(112 days)
The KSEA MegaFix®-C Elioabsorbable Composite Interference Screw is intended for use by qualified surgeons for tibial and femoral fixation (primary anchorage) of tendon grafts in human cruciate ligament reconstruction.
The KSEA MegaFix®-C Bioabsorbable Composite Interference Screw is a one-time use biodegradable implant, provided to the end user in a sterile condition, and intended for interference fixation of grafts in human cruciate ligament reconstruction. The device is a bioabsorbable composite interference screw which utilizes lactide polymer composite technology to perform the intended use.
The provided text describes the KSEA MegaFix®-C Bioabsorbable Composite Interference Screw, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing performance data against specific acceptance criteria. It mentions the device description, indications for use, and technological characteristics, and lists predicate devices, but no performance study details are included.
Therefore, I cannot populate the requested table or answer the specific questions related to a study's methodology, sample sizes, ground truth, or expert involvement.
§ 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.