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The Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process.

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I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets said criteria. The document is an FDA 510(k) clearance letter for a "Silicone Block" device, indicating that it has been found substantially equivalent to a legally marketed predicate device.

The clearance letter primarily discusses:

• The FDA's decision regarding the premarket notification.
• The regulatory classification of the device.
• General controls and existing regulations applicable to the device.
• Contact information for further regulatory guidance.
• The intended use of the device, which is "in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process."

It does not include any performance data, clinical study details, acceptance criteria, or ground truth establishment methods typical for AI/ML device submissions. This is an older 510(k) from 2004 for a physical medical device (silicone block), not a software or AI medical device, which is why the requested information is absent.

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The Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process.

Silicone Blocks

The provided document is an FDA 510(k) clearance letter for "Silicone Blocks." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth, or details typically found in a clinical study report.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text. This document is a regulatory communication, not a performance study report.

Ask a specific question about this device