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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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