(448 days)
The Kisar Stratford SI Screw system is intended for fusion of the sacroillac joint for conditions including SI joint dysfunction resulting from SI joint disruption or degenerative sacroiliitis.
The Kisar Stratford SI Screw System consists of threaded, fenestrated implant screws with a porous layer and an instrument system. The screws are inserted into the sacroiliac (SI) joint and intended to prevent and minimize motion of the joint thus promoting joint fusion. Bone graft material may be used in the fenestration of the implants as an additional means of promoting joint fusion. The screws are available in multiple diameters and lengths to accommodate different patient anatomy. All implants are fabricated from medical grade titanium alloy per ASTM F3001 and system instrumentation is manufactured from surgical grade stainless steel and other surgical grade materials.
The provided text is a 510(k) summary for the Kisar Stratford SI Screw System. It describes the device, its intended use, and compares its technological characteristics to predicate devices. However, this document does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical studies for AI/ML-enabled devices.
The "Mechanical Testing" section briefly mentions acceptance criteria in the context of mechanical performance. Since the request is likely for AI/ML device evaluations, and this document pertains to a medical screw system, the requested information (sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable or present in this document.
The document focuses on demonstrating substantial equivalence based on:
- Intended Use: Fusion of the sacroiliac joint for conditions including SI joint dysfunction resulting from SI joint disruption or degenerative sacroiliitis.
- Technological Characteristics: Materials (medical grade titanium alloy), design (threaded, fenestrated implant screws with porous layer), and dimensions (diameters, lengths).
- Mechanical Testing: Torsion, driving torque, axial pullout, static and dynamic cantilever bend, static tensile strength, static shear strength, shear fatigue, and particulate characterization.
Based on the provided text, none of the requested information regarding acceptance criteria and studies (as would be relevant for an AI/ML device) can be extracted.
The "Mechanical Testing" section merely states: "Results support that the subject device performs as well as or better than the chosen acceptance criteria." It does not define those acceptance criteria or detail the study design in a way that aligns with the questions posed for AI/ML device evaluations.
§ 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.