(89 days)
The MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryShape™ breast implant to be implanted.
The MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryGel™ breast implant to be implanted.
The MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer is indicated for single use only for temporary insertion intraoperatively to evaluate the shape and size of the MemoryGel™ Enhance Breast Implant to be implanted.
The MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer STERILE (Gel Sizer) is designed for temporary intra-operative placement in the surgically prepared breast pocket. The Gel Sizer is used to evaluate the appropriate breast implant size and shape for each patient prior to implantation of a MemoryShape™ (contour shape) breast implant. The Gel Sizer is provided sterile and can be used out of the box for the initial use. The Gel Sizer is then resterilized 9 additional times for a total of 10 uses. The MemoryShape™ sizers are offered in various sizes to match the corresponding MemoryShape™ breast implants. These gel sizers contain raised orientation marks on the anterior and posterior of the device to help the physician with placement.
The MENTOR™ Resterilizable Gel Breast Implant Sizer) is a silicone elastomer device, filled with silicone gel, that is designed for temporative placement in the surgically prepared breast pocket. The Sizer is used to evaluate the appropriate MemoryGel™ breast implant size and shape for each patient prior to implantation of a breast implant. It is provided non-sterile and must be sterilized prior to use. The Sizer should not be sterilized more than ten times.
The MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer (Sizer) is a silicone elastomer device, filled with silicone gel, that is designed for temporary intra operative placement in the surgically prepared breast pocket. The Sizer is used to evaluate the appropriate MemoryGel™ Breast lmplant size and shape for each patient prior to implantation of a breast implant. It is provided sterile and is for single use only. The Sizer should not be resterilized.
The provided text is a 510(k) summary for the MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer, MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer, and MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer. The primary change described is a material change for the Dip Coat component from Krayden / Dow DC 92-009 to NuSil MED6-6605.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides two tables outlining acceptance criteria and results for:
- Dip Coat Process PQ Testing (Table 4): This assesses the manufacturing process of applying the new dip coat material.
- Sizers Reprocessing Product Lifetime Testing (Table 5): This evaluates the durability and integrity of the new dip coat material over the expected device lifetime.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance | Pass/Fail |
|---|---|---|---|
| Dip Coat Process PQ Testing (Table 4) | |||
| In Process Visual Inspection | Yield ≥ Product Target Yield | "In Process Visual inspection on each of the lots showed a Yield above the Product Target Yield." | PASS |
| Visual Inspection after 2X Sterilization Process | C=0 / 100% Pass | "Visual inspection after 2X Sterilization Process showed 100% acceptable Dip Coat." | PASS |
| Sizers Reprocessing Product Lifetime Testing (Table 5) | |||
| Visual examination (Dip coat integrity) | The dip coat on each device shall maintain full integrity and adherence of the dipcoat to the substrate posterior side of the sizer. | "PASS" (Implied: The dip coat maintained full integrity and adherence.) | PASS |
| Visual examination (Leakage) | There shall be no evidence of leakage of gel or like fluid in and around the dip coat at the injection hole site. | "PASS" (Implied: No evidence of leakage of gel or like fluid.) | PASS |
| Visual examination (Cracking/Delamination) | Dip coat shall show no sign of cracking, delamination, or any leakage from fill hole. | "PASS" (Implied: Dip coat showed no sign of cracking, delamination, or any leakage from fill hole.) | PASS |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state a specific numerical sample size for the "Dip Coat Process PQ Testing" or the "Sizers Reprocessing Product Lifetime testing." For the PQ testing, it mentions "each of the lots" and "100% acceptable Dip Coat," suggesting all manufactured units in the tested lots were visually inspected. For the lifetime testing, it refers to "any of the test samples."
- Data Provenance: The studies were conducted by MENTOR™ as part of their performance qualification and product lifetime testing for their manufacturing process in MENTOR™ Texas. This is an internal, prospective study to validate a material change.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This submission concerns mechanical and material performance, not diagnostic accuracy requiring human expert interpretation for ground truth. Therefore, there were no human experts used to establish a ground truth as would be relevant for an AI/CADe device. The ground truth for performance was established by measurable engineering and material integrity criteria.
4. Adjudication Method for the Test Set:
Not applicable, as no human expert interpretation or adjudication was involved for establishing ground truth performance for this type of device and material change. The criteria were objective (e.g., visual inspection for yield, integrity, and absence of leakage/cracking).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No. This is not a comparative effectiveness study for human readers with and without AI assistance. The device is a breast implant sizer, and the studies focus on the physical performance and biocompatibility of a material change.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This submission is not for an algorithm or AI device. It is for a physical medical device (breast implant sizer).
7. The Type of Ground Truth Used:
The ground truth used for these performance studies is based on objective engineering and material integrity criteria. This includes:
- Visual inspection for manufacturing yield.
- Visual inspection for dip coat integrity (adherence, absence of cracking, delamination).
- Detection of leakage.
- Biocompatibility test results (cytotoxicity, sensitization, irritation, pyrogenicity, acute systemic toxicity) against established standards and historical data for similar materials.
8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI device that requires a training set. The studies are physical performance tests of a material.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for a training set.
N/A