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The intended use of the AART Calf Implant (Silicone Carving Block) is for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary. It may be used in body contouring to minimize muscular defects.

The AART Calf Implants (Silicone Carving Blocks) are manufactured from a medical grade silicone elastomer that has been molded into various convex oval shapes. They are provided in two styles with dimensions varying in length, width, height and initial shape. The AART Calf Implant (Silicone Carving Block) is intended to be used for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary.

The provided text describes a 510(k) premarket notification for the AART Calf Implant, a silicone carving block device. The FDA's substantial equivalence determination means that the device is considered as safe and effective as a legally marketed predicate device.

However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies. This type of information is typically found in performance testing reports, validation studies, or clinical trial summaries, which are not included in this document.

The document primarily focuses on:

• The applicant and contact information.
• The device's proprietary and common names, classification, and regulatory information.
• A comparison to a predicate device (Silimed Calf Implant) to establish substantial equivalence based on function, design, performance, and materials.
• Device description, intended use, packaging, and sterilization information.
• The FDA's decision letter confirming substantial equivalence and outlining regulatory responsibilities.
• The "Indications For Use" statement.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is not present in the provided text.

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