(44 days)
The Silimed Silicone Carving Block is designed to be used in aesthetic, corrective or reconstructive surgery. The Silimed Silicone Carving Block allows the surgeon to carve a finished device for his own custom use.
Silimed Silicone Carving Blocks
I am sorry, but based on the provided text, there is no information about acceptance criteria for a device, a study that proves a device meets acceptance criteria, or any of the detailed study parameters you've requested.
The document is an FDA 510(k) clearance letter for a device called "Silimed Silicone Carving Block." It confirms that the device is substantially equivalent to a predicate device and can be marketed.
It contains:
- The FDA's decision regarding substantial equivalence.
- Regulatory information and responsibilities for the manufacturer.
- The indications for use for the "Silimed Silicone Carving Block."
It does not include:
- A table of acceptance criteria or performance data.
- Details about a study (sample sizes, data provenance, expert qualifications, adjudication, MRMC, standalone performance, ground truth, or training set info).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the given text.
§ 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.