(30 days)
The Artoura (TM) Breast Tissue Expanders can be utilized for breast reconstruction after mastectomy, 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.
The Mentor® Artoura™ Breat Tissue Expander consists 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 center of 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 Expander incorporates suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability.
The Mentor® Artoura™ devices are provided sterile in various styles and sizes.
The following accessories are packaged with the Artoura™ Tissue Expander:
. Centerscope Magnetic Injection Port Finder
. Winged Infusion Set
Here's a breakdown of the acceptance criteria and the study that proves the device (Mentor® Artoura™ Breast Tissue Expander) meets them, based on the provided text:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain an independent clinical study to establish detailed efficacy or safety metrics in the same way a PMA (Premarket Approval) application would. Therefore, the "acceptance criteria" here are geared towards demonstrating equivalence and safety, not a detailed performance study with human subjects.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | All materials used must be biocompatible for permanent, tissue-contacting implant. | "All materials used in the Artoura™ tissue expander are identical to the materials used in the predicate device [K142998, which would have demonstrated biocompatibility]." (Implies the criteria were met by material equivalence and previous successful testing of the predicate). |
| Mechanical Performance | Device must meet pre-determined acceptance criteria for: |
- Joint strength
- Leak performance
- Other performance characteristics | "All mechanical performance testing results met their pre-determined acceptance criteria, thus demonstrating that the proposed device is substantially equivalent to the predicate device." (Specific values for joint strength, leak performance, etc., are not provided in this summary but are stated to have passed). |
| Compliance with Standards | Testing performed in accordance with ASTM F1441-03, Standard Specification for Soft-Tissue Expanders. | Mechanical testing was conducted "in accordance with ASTM F1441-03." |
| Technological Characteristics | Maintenance of same scientific technology, principles of operation, Intended Use, and Indications for Use as the cleared predicate device (K142998). | "The proposed device has the same scientific technology, principles of operation, Intended Use, and Indications for Use as the cleared predicate device, CPX™ Control Breast Tissue Expander (K142998)." (The only changes relate to size/dimensions and brand name). |
| Substantial Equivalence | Demonstrate substantial equivalence to the predicate device, Mentor® CPX™ Control Breast Tissue Expander (K142998), despite minor modifications (size/dimensions). | "The Mentor® Artoura™ Breast Tissue Expander is substantially equivalent to the predicate device, Mentor®CPX™ Control Breast Tissue Expander (K142998). The Artoura® Breast Tissue Expander has the same indications for use, operating principle and technological characteristics as the predicate device. Performance evaluations demonstrate that the subject device is substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical (bench) testing for mechanical performance and biocompatibility.
- Sample Size for Test Set: Not explicitly stated as a number of devices in batches, but the testing was performed on the "modified device." This would typically involve a statistically appropriate number of devices to demonstrate reliability for batch release or design verification.
- Data Provenance: The data is generated from internal laboratory testing conducted by Mentor Worldwide LLC, as part of their design control procedures and in support of their 510(k) submission. It's essentially prospective internal testing for regulatory submission purposes. No information is provided regarding the country of origin or whether it's retrospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission for a breast tissue expander. The "ground truth" for mechanical testing is established by technical specifications, engineering standards (like ASTM F1441-03), and validated test methods, not by expert human interpretation like in diagnostic AI.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical studies, particularly in imaging or diagnostic AI, where ambiguous cases are resolved by multiple human experts. For mechanical and biocompatibility testing of a medical device, the results are typically quantitative measurements or qualitative observations against predefined criteria, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic devices or AI systems where human readers interpret patient data (e.g., images). The Artoura™ Breast Tissue Expander is a physical implant used for reconstruction, not a diagnostic tool requiring interpretation by multiple readers. The evaluation here is based on physical and material properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical implant, not an algorithm or an AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. The Type of Ground Truth Used
For the mechanical and biocompatibility testing, the "ground truth" is established by:
- Engineering Specifications and Design Requirements: The device must perform within predefined limits for parameters like joint strength and leak performance.
- Established Industry Standards: Specifically, ASTM F1441-03 ("Standard Specification for Soft-Tissue Expanders") serves as a benchmark for acceptable performance.
- Material Equivalence: For biocompatibility, the ground truth relies on the previously established biocompatibility of identical materials used in the predicate device.
8. The Sample Size for the Training Set
Not applicable. "Training set" refers to data used to train machine learning models. This device is not an AI/ML product; it's a physical medical device. Therefore, there is no training set in this context. The "design" and "development" of the device are based on engineering principles and material science, not data training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for this physical device, the concept of establishing ground truth for it does not apply.
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