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K Number
K240086
Device Name
Ion 3D
Manufacturer
SurGenTec, LLC
Date Cleared
2024-02-08

(28 days)

Product Code
MRW,FMF,HTR
Regulation Number
N/A
Type
Special
Panel
OR
Reference & Predicate Devices
K211855
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Ion 3D Facet Screw may be used in conjunction with the Ion 3D GraftRasp to perform posterior spinal fusion. The Ion 3D GraftRasp may be used to rasp or decorticate bone from the facets and/or transverse and for the delivery of hydrated allograft or autograft.

The Ion 3D Facet Screw is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following:

  • Spondylolisthesis .
  • o Spondylolysis
  • . Pseudoarthrosis or failed previous fusions which are symptomatic

. Degenerative disc disease (DDD) as defined by back pain of discogenc origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability

The Ion 3D Facet Screw is intended for use with bone graft material (allograft, or autograft).

Device Description

The Ion 3D contains various sized facet screws for bilateral stabilization of the facets from C2-S1. The Ion 3D is provided in various configurations, including single-use, and reusable. The Instruments are offered in sterile and non-sterile configurations. All implants are manufactured from Ti6A14V per ASTM F136.

AI/ML Overview

The provided text is a 510(k) summary for the SurGenTec Ion 3D, a medical device. This type of document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for a novel diagnostic or AI-powered device.

Therefore, the input document does not contain the specific information requested regarding acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/diagnostic device.

The document lists "Performance Testing of the Ion 3D," which includes:

  • Usability Testing
  • Sterilization Validation
  • Cleaning Validation
  • Mechanical Testing per ASTM F543, ASTM F1264, and ASTM F2193
  • Biocompatibility Testing
  • Functionality – Common Material Test
  • Rasp Functionality Test
  • Volume Dispensing Verification Test
  • Simulated Use Validation Testing

These are standard engineering and safety tests for a surgical implant and instrumentation, not performance metrics and studies related to diagnostic accuracy, sensitivity, specificity, or reader studies commonly associated with AI/diagnostic devices.

Without this specific information in the provided text, I cannot complete the table or answer the subsequent questions.

N/A