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The Innovasis HAtetracell™-C Titanium Cervical IBF System is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.

This device is to be used in patients who have had six weeks of non-operative treatment. The HAtetracell™-C device is to be used with supplemental fixation, such as the Innovasis Oryx® Cervical Plate System. The HAtetracell™-C device is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone and is to be implanted via an anterior approach.

The HAtetracell™-C Titanium Cervical IBF System is an intervertebral body fusion (IBF) device with associated instrumentation, used with bone graft material, intended to stabilize a cervical spinal segment to promote fusion which restricts motion and decreases pain. The HAtetracel™ -C Titanium Cervical IBF System is implanted via an Anterior Cervical Discectomy and Fusion (ACDF) surgical aproach. The HAtetracel™ - C implants are an additive mane from titanium alloy Ti-6Al-4V ELI per ASTM F3001 and are coated with a hydroxyapatite HAnano surface. The trabecular structures on the endplate contact surfaces , micro-, and nanofeatures that are designed to mimic cortical and cacellous bone to help facilitate intervertebral fusion. The HAtetracell™-C implant features a tapered nose to aid in insertion and protect the porous layer during insertion, a graft cavity to provide volume for bone graft, and the open lattice structure is designed to radiographic signature. The implant is available in multiple size options to match vertebral anatomy and is designed to restore height in the cervical spinal column during the fusion process. Implants are supplied sterile. Reusable instruments to support the surgery are provided with the implants in sterilization trays.

{
  "acceptance_criteria_and_performance_table": {
    "title": "Summary of Mechanical Testing and Acceptance Criteria",
    "headers": [
      "Test Type",
      "Standard",
      "Acceptance Criteria",
      "Reported Device Performance"
    ],
    "rows": [
      [
        "Static and dynamic torsion testing",
        "ASTM F2077",
        "Met acceptance criteria when compared with the predicate device and/or FDA cleared devices.",
        "Met acceptance criteria."
      ],
      [
        "Static and dynamic axial compression testing",
        "ASTM F2077",
        "Met acceptance criteria when compared with the predicate device and/or FDA cleared devices.",
        "Met acceptance criteria."
      ],
      [
        "Static and dynamic compression shear testing",
        "ASTM F2077",
        "Met acceptance criteria when compared with the predicate device and/or FDA cleared devices.",
        "Met acceptance criteria."
      ],
      [
        "Static subsidence testing",
        "ASTM F2267",
        "Met acceptance criteria when compared with the predicate device and/or FDA cleared devices.",
        "Met acceptance criteria."
      ],
      [
        "Particulate analysis after dynamic testing",
        "ASTM F1877",
        "Met acceptance criteria when compared with the predicate device and/or FDA cleared devices.",
        "Met acceptance criteria."
      ],
      [
        "Static expulsion testing",
        "FDA guidance special controls document",
        "Met acceptance criteria when compared with the predicate device and/or FDA cleared devices.",
        "Met acceptance criteria."
      ],
      [
        "Abrasive resistance testing",
        "ASTM F1978",
        "Met acceptance criteria when compared with the predicate device and/or FDA cleared devices.",
        "Met acceptance criteria."
      ]
    ]
  },
  "sample_size_test_set_provenance": "Not applicable as no clinical data or test set involving human subjects was used. All testing was non-clinical (mechanical).",
  "num_experts_ground_truth_qualifications": "Not applicable as no clinical data or ground truth established by experts was used.",
  "adjudication_method": "Not applicable as no clinical data or ground truth adjudication was performed.",
  "mrmc_comparative_effectiveness_study": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed.",
  "standalone_performance": "Not applicable, as this is a physical intervertebral body fusion device and not a software algorithm.",
  "type_of_ground_truth_used": "Not applicable. The 'ground truth' for the mechanical tests was established by adherence to industry standards (ASTM) and FDA guidance for performance criteria.",
  "sample_size_training_set": "Not applicable as no training set was used for this device's evaluation (no AI/machine learning component).",
  "how_ground_truth_for_training_set_established": "Not applicable as no training set was used."
}

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