans are substantially equivalent to the predicate device MEDPOR Surgical Implant Material; Preformed Cranial & Facial Implans. The comparison table below details the similarities between MEDPOR Customized Surgical Implants and the predicate device:

Characteristic	MEDPOR Surgical Implant	MEDPOR CustomizedSurgical Implant	SEY/N
Intended Use	For augmentation or restoration of bonycontour in craniofacial defects.	For augmentation or restoration of bonycontour in craniofacial defects.	Y
Materials	A linear, high-density polyethylenebiomaterial	A linear, high-density polyethylenebiomaterial	Y
Manufacturing Process	Preformed Shapes	Patient Specific Preformed Shapes	Y
Size Ranges/Specifications	Refer to Product Catalog	Customized according to a signedprescription form	Y
Shapes	Refer to Product Catalog	Customized according to a signedprescription form	Y
Packaging	Double peel pouched and put in aClamshell or shelf box	Double peel pouched and put in aClamshell or shelf box	Y
Sterile/Non-Sterile	Sterile	Sterile	Y
Sterilization Method	EO Gas	EO Gas	Y
Non-Pyrogenic Claim	YES	NO	N

{2}------------------------------------------------

Shelf-Life	10 years	10 years	Y
Biocompatibility	Yes	Yes	Y
Prescription Device	Yes - Sale by or on the order of a physician	Yes - Sale by or on the order of a physician	Y
Labeling	MEDPOR Surgical Implants including TITAN!™ and BARRIER™ Implant Instructions For Use	MEDPOR CUSTOMIZED Surgical Implants	Y - Different only in that the labeling removes NON-PYROGENIC claim and has the statement "not tested for endotoxin".

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

: 上一篇:

ﺎ ﻓﻲ

: 1

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Porex Surgical, Inc. c/o Jerri L. Mann Regulatory Compliance Manager 15 Dart Road Newman. GA 30265-1017

FEB - 3 2009

Re: K083621

Trade/Device Name: MEDPOR® Customized Surgical Implant Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: Class II Product Code: JOF, GWO Dated: December 3, 2008 Received: December 16, 2008

Dear Ms. Mann:

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. Iisting 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.

{4}------------------------------------------------

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

M.B. Epolins, mD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

K083621

Indications for Use

510(k) Number (if known):

Device Name: MEDPOR® Customized Surgical Implant

Indications for Use: The MEDPOR Customized Surgical Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

Page

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Amaloui

(Division Sign-Off) (Division Sign-Off)
Division of Ophthalmic and Ear,
Throat Throat Devices Division of Ophicial
Nose and Throat Devices

Nose and
510(k) Number k08362

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.