Search Results

The MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs 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 PliaForm™ Breast Tissue Expander w/ Suture Tabs is designed for breast reconstruction, designed for thinner components and a reduction of reinforcement features and minimized insertion profile. The integrated port design consists of a plastic needle guard and a smaller magnetic element to improve MR compatibility (MR Conditional). The next generation design control technology (DCT) facilitates predictable expansion and is shape-optimized to better match the entire implant portfolio. An improved Bufferzone features a new sheeting-based self-sealing technology that offers protection from inadvertent needle punctures across the entire coverage area, and a more flexible design, which improves the overall device flexibility. An internally fixated injection port reduces device bulkiness. The injection port will incorporate a new plastic needle guard with a silicone backing and smaller magnet with reduced magnetic field strength compared to the Artoura™ breast tissue expander devices. This feature reduction improves device compatibility with MR-CT imaging, and external beam radiation (such as photon beam).

Identification of the injection port site is accomplished by use of the CENTERSCOPE™ 2.0 Magnetic Injection Port Locator, which is provided with the Tissue Expander. When the Centerscope™ 2.0 device is placed on top of the skin, the magnetic arm points to the center of the tissue expander's injection port. Injections into the injection port area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution.

The MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs incorporates suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability.

The MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs are provided sterile in three styles (Low Height, Medium Height, and Tall Height) and various sizes.

The following accessories are packaged with the MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs:

• Centerscope™ 2.0 Magnetic Injection Port Finder
• Winged Infusion Set (21G)

The provided FDA 510(k) clearance letter is for a physical medical device, the MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs, and not for an AI/software as a medical device (SaMD).

Therefore, the requested information regarding AI/SaMD specific aspects like:

• A table of acceptance criteria and reported device performance for an AI model
• Sample sizes, data provenance, expert ground truth, adjudication methods for training and test sets of an AI model
• Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance for an AI model
• Type of ground truth and how it was established for training and test sets of an AI model

cannot be extracted from this document.

The document describes acceptance criteria and studies for a physical medical device, focusing on its mechanical properties, biocompatibility, and compatibility with imaging modalities (MR/CT/RT).

Here's the information that can be extracted, tailored to the context of a physical device:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs

This document describes the premarket notification for a physical medical device, the MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs. The acceptance criteria and supporting studies are focused on the device's physical and material performance, safety, and compatibility, rather than the performance of an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that all mechanical performance testing results met their pre-determined acceptance criteria. While specific numerical acceptance criteria (e.g., minimum bond strength in Newtons) are not explicitly detailed in the summary, the categories of tests and the conclusion that they were met serve as the reported performance against the criteria.

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

The document does not explicitly state the sample sizes for each mechanical, biocompatibility, or MR/CT/RT test. For a physical device, testing is typically done on a defined number of manufactured units to demonstrate design validation and manufacturing quality. The data provenance is derived from these laboratory tests, not from patient data, and is prospective based on manufacturing and testing protocols. No specific country of origin for test data is mentioned, as is common for laboratory-based performance testing of medical devices.

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

This question is not applicable in the context of this device. "Ground truth" for a physical device is established through engineering specifications, material science principles, and adherence to industry standards (e.g., ASTM F1441-03 for soft-tissue expanders). The "experts" involved would be engineers, material scientists, and quality assurance personnel responsible for designing, manufacturing, and testing the device against these objective criteria.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or AI evaluations to resolve discrepancies in human interpretations or expert annotations. For physical device testing, results are typically quantitative and objectively measured against pre-defined engineering thresholds. Deviations from these thresholds would be considered failures, not subject to subjective adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. MRMC studies are used to assess the diagnostic performance of human readers, often comparing performance with and without AI assistance. This document pertains to a physical implantable device, not a diagnostic AI system or an imaging modality.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance

Not applicable. This device is not an algorithm or AI system. Its "performance" is inherent to its physical properties and function when implanted.

7. The Type of Ground Truth Used

The "ground truth" for this physical device is defined by:

• Engineering Specifications: Design parameters, material properties, and functional requirements established during product development.
• Industry Standards: Compliance with recognized standards such as ASTM F1441-03 for soft-tissue expanders.
• Biocompatibility Standards: Adherence to ISO 10993 series for medical device biocompatibility.
  All test methods measure against these predefined, objective criteria.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI model requiring a training set. Its design and manufacturing processes are developed through engineering R&D, not machine learning.

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

Not applicable. As this is not an AI model, there is no "ground truth for a training set." The design and manufacturing are based on established engineering principles, material science, and regulatory requirements.

Ask a specific question about this device