(87 days)
The Intex Screw is to be for fixation of bone fractures and for bone reconstruction (i.e. fresh fractures, osteotomy, revision procedure where other treatments or devices have failed, arthrodesis, and in conjunction with fixation hardware).
The Intex Screw is an internal fixation device intended to aid in the alignment and stabilization of fractures in the skeletal system until healing has occurred. The Intex Screw consists of an internal cannulated screw and an external stud joined at a junction. After inserting the device, the external stud is held in place by an external fixator to allow for healing. When the surgeon feels that external fixation is no longer needed, the external stud is removed, leaving the internal cannulated screw. This design allows the surgeon to maintain internal fixation after the external fixation device is removed.
This document does not contain the information required to populate the requested table and study details regarding acceptance criteria and device performance. The provided text is a 510(k) summary for the Biomet Intex Screw, which outlines the device's name, classification, indications for use, device description, and potential risks, as well as the FDA's clearance letter. It does not include details about acceptance criteria, specific performance metrics, or any studies demonstrating the device meets such criteria.
Therefore, I cannot provide:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance study details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.