(135 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 XYcor™ Spinal Implant is intended for use with bone graft and supplemental internal fixation for vertebral body replacement. The supplemental internal fixation systems that may be used with the XYcor™ 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 screwrod/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 XY cor™ Spinal Implant is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e., facet screw fixation systems, facet compression devices, and posterior pedicle screw and rod systems).
The XY cor™ Spinal Implant is a spinal implant fabricated from titanium that can be used as a vertebral body replacement device or an intervertebral body fusion device. The XYcor™ Spinal Implant deploys with a self-locking mechanism. The footprint of XYcor™ Spinal Implant V2-25 before and after deployment is of comparable size and shape to the other sizes of the XY cor™ implant.
The provided text describes a 510(k) submission for the XYcor™ Spinal Implant, focusing heavily on its intended use, design, and claiming substantial equivalence to a previously cleared device. The "Performance Data" section specifically mentions mechanical testing.
Here's an analysis of the acceptance criteria and study information based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sufficient strength for static compressive loading | Demonstrated sufficient strength for static compressive loading modes. |
| Sufficient strength for dynamic compressive loading | Demonstrated sufficient strength for dynamic compressive loading modes. |
| Sufficient strength for torsional loading | Demonstrated sufficient strength for torsional loading modes. |
| Resistance to subsidence | Demonstrated resistance to subsidence. |
| Resistance to expulsion | Demonstrated resistance to expulsion. |
| Safety and effectiveness | The results did not raise any issues on the safety or effectiveness of the device. |
Explanation: The document does not explicitly state numerical or specific pass/fail criteria for the mechanical tests (e.g., "must withstand X N of compression"). However, it does report that the device "demonstrated sufficient strength" and "resistance," implying these were the criteria evaluated. The final statement regarding safety and effectiveness acts as an overarching acceptance criterion.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only states "Mechanical testing was performed on the XY cor™ Spinal Implant V2-25." It does not provide the number of devices tested.
- Data Provenance: The document does not specify the country of origin of the data. Given it's a 510(k) submission to the FDA, it can be inferred the data was generated to meet US regulatory requirements, but the physical location of the testing is not stated. The study is prospective in the sense that the testing was conducted specifically to support this regulatory submission for the V2-25 small size implant.
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 testing study, not a clinical study involving expert interpretation of data (e.g., imaging). The "ground truth" for mechanical testing is based on engineered specifications and physical measurements, not expert consensus.
4. Adjudication Method for the Test Set
- This information is not applicable for the same reasons as point 3. Mechanical test results do not typically involve adjudication by experts in the way clinical data might. The measured outcomes are objective physical properties.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in the provided text. The submission focuses on mechanical testing.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- This information is not applicable. The device is a physical spinal implant, not an algorithm or AI software. Therefore, the concept of "standalone (algorithm only)" performance does not apply.
7. Type of Ground Truth Used
- The ground truth for this device's performance is based on mechanical engineering principles and measurements. The "sufficient strength" and "resistance" claims are derived from objective physical testing against established biomechanical standards and possibly comparison to the predicate device's performance.
8. Sample Size for the Training Set
- This information is not applicable. There is no mention of a "training set" because the device is a physical implant, not an AI/machine learning model.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reasons as point 8.
§ 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.