(101 days)
The XY cor™ Spinal Implant is indicated for use as a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The XYcor™ Spinal Implant is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
The XY cor™ Spinal Implant is intended for use with bone graft and supplemental internal fixation. The supplemental internal fixation systems that may be used with the X Y cor™ System include Medtronic Sofamor Danek TSRH 3D, DePuy Spine Expedium or Monarch pedicle screw fixation systems, Biomet, Polaris, Array or Omega-21 pedicle screw fixation systems, and other pedicle screw-rod/plate fixation systems that have biomechanical properties similar to those of the above-listed systems, including trans-facet fixation systems but excluding semi-rigid or flexible rod-screw systems.
The XYcor™ Spinal Implant is a vertebral body replacement device fabricated from titanium. The XYcor™ Spinal Implant deploys with a self-locking mechanism. The footprint of XY cor™ Spinal Implant prior to deployment is of comparable size and shape to the DEVEX™ System and, after deployment, is of comparable size to the InFix® System.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sufficient strength for static loading modes. | "The XYcor™ Spinal Implant demonstrated sufficient strength for static... compressive and torsional loading modes..." |
| Sufficient strength for dynamic compressive loading modes. | "The XYcor™ Spinal Implant demonstrated sufficient strength for... dynamic compressive and torsional loading modes..." |
| Sufficient strength for dynamic torsional loading modes. | "The XYcor™ Spinal Implant demonstrated sufficient strength for... dynamic... torsional loading modes..." |
| Resistance to subsidence. | "The XYcor™ Spinal Implant demonstrated... resistance to subsidence..." |
| Resistance to expulsion. | "The XYcor™ Spinal Implant demonstrated... resistance to... expulsion." |
| Not raise any issues on the safety of the device. | "The results did not raise any issues on the safety... of the device." |
| Not raise any issues on the effectiveness of the device. | "The results did not raise any issues on the... effectiveness of the device." |
| Comparable material, intended use, basic design concept, size of footprint, and biomechanical properties to the INFIX® System (K010530). | The device is stated to be "substantially equivalent to INFIX® System... in material, intended use, basic design concept, size of the footprint, and biomechanical properties." (This is a comparative criterion rather than an absolute performance metric for the XYcor itself, but serves as an acceptance criterion for substantial equivalence). |
| Comparable self-locking mechanism after distraction to the SYNEX™ Spacer System (K003836). | The device is stated to be "also substantially equivalent to the SYNEX™ Spacer System... in its self-locking mechanism after distraction." (Again, a comparative criterion for substantial equivalence). |
| Comparable shape prior to deployment and posterior approach used in surgical placement to the DEVEX™ System (K023835). | The device is stated to be equivalent to "the DEVEX ™ System... in its shape prior to deployment and the posterior approach used in surgical placement." (Again, a comparative criterion for substantial equivalence). |
Note: The acceptance criteria are largely implied from the "Performance Data" section. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed, explicit acceptance criteria with specific numerical thresholds typical of a full design verification report.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set. The reported "Performance Data" refers to "Mechanical testing" but does not detail the number of units tested. This is a common characteristic of 510(k) summaries where detailed testing protocols and results (including sample sizes) are typically found in the full submission, not the summary.
Furthermore, there is no information provided on data provenance (e.g., country of origin, retrospective or prospective nature of clinical data). The evaluation appears to be based solely on mechanical testing, not clinical studies involving patient data in the typical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided and is not relevant for the type of study described. The study is a mechanical engineering test on a medical device, not an image-based diagnostic or clinical study requiring expert ground truth for interpretation.
4. Adjudication Method
This information is not provided and is not relevant for the type of study described (mechanical testing).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission relies on mechanical testing to demonstrate substantial equivalence to predicate devices, not improvement in human reader performance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, a standalone performance study in the form of mechanical testing was performed. The "Performance Data" section states, "Mechanical testing was performed on the XYcor™ Spinal Implant and the results are presented." This implies the device was tested independently of human interaction in simulating its intended biomechanical function.
7. Type of Ground Truth Used
The "ground truth" for this study is based on engineering standards and established biomechanical testing methodologies for vertebral body replacement devices. The performance metrics (strength for static/dynamic loading, resistance to subsidence/expulsion) are evaluated against pre-defined engineering requirements and comparison to predicate devices, rather than expert consensus, pathology, or outcomes data which are typically associated with clinical studies.
8. Sample Size for the Training Set
This information is not applicable as this is not a study involving machine learning or algorithms that require a training set. The study describes mechanical testing of a physical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of mechanical testing 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.