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The DIO Medical IVA (ACIF) Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The DIO Medical IVA (PLIF, TLIF, DLIF and ALIF) Cage is indicated for intervertebral body fusion of the lumbar spine, L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage consists of PEEK+Tantalum which is identical to its predicate devices. All of the heights, lengths, and widths are within range covered by its predicate devices.

The provided text describes a medical device, the DIO Medical IVA Cage, and its substantial equivalence to predicate devices, rather than an AI/ML powered device. Therefore, the questions related to acceptance criteria, device performance, sample size, ground truth, expert adjudication, MRMC studies, and training/test sets are not applicable to this document. These questions are typically relevant for evaluating AI/ML models in medical imaging or diagnostics.

The document focuses on the mechanical and material properties of an intervertebral body fusion device and its comparison to existing devices to demonstrate substantial equivalence for regulatory approval.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Device Performance:

• Acceptance Criteria: The device underwent testing according to specific ASTM standards:
  • ASTM F2077: Static and dynamic axial compression testing, static and dynamic torsion testing, static compression shear testing.
  • ASTM F2267: Subsidence testing.
• Reported Device Performance: The document states that "Performance data demonstrate that the DIO Medical IVA (ACIF, PLIF, TLIF, DLIF and ALIF) Cage is as safe and effective as [list of predicate devices]." However, specific quantitative performance metrics (e.g., exact load limits, displacement values, or fatigue life) from these tests are not provided in this summary. The summary only confirms that the testing was performed and deemed sufficient to show substantial equivalence.

2-9. Not Applicable (AI/ML Device):

The following questions are not applicable as the document describes a physical medical implant, not an AI/ML software device:

• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

Summary of Relevant Information:

The DIO Medical IVA Cage is an intervertebral body fusion device. Its acceptance criteria are based on compliance with established ASTM standards for mechanical properties (ASTM F2077 and ASTM F2267). The study performed was a series of mechanical tests to demonstrate that the device performs equivalently to previously approved predicate devices in terms of safety and effectiveness. The specific numerical results of these tests and the test sample sizes are not detailed in this 510(k) summary but are implied to have met the necessary thresholds for substantial equivalence.

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