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Zeus Small Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Zeus Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Zeus Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Zeus Lumbar Cages are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from 12-51. 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 at the involved level. Zeus implants are to be used with autogenous bone graft and implanted via an anterior/transforaminal/posterior approach. The Zeus Lumbar Cages are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Zeus Small Cervical Cage was developed as an intercorporal implant for anterior cervical spondylodesis. The top view is trapezoidal with a trapezoidal window for bone graft. The Zeus Cervical Cage has a flat top and bottom.

The Zeus Large/Extra Large Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using an Anterior Lumbar Interbody Fusion (ALIF) technique. To eliminate migration, ridges are incorporated on both the superior and inferior surfaces. Two large windows allow bony growth to form.

The Zeus Curved Large Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Transforaminal Lumbar Interbody Fusion (T-LIF) technique. The Zeus Curved implant has ridges on both its inferior and superior surfaces to prevent migration, and two large graft windows which help facilitate bony integration. It is a curved shape to facilitate insertion using a T-LF approach.

The Zeus Straight Lumbar Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Posterior Lumbar Interbody Fusion (PLIF) technique and is used in pairs. The Zeus Straight implant incorporates ridges on both its superior and inferior surfaces to help eliminate migration. A large rectangular graft space help facilitate bony integration once implanted.

Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications)

This document is a 510(k) summary for the Interbody Innovation Zeus Intervertebral Fusion Devices. It focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel acceptance criteria and studies. Therefore, much of the requested information regarding AI device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC studies is not applicable or available in this document.

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Acceptance Criteria and Device Performance

The document does not detail specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) for an AI device, as it is describing a physical medical device (intervertebral fusion devices). Instead, the "acceptance criteria" are implied by compliance with established standards and comparison to predicate devices.

Study Details:

The study referenced is a non-clinical test conducted to demonstrate the mechanical strength of the device.

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

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

   • The document does not specify a "test set" in the context of an AI device or a clinical study with human subjects.
   • For the mechanical tests, the sample size (number of devices tested) is not explicitly stated.
   • Data provenance: The tests were conducted according to ASTM standards (F2077/F2267). This implies a laboratory setting, not a country of origin in the typical sense of clinical data. The tests are non-clinical.

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

   • N/A. This is a physical device, and the "ground truth" for mechanical performance is defined by the ASTM standards and the physical properties of the device, not by expert consensus on data like images or patient outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • N/A. Adjudication methods are typically for subjective assessments or discrepancy resolution in clinical or image-based studies, which are not described here.

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:

   • N/A. This document describes a physical medical implant, not an AI device or a diagnostic tool utilizing human readers.

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

   • N/A. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the mechanical strength, the "ground truth" is defined by established engineering standards (ASTM F2077/F2267) and the physical properties and performance observed during the non-clinical testing.

8. The sample size for the training set:

   • N/A. This is not an AI device, so there is no training set.

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

   • N/A. As there is no AI training set, this is not applicable.

In summary, this 510(k) pertains to a physical intervertebral fusion device and demonstrates its safety and effectiveness through mechanical testing against recognized standards and substantial equivalence to predicate devices. It does not involve AI, clinical studies with human "test sets," or the establishment of ground truth by clinical experts in the way an AI diagnostic device would.

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