(18 days)
The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System consists of an X shaped implant designed to assist in the healing of sacroiliac (SI) joints for fusion by providing fixation of the sacroiliac joint. The implant is not intended to replace normal body structures. The implant is offered in five variations with one size per variation. The implant is manufactured from titanium alloy per ASTM F136.
The SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System was designed as a less invasive alternative to traditional open posterior surgical SI joint fusion. The titanium implant consists of a sacrum engaging side and an ilium engaging side connected by a bridge. During the procedure, bone graft material is placed in the window of the implant to facilitate stabilization. The implant is intended for single-use only. Implants are provided clean and non-sterile and designed for routine steam sterilization prior to use.
The provided document is a 510(k) clearance letter for a medical device (SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System), not an AI/ML medical device. As such, it does not contain any information about acceptance criteria, device performance metrics, sample sizes for test or training sets, expert ground truth establishment, adjudication methods, or MRMC studies, which are typical requirements for AI/ML device submissions.
The document is for a mechanical implant system and focuses on demonstrating substantial equivalence to a predicate device through:
- Identical indications for use.
- Identical technological design principles.
- Justifications and adoptions of existing performance testing (e.g., steam sterilization, FEA, pushout testing) from the predicate device (K241813), rather than new performance studies on clinical data or AI model outputs.
Therefore, I cannot extract the requested information to fill in the table or answer the questions related to AI/ML device validation.
Summary of why the requested information cannot be provided from the input:
- No AI/ML Component: The device is a physical implant (sacroiliac joint fusion system), not a software or AI-driven diagnostic/therapeutic device.
- Substantial Equivalence: The clearance is based on demonstrating substantial equivalence to a predicate device, meaning it relies on already established safety and efficacy data for a previous version or similar device, not de novo clinical trials or performance studies specific to an AI algorithm.
- Focus on Physical Properties: The "Performance Testing" section mentions engineering analyses (FEA, pushout testing) and sterilization, which are relevant to the physical characteristics and safety of an implant, not the diagnostic or analytical performance of an AI system.
§ 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.