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The CPX(TM) Control 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.

The CPX™ Control Breast 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 CPX™ Control Breast Tissue Expander incorporates suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability. The CPX Control devices are provided sterile in various styles and sizes. The following accessories are packaged with the CPX Control Tissue Expander: Centerscope Magnetic Injection Port Finder, Winged Infusion Set.

This document describes a 510(k) premarket notification for the Mentor CPX™ Control Breast Tissue Expanders, submitted to the FDA. The purpose of the submission is to demonstrate substantial equivalence to a predicate device.

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: Not explicitly stated for each individual test. The document generally refers to "mechanical testing" being conducted.
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing was performed in support of the 510(k) submission, implying it's new data generated for the current device rather than retrospective.

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

• This information is not applicable to this submission. The "ground truth" here refers to the performance criteria established by recognized standards (ISO, ASTM) and FDA guidance for medical device testing, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set:

• This information is not applicable. Adjudication methods are typically used in clinical studies or studies involving expert review of subjective data, not for objective mechanical and biocompatibility testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not conducted. This type of study is for evaluating diagnostic performance (e.g., of an AI algorithm) with human readers, which is not relevant for the mechanical and biocompatibility evaluation of a breast tissue expander.

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

• No, a standalone algorithm performance study was not conducted. This device is a physical medical device, not a software algorithm.

7. The type of ground truth used:

• For biocompatibility: Adherence to recognized standards (ISO 10993-1) and the established biocompatibility of identical materials from the predicate device.
• For mechanical testing: Adherence to recognized standards (ASTM F1441-03) and FDA guidance (Draft Guidance for Industry and Staff -Class II Special Controls Guidance for Tissue Expanders), which define the expected performance characteristics. The "ground truth" is that the device must perform within the specified parameters of these standards.

8. The sample size for the training set:

• This information is not applicable. The device is a physical medical device, not a machine learning model, so there is no "training set."

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

• This information is not applicable for the same reason as point 8.

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