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

The AeroForm® Tissue Expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond 6 months.

The AeroForm Tissue Expander System (AeroForm System) is a sterile temporary implant for breast reconstruction and is comprised of a sterile, implantable tissue expander), a remote control (Controller), and a Master Key. The AeroForm Tissue Expander is a comprised of an outer textured silicone shell, an inner gas barrier (bag), with an internal reservoir of compressed Carbon Dioxide (CO2) gas, which is released within the Expander by using the remote control (Controller), resulting in gradual expansion of the Expander. In a typical, twostage 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 regulatory submission for the AeroForm Tissue Expander System. It is not an AI/ML device, so many of the requested fields are not applicable. I will fill in the applicable information about the device's acceptance criteria and the studies performed.

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes pre-clinical and verification/validation testing for a physical medical device (tissue expander). There is no mention of a "test set" in the context of an AI/ML device employing a dataset for evaluation. The "test set" for mechanical and biological performance refers to the physical devices and materials tested. The provenance of these tests are standard laboratory and engineering tests; no data provenance from patient populations is mentioned for these specific tests in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not an AI/ML device relying on expert-annotated ground truth for a test set. The "ground truth" for the performance attributes is established through recognized international standards (e.g., ASTM F1441, EN ISO 10993) and internal engineering specifications, executed and assessed by qualified engineering and scientific personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As this is not an AI/ML device, there is no expert adjudication of outputs from an algorithm. Results are assessed against pre-defined quantitative and qualitative acceptance criteria from recognized standards and internal specifications.

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. This is not an AI/ML device, and no MRMC study with human readers or AI assistance was conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (tissue expander) with a software component for control; it is not a standalone algorithm. The software testing mentioned is for the functionality and compliance of the embedded software, not for a diagnostic or predictive AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance evaluation lies in:

• Mechanical Integrity/Performance: Compliance with ASTM F1441 standards and internal engineering design specifications.
• Biocompatibility: Conformance to EN ISO 10993 standards.
• Software: Compliance with EN 62304 and FDA guidance for software development (functional correctness, safety).
• Sterilization/Shelf Life: Compliance with applicable standards for sterility, package integrity, and stability over time.

These are established through standardized testing methodologies rather than expert consensus on medical images or pathology.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires a training set.

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