(45 days)
The use of the Kompressor compresion screw is generally indicated for the reduction and fixation of fractures of the small bones of the hand and wrist, such as the scaphoid. It is indicated for use in the fixation of fractures classified as acute or fresh, as well as cases of non-union where conservative treatment options have failed.
Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone stock inadequate.
The Kompressor bone screw implant is a two-piece fixation device intended for use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fıx fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites.
Materials: Titanium; Ti-6A14V-ELI as per ASTN F136
Function: The system functions to draw bone fractures together, thereby facilitating fixation.
The provided text describes a 510(k) premarket notification for a medical device called the "Kompressor Compression Screw System." This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing de novo performance criteria through a clinical study with acceptance criteria.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment for a study is not present in the provided text. The 510(k) pathway primarily relies on comparing the new device's technological characteristics, materials, and intended use to those of already approved devices.
Here's a breakdown of why the requested information cannot be provided based on the given text:
- Acceptance Criteria and Reported Device Performance: This type of information is typically found in a clinical trial report or a performance study. The 510(k) document (K024233) aims to show that the Kompressor Compression Screw System is substantially equivalent to predicate devices (Milennium Medical Technologies Headless Bone Screw K020791 and Newdeal I.CO.S Ideal Compression Screw K993762), implying it performs similarly to devices already on the market. It does not outline specific, measurable performance criteria to be met and their achievement in a study.
- Sample Size, Data Provenance, Number of Experts, Adjudication Method, MRMC Study, Standalone Study, Type of Ground Truth, Training Set Sample Size, and Training Set Ground Truth Establishment: These details are standard components of a detailed clinical or performance study. The provided text is a summary of safety and effectiveness within a 510(k) submission, which does not typically include the intricate design and results of such studies. The document mentions "Comparison of technological characteristics" and highlights that "There are no significant differences...which would adversely affect the use of the product." This comparative approach, rather than a de novo performance study, is the core of a 510(k).
In summary, the provided document (K024233) is a 510(k) premarket notification, which establishes substantial equivalence to predicate devices, not de novo performance through a study with explicit acceptance criteria.
§ 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.