The Artoura (TM) Breast 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 Mentor® Artoura™ Breat Tissue Expander consists of a silicone elastomer shell, with interior structural elements to allow for directional expansion in the lower pole of the device. The device has an integral, silicone elastomer, magnetically detectable injection port. The injection port also incorporates a BUFFERZONE® area with self-sealing technology which is attached to the inside of the anterior surface of the device. The BUFFERZONE®is intended to minimize and/or prevent leakage in the event of an accidental needle puncture.

Identification of the injection port site is accomplished by use of the CENTERSCOPE® Magnetic Injection Port Locator, which is provided with the Tissue Expander. When the Centerscope device is placed on top of the skin, the magnetic arm points to the center of the tissue expander's injection dome. 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.

The Mentor® Artoura™ Breast Tissue Expander incorporates suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability.

The Mentor® Artoura™ devices are provided sterile in various styles and sizes.

The following accessories are packaged with the Artoura™ Tissue Expander:
. Centerscope Magnetic Injection Port Finder
. Winged Infusion Set

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device (Mentor® Artoura™ Breast Tissue Expander) meets them, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain an independent clinical study to establish detailed efficacy or safety metrics in the same way a PMA (Premarket Approval) application would. Therefore, the "acceptance criteria" here are geared towards demonstrating equivalence and safety, not a detailed performance study with human subjects.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Biocompatibility	All materials used must be biocompatible for permanent, tissue-contacting implant.	"All materials used in the Artoura™ tissue expander are identical to the materials used in the predicate device [K142998, which would have demonstrated biocompatibility]." (Implies the criteria were met by material equivalence and previous successful testing of the predicate).
Mechanical Performance	Device must meet pre-determined acceptance criteria for: - Joint strength - Leak performance - Other performance characteristics	"All mechanical performance testing results met their pre-determined acceptance criteria, thus demonstrating that the proposed device is substantially equivalent to the predicate device." (Specific values for joint strength, leak performance, etc., are not provided in this summary but are stated to have passed).
Compliance with Standards	Testing performed in accordance with ASTM F1441-03, Standard Specification for Soft-Tissue Expanders.	Mechanical testing was conducted "in accordance with ASTM F1441-03."
Technological Characteristics	Maintenance of same scientific technology, principles of operation, Intended Use, and Indications for Use as the cleared predicate device (K142998).	"The proposed device has the same scientific technology, principles of operation, Intended Use, and Indications for Use as the cleared predicate device, CPX™ Control Breast Tissue Expander (K142998)." (The only changes relate to size/dimensions and brand name).
Substantial Equivalence	Demonstrate substantial equivalence to the predicate device, Mentor® CPX™ Control Breast Tissue Expander (K142998), despite minor modifications (size/dimensions).	"The Mentor® Artoura™ Breast Tissue Expander is substantially equivalent to the predicate device, Mentor®CPX™ Control Breast Tissue Expander (K142998). The Artoura® Breast Tissue Expander has the same indications for use, operating principle and technological characteristics as the predicate device. Performance evaluations demonstrate that the subject device is substantially equivalent to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes non-clinical (bench) testing for mechanical performance and biocompatibility.

Sample Size for Test Set: Not explicitly stated as a number of devices in batches, but the testing was performed on the "modified device." This would typically involve a statistically appropriate number of devices to demonstrate reliability for batch release or design verification.
Data Provenance: The data is generated from internal laboratory testing conducted by Mentor Worldwide LLC, as part of their design control procedures and in support of their 510(k) submission. It's essentially prospective internal testing for regulatory submission purposes. No information is provided regarding the country of origin or whether it's retrospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this 510(k) submission for a breast tissue expander. The "ground truth" for mechanical testing is established by technical specifications, engineering standards (like ASTM F1441-03), and validated test methods, not by expert human interpretation like in diagnostic AI.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical studies, particularly in imaging or diagnostic AI, where ambiguous cases are resolved by multiple human experts. For mechanical and biocompatibility testing of a medical device, the results are typically quantitative measurements or qualitative observations against predefined criteria, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic devices or AI systems where human readers interpret patient data (e.g., images). The Artoura™ Breast Tissue Expander is a physical implant used for reconstruction, not a diagnostic tool requiring interpretation by multiple readers. The evaluation here is based on physical and material properties.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical implant, not an algorithm or an AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

For the mechanical and biocompatibility testing, the "ground truth" is established by:

Engineering Specifications and Design Requirements: The device must perform within predefined limits for parameters like joint strength and leak performance.
Established Industry Standards: Specifically, ASTM F1441-03 ("Standard Specification for Soft-Tissue Expanders") serves as a benchmark for acceptable performance.
Material Equivalence: For biocompatibility, the ground truth relies on the previously established biocompatibility of identical materials used in the predicate device.

8. The Sample Size for the Training Set

Not applicable. "Training set" refers to data used to train machine learning models. This device is not an AI/ML product; it's a physical medical device. Therefore, there is no training set in this context. The "design" and "development" of the device are based on engineering principles and material science, not data training.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for this physical device, the concept of establishing ground truth for it does not apply.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 24, 2015

Mentor Worldwide LLC Manchi Cheung Regulatory Manager 201 Mentor Drive Santa Barbara, California 93111

Re: K150777

Trade/Device Name: Artoura™ Breast Tissue Expanders Regulatory Class: Unclassified Product Code: LCJ Dated: March 25, 2015 Received: March 26, 2015

Dear Cheung:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150777

Device Name Artoura (TM) Breast Tissue Expanders

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) SUMMARY

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Mentor® ArtouraTM Breast Tissue Expanders is provided below.

I. SUBMITTER

Mentor Worldwide LLC 201 Mentor Drive Santa Barbara, CA 93111

Contact Person: Manchi Cheung Regulatory Manager Phone: 805 -879-6790 Fax: 805-879-6167 mcheung3@its.jnj.com

Date Prepared: March 24, 2015

II. DEVICE

510 (k) Number:	K150777
Name of Device:	Mentor Artoura® Breast Tissue Expanders
Common Device Name:	Expander, Skin, Inflatable
ClassificationRegulation:	Unclassified, Pre-Amendment
Panel:	General & Plastic Surgery
Product Code:	LCJ

III. PREDICATE DEVICE

K142998, Mentor® CPX™ Control Breast Tissue Expanders This predicate has not been subjected to a design-related recall.

IV. DEVICE DESCRIPTION

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tissue expander's injection dome. 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.

The Mentor® Artoura™ Breast Tissue Expander incorporates suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability.

The Mentor® Artoura™ devices are provided sterile in various styles and sizes.

The following accessories are packaged with the Artoura™ Tissue Expander:

. Centerscope Magnetic Injection Port Finder
. Winged Infusion Set

V. INDICATIONS FOR USE

The Mentor® Artoura™ Breast Tissue Expander 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.

COMPARISON OF TECHOLOGICAL CHARACTERISTICS WITH PREDICATE VI.

The technological principle for both the proposed and predicate devices is the same. Both devices' expansion are based on incremental filling of a silicone shell with saline fluid to stretch the surrounding tissue. Filling is achieved via an integral injection dome with needle guard, and a magnetic injection finder to locate the dome. The proposed device has the same scientific technology, principles of operation, Intended Use, and Indications for Use as the cleared predicate device, CPX™ Control Breast Tissue Expander (K142998)

This 510 (k) pre-market notification describe changes to the predicate's device size and dimensions. All other components, device features and specifications remain unchanged. In addition, the brand name of the device is being updated to Artoura™ Breast Tissue Expander.

VII. PERFORMANCE DATA

Biocompatibility Testing:

The Mentor® Artoura™ Breast Tissue Expander is an implantable device, the contact category according to ISO10993-1 is: Implant, tissue contacting, permanent (> 30 days). All materials used in the Artoura™ tissue expander are identical to the materials used in the predicate device.

Mechanical Testing:

Mechanical testing was conducted on the modified device 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 performed evaluated parameters related to joint strength, leak performance and other performance characteristics

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in accordance with ASTM F1441-03, Standard Specification for Soft-Tissue Expanders.

All mechanical performance testing results met their pre-determined acceptance criteria, thus demonstrating that the proposed device is substantially equivalent to the predicate device.

VIII. CONCLUSION

The Mentor® Artoura™ Breast Tissue Expander is substantially equivalent to the predicate device, Mentor®CPX™ Control Breast Tissue Expander (K142998). The Artoura® Breast Tissue Expander has the same indications for use, operating principle and technological characteristics as the predicate device. Performance evaluations demonstrate that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

N/A