(166 days)
The BRM SWING-OFF SCREW is indicated for surgical fixation of bone fractures, osteotomies and bone reconstruction in order to position and maintain bony fragments in a desired orientation and to provide stable fixation of the osteotomy site until a stable bony union occurs.
Examples include but are not limited to:
-Fixation of small bone fragments
-Weil osteotomy
-Mono-cortical fixation
-Osteotomies and fractures fixation in foot and hand
The BRM SWING OFF Screw is made of titanium alloy (Ti6A14V- ELI) according to ISO 5832-3 and ASTM F 136. It is self-drilling and self-tapping and consists of a screw with a flat thin head which is integrated with a short round shaft. The shaft is fixed on a standard surgical shaft and separates from the screw when the head comes in contact with cortical bone.
The screw is available in two different diameters (2.0 and 2.7 mm) and in length from 10 to 15 mm for Ø 2.0 mm and from 10 to 17 mm for Ø 2.7 mm. The screws are anodized and color-coded (yellow) to be easily recognized. The head design facilitates maximum loading and compression. The self-drilling tip easily penetrates the cortical shell. A Swing-Off Terminal Screw Driver is offered for ease of use.
The provided text is a 510(k) summary for a medical device called "BRM SWING-OFF SCREW," which is a bone fixation screw. The document focuses on establishing substantial equivalence to predicate devices based on indications for use, material, technology, and design specifications. It does not include information about acceptance criteria, device performance metrics, or any clinical or technical studies demonstrating performance through quantitative metrics.
Therefore, I cannot fulfill the request as the necessary information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided text.
Specifically, the document states: "Based on available 510k information including engineering analyses and insertion testing, AIT bone fixation (screw) devices are deemed substantially equivalent to the predicate devices in terms of indications for use, material, technology and design specifications." This indicates that some engineering analyses and insertion testing were performed, but no details of these tests, their results, or how they relate to specific acceptance criteria are provided in a quantifiable manner as you've requested.
§ 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.