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K Number
K243838
Device Name
NEXXT MATRIXX® SI System
Manufacturer
Nexxt Spine
Date Cleared
2025-03-14

(91 days)

Product Code
OUR,HWC
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
K241574,K193524,K021932
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The NEXXT MATRIXX® SI System is indicated for sacroiliac joint fusion for:

· Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroillitis.

· Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients

undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The NEXXT MATRIXX® SI System is also indicated for fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures.

Device Description

The NEXXT MATRIXX® SI System is a collection of additively manufactured implants intended to facilitate fusion of the sacroiliac joint. The NEXXT MATRIXX® SI System includes three different implants which are press-fit shafts or threaded screws including the IMPAXX SI Implant, HELIXX SI Fully Threaded Implant, and the HELIXX SI Lag Implant. The HELIXX SI Lag Implants may be used with optional HELIXX SI Modular Washers. All subject implants are manufactured from Ti-6A1-4V per ASTM F3001 or Ti-6A1-4V ELI titanium alloy per ASTM F136 and are offered in various sizes to accommodate patient anatomical needs.

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification for a medical device (NEXXT MATRIXX® SI System), which is an orthopedic implant for sacroiliac joint fusion and fracture fixation.

This document describes the device, its intended use, technological characteristics, and references non-clinical performance testing. However, it does not contain information about studies related to AI/software performance, human reader studies (MRMC), or the evaluation of an algorithm against acceptance criteria for diagnostic or prognostic purposes.

Therefore, I cannot extract the information required to answer your questions regarding:

  1. A table of acceptance criteria and the reported device performance (in the context of AI/software).
  2. Sample sizes used for a test set or data provenance (related to AI/software performance).
  3. Number of experts used to establish ground truth or their qualifications.
  4. Adjudication method for a test set.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
  6. Standalone (algorithm-only) performance.
  7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
  8. Sample size for the training set (for AI).
  9. How ground truth for the training set was established.

The document focuses on the mechanical and material performance of a physical implant and its substantial equivalence to predicate devices based on non-clinical (mechanical) testing, not on the performance of a software or AI component.

§ 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.