(139 days)
The SMV Scientific 2.4mm and 3.0mm Cannulated Screws are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies. The SMV Scientific 3.5mm Cannulated Screws are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodeses of the carpals and phalanges, steochondritis dissecans, and ligament fixation. The SMV Scientific 4.5mm Cannulated Screws is intended for fracture fixation of long bones and long bone fragments. The SMV Scientific 6.5mm and 7.3mm Cannulated Screws are intended for fracture fixation of large bones and large bone fragments, femoral neck fractures, slipped capital femoral epiphyses, as an adjunct to DHS in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, and subtalar arthrodesis.
The SMV Scientific Cannulated Bone Screws consist of cannulated screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws are provided non-sterile. Screws are manufactured from Stainless Steel per ASTM F138 or Titanium per ASTM F136 or F1295.
I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria or any study that proves the device meets those criteria. The document is a 510(k) premarket notification letter from the FDA, a summary of the device, and a comparison to predicate devices, focusing on substantial equivalence for a medical device (SMV Scientific Cannulated Screws).
The information you are requesting, such as performance metrics, sample sizes, data provenance, expert qualifications, ground truth establishment, or any details about a multi-reader multi-case (MRMC) study or standalone algorithm performance, is not present in this document.
The document primarily states that the SMV Scientific Cannulated Screws are substantially equivalent to legally marketed predicate devices based on:
- Identical indications for use
- Identical materials of manufacture
- Identical principles of operation
- Engineering analysis and dimensional comparison
- Mechanical performance data (though no specific data or acceptance criteria are detailed).
§ 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.