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The AeroForm® Tissue Expander System, Smooth is used for soft tissue expansion in breast reconstruction following mastectomy, for the treatment of underdeveloped breasts and for the treatment of soft tissue deformities in the breast.

The AeroForm® Tissue Expander, Smooth is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months

The AeroForm Tissue Expander System, Smooth is a sterile, temporary implant for breast reconstruction. This device is comprised of an implantable tissue expander (Expander), a remote control (Controller), and a Master Key. The AeroForm Tissue Expander, Smooth is constructed of an outer silicone shell and an inner gas barrier (bag) with an internal reservoir of compressed Carbon Dioxide (CO2) gas. The CO2 gas is released within the Expander by using the remote control (Controller), resulting in gradual expansion of the Expander. In a typical, two-stage breast reconstruction, a tissue expander device is placed under the pectoralis major muscle and remaining skin following a mastectomy procedure. The Expander is gradually expanded over time through the release of carbon dioxide, causing the overlying skin and muscle to stretch. When adequate tissue coverage is achieved, the expansion device is removed and replaced with a breast implant.

This document describes the premarket notification for the AeroForm Tissue Expander System, Smooth. The "acceptance criteria" and "device performance" in this context refer to the mechanical and performance testing conducted to demonstrate substantial equivalence to a predicate device, rather than the performance of an AI/ML model.

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Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating that the modified device (smooth shell) meets the design input requirements and performs equivalently to the predicate device (textured shell). The study focuses on mechanical performance testing as outlined in ASTM F1441 and internal design verification and validation testing.

Table of Acceptance Criteria and Reported Device Performance:

Since this submission is for a medical device (tissue expander) and not an AI/ML product, the following points regarding AI/ML study design are not applicable to this document. The information provided does not describe an AI/ML study.

2. Sample size used for the test set and the data provenance: Not applicable; no AI/ML test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; ground truth establishment for an AI/ML model is not described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable; no expert adjudication for an AI/ML test set.
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: Not applicable; no AI assistance for human readers is described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable; this device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable; no ground truth for an AI/ML model. The "ground truth" for this device's performance is derived from standardized mechanical testing and design verification.
8. The sample size for the training set: Not applicable; no AI/ML training set is described.
9. How the ground truth for the training set was established: Not applicable; no AI/ML training set is described.

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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

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.

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