(72 days)
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:
| Acceptance Criteria Category | Specific Tests/Requirements | Reported Device Performance |
|---|---|---|
| Mechanical Performance | - Simulated Use Testing | All mechanical performance testing results met pre-determined acceptance criteria |
| - Endurance / Stress Tests | All mechanical performance testing results met pre-determined acceptance criteria | |
| - Dimensional Measurement | All mechanical performance testing results met pre-determined acceptance criteria | |
| - Shell Tensile Set | All mechanical performance testing results met pre-determined acceptance criteria | |
| - Shell Break Force | All mechanical performance testing results met pre-determined acceptance criteria | |
| - Non-Critical Fused or Adhered Joints | All mechanical performance testing results met pre-determined acceptance criteria | |
| Standard Compliance | - Requirements of ASTM F1441, Standard Specification for Soft Tissue Expanders | The device met the requirements of the ASTM F1441 standard. |
| Design Control | - Internal company controls and design control procedures for safety and intended use | Design verification and validation testing criteria were met. |
| Risk Assessment | - No new harms or risks introduced compared to predicate | No new risks were introduced as a result of the device modifications. |
| Substantial Equivalence | - Identical intended use, indications for use, operating principles, performance, and technological characteristics (except shell texture) | Demonstrated substantial equivalence to the predicate device. |
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.
- Sample size used for the test set and the data provenance: Not applicable; no AI/ML test set is described.
- 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.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable; no expert adjudication for an AI/ML test set.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable; this device is not an algorithm.
- 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.
- The sample size for the training set: Not applicable; no AI/ML training set is described.
- How the ground truth for the training set was established: Not applicable; no AI/ML training set is described.
§ 878.3510 Carbon dioxide gas controlled tissue expander.
(a)
Identification. A carbon dioxide gas controlled tissue expander is a prescription device intended for temporary subcutaneous or submuscular implantation to stretch the skin for surgical applications, specifically to develop surgical flaps and additional tissue coverage. The device is made of an inflatable elastomer shell and is filled with carbon dioxide gas. The device utilizes a remote controller to administer doses of carbon dioxide gas from an implanted canister inside the device.(b)
Classification. Class II (special controls). The special controls for this device are:(1) In-vivo performance testing must be conducted to obtain the adverse event profile associated with use, and demonstrate that the device performs as intended under anticipated conditions of use.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance data must demonstrate the sterility of patient-contacting components of the device.
(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Cycle testing of expander showing that there are no leaks or tears after repeated cycling;
(ii) Mechanical assessment of implanted carbon dioxide (CO
2 ) canister including high impact testing;(iii) Leak testing of expander showing that device does not leak CO
2 ;(iv) Assessment of gas permeability during expansion and after full expansion; and
(v) Mechanical assessment of expander (tensile set, breaking force, shell joint test, and fused or adhered joint testing).
(5) Performance data must be provided to demonstrate the electromagnetic compatibility, electrical safety, and wireless compatibility of the device.
(6) Software verification, validation, and hazard analysis must be performed.
(7) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components, package integrity, and device functionality over the identified shelf life.
(8) Human factors testing and analysis must validate that the device design and labeling are sufficient for the end user.
(9) Physician labeling must include:
(i) The operating parameters, name, and model number of the indicated external dosage controller;
(ii) Information on how the device operates and the typical course of treatment;
(iii) Information on the population for which the device has been demonstrated to be effective;
(iv) A detailed summary of the device technical parameters; and
(v) Provisions for choosing an appropriate size implant that would be exchanged for the tissue expander.
(10) Patient labeling must include:
(i) Warnings, precautions, and contraindications, and adverse events/complications;
(ii) Information on how the device operates and the typical course of treatment;
(iii) The probable risks and benefits associated with the use of the device;
(iv) Post-operative care instructions; and
(v) Alternative treatments.
(11) Patient training must include instructions for device use, when it may be necessary to contact a physician, and cautionary measures to take when the device is implanted.