(63 days)
The M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System is intended for use in skeletally mature patients for fracture fixation of small and long bones of the pelvis, and for sacroiliac joint fusion for patients suffering from sacroiliac joint disruptions and degenerative sacroiliitis.
The M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System is designed for sacroiliac joint fusion in degenerative sacroiliitis, as well as for the fixation of small and long bone fractures in trauma cases. The screws are hollow-body threaded fusion devices with a self-tapping design, tapered tip, long pitch and dual thread, and a reverse cutting flute. They are cannulated to accept a Ø 3.2 mm guide wire. Sacroiliac joint screws are available in titanium with a rough Hydroxyapatite (HA) coating. Pelvic trauma screws are available in both full and partial thread designs in Titanium-6Aluminum-4Vanadium Extra Low Interstitial (Ti-6A1-4V ELI) and Stainless Steel. Washers are available in standard and favored designs. Radial windowed slots along the screw's body are intended to allow surrounding bone access to bone substitute.
This document describes a 510(k) premarket notification for the "M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System." The information provided does not contain details about an AI/ML powered device, nor does it describe acceptance criteria and a study proving an AI/ML device meets those criteria.
Instead, this document is for a physical medical device (screws and plates for bone fixation) and focuses on demonstrating substantial equivalence to predicate devices through:
- Comparison of technological characteristics: Comparing the new device's material, dimensions, design, and sterilization methods to existing, legally marketed devices.
- Non-clinical performance testing: Referring to mechanical and material tests conducted according to established ASTM and ISO standards (e.g., ASTM F543-13 for bone screws, ISO 13779-3 for hydroxyapatite coating). These tests are typically for mechanical strength, biocompatibility, and material properties.
- No clinical studies were conducted for this particular submission, as stated under "Clinical Studies."
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device based on the provided text. The document doesn't discuss AI model performance metrics like accuracy, sensitivity, or specificity, nor does it mention training/test sets, expert adjudication, or MRMC studies.
§ 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.