The Contour Profile Tissue Expanders can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

Device Description

The CPX™4 Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.

In order to provide these tissue expanders with elasticity and integrity, the shells are made with successive cross-linked layers of silicone elastomer. Superior and anterior reinforcement allows for directional expansion in the lower pole of the devices have integral, silicone elastomer, magnetically detected, injection ports and incorporate a BUFFERZONE® area with self-sealing technology that is attached to the inside of the anterior surface of the device to minimize and/or prevent leakage in the event of an accidental needle puncture. The textured shell provides a disruptive surface for collagen interface.

Identification of the injection port site is accomplished by use of the CENTERSCOPE® Magnetic Injection Port Locator, which is provided with the Tissue Expander. Injections into the injection dome area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution.

Suture fixation tabs are incorporated into some models of the MENTOR® CPX™4 Tissue Expanders to give surgeons the option to attach the device to surrounding tissue for enhanced device stability. Surgeons can suture on any part of the tab surface or the suturing hole can be used for added convenience.

AI/ML Overview

This document is a 510(k) summary for the Mentor CPX™4 Tissue Expander, a physical medical device, not an AI/ML powered software product. Therefore, many of the requested categories in your prompt, which are typically relevant for AI/ML device studies, are not applicable.

Here's an attempt to extract and frame the information based on the provided document, addressing the prompt's specific points where possible, and indicating "N/A" where the information is not relevant or available for a physical device submission:

Acceptance Criteria and Device Performance for Mentor CPX™4 Tissue Expander

This 510(k) summary describes modifications to an existing physical medical device, the Mentor Contour Profile Tissue Expander. The "studies" conducted are non-clinical performance tests to demonstrate substantial equivalence to the predicate device, not clinical trials or AI/ML model performance evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from "demonstrates substantial equivalence")	Reported Device Performance
Primary Goal	Substantial Equivalence to predicate device	Achieved
Joint Strength	Meet pre-determined acceptance criteria for device integrity	Met acceptance criteria
Leak Performance	Meet pre-determined acceptance criteria for preventing leakage	Met acceptance criteria
Other Device Performance Parameters	Meet pre-determined acceptance criteria (e.g., pliability, dimensional accuracy, magnet function)	Met acceptance criteria

Explanation of Acceptance Criteria:
The document states, "All non-clinical performance testing results met their pre-determined acceptance criteria, thus demonstrating that the modified device performs as well as or better than the predicate device." The specific numerical or qualitative thresholds for these criteria are not detailed in this 510(k) summary. The overarching acceptance criterion for the submission is demonstrating "substantial equivalence" to the predicate device.

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

Sample Size: Not explicitly stated as "test set" in the context of an AI/ML model. For non-clinical performance testing of a physical device, this would typically refer to the number of units tested per parameter. This information is not detailed in the 510(k) summary.
Data Provenance: N/A for AI/ML data provenance. The testing was non-clinical performance testing conducted by the manufacturer, MENTOR Worldwide LLC.

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

N/A. This concept is not applicable to the non-clinical performance testing of a physical product where "ground truth" typically refers to physical measurements and adherence to engineering specifications, rather than expert interpretation of data.

4. Adjudication method for the test set

N/A. Adjudication methods (e.g., 2+1) are common in clinical studies or AI/ML ground truth establishment. For non-clinical performance testing, results are typically determined by adherence to pre-defined specification limits.

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

N/A. This is a physical medical device, not an AI/ML system, so MRMC studies involving human readers and AI assistance are not relevant.

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

N/A. This is a physical medical device, not an AI/ML algorithm.

7. The type of ground truth used

For physical device testing, "ground truth" refers to established engineering specifications, performance standards, and the physical properties of the device. The non-clinical testing was based on meeting pre-determined acceptance criteria for parameters like joint strength and leak performance, likely against internal specifications and potentially relevant industry standards.

8. The sample size for the training set

N/A. There is no AI/ML model or "training set" for this physical device.

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

N/A. There is no AI/ML model or "training set" for this physical device. The "ground truth" for physical device manufacturing and testing would be based on validated design specifications and quality control procedures.

Summary

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Mentor CPX™4 Tissue Expander

5.0 510(k) Summary

Image /page/0/Picture/5 description: The image shows the logo for MENTOR Worldwide LLC. The word "MENTOR" is written in large, bold, black letters. To the left of the word "MENTOR" is a symbol that looks like a compass rose. Below the word "MENTOR" are the words "WORLDWIDE LLC" in smaller, black letters.

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Mentor® CPX™4 Breast Tissue Expanders and Mentor® CPX™4 With Suture Tabs Breast Tissue Expanders device is provided below.

Device Common Name:	Expander, Skin, Inflatable
Device Proprietary Name:	Mentor® CPXTM4 Breast Tissue Expanders and Mentor®CPXTM4 with Suture Tabs Breast Tissue Expanders
Submitter:	MENTOR Worldwide LLC201 Mentor DriveSanta Barbara, CA 93111Phone: 908-218-2651
Contact:	Martin SprunckManager, Regulatory AffairsMENTOR Worldwide LLC201 Mentor DriveSanta Barbara, CA 93111Phone: 908-218-2651Fax: 908-218-2595msprunc9@its.jnj.com
Date Prepared:	March 21, 2013
Classification	Unclassified, Pre-Amendment
Regulation:	General & Plastic Surgery
Panel:	LCJ
Product Code:	K011500, Mentor Contour Profile Tissue Expander
Predicate Device:

Indication for Use:

Device Description:

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device to minimize and/or prevent leakage in the event of an accidental needle puncture. The textured shell provides a disruptive surface for collagen interface.

Technological Characteristics:

The proposed modifications to the already cleared Contour Profile Tissue Expander include minor configuration changes to make the device more pliable, minor dimensional changes, and a modified magnet component. No new technological characteristics were introduced as a result of the proposed modifications.

Performance Data:

Non-clinical performance testing was conducted in order to demonstrate substantial equivalence with the predicate device. This testing was performed as required by the risk analysis and in accordance with design control procedures. The testing that was performed evaluated parameters related to joint strength, leak performance and other device performance parameters.

All non-clinical performance testing results met their pre-determined acceptance criteria, thus demonstrating that the modified device performs as well as or better than the predicate device.

Substantial Equivalence:

This 510(k) describes minor changes to the design of the Mentor Contour Profile Tissue Expander. There have been no changes to the indications for use or the intended use. The changes do not raise different questions of safety or effectiveness and results of non-clinical performance evaluations demonstrate that the proposed device is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract, curved shapes that resemble human figures or flowing lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

April 11. 2013

MENTOR Worldwide LLC % Mr. Martin Sprunck Manager, Regulatory Affairs 201 Mentor Drive Santa Barbara, California 93111

Re: K130813

・

Trade/Device Name: Mentor® CPXTM4 Breast Tissue Expanders and Mentor®CPXTM4 with Suture Tabs Breast Tissue Expanders Regulatory Class: Unclassified Product Code: LCJ Dated: March 21, 2013 Received: March 25, 2013

· Dear Mr. Sprunck:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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Page 2 - Mr. Martin Sprunck

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours, FOR

Peter DERumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use Statement 4.0

K130813 510(k) Number (if known):

Device Name:

Mentor® CPXTM4 Breast Tissue Expanders and Mentor® CPX™4 with Suture Tabs Breast Tissue Expanders

Indications For Use:

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

Over-The-Counter Use (21 CFR 80l'Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krause

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130813

Regulation Number and Section

N/A