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K Number
K033961
Device Name
ALTIUS OCT SYSTEM
Manufacturer
INTERPORE CROSS INTL.
Date Cleared
2004-04-14

(114 days)

Product Code
KWP
Regulation Number
888.3050
Type
Special
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Altius OCT System is indicated for:

  • DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient . history and radiographic studies)
  • Spondylolisthesis .
  • ◆ Spinal stenosis
  • ◆ Fracture/dislocation
  • Atlantoaxial fracture with instability .
  • . Occipitocervical dislocation
  • . Revision of previous cervical spine surgery
  • . Tumors

The occipital bone screws are limited to occipital fixation only.

The Altius OCT System can be linked to the Synergy Spinal System using the Transitional Rods and Rod Connectors from the Altius OCT System.

Device Description

The Altius OCT System is a titanium system composed of rods, bone screws, hooks, set screws, nuts, cross connectors, plates. For occipito-cervico-thoracic fusion, the occipital plate is fixed to the occiput with bone screws. The pre-bent rod is cut to the appropriate length. Bonc screws are placed in the thoracic spine (T1-T3) and hooks are placed in the cervical spine. The rod is inserted and the construct is locked with screws and nuts. Cross connectors can be added to the construct.

AI/ML Overview

The provided text is a 510(k) summary for the Altius OCT System, a spinal interlaminal orthosis fixation device. It details the device description, indications for use, and its comparison to a predicate device for substantial equivalence.

Based on the information provided, no specific acceptance criteria or results from a study proving the device meets those criteria are described.

Instead, the document states:

  • Comparison to the Predicate Device: "Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the Altius OCT System is considered substantially equivalent to the legally marketed predicate device."

This indicates that the FDA granted clearance based on the device's substantial equivalence to an already legally marketed predicate device, rather than requiring a standalone study with specific performance acceptance criteria. The "equivalent biomechanical performance" mentioned suggests that some biomechanical testing was likely performed to demonstrate similarity to the predicate, but specific acceptance criteria or detailed study results are not included in this summary.

Therefore, for your requested information, the following applies:

  1. A table of acceptance criteria and the reported device performance: Not provided. The basis for clearance is substantial equivalence to a predicate device.
  2. Sample size used for the test set and the data provenance: Not provided. No specific test set for clinical performance is described.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring ground truth establishment is described.
  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a spinal implant device, not an AI-powered diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a spinal implant device, not an AI-powered algorithm.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical test set requiring ground truth is described. The assessment focused on similarity to a predicate device based on indications, materials, and biomechanical performance.
  8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
  9. How the ground truth for the training set was established: Not applicable.

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.