(57 days)
The Omnia Medical VBR is a vertebral body replacement system indicated for use in skeletally mature patients to replace a collapsed, damaged, diseased, or unstable vertebral body due to tumor or trauma (i.e. fracture) or for reconstruction following corpectomy performed to achieve decompression of the spinal tissues. The device is intended for use in the cervical spine (from C3 to C7) and in the thoracolumbar spine (from T1-L5). The device is intended for use with supplemental fixation cleared by the FDA for use in the cervical, thoracic, or lumbar spine and is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
The Omnia Medical VBR is manufactured from PEEK-OPTIMA™ HA Enhanced and tantalum markers conforming to ASTM F560. This implant is available in two footprint sizes and offers spacers and endplates which allow for fine adjustments of the height and lordosis to accommodate various patient anatomy. The device features a hollow center and through holes for use with autograft to encourage formation of new bone. The device is intended to be used with supplemental fixation.
Based on the provided text, the document is a 510(k) Premarket Notification from the FDA to Omnia Medical, LLC, regarding their VBR (Vertebral Body Replacement) system. This document is a clearance letter, not a study report, and therefore does not contain the detailed information typically found in a study proving a device meets acceptance criteria for an AI/ML powered device. The document focuses on establishing substantial equivalence to existing predicate devices based on design, materials, and mechanical testing for a physical medical implant, not a diagnostic or prognostic algorithm that would require human-in-the-loop or standalone performance studies against acceptance criteria related to accuracy, sensitivity, or specificity.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, as these are not relevant to the approval of this type of device (a spinal implant) based on the provided text.
The closest relevant information is about "Mechanical Testing," which supports the device's substantial equivalence.
Mechanical Testing Information (as described in the document, which serves as the "study" for this type of device):
- Study Purpose: To demonstrate substantial equivalence to predicate devices.
- Tests Conducted:
- Static and dynamic compression per ASTM F2077
- Static and dynamic torsion per ASTM F2077
- Subsidence per ASTM F2267
- Expulsion testing
- Data Provenance: The data for these tests was "presented in the reference predicate submission (K172323)." This implies the data was collected previously for another submission and reused, rather than newly generated for this specific K191778 submission.
- Device Status: "No new device designs or worst-case sizes are being introduced."
- Conclusion: The previously submitted data supports the expanded indications for use.
Summary of absent information (and why, given the document type):
- A table of acceptance criteria and the reported device performance, sample size, data provenance: Not applicable in the context of an FDA 510(k) clearance letter for a physical implant, where performance is demonstrated through mechanical testing against standards, not clinical accuracy metrics.
- Number of experts, qualifications, adjudication method: Not applicable for mechanical testing of a physical implant. These relate to human interpretation of data, typically for AI/ML or diagnostic devices.
- MRMC comparative effectiveness study: Not applicable. This is for assessing the impact of AI assistance on human readers, relevant for diagnostic AI.
- Standalone (algorithm only) performance: Not applicable. This identifies if a device is a standalone AI algorithm.
- Type of ground truth: Not applicable in the traditional sense. The "ground truth" for a physical implant's mechanical properties is adherence to established ASTM standards under specific testing conditions.
- Sample size for training set & how ground truth for training set was established: Not applicable. These pertain to the development of AI/ML algorithms.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.