(116 days)
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 text is a 510(k) clearance letter for the MENTOR™ PliaForm™ Breast Tissue Expander. It describes the device, its intended use, a comparison to a predicate device, and the performance data used to demonstrate substantial equivalence.
However, it does not contain any information about a study involving an AI/software device or human-in-the-loop performance. The "performance data" section exclusively details biocompatibility and mechanical testing of the physical breast tissue expander, along with MR/CT/RT qualification studies for the expander's physical properties when exposed to these imaging modalities.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria for an AI/software device or human reader performance, as this information is absent from the provided document.
The document discusses acceptance criteria and study results for the physical device's performance, which are summarized below, but these are not related to AI or human-in-the-loop studies.
Summary of Device Performance and Acceptance Criteria (for the physical device from the provided text):
1. Table of Acceptance Criteria and Reported Device Performance (for the physical device):
| Test Name | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | No change in biocompatibility safety profile compared to predicate. | "Results from testing and biocompatibility risk analysis concluded no change in the biocompatibility safety profile, compared to the predicate device." |
| Valve Functionality and Device Leakage (ASTM F1441-03 - Section 9.2.5) | Meet pre-determined acceptance criteria for this specific test. | "All mechanical performance testing results met their pre-determined acceptance criteria..." |
| Joint Bond Strength (Shell/Bufferzone, Shell/Patch, Shell/Insert) (ASTM F1441-03 - Section 9.2.8.2 / 9.2.8.1) | Meet pre-determined acceptance criteria for this specific test. | "All mechanical performance testing results met their pre-determined acceptance criteria..." |
| Tensile/Elongation Properties of Elastic Materials (Legs/Bufferzone Joint, Legs/Base Joint, Shell) (ASTM F1441-03 - Section 9.2.2.2 / 9.2.2.1) | Meet pre-determined acceptance criteria for this specific test. | "All mechanical performance testing results met their pre-determined acceptance criteria..." |
| Shell Tension Set (ASTM F1441-03 - Section 9.2.7) | Meet pre-determined acceptance criteria for this specific test. | "All mechanical performance testing results met their pre-determined acceptance criteria..." |
| Needle Stop Penetration (ASTM F1441-03 - Section 9.2.7) | Meet pre-determined acceptance criteria for this specific test. | "All mechanical performance testing results met their pre-determined acceptance criteria..." |
| Injection Site (Dome) Leakage (ASTM F1441-03 - Section 9.2.4) | Meet pre-determined acceptance criteria for this specific test. | "All mechanical performance testing results met their pre-determined acceptance criteria..." |
| Bufferzone Self-Sealing (TM000412) | Meet pre-determined acceptance criteria for this specific test. | "All mechanical performance testing results met their pre-determined acceptance criteria..." (specifically mentioned and passed for post-radiation exposure as well). |
| Needle Guard Detachment Force (101040589) | Meet pre-determined acceptance criteria for this specific test. | "All mechanical performance testing results met their pre-determined acceptance criteria..." |
| Suture Tab Tear (100899657) | Meet pre-determined acceptance criteria for this specific test. | "All mechanical performance testing results met their pre-determined acceptance criteria..." |
| MR Safety (Induced Force, Induced Torque, Induced Heating) | Device to be MR Conditional. | Tests performed and demonstrate MR safety. |
| Device Integrity Post MR, CT, and RT Exposure | Meet physical property testing per ASTM F1441-03 (overexpansion, injection port competence, shell break force, shell tensile set, joint testing, Bufferzone self-sealing, port locator functionality). | "Post radiation exposure, PliaForm™ expanders were shown to meet physical property testing per ASTM F1441-03 'Standard Specification for Soft-Tissue Expander Devices'..." |
| Radiation Dose Distribution (Homogeneity Index (HI), Conformity Index (CI), Quality of Coverage (QOC)) in Preclinical Phantom Model | Results for PliaForm™ within 5% of sham control (phantom without expander). | "Results for PliaForm™ were compared to results of the sham control (phantom without any expander) and were found to be within 5% of dosimetry values." |
2. Sample Size Used for the Test Set and Data Provenance:
- The document refers to "samples" used for various biocompatibility and mechanical tests, but does not specify the exact sample sizes for each test. It states, "All mechanical performance testing results met their pre-determined acceptance criteria."
- The data provenance is not explicitly stated in terms of country of origin, nor whether it was retrospective or prospective. It is implied to be laboratory testing of manufactured devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable as no human-in-the-loop or AI study is described. The ground truth for the physical device performance is established through standardized engineering and materials science testing methods (e.g., ASTM standards) and comparisons to established safe profiles for biocompatibility.
4. Adjudication Method:
- Not applicable as no human-in-the-loop or AI study is described.
5. MRMC Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done, as this is a physical medical device, not an AI or imaging diagnostic tool.
6. Standalone Performance (Algorithm Only):
- Not applicable as this is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
- For biocompatibility: Analytical characterization and comparison to established safe materials and predicate device.
- For mechanical testing: Engineering specifications, ASTM standards (e.g., ASTM F1441-03), and internal "pre-determined acceptance criteria."
- For MR/CT/RT qualification: Physical measurements (induced force, torque, heating), post-exposure device integrity checks against ASTM standards, and dosimetry measurements in a preclinical phantom model compared to sham controls.
8. Sample Size for the Training Set:
- Not applicable as this is a physical medical device, not an AI system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable as this is a physical medical device, not an AI system.
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.