(27 days)
The Mentor® ArtouralM Breast Tissue Expanders with Smooth Surface can be utilized for breast reconstruction after mastectony, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.
MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface consist of a silicone elastomer shell, with interior structural elements to allow for directional expansion in the lower pole of the device. The device has an integral, silicone elastomer, magnetically detectable injection port. The injection port also incorporates a BUFFERZONE® area with self-sealing technology which is attached to the inside of the anterior surface of the device. The BUFFERZONE® is intended to minimize and/or prevent leakage in the event of an accidental needle puncture. Identification of the injection port site is accomplished by use of the CENTERSCOPE® Magnetic Injection Port Locator, which is provided with the Tissue Expander. When the Centerscope device is placed on top of the skin, the magnetic arm points to the tissue expander's injection dome. Injections into the injection dome area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution. The MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface incorporate suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability. The MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface are provided sterile in two styles (High and Ultra High) and various sizes. The following accessories are packaged with the MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface: . Centerscope Magnetic Injection Port Finder . Winged Infusion Set
The provided text describes the 510(k) summary for the MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface. It details the device, its intended use, and a comparison to a predicate device, focusing on mechanical testing and biocompatibility.
Here's the information broken down as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Testing | Joint Strength | Not explicitly stated (implied "pre-determined acceptance criteria") | All mechanical performance testing results met their pre-determined acceptance criteria. |
| Overexpansion | Not explicitly stated (implied "pre-determined acceptance criteria") | All mechanical performance testing results met their pre-determined acceptance criteria. | |
| ASTM F1441-03 Compliance | Compliance with ASTM F1441-03 | Testing was performed in accordance with ASTM F1441-03, Standard Specification for Soft-Tissue Expanders. | |
| Biocompatibility | Material Safety | Materials are identical to the predicate device, which has established biocompatibility. | All patient contact materials are identical to the predicate device. No changes warranted new biocompatibility testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the mechanical testing (test set) in terms of number of devices tested. It mentions that testing was conducted on "the modified device."
- Sample Size: Not explicitly stated.
- Data Provenance: Not specified, but generally, such testing would be conducted in-house by the manufacturer (Mentor Worldwide LLC). The document does not indicate country of origin of data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study described is for a medical device (breast tissue expander) and involves mechanical and biocompatibility testing, not diagnostic performance where expert ground truth would be established.
4. Adjudication Method for the Test Set
This information is not applicable for mechanical and biocompatibility testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of results by multiple experts.
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
This information is not applicable. The device is a breast tissue expander, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
For mechanical testing, the "ground truth" is typically defined by pre-determined acceptance criteria based on established engineering standards (like ASTM F1441-03) and risk analysis. For biocompatibility, the "ground truth" is that the materials are safe for human implantation, established by prior testing and regulatory clearance of the predicate device's materials.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of mechanical and biocompatibility testing for a medical device like a breast tissue expander.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
N/A