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The Sientra AlloX2 Pro Tissue Expanders are intended for temporary (less than six months) subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstructions following mastectomy, to aid in the treatment of underdeveloped breasts and to aid in treatment of soft tissue deformities.

Additionally, the Sientra AlloX2 Pro Tissue Expanders contain a silicone drain component which allows access to and drainage of latent fluids from the periprosthetic space. This drain component does not teplace short-term, immediate, intraoperatively placed drains.

The Sientra AlloX2 Pro Tissue Expanders are constructed from silicone elastomer and consist of an expansion envelope with a smooth surface and an integrated magnetically locatable port system for incremental expander filling. The Sientra AlloX2 Pro Tissue Expanders have an incorporated drainage system accessed by a drain port. The incorporated drain system allows for aspiration of fluids from the periprosthetic space that may present during the expansion process. Both the integrated fill and drain ports can be accessed with an 18- gauge needle or smaller. The AlloX2 Pro Tissue Expanders have suture tabs providing an option for surgeons to suture the expander within the breast pocket. The AlloX2 Pro Tissue Expanders are labeled Magnetic Resonance (MR) Conditional. Patients implanted with the AlloX2 Pro Tissue Expanders may undergo Magnetic Resonance Imaging under specific MR conditions. The potential resulting risks associated with using the device in the MRI environment include the inability to fill the device, loss of port location functionality and potential reoperation should the patient require continued function of the tissue expander device after MRI exposure.

The Sientra AlloX2 Pro Tissue Expanders are manufactured in both mid-height and fullheight base options from 11 cm to 16 cm to meet diverse patient needs and to achieve individualized aesthetic results. The Sientra AlloX2 Pro Tissue Expanders are supplied sterile. The Sientra AlloX2 Pro Tissue Expander accessories include a magnetic port locating device (PRO Locator) that allows for simultaneous identification of the fill and drain ports for ease of identification, and a 21-gauge winged needle infusion set. Both are supplied sterile and individually packaged inside the product box.

This document describes the premarket notification (510(k)) for the Sientra AlloX2 Pro Tissue Expanders. The device is a silicone elastomer tissue expander with an integrated magnetically locatable port system and a drainage system. The submission aims to demonstrate substantial equivalence to the predicate device, the Sientra AlloX2 Tissue Expander (K140383).

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state specific sample sizes for each test in terms of individual devices or units. It broadly refers to "All necessary performance testing" and implies that a sufficient number of samples were used to meet the requirements of the standards (e.g., ASTM, ISO).

• Data Provenance: The studies were non-clinical bench testing. The country of origin for the data is not specified, but it can be inferred that the testing was conducted by or on behalf of Sientra, Inc., a US-based company. The data is retrospective in the sense that it was generated prior to the 510(k) submission to demonstrate equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There were no human experts used to establish a "ground truth" for the performance testing in the traditional sense of clinical assessment. This device's evaluation relies on objective engineering and material science standards. The ground truth for these tests is defined by the technical specifications and acceptance criteria outlined in the relevant ASTM and ISO standards.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical bench testing study relying on objective measurements against established engineering and material standards, not subjective assessments requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "Clinical data is not necessary to establish the substantial equivalence of this device." This implies no human reader studies were conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, from a performance perspective, the "standalone" performance of the device (without human interaction for evaluation purposes) was assessed through the various bench tests. The device itself does not involve an algorithm or AI. All performance testing described (sterilization, shelf-life, biocompatibility, mechanical, MR safety) is of the device's inherent properties and function, without direct human influence on the results of the test beyond setting up the experiment.

7. The Type of Ground Truth Used

The ground truths used for the performance testing were:

• Standard Specifications and Industry Norms: For mechanical testing, this was ASTM F1441-03. For MR safety, this was ASTM F2503-20 and FDA Guidance.
• Regulatory Requirements: For biocompatibility, this was ISO 10993-1. For sterilization, this was achieving a Sterility Assurance Level (SAL) of -6.
• Predicate Device Equivalence: The ultimate ground truth for this submission is demonstrating that the new device performs equivalently to the legally marketed predicate device (Sientra AlloX2 Tissue Expander, K140383) in terms of safety and effectiveness, based on these objective tests.

8. The Sample Size for the Training Set

Not applicable. This device is a medical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

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