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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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The Sientra Portfinder is a battery-operated standalone port detection device that is intended for use with the Sientra AlloX2 Pro and Dermaspan Tissue Expanders.

The Portfinder is an electronic handheld injection port detector device that externally locates subcutaneous ports of an implanted tissue expander, enabling fill of the tissue expander or use of the drain system.

The enclosed device is nonsterile and for postoperative use only.

The Portfinder is an electronic handheld injection port detector device that externally locates subcutaneous ports of an implanted tissue expander. The Portfinder is intended to locate the fill and drain ports of the Sientra AlloX2 Pro Breast Tissue Expanders (AlloX2 Pro) and fill port of the Sientra OPUS Dermaspan Breast Tissue Expanders (Dermaspan); enabling the user to mark the location of the ports for subsequent fill and drain of the respective tissue expander.

The Portfinder contains an LCD screen that displays the location of the intended port (drain or fill port). A single button of the Portfinder is used to power on/off and change modes.

The Portfinder housing has features to temporarily indent the port location on the surface of the skin or use a skin marker to mark the port location.

The Portfinder is intended to be used by clinicians in medical settings such as hospitals and medical clinics. It can be disinfected between uses for multi-patient reuse.

The provided document does not contain detailed information about the acceptance criteria or a specific study proving the device meets those acceptance criteria. However, it does mention "Design verification tests were performed on the Portfinder as a result of the risk analysis and product requirements" and "Software Verification and Validation testing was performed on Portfinder".

Without the full details of these verification and validation tests, it's not possible to populate all the requested fields comprehensively. The document explicitly states that clinical testing was not necessary to demonstrate substantial equivalence, which means the study described would likely be bench testing.

Based on the available information, here is a summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample size: Not specified. The document only mentions "Design verification tests" and "Software Verification and Validation testing."
• Data provenance: Not specified. These would be laboratory-based verification and validation data, likely from internal testing at Sientra, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided. Since clinical testing was not performed, "experts" in the context of establishing clinical ground truth (e.g., radiologists) would not be applicable here. Ground truth would likely be based on engineering specifications and direct measurement/observation in a lab setting.

4. Adjudication method for the test set

• Not specified. Given the nature of bench and software testing, a formal adjudication process like 2+1 or 3+1 would not typically be used. Testing would likely involve comparing device output against known inputs or expected behaviors.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states, "Clinical testing was not necessary to demonstrate substantial equivalence of Portfinder to the predicate device." The device is a port detector, not an AI-assisted diagnostic tool for human readers.

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

• Yes, a form of standalone performance was assessed. The "Software Verification and Validation testing" and "Design verification tests" would evaluate the device's performance independently, without human interaction in a clinical setting, to ensure it met its operational requirements. The device itself is described as a "standalone port detection device."

7. The type of ground truth used

• Engineering specifications and known physical properties/measurements. For functional testing, ground truth would be established by the known location of the tissue expander ports in test setups. For software testing, the ground truth would be defined by the expected behavior and outputs based on software requirements.

8. The sample size for the training set

• Not applicable as this is not an AI/machine learning device that requires a training set in the conventional sense. The software mentioned is likely embedded control software, not a learning algorithm.

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

• Not applicable (see point 8).

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The Sientra OPUS® Silicone Gel Breast Implant Sizer is a single-use, sterile, intraoperative device indicated for temporary placement during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size of the long-term Sientra OPUS® Breast Implant to be implanted.

The Sientra OPUS® Silicone Gel Breast Implant Sizer is a single-use, sterile, intraoperative device indicated for temporary placement during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size Sientra Breast Implant to be implanted. The Sientra Gel Sizers are designed to complement the portfolio of Sientra OPUS® Silicone Gel Breast Implants ("Breast Implants" or "Implants"), and are therefore available in the same range of styles, dimensions and fill volume as Sientra Implants. The Sientra OPUS® Silicone Gel Breast Implant Sizers are constructed with a smoothsurfaced, silicone elastomer shell and a filler made of clear, high-strength silicone gel. Sientra's Gel Sizers have been demonstrated to be biocompatible. The printing on the exterior of the Gel Sizer shell is clearly marked, "SIZER", "SINGLE USE ONLY", and "DO NOT IMPLANT", to clearly differentiate the Gel Sizers from Sientra's OPUS Breast Implants. Each Sientra Gel Sizer is dry-heat-sterilized, for single patient use only, and is not intended for long-term implantation or re-sterilization.

This document describes the Sientra OPUS® Silicone Gel Breast Implant Sizer, a medical device, and its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state specific sample sizes for each bench test conducted. It generally refers to "performance testing" being conducted. The data provenance is from non-clinical bench testing. The country of origin of the data is not specified, but the submission is to the U.S. FDA, implying the data was generated to meet U.S. regulatory standards. The testing is retrospective in the sense that the device was developed and then tested, but it pertains to the device itself and not to patient data.

3. Number of Experts and Their Qualifications for Ground Truth

This information is not applicable as the evaluation of this device relies on non-clinical bench testing against engineering and material specifications, not on expert interpretation of clinical data. Therefore, there was no ground truth established by medical experts for the test set.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation of this device relies on non-clinical bench testing against predefined acceptance criteria, not on expert consensus or adjudication of clinical cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this device is a physical breast implant sizer, not an AI or imaging-based device that would benefit from such a study. The document explicitly states: "No clinical testing was performed to support this 510(k) submission."

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not applicable / not done as this is a physical medical device (a breast implant sizer), not an algorithm or software. The performance testing was of the physical properties and characteristics of the sizer itself.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on predefined engineering specifications, material properties, and regulatory standards for biocompatibility, sterility, and physical integrity that the device must meet to be considered safe and effective and substantially equivalent to its predicate.

8. Sample Size for the Training Set

This information is not applicable as this device is not an AI/machine learning model that requires a training set. The device is a physical product.

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

This information is not applicable as there is no training set for this device.

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