(342 days)
The Synthes XRL device is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Synthes XRL device is intended to be used with Synthes supplemental internal fixation systems (e.g., USS, including Matrix and Pangea, and TSLP). The interior of Synthes XRL can be packed with bone (i. e., autograft or allograft). The Synthes XRL device is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The Synthes XRL System is an addition to Synthes' existing thoracolumbar vertebral body replacement systems. These implants are designed to replace a collapsed, damaged or unstable vertebral body and provide anterior spinal column support. These additional implants include telescoping cylindrical components with spiked endplates to grip the adjacent vertebral bodies. These devices are manufactured from PEEK (ASTM F1579-02e1 and ASTM D 6262) with titanium (ASTM F 1295) locking rings and stop pins and tantalum (ASTM F 560) radiopaque markers.
Here's a breakdown of the acceptance criteria and study information for the Synthes XRL System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance (Outcome) |
|---|---|
| Static Axial Compression | Substantially equivalent to predicate devices |
| Dynamic Axial Compression | Substantially equivalent to predicate devices |
| Static Axial Torsion | Substantially equivalent to predicate devices |
| Dynamic Axial Torsion | Substantially equivalent to predicate devices |
| Expulsion | Substantially equivalent to predicate devices |
| VBR Height-Locking Test | Substantially equivalent to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set. It mentions "bench testing results," which implies laboratory-based tests of the device itself rather than patient data. Therefore, the data provenance is likely in-vitro testing and not retrospective or prospective patient data. No country of origin for the data is specified beyond it being performed by Synthes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists interpreting images) is not applicable here. The testing involved bench testing against established ASTM standards (ASTM F2077 and ASTM F1717). The "ground truth" would be the performance requirements set forth in these standards. The individuals conducting and analyzing these engineering tests would be qualified engineers or technicians, but their specific number and detailed qualifications are not provided.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation. Since this was bench testing, no such adjudication method would have been used. The results would be objectively measured against the ASTM standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "Clinical data and conclusions were not needed for this device." Therefore, an MRMC comparative effectiveness study was not performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not relevant as the device is a physical vertebral body replacement system, not a software algorithm. The "performance" refers to the mechanical integrity and function of the implant itself.
7. Type of Ground Truth Used
The ground truth used for the device's performance assessment was based on ASTM standards (ASTM F2077 and ASTM F1717), which define the mechanical properties and performance requirements for spinal implants.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable here. This device underwent bench testing, not machine learning algorithm development.
9. How the Ground Truth for the Training Set Was Established
As stated in point 8, a training set is not relevant for this type of device and study.
§ 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.