(53 days)
The Mentor 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 Resterilizable Gel Breast Implant Sizer (Sizer) is a silicone elastomer device, filled with silicone gel, that is designed for temporary intraoperative 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.
This document describes the validation of the Mentor Resterilizable Gel Breast Implant Sizer.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Materials used in the Sizer must meet the requirements of ISO 10993 for biological safety. | "All materials passed the requirements of ISO 10993 for biocompatibility." |
| Physical Properties after Repeated Use: The Sizers must maintain their physical characteristics after ten cleanings, sterilizations, and insertions. This includes meeting design specifications. | "All physical characteristics passed the acceptance criteria as defined in the protocol. These results confirmed that the Sizer met the design specifications after ten cleanings, sterilizations and insertions." |
| Cleaning and Sterilization Effectiveness: The recommended cleaning and sterilization procedures must achieve a minimum sterility assurance level (SAL) of 10⁻⁶. | "The results of this qualification provide documented evidence that Mentor's cleaning and sterilization procedures as recommended in the labeling achieve a minimum sterility assurance level of 10⁻⁶." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set in the material biocompatibility or physical properties testing. It mentions "materials being used" and "the Sizers."
The data provenance is prospective, as these tests were conducted specifically for the device's clearance. The country of origin is USA, as the manufacturer is Mentor Corporation, located in Santa Barbara, CA and Irving, TX.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. The studies described are technical performance tests (biocompatibility, physical integrity, sterilization effectiveness) which typically rely on standardized laboratory testing protocols rather than expert medical interpretation of results for "ground truth."
4. Adjudication Method:
The document does not describe an adjudication method as it's not relevant for the types of technical performance tests conducted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not performed or described. The device is a physical breast implant sizer, not an AI or imaging diagnostic tool that would typically involve human reader performance comparisons.
6. Standalone Performance:
Standalone performance for the device was performed. The studies focused on the intrinsic properties and performance of the Sizer itself (biocompatibility, physical durability, sterilization effectiveness) without human interaction as part of the primary measurement.
7. Type of Ground Truth Used:
The ground truth used for these studies was based on:
- Standardized laboratory testing protocols and established thresholds: For biocompatibility (ISO 10993), physical properties (design specifications and defined acceptance criteria in a protocol), and sterilization effectiveness (achieving a minimum SAL of 10⁻⁶). This is a form of empirical measurement against defined standards.
8. Sample Size for the Training Set:
The concept of a "training set" is not applicable to this device validation. Training sets are typically used for machine learning algorithms. This device is a physical medical device, and its validation relies on engineering and biological safety testing, not AI model training.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for a physical device, this question is not applicable.
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