(54 days)
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.
Not Found
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.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.