The Mentor™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander with fill volume to 1445cc can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.
The MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander is used for breast reconstruction following mastectomy and is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. The proposed device consists of a smooth surface shell made with successive cross-linked layers of silicone elastomer. Superior and anterior reinforcement allows for directional expansion in the lower pole of the device has an integral, silicone elastomer, magnetically detected, injection dome and incorporates a BUFFERZONE™ area with selfsealing technology (containing silicone gel) to the front patch of the device to minimize and/or prevent leakage in the event of an accidental needle puncture. The CPX™4 PLUS Enhance Breast Tissue Expander Injection Dome houses a rare-earth, permanent magnet, This internal magnet, when in conjunction with the CENTERSCOPE™ Magnetic Injection Port Locator accessory, helps the injector accurately identify the injection dome during patient tissue expander fill procedures.
Identification of the injection dome site can be accomplished by use of the CENTERSCOPE™ Magnetic Injection Port Locator provided with the Tissue Expander. Instructions for use of the CENTERSCOPE™ Magnetic Injection Port Locator are provided within this document. Injections must be made using sterile, pyrogen-free Sodium Chloride U.S.P. Solution and into the injection dome area. If injections are made on or outside the injection dome, leakage can occur.
The MENTOR™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander gives surgeons the option to attach the device to surrounding tissue to enhance device stability. Surgeons can suture on any part of the tab surface or the suturing hole can be used for added convenience.
The MENTOR™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander, Catalogue Number SCPX-15TH-E, provides fill volume options from 930 cc to 1445 cc.
The following accessories are packaged with the CPX™4 PLUS Enhance Breast Tissue Expander:
- Centerscope Magnetic Injection Port Finder .
- Winged Infusion Set .
The provided text describes the 510(k) premarket notification for the MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's clinical performance. As such, information regarding acceptance criteria for AI/algorithm performance, sample sizes for test and training sets, expert qualifications, or multi-reader multi-case studies is not applicable to this document.
The document primarily outlines the device's technical specifications, indications for use, and a comparison to predicate devices, supported by biocompatibility and mechanical testing.
Here's a breakdown of the information that is available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/Algorithm Related)
The document mentions acceptance criteria related to mechanical testing, but the specific numerical criteria are not detailed. It only states that the results met the pre-determined acceptance criteria.
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Biocompatibility | All materials are identical to the predicate device, which are implant, tissue contacting, permanent (> 30 days). No new testing warranted. | The materials themselves are considered acceptable based on prior predicate device clearance. |
| Mechanical Testing | All mechanical performance testing results met their pre-determined acceptance criteria. | Testing evaluated parameters related to overexpansion and bladder leak testing in accordance with ASTM F1441-03. Specific numerical acceptance criteria are not provided. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is not a study involving a "test set" of data in the context of an AI/algorithm. The device underwent physical and material testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This is not a study involving expert-established ground truth for an AI/algorithm.
4. Adjudication Method
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size
No, an MRMC comparative effectiveness study was not done. This device is a breast tissue expander, not an AI/algorithm.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
Not applicable.
8. The Sample Size for the Training Set
Not applicable.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria (Based on the Provided Text):
The device (MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander) demonstrates that it meets acceptance criteria through:
- Biocompatibility Testing: The device utilizes materials identical to a previously cleared predicate device for permanent tissue contact. This indicates that the materials have already met biocompatibility standards and no new testing was required.
- Mechanical Testing: Specific mechanical tests were conducted in accordance with ASTM F1441-03, "Standard Specification for Soft-Tissue Expanders." These tests evaluated parameters such as overexpansion and bladder leak. The document states that all results met pre-determined acceptance criteria, thus demonstrating substantial equivalence to the predicate device. The changes specifically addressed in this testing were the change to a smooth surface and the addition of three suture tabs, which impacted the connection of external components (Base and Injection Dome) to the shell surface.
The "study" described is primarily a series of engineering and materials tests demonstrating that the modified physical device (with a smooth surface and additional suture tabs) maintains the same safety and performance characteristics as its predicate devices, especially regarding its physical integrity and material compatibility.
N/A