(56 days)
The ARS and SLANT SCREW medical devices are indicated for the fixation of bone fractures and bone reconstruction. Examples include but are not limited to:
· Fixation of bone fragments in long or small bone fractures
· arthrodesis in hand or foot surgery
· mono or bi-cortical osteotomies in the foot or hand
· distal or proximal metatarsal or metacarpal osteotomies
· fixation of osteotomies for hallux valgus treatment (such as Scarf, Chevron, etc.)
The ARS and SLANT Screws are made of titanium alloy (Ti6A14V) according to ISO 5832-3 and ASTM F 136. They are self-drilling, self-tapping and designed with a double thread for better grip on tissue. The ARS and SLANT Screws are intended for single use only.
The titanium ARS and SLANT SCREWs are cannulated for use with a guide wire and have double-threading and different pitch for the proximal and distal threads. The headless screws can be completely embedded in the bone thus avoiding any protrusion that could cause irritation to the tissue. The double-thread design assures compression and stability of the fractures. Both screws have reverse-cutting flutes in the head threaded portion to facilitate removal of the screw.
The code to clearly identify each product is laser-marked on the unthreaded cylindrical screw part. The screws are color coded (anodized) to be easily recognized ARS (blue) from SLANT (green).
The provided text is related to a 510(k) submission for bone fixation screws, not an AI/ML powered medical device. Therefore, it does not contain information about acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), ground truth establishment, sample sizes for training/test sets, expert qualifications, or details of a comparative effectiveness study that would be relevant to an AI/ML device.
The document is a traditional medical device submission for orthopedic screws and focuses on demonstrating substantial equivalence to predicate devices based on material, design, and indications for use.
Therefore, I cannot fulfill the request as the provided input does not describe an AI/ML powered medical device.
§ 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.