(156 days)
The Giza® Vertebral Body Replacement is intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g. fracture). The Giza® Vertebral Body Replacement is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The use of allograft with the Giza® Vertebral Body Replacement device is optional.
The Giza® is a thoracolumbar vertebral body replacement device. The Giza is comprised of a variety of implant sizes to accommodate various patients' anatomy and pathology, and associated instrumentation. The devices are available in three diameters, 14mm, 21mm and 27mm. The Giza® device can accommodate lordosis from 2-12 degrees and from18 mm to 90mm in height. . All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).
The provided document is a 510(k) summary for the Giza® Vertebral Body Replacement. This type of regulatory submission is for a medical device that demonstrates substantial equivalence to a legally marketed predicate device, rather than proving novel clinical efficacy. Therefore, the information typically requested in your prompt (e.g., acceptance criteria for device performance, clinical study results, expert adjudication, MRMC studies, standalone algorithm performance, number of experts, and training set details) is not relevant or present in this document.
Instead, the submission focuses on bench testing to demonstrate that the Giza® device performs comparably to its predicate devices in specific mechanical aspects.
Here's a breakdown of the relevant information provided:
1. Acceptance Criteria and Reported Device Performance (Bench Testing):
| Performance Test | Acceptance Criteria | Reported Device Performance (Giza®) |
|---|---|---|
| Static Axial Compression | Following ASTM F2077-03 | Indicated "substantially equivalent to the predicate devices and is adequate for the intended use." |
| Dynamic Axial Compression | Following ASTM F2077-03 | Indicated "substantially equivalent to the predicate devices and is adequate for the intended use." |
| Static Torsion | Following ASTM F2077-03 | Indicated "substantially equivalent to the predicate devices and is adequate for the intended use." |
| Dynamic Torsion | Following ASTM F2077-03 | Indicated "substantially equivalent to the predicate devices and is adequate for the intended use." |
| Subsidence | Following ASTM F2267-04 | Indicated "substantially equivalent to the predicate devices and is adequate for the intended use." |
| Expulsion Testing | Following a recognized protocol to allow comparison evaluation of intervertebral body fusion device assemblies, and characterize their resistance to expulsion. | Indicated "substantially equivalent to the predicate devices and is adequate for the intended use." |
| Packaging | ISO 11607 | Provided according to ISO 11607 |
| Sterility | (Implicitly meet standards for sterile devices) | Provided sterile (according to ISO 11607 packaging) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the bench tests.
- Data Provenance: The tests are "pre-clinical testing" and "bench testing," meaning they were conducted in a laboratory setting. There is no mention of human data, country of origin, or whether it was retrospective or prospective, as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to bench testing. The "ground truth" for these tests is defined by the ASTM standards and recognized protocols, which are engineering and materials science specifications.
4. Adjudication method for the test set:
- Not applicable to bench testing. Testing against engineering standards does not involve expert adjudication in the way clinical data might.
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 device is a physical implant, not an AI or imaging diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used:
- For bench testing, the "ground truth" is adherence to established international standards (ASTM F2077-03, ASTM F2267-04, ISO 11607) and recognized protocols for assessing mechanical performance, such as resistance to expulsion.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of this device's mechanical performance assessment against standards.
9. How the ground truth for the training set was established:
- Not applicable.
In summary: The provided document describes the mechanical testing conducted on the Giza® Vertebral Body Replacement to demonstrate its substantial equivalence to previously approved predicate devices. This involves proving that the new device meets established engineering performance standards for spinal implants, rather than clinical trial data or AI performance metrics.
§ 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.