(71 days)
The Spectrum Designs Pre-Form Contour Silicone Carving Block is a pre-formed solid silicone block, to be used where a shaped, cut-to-fit implant is desired. It is designed for use in augmenting or reconstructing cartilaginous tissue, soft tissue and bone. The preshaped aspect of the implant allows the surgeon increased options when cutting or shaping the implant to the size and shape demanded by a specific surgical situation.
The Spectrum Designs Pre-Form Contour Silicone Carving Block Implant is fabricated from solid silicone elastomer and has an inherent, pre-formed, rounded shape.
This document is a 510(k) summary for the "Spectrum Designs Pre-Form Contour Silicone Carving Block Implant." It does not contain information about acceptance criteria or a study that proves the device meets those criteria.
The 510(k) process is for demonstrating substantial equivalence to a predicate device, not for proving device performance against specific acceptance criteria through clinical or performance studies in the way you've outlined. This document primarily details:
- Submitter's Data: Company contact information.
- Device Name, Classification: "Spectrum Designs Pre-Form Contour Silicone Carving Block," Class II, FDA Code MIB.
- Substantially Equivalent Devices: Lists similar silicone block implants.
- Device Description: Fabricated from solid silicone elastomer with a pre-formed, rounded shape.
- Indications for Use: To be used where a shaped, cut-to-fit implant is desired for augmenting or reconstructing cartilaginous tissue, soft tissue, and bone.
- Contraindications for Use: Presence of infection.
- Warnings, Precautions: Potential complications such as displacement, errors in positioning, tissue necrosis, bone resorption, fibrous tissue encapsulation, infection, neural damage, hematoma, poor wound healing, and patient intolerance.
The FDA's response letter (pages 1 and 2 of the provided text) confirms that the device is "substantially equivalent" to predicate devices, allowing it to be marketed. This determination is based on the information provided in the 510(k) submission, not on a performance study against specific acceptance criteria.
Therefore, I cannot provide the requested table or information about acceptance criteria, sample sizes, ground truth, or MRMC studies because this document does not contain that type of information.
§ 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.