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CO Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (T1-L5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.e. fracture). These are not stand-alone devices, ISOBAR Ø6.2 Hemispherical Screws with Offset Clamps and Ø5.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.

The CO Vertebral Body Replacements are rectangular shaped in pairs for full corpectomy or individually when only a portion of the vertebral body is resected. The interior of the spacers is open to provide space for bone graft. The implant is always implanted in the vertical position. These components are available in various heights (7mm-150mm) and cross sections to accommodate the variability of patient size, anatomic variation, and the size of the vertebral body defect. The superior and inferior surfaces of these components have ridges to interface with the vertebral endplates to resist rotation and migration. The body has a multitude of holes to allow additional impaction of bone graft.

The CO components are fabricated from pure poly(ether cther ketone) (PEEK). This material closely matches the modulus of elastical bone, improving the biomechanical interface and reducing the stress shielding effect. They are fully radio-translucent, which enables optimum follow-up with diagnostic imaging, as the interbody fusion progresses. I wo metal wires at the opposite cads of the spacers allow radiological confirmation of the cage position post operatively.

This 510(k) summary describes a spinal implant device (CO Vertebral Body Replacements) and therefore does not include information about acceptance criteria or a study proving that the device meets them in the context of device performance metrics like sensitivity, specificity, accuracy, etc., which are typically found for AI/ML-driven devices or diagnostic tools.

Instead, the documentation focuses on demonstrating substantial equivalence to a predicate device based on its design, materials, and intended use. The "study" mentioned is a non-clinical summary that compares the new device to a previously cleared one.

Therefore, many of the requested categories (e.g., sample size for test/training sets, experts, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This is a mechanical device, and the "test set" in this context refers to the non-clinical comparative analysis against a predicate device, not empirical data from a study with patients.

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

• Not Applicable. Ground truth, in the sense of expert consensus on medical images or diagnoses, is not relevant for the regulatory clearance of this mechanical spinal implant based on substantial equivalence.

4. Adjudication method for the test set

• Not Applicable. See above.

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

• Not Applicable. This is a mechanical spinal implant, not an AI-driven diagnostic or assistive device.

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

• Not Applicable. This is a mechanical device.

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

• The ground truth for this submission is based on the previously cleared predicate device (Scient'x Ellys VBR, K033109). The "truth" is established by demonstrating that the new device shares fundamental technological characteristics with a device already deemed safe and effective.

8. The sample size for the training set

• Not Applicable. This is a mechanical device, and there is no "training set" in the computational sense.

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

• Not Applicable. See above.

In summary: The provided document is a 510(k) summary for a mechanical spinal implant. The regulatory pathway for such devices typically relies on demonstrating substantial equivalence to an existing, legally marketed predicate device, rather than extensive clinical trials or performance studies with acceptance criteria as would be seen for diagnostic software or AI/ML devices. The "study" mentioned is a non-clinical comparison focusing on design, materials, and intended use.

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