(93 days)
The Life Spine SIMPACT Sacroiliac Joint Fixation System is intended for sacroiliac fusion for the following conditions:
· 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.
· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
The Life Spine SIMPACT Sacroiliac Joint Fixation System consists of fully threaded screws and partially threaded cannulated screws in various diameters and lengths to enhance sacroiliac joint fusion. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136. The purpose of this submission is to add the Posterior Oblique approach technique.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine Simpact Sacroiliac Joint Fixation System components with components from any other system or manufacturer. The Life Spine Simpact Sacroiliac Joint Fixation System components should never be reused under any circumstances.
Based on the provided text, the document is an FDA 510(k) clearance letter for a medical device called the "Life Spine SIMPACT Sacroiliac Joint Fixation System." This type of document does not contain the details of a study on device performance against specific acceptance criteria for AI/ML-based devices. The content focuses on the regulatory clearance process for a traditional implantable medical device, asserting substantial equivalence to existing predicate devices.
Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device, as this document does not pertain to such a device or studies.
The document discusses:
- Device Name: Life Spine SIMPACT Sacroiliac Joint Fixation System
- Regulation Number/Name: 21 CFR 888.3040, Smooth Or Threaded Metallic Bone Fixation Fastener
- Regulatory Class: Class II
- Product Code: OUR, HWC
- Indications for Use: Sacroiliac fusion for specific conditions (dysfunction, augmentation in sacropelvic fixation, fractures).
- Device Description: Fully threaded and partially threaded cannulated screws made from titanium alloy 6AL-4V-ELI.
- Purpose of Submission: To add the Posterior Oblique approach technique.
- Predicates: Medtronic, Inc. Rialto Sacroiliac Fusion System (K161210) and others.
- Substantial Equivalence: Based on design, materials, indications for use, sizing, and mechanical performance (for the new technique).
There is no mention of AI or ML, nor any performance data related to algorithms, expert readers, or ground truth for diagnostic accuracy studies. The "Performance Data" section explicitly states: "There are no new devices in this submission, only Design of Experiment validating Posterior Oblique approach." This refers to non-clinical performance (e.g., mechanical testing, not clinical AI performance).
§ 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.