(86 days)
The Omnia Medical VBR is a vertebral body replacement system indicated for use to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e. fracture). The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The device is intended for use with supplemental fixation cleared for use in the thoracolumbar spine and is to be used with autograft and/or allograft.
The Omnia Medical VBR is manufactured from PEEK-OPTIMA™ HA Enhanced conforming to ASTM F2026 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 or allograft to encourage formation of new bone. The device is intended to be used with supplemental fixation.
The FDA 510(k) K172323 submission for the Omnia Medical VBR (Vertebral Body Replacement) provides the following information regarding its acceptance criteria and the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes the type of mechanical testing performed, but does not explicitly state numerical acceptance criteria or specific reported performance values. The primary acceptance criterion appears to be demonstrating substantial equivalence to the predicate device (Vu Mesh VBR, K070381) through these mechanical tests.
| Acceptance Criteria Type | Reported Device Performance (as implied by the document) |
|---|---|
| Static Compression | Supports substantial equivalence |
| Dynamic Compression | Supports substantial equivalence |
| Static Torsion | Supports substantial equivalence |
| Dynamic Torsion | Supports substantial equivalence |
| Subsidence | Supports substantial equivalence |
| Expulsion Testing | Supports substantial equivalence |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions that mechanical testing was performed per ASTM F2077 and ASTM F2267. These standards typically specify the number of samples required for such tests. However, the exact sample sizes used in this specific study are not explicitly stated in the provided text.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given that it's mechanical testing of a device, the data would have been generated experimentally in a lab setting, likely in the US where Omnia Medical, LLC is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the study described is a mechanical performance test of a medical device, not a human or animal study requiring expert-established ground truth. The "ground truth" for mechanical testing is based on established engineering principles and ASTM standards.
4. Adjudication Method for the Test Set:
This information is not applicable for mechanical performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not conducted. This type of study is typically performed for diagnostic or AI-assisted interpretation devices involving human readers. The Omnia Medical VBR is a physical implant, and its evaluation focuses on mechanical integrity.
6. If a Standalone Performance Study Was Done:
Yes, a standalone performance study was done in the form of mechanical testing of the device itself (algorithm only without human-in-the loop performance, if we consider the device's inherent mechanical properties as its "algorithm"). The document states: "Substantial equivalence is supported by the results of mechanical testing including static and dynamic compression per ASTM F2077, static and dynamic torsion per ASTM F2077, subsidence per ASTM F2267, and expulsion testing." This indicates the device's performance was evaluated independently against established standards.
7. The Type of Ground Truth Used:
The "ground truth" for this study was based on established engineering standards and regulatory requirements (ASTM F2077, ASTM F2267) which define acceptable mechanical properties for spinal implants. The device's performance was compared to these standards and to the characteristics of a legally marketed predicate device.
8. The Sample Size for the Training Set:
This information is not applicable. Mechanical testing does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable.
§ 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.