(26 days)
The Mentor Resterilizable MemoryShape™ Gel Sizer is indicated for temporary insertion intra-operatively to evaluate the size and shape of the MemoryShape™ breast implant to be implanted.
The Mentor Resterilizable MemoryShape™ Gel Breast Implant Sizer (Gel Sizer) is designed for temporary intraoperative 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 non-sterile to be sterilized prior to initial use and 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.
This document describes the validation of the Mentor MemoryShape™ Resterilizable Gel Sizer, which is a device used to evaluate the appropriate size and shape of breast implants during surgery. The validation process focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Elongation | Not explicitly stated, implied to meet pre-determined criteria | All non-clinical performance testing results met their pre-determined acceptance criteria. |
| Tension Set | Not explicitly stated, implied to meet pre-determined criteria | All non-clinical performance testing results met their pre-determined acceptance criteria. |
| Break Force | Not explicitly stated, implied to meet pre-determined criteria | All non-clinical performance testing results met their pre-determined acceptance criteria. |
| Patch to Shell Joint Testing | Not explicitly stated, implied to meet pre-determined criteria | All non-clinical performance testing results met their pre-determined acceptance criteria. |
| Gel Cohesion | Not explicitly stated, implied to meet pre-determined criteria | All non-clinical performance testing results met their pre-determined acceptance criteria. |
| Gel Penetration | Not explicitly stated, implied to meet pre-determined criteria | All non-clinical performance testing results met their pre-determined acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical data for human or image-based evaluation. The performance data is derived from non-clinical performance testing (physical and material properties). Therefore, the concept of sample size for human users or geographical data provenance is not applicable here.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The ground truth for this device's performance is established through physical and material property testing, not expert human evaluation of clinical outcomes or images.
4. Adjudication Method for the Test Set
Not applicable. There is no human-based "test set" or adjudication process described. The performance is determined by meeting pre-determined engineering and material science criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes the testing of a physical medical device (an implant sizer), not a diagnostic or AI-driven system that would involve human readers or comparative effectiveness studies with AI assistance.
6. Standalone (Algorithm Only) Performance Study
No. This document describes the testing of a physical medical device. The concept of an "algorithm only" or a "standalone" performance for human-in-the-loop systems is not relevant.
7. Type of Ground Truth Used
The ground truth used for this study is based on pre-determined engineering and material science specifications and standards. These specifications define the acceptable physical and chemical properties of the device components.
8. Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is not an AI/machine learning device. The testing described is for the physical attributes of the product.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, the ground truth establishment for such a set is not relevant. The "ground truth" for the device's performance is founded on established engineering best practices and material science principles.
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