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The Hexanium® PLIF (Posterior Lumbar Interbody Fusion) system is an intervertebral body fusion device indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two continuous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least 6 months of non-operative treatment prior to treatment with Hexanium PLIF system. This device has to be filled with autogenous bone graft material. This device is implanted via the posterior approach. Hexanium PLIF system must be used in combination with supplemental internal spinal fixation which has been cleared by the FDA for use in the lumbar spine.

The Hexanium® PLIF (Posterior Lumbar Interbody Fusion) is a titanium alloy (Ti6Al4V ELI) interbody cage manufactured via an Additive Manufacturing method. The honeycomb structure allows for bone through-growth through the structure of the cage as well as providing lateral and vertical bone graft windows in the body of the cage. Hexanium® PLIF cages are available in heights of 7-16 mm (in 1 mm increments), width of 9 mm, lengths of 22 and 25 mm, and lordosis angles of 0°, 5°, and 8°. Hexanium® PLIF cages are provided sterile and supplied with a set of non-sterile surgical instruments.

The Hexanium® PLIF (Posterior Lumbar Interbody Fusion) system is an intervertebral body fusion device. The provided text lacks the detailed "acceptance criteria" and subsequent "reported device performance" typically found in a clinical study report for AI-powered devices. The document is a 510(k) summary for a medical device (an intervertebral body fusion device, not an AI device) where equivalence to a predicate device is established through mechanical testing, not clinical performance data. Therefore, the questions related to AI device performance metrics, such as sensitivity, specificity, or human-in-the-loop performance, and associated study details are not applicable here.

However, I can extract information related to the device's performance data that was provided to demonstrate substantial equivalence:

1. A table of acceptance criteria and the reported device performance:

The document states that the Hexanium® PLIF cages conform to the FDA guidance "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" dated June 12, 2007. The device was evaluated against predetermined functional and performance requirements and external standard requirements.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the document for mechanical testing. These tests typically involve a specific number of device samples (e.g., typically N=6 or more) for each test configuration, as defined by the ASTM standards, but the exact number is not provided.
• Data Provenance: The tests are laboratory-based mechanical and biocompatibility tests, not human data. The document does not specify a country of origin for the testing itself, but the submitter is based in France.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable. The device is not an AI device requiring expert-established ground truth for a test set. The performance is assessed against engineering standards and material properties.

4. Adjudication method for the test set:

This question is not applicable. There was no clinical adjudication for an AI device. Mechanical and biocompatibility tests are assessed against predefined pass/fail criteria from international standards.

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:

This question is not applicable. No MRMC study was conducted as this is not an AI device. The document explicitly states: "No clinical data has been presented."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This question is not applicable. This is not an AI device.

7. The type of ground truth used:

For mechanical testing, the "ground truth" is defined by the objective pass/fail criteria established within the referenced ASTM international standards for intervertebral body fusion devices (e.g., F2077, F2267, F-04.25.02.02). For biocompatibility, the ground truth is the pyrogen limit specification as per USP.

8. The sample size for the training set:

This question is not applicable. There is no training set as this is not an AI/machine learning device. The device's design and manufacturing process are based on established engineering principles for intervertebral body fusion devices.

9. How the ground truth for the training set was established:

This question is not applicable. There is no training set for an AI device. The device's performance is demonstrated through in-vitro mechanical and biocompatibility testing against predefined standards.

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The Hexanium® ACIF (Anterior Cervical Interbody Fusion) system is an intervertebral body fusion device indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from C3-T1. DDD is defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least 6 weeks of non-operative treatment prior to treatment with Hexanium® ACIF system. This device has to be filled with autogenous bone graft material. This device is implanted via an anterior approach.

The Hexanium® ACIF is a titanium alloy (Ti6Al4V ELI) interbody cage manufactured via an Additive Manufacturing method. The honeycomb structure allows for bone through-growth through the structure of the device as well as providing lateral and vertical bone graft windows in the body of the cage. Hexanium® ACIF is available in 2 sagittal profiles (lordotic 6º and convex 6°), heights of 5-12 mm, and 3 footprints (15x12mm, 17x14mm, and 19x15mm). The Hexanium® ACIF screws are self-drilling and available in lengths of 10, 12, 14, and 16mm and diameters of 3.50 and 3.80mm. Hexanium® ACIF is provided sterile. The Hexanium® ACIF system includes a set of reusable surgical instruments. The purpose of this Special 510(k) application is to propose minor modifications to the currently cleared surgical instruments. There are no modifications being proposed for the implantable components of the system

This is not an AI/ML medical device. This is a medical device for intervertebral body fusion. Thus the acceptance criteria for AI devices do not apply here.

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