(171 days)
The CPX4 (TM) Breast Tissue Expanders can be utilized for breast reconstruction after mastection 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 Mentor® CPX™4 Breast Tissue Expander consists of a silicone elastomer shell, with superior and anterior reinforcement 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 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™4 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® CPX™4 Breast Tissue Expander are provided sterile and deflated. The proposed Mentor® CPX™4 Breast Tissue Expander is provided in Tall Height Style with fill volume range from 850 cc to 1445 cc.
This document is a 510(k) premarket notification for the Mentor® CPX™4 Breast Tissue Expanders. It describes the device, its intended use, and substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993-1 requirements for implantable devices (> 30 days tissue contact). | All materials used in the modified CPX™4 tissue expander are identical to the materials used in the predicate device, which would have already met biocompatibility standards. |
| Mechanical Testing: Meet pre-determined acceptance criteria for overexpansion and bladder leak testing in accordance with ASTM F1441-03. | All mechanical performance testing results met their pre-determined acceptance criteria. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size for the mechanical testing or the data provenance (e.g., country of origin, retrospective or prospective). It refers to "testing was conducted on the modified device," implying internal testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a medical device submission, primarily focused on mechanical and biocompatibility performance, not diagnostic accuracy requiring expert panel review for ground truth.
4. Adjudication Method for the Test Set
Not applicable. The testing described is objective mechanical and material testing, not subjective assessment 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 device is a breast tissue expander, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable, as this is a medical device, not an algorithm.
7. The Type of Ground Truth Used
For biocompatibility, the ground truth is established by meeting the requirements of ISO 10993-1, which are international standards for biological evaluation of medical devices.
For mechanical testing, the ground truth is established by meeting the requirements of ASTM F1441-03, which is a standard specification for soft-tissue expanders. This involves objective measurements of physical properties like resistance to overexpansion and leak integrity.
8. The Sample Size for the Training Set
Not applicable. This document refers to the evaluation of a physical medical device. There is no "training set" in the context of an AI algorithm here.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of medical device evaluation.
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