(30 days)
The MENTOR® MemoryShape™ Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intra-operatively to evaluate the size and shape of the MemoryShape™ 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 document describes a 510(k) premarket notification for the MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer STERILE. It compares this device to a predicate device (MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer, K131853) to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All non-clinical performance testing results met their pre-determined acceptance criteria, thus demonstrating that the modified device is substantially equivalent to the predicate device." However, the specific quantitative acceptance criteria for each test are not provided in this document. The document lists the types of tests performed:
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Elongation | (Not specified in document) | Met pre-determined criteria |
| Tension Set | (Not specified in document) | Met pre-determined criteria |
| Break Force | (Not specified in document) | Met pre-determined criteria |
| Patch to Shell Joint Testing | (Not specified in document) | Met pre-determined criteria |
| Gel Cohesion | (Not specified in document) | Met pre-determined criteria |
| Stability | (Not specified in document) | Data demonstrates no new safety/effectiveness questions |
| Sterilization | (Not specified in document) | Data demonstrates no new safety/effectiveness questions |
| Packaging | (Not specified in document) | Data demonstrates no new safety/effectiveness questions |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each non-clinical performance test. It only mentions that "non-clinical performance testing was conducted." The provenance of the data (country of origin, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
N/A. This is a medical device for surgical sizing, not an AI or diagnostic imaging device that typically requires expert-established ground truth for a test set. The "ground truth" here would be the physical and mechanical properties of the device meeting engineering specifications, verified by laboratory testing.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving expert interpretation, which is not applicable to the non-clinical performance testing described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A. This device is a physical surgical sizer, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance testing is based on engineering specifications and established material science properties. The tests (Elongation, Tension Set, Break Force, Patch to Shell Joint Testing, Gel Cohesion, Stability, Sterilization, and Packaging) are designed to confirm that the physical and mechanical characteristics of the device meet predetermined quality and safety standards.
8. The Sample Size for the Training Set
N/A. This is a physical medical device undergoing performance testing, not a machine learning model requiring a "training set."
9. How the Ground Truth for the Training Set was Established
N/A. As mentioned above, a training set is not applicable here.
N/A