(28 days)
The CPX 14 Breast Tissue Expanders with Smooth Surface 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™4 Tissue Expanders with Smooth Surface consist of a silicone elastomer shell, with superior and anterior reinforcement that allows 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 CPX™4 Tissue Expanders with Smooth Surface incorporate suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability. The CPX™4 Tissue Expanders with Smooth Surface are provided sterile. The devices are provided in three styles (Low, Medium and Tall) and in various sizes. The following accessories are packaged with the CPX™4 Tissue Expanders with Smooth Surface: Centerscope Magnetic Injection Port Finder, Winged Infusion Set.
This document is a 510(k) Premarket Notification for a medical device (breast tissue expander). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that an AI device meets specific acceptance criteria. Therefore, most of the requested information regarding AI device performance, sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment will not be found in this document.
However, I can extract information related to the device's
mechanical testing performance and the acceptance criteria for those tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Parameter) | Reported Device Performance (Result/Outcome) |
|---|---|
| Joint Strength (adherence of components to smooth shell) | Met pre-determined acceptance criteria. |
| Overexpansion | Met pre-determined acceptance criteria. |
Note: The specific quantitative acceptance criteria values (e.g., specific force in N, volume thresholds) are not provided in this summary, only that they were "pre-determined" and met.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "mechanical testing was conducted on the modified device." It does not specify the number of devices or test repetitions.
- Data Provenance: Not applicable in the context of clinical data for AI. This is a report on mechanical bench testing for a physical device.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
- Not applicable. This relates to mechanical bench testing, not image analysis or clinical diagnosis where expert ground truth would be established. The "ground truth" here is the physical measurement of mechanical properties.
4. Adjudication Method for the Test Set
- Not applicable. This relates to mechanical bench testing. Adjudication methods are typically used for subjective human assessments, e.g., in clinical trials or image labeling.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- No. This document is not about an AI device. It's about a physical medical implant (a breast tissue expander).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done
- No. This is not an AI device.
7. The Type of Ground Truth Used
- Engineering/Physical Measurements: The "ground truth" for this device's performance is derived from standardized mechanical testing (specifically, ASTM F1441-03 for soft-tissue expanders) and risk analysis procedures. The results are objective measurements of physical properties (joint strength, overexpansion).
8. The Sample Size for the Training Set
- Not applicable. This is not an AI device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no training set as it's not an AI device.
Summary of what the document addresses regarding the device:
The document focuses on demonstrating that the modifications to the CPX™4 Breast Tissue Expander (specifically, a smooth surface instead of textured and increased suture tabs) do not negatively impact its safety and effectiveness compared to the predicate device. This is primarily done through:
- Comparison of Technological Characteristics: Stating that the fundamental technology, principles of operation, intended use, and indications for use remain the same.
- Mechanical Testing: Bench testing was performed to evaluate parameters related to "joint strength and overexpansion" according to ASTM F1441-03. The key finding is that "All mechanical performance testing results met their pre-determined acceptance criteria."
- Biocompatibility Assessment: Confirming that all patient-contact materials are identical to the predicate device, thus new biocompatibility testing was not warranted.
The "acceptance criteria" are implied to be the thresholds or standards outlined in the ASTM F1441-03 standard and Mentor's internal design control procedures for mechanical performance, which the modified device successfully met.
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