(29 days)
The Natrelle® 133S Tissue Expander can be used for breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.
Natrelle® 133S Plus Tissue Expanders are designed to develop tissue flaps as part of two-stage reconstruction mammoplasty. The devices are constructed from silicone elastomer and consist of a smooth surface expansion envelope, an orientation line, suture tabs, a MAGNA-SITE® integrated injection site, and a stable base to enable outward expansion. The tissue expanders are available in multiple styles and sizes to meet diverse surgical needs.
The MAGNA-SITE® injection site and MAGNA-FINDER® Xact external locating device contain rare-earth, permanent magnets for an accurate injection system. When the MAGNA-FINDER® Xact external locating device is passed over the surface of the tissue being expanded, its rare-earth, permanent magnet indicates the location of the MAGNA-SITE® injection site. The injection site is self-sealing and includes a titanium needle guard to prevent inadvertent puncture through the base of the injection site.
The document describes the Natrelle® 133S Tissue Expander, a medical device, and its substantial equivalence to a predicate device. The information provided heavily focuses on non-clinical performance data and does not involve AI or human reader performance. Therefore, many of the requested points related to AI/human reader studies, ground truth derivation for AI, and specific expert qualifications/adjudication methods are not applicable to this submission.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical properties of the shell | All pre-established acceptance criteria were met. |
| Bond strength at non-critical and critical joints | All pre-established acceptance criteria were met. |
| Injection port competence | All pre-established acceptance criteria were met. |
| Meeting design input requirements (overall) | The modified device met design input requirements. |
| No new questions of safety and effectiveness | Design features do not raise different questions of safety and effectiveness or negatively impact safety and effectiveness. |
Note: The specific quantitative acceptance criteria values (e.g., minimum bond strength, pressure resistance for injection port) are not provided in this summary but are indicated to have been met.
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "mechanical testing data" and "non-clinical performance data." It does not specify a "test set" in the context of patient data or clinical imaging. The testing performed is related to the physical and mechanical properties of the device.
- Sample Size for Test Set: Not specified in terms of number of devices or units tested for each specific mechanical test.
- Data Provenance: The data is from non-clinical performance testing conducted by Allergan or its contractors. No information on country of origin for data is provided as it's not patient-level data. The data is by nature prospective in the sense that the tests were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device is a physical tissue expander, and the "ground truth" for its performance is established through objective mechanical and physical testing according to standards like ASTM F1441-03. There's no interpretive clinical data requiring expert consensus or ground truth establishment in the way AI models typically do.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated in point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for AI-assisted image interpretation or diagnostic performance involving human readers. This submission concerns a physical medical implant (tissue expander).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this medical device is based on pre-established objective performance criteria derived from engineering standards (e.g., ASTM F1441-03) and risk analysis, validated through mechanical testing data.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI model for this physical medical device submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons stated in point 8.
N/A