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NATRELLE INSPIRA® Single Use Sizers are used during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size breast implant.

NATRELLE INSPIRA® Single Use Sizers are designed for temporary intraoperative placement, to assist in determining the desired breast implant volume. They are used during breast augmentation or reconstruction procedures.

NATRELLE INSPIRA® Single Use Sizers are constructed of a smooth silicone elastomer shell and are filled with responsive gel that contains the colorant cobalt aluminate blue spinel at a concentration of 0.1%. They have been designed to match the dimensions of the NATRELLE INSPIRA® breast implants.

NATRELLE INSPIRA® Single Use Sizers are supplied sterile and are for single patient use, one sizer per breast.

The provided text is an FDA 510(k) clearance letter and summary for a medical device: "NATRELLE INSPIRA® Single Use Sizers." This document does not contain information about an AI/ML-driven device or a study involving human readers or ground truth establishment relevant to AI/ML performance.

Specifically, the document focuses on demonstrating substantial equivalence to a predicate device (Natrelle® Re-Sterilizable Breast Implant Sizers) through non-clinical performance data, primarily mechanical testing and biocompatibility. The device itself is a physical sizer filled with silicone gel, used by surgeons during breast augmentation procedures.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them, including:

• Table of acceptance criteria and reported device performance (for AI/ML): Not applicable. The "performance data" mentioned in the document refers to non-clinical tests like mechanical testing and biocompatibility, not AI performance metrics.
• Sample size and data provenance (for AI/ML test set): Not applicable. There is no AI test set.
• Number of experts and qualifications (for AI/ML ground truth): Not applicable. There is no AI ground truth establishment.
• Adjudication method (for AI/ML test set): Not applicable.
• MRMC comparative effectiveness study: Not applicable. This is a physical medical device, not an AI system.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data): Not applicable. The ground truth for this device's testing relates to physical properties and biocompatibility, not diagnostic or clinical accuracy determined by experts or pathology.
• Sample size for training set (for AI/ML): Not applicable. There is no AI training set.
• How ground truth for training set was established (for AI/ML): Not applicable.

The document explicitly states that "Non-clinical performance data including mechanical testing and biocompatibility data were submitted to support clearance... All pre-established acceptance criteria were met." However, these acceptance criteria and the associated study are not related to the performance of an AI/ML device, human reader improvement, or ground truth for diagnostic accuracy, which are the typical focus of the questions posed.

To summarize, the provided text describes a traditional medical device and its clearance process, not an AI/ML device study.

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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.

Here's an analysis based on the provided text:

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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