(51 days)
The EBI ESL Spine Spacer System is intended for use in the thoracolumbar spine (i.e., T l to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The EBI ESL Spinc Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI ESL Spinc Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged time. The system must be used in conjunction with the EBI NGC Spinal System, EBI Omega 21 Spinal System or the EBI SpineLink II Spinal System.
The ESL Spine Spacer is an endplate sparing vertebral body replacement device. The superior and inferior ends are arranged in a convex shape to toolir on the supe of the vertebral endplate. The device is open in the transverse plane to allow the surgeon to pack the device with bone graft prior to insertion. There transverse plane to anow the bateral direction to allow for more bone growth through the all also nors through the medial lateral are available in order to connect two devices within the vertebral space.
The provided 510(k) summary for the EBI ESL Spine Spacer System does not contain details about acceptance criteria, device performance tables, or a study report in the format typically used for AI/ML device evaluations. This document is related to a spinal implant and focuses on mechanical testing and substantial equivalence to predicate devices, rather than a performance study of software or an AI algorithm.
Therefore, many of the requested categories cannot be populated from the provided text.
Here's a breakdown of what can be extracted and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
- Not applicable / Not found in the provided document. The document states "Mechanical testing comparing the EBI devices in regards to intended use, materials and function. Mechanical testing... demonstrated that the device complies with applicable standards and guidelines and meets all of its functional requirements." However, no specific performance metrics or acceptance criteria are listed.
2. Sample Size for the Test Set and Data Provenance
- Not applicable / Not found in the provided document. This information is typically relevant for studies involving data-driven devices or AI. For this spinal implant, "testing" likely refers to benchtop mechanical tests rather than a clinical dataset.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable / Not found in the provided document. This type of expert review is not mentioned as part of the approval process described.
4. Adjudication Method for the Test Set
- Not applicable / Not found in the provided document. This is relevant for studies requiring expert consensus, not for mechanical testing of an inert implant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable / Not found in the provided document. This type of study would compare human performance with and without AI assistance, which is not relevant for this device.
6. Standalone (Algorithm Only) Performance Study
- Not applicable / Not found in the provided document. This device is a physical medical implant, not an algorithm.
7. Type of Ground Truth Used
- Not applicable / Not found in the provided document. No "ground truth" as understood in expert-reviewed data studies is mentioned. The "truth" for this device would be its mechanical properties and biocompatibility.
8. Sample Size for the Training Set
- Not applicable / Not found in the provided document. This pertains to AI/ML model development, which is not relevant here.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not found in the provided document. This pertains to AI/ML model development, which is not relevant here.
Summary of Device-Specific Information from the Document:
- Device Name: EBI ESL Spine Spacer System
- Intended Use: To replace a diseased vertebral body (T1 to L5) resected for tumors, achieve anterior decompression, and restore height of a collapsed vertebral body. Also indicated for treating thoracic and lumbar spine fractures. Designed to restore biomechanical integrity.
- Materials: Titanium, Ti-6Al-4V ELI, per ASTM F136.
- Predicate Devices: EBI Ionic Spine Spacer System (K020887), Synthes Vertebral Spacer Ti (K024364).
- Study/Evidence Provided: "Mechanical testing comparing the EBI devices in regards to intended use, materials and function. Mechanical testing... demonstrated that the device complies with applicable standards and guidelines and meets all of its functional requirements." This indicates bench testing was performed to demonstrate substantial equivalence to predicate devices, focusing on the mechanical properties and function expected of a spinal implant.
- Approval Date: April 16, 2004.
§ 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.