(98 days)
The Biofusion Medical SI-Restore® Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The SI-Restore® Sacroiliac Joint Fixation System consists of a cannulated titanium (Ti 6AI4V ELI, per ATSM F136) screw with a titanium (Ti 6AI4V ELI, per ATSM F136) washer affixed to the head of the screw for full cortex engagement. The Implant is designed to prevent motion of the sacroiliac (SI) joint. The delivery system uses guide pins for accurate preparation for and placement of the implant.
The provided document is a 510(k) Premarket Notification for the Biofusion Medical SI-Restore® Sacroiliac Joint Fixation System. This document describes a medical device (a bone fixation system), not a software or AI/ML-based device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device, such as sample size for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this submission.
The document discusses the following types of performance data for this physical medical device:
- Static Axial Pull-out and Static Torque to Failure testing (per ASTM F543-13)
- Static Three-Point Bending and Dynamic Three-Point Bending (per ASTM F1264-14)
These tests confirmed that the device performed as intended and supported the claim of substantial equivalence to a legally marketed predicate device (SI-LOK™ Sacroiliac Joint Fixation System, K112028).
Since the request specifically asks about acceptance criteria and studies for an AI/ML device, and this document pertains to a physical orthopedic implant, I can only state that the requested information is not present in the provided text because the device in question is not an AI/ML product.
§ 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.