(243 days)
The Sientra OPUS® Silicone Gel Breast Implant Sizer is a single-use, sterile, intraoperative device indicated for temporary placement during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size of the long-term Sientra OPUS® Breast Implant to be implanted.
The Sientra OPUS® Silicone Gel Breast Implant Sizer is a single-use, sterile, intraoperative device indicated for temporary placement during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size Sientra Breast Implant to be implanted. The Sientra Gel Sizers are designed to complement the portfolio of Sientra OPUS® Silicone Gel Breast Implants ("Breast Implants" or "Implants"), and are therefore available in the same range of styles, dimensions and fill volume as Sientra Implants. The Sientra OPUS® Silicone Gel Breast Implant Sizers are constructed with a smoothsurfaced, silicone elastomer shell and a filler made of clear, high-strength silicone gel. Sientra's Gel Sizers have been demonstrated to be biocompatible. The printing on the exterior of the Gel Sizer shell is clearly marked, "SIZER", "SINGLE USE ONLY", and "DO NOT IMPLANT", to clearly differentiate the Gel Sizers from Sientra's OPUS Breast Implants. Each Sientra Gel Sizer is dry-heat-sterilized, for single patient use only, and is not intended for long-term implantation or re-sterilization.
This document describes the Sientra OPUS® Silicone Gel Breast Implant Sizer, a medical device, and its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Conducted | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Gel Cohesion | Not explicitly stated, but implied to demonstrate appropriate gel properties relative to the predicate device. | Met predetermined acceptance criteria. |
| Elongation | Not explicitly stated, but implied to demonstrate appropriate material flexibility and strength relative to the predicate device. | Met predetermined acceptance criteria. |
| Break Force | Not explicitly stated, but implied to demonstrate appropriate material strength and integrity relative to the predicate device. | Met predetermined acceptance criteria. |
| Tensile Set | Not explicitly stated, but implied to demonstrate appropriate material elasticity and recovery properties relative to the predicate device. | Met predetermined acceptance criteria. |
| Patch to Shell Joint Integrity | Not explicitly stated, but implied to demonstrate the secure attachment of any patches or markings to the sizer shell, ensuring no detachment during use. | Met predetermined acceptance criteria. |
| Implant Marking Verification and Rub Testing | Not explicitly stated, but implied to ensure that the markings "SIZER", "SINGLE USE ONLY", and "DO NOT IMPLANT" are clearly present, legible, and resistant to degradation (e.g., rubbing off) during handling and use. Intended to prevent misuse. | Met predetermined acceptance criteria for marking clarity and durability. |
| Biocompatibility | Demonstrated to be biocompatible. | Demonstrated to be biocompatible. |
| Sterility | Dry-heat-sterilized for single patient use. | Dry-heat-sterilized. |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state specific sample sizes for each bench test conducted. It generally refers to "performance testing" being conducted. The data provenance is from non-clinical bench testing. The country of origin of the data is not specified, but the submission is to the U.S. FDA, implying the data was generated to meet U.S. regulatory standards. The testing is retrospective in the sense that the device was developed and then tested, but it pertains to the device itself and not to patient data.
3. Number of Experts and Their Qualifications for Ground Truth
This information is not applicable as the evaluation of this device relies on non-clinical bench testing against engineering and material specifications, not on expert interpretation of clinical data. Therefore, there was no ground truth established by medical experts for the test set.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation of this device relies on non-clinical bench testing against predefined acceptance criteria, not on expert consensus or adjudication of clinical cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this device is a physical breast implant sizer, not an AI or imaging-based device that would benefit from such a study. The document explicitly states: "No clinical testing was performed to support this 510(k) submission."
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not applicable / not done as this is a physical medical device (a breast implant sizer), not an algorithm or software. The performance testing was of the physical properties and characteristics of the sizer itself.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is based on predefined engineering specifications, material properties, and regulatory standards for biocompatibility, sterility, and physical integrity that the device must meet to be considered safe and effective and substantially equivalent to its predicate.
8. Sample Size for the Training Set
This information is not applicable as this device is not an AI/machine learning model that requires a training set. The device is a physical product.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device.
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