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The HAnano InterFuse® Modular Interbody is intended to be used for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The HAnano InterFuse® device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous nonfusion surgery at the involved spinal level(s). The HAnano InterFuse® device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems).

The HA™" InterFuse® Modular Interbody is a modular lumbar intervertebral body fusion device with an implantable portion composed of polyetheretherketone (PEEK), a polymer with a history of use in interbody fusion device designs, and which has a compressive modulus similar to bone. This device is designed to be implanted via a PLIF approach utilizing a minimally invasive surgical technique to restore collapsed/afflicted disc space. The device construct consists of an initial A module, any number of middle B modules to appropriately fill the interbody space, and a final C module in which each module interlocks with the adjacent module(s). These modules are inserted via a rail system in which a PEEK and stainless steel tail attached to each module extends beyond the disc space and allows the modules to be inserted in a sequential fashion. The PEEK portion of the tail can be detaches the entire rail and allows the modules to be progressed laterally in the disc space and repeated to construct the implant in an in situ fashion. The modules will be manufactured in several different size/lordotic options to appropriately accommodate patient pathologies.

I am sorry, but the provided text does not contain the information required to fulfill your request. The document describes a 510(k) submission for a medical device (Intervertebral Body Fusion Device) and focuses on demonstrating substantial equivalence to a predicate device. It discusses the device's description, indications for use, modifications, and a summary of technological characteristics.

Crucially, it explicitly states:

• "Performance Testing - Clinical: Clinical testing was not applicable to support a substantial equivalence determination for the subject device."

This indicates that no clinical study (which would typically involve defining acceptance criteria, using a test set, establishing ground truth, and potentially MRMC studies) was conducted or presented in this submission. Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily relies on non-clinical performance testing related to material strength and surface coating (adhesion testing) to support the substantial equivalence claim.

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