(56 days)
The Xspan™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Xspan Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent expulsion of the allograft or impingement of the spinal cord.
The Xspan™ Laminoplasty Fixation System is a posterior implant system comprised of laminoplasty plates, hinge plates, and mounting screws. Various forms and sizes of these implants are available so that adaptations can be made to take into account the pathology and anatomy of an individual patient. The system components are manufactured from Titanium based alloy in accordance with ASTM F136. The single use only implants are provided sterile [gamma radiation] and should not be reused under any circumstances.
The system also includes instrumentation to aid with implantation. The instruments are supplied in a tray which is used for instrument sterilization and storage.
The provided text is a 510(k) Summary for the Xspan™ Laminoplasty Fixation System, a medical device for spinal surgery. This document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and mechanical performance. It does not contain information typically found in a study demonstrating the device meets specific acceptance criteria related to a diagnostic or AI algorithm's performance.
Therefore, many of the requested categories cannot be filled as they pertain to studies evaluating the performance of AI/diagnostic devices, which is not the subject of this 510(k) summary. I will answer based on the information available in the document, and indicate "Not Applicable" or "Not Provided" where the information is not present.
Acceptance Criteria and Study Summary for Xspan™ Laminoplasty Fixation System
This device is a surgical implant, not a diagnostic or AI-driven device. The "acceptance criteria" here refer to the performance benchmarks established through mechanical testing to demonstrate equivalence to predicate devices, rather than criteria for diagnostic accuracy (e.g., sensitivity, specificity).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Equivalent performance to predicate devices through static and dynamic 4-point bend testing (referenced ASTM F2193 and ASTM F382). | The Xspan™ Laminoplasty Fixation System demonstrated equivalent performance to the predicate systems through static and dynamic 4-point bend testing. |
| Biocompatibility | Conformance to ASTM F136 for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications. Material historically proven biocompatible, corrosion-resistant, and non-toxic. | Implants are made of titanium alloy conforming to ASTM F136. The material has a long history of use and proven biocompatibility, corrosion-resistance, and non-toxicity. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as "sample size" in the context of a clinical test set. For mechanical testing, the information on the number of devices or test specimens is not provided.
- Data Provenance: Not applicable in the context of clinical data. For mechanical testing, the data origin is from internal testing performed by X-spine Systems, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a surgical implant, and the performance evaluations primarily involve mechanical testing and material conformance, not expert-adjudicated ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for establishing ground truth in diagnostic studies, not for mechanical performance testing of a spinal implant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
Not applicable. This is a medical device (spinal implant), not an AI-driven diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a medical device, not an AI algorithm.
7. Type of Ground Truth Used
- For Mechanical Testing: Engineering specifications and standardized test methods (ASTM F2193 and ASTM F382) served as the "ground truth" or benchmarks for performance. Comparison was made against established performance profiles of predicate devices.
- For Biocompatibility: Material standards (ASTM F136) and historical evidence of biocompatibility for the specified titanium alloy served as the "ground truth."
8. Sample Size for the Training Set
Not applicable. This device does not involve an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device does not involve an AI algorithm or a training set.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.