(83 days)
The Phenix™ VBR is a vertebral body replacement device intended for use in the thoracic spine (i.e., T1-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy) due to tumor or trauma (i.e., fracture). The Phenix™ VBR is designed to restore the mechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The Phenix™ VBR is intended for use with supplemental spinal fixation systems that have been labeled for use in the thoracic spine. The interior of the Phenix™ VBR may be packed with bone graft.
The Phenix™ VBR is a rectangular implant with an open center comprised of titanium, (Ti-6Al-4V). The Phenix™ VBR's superior and inferior ends have ridges to interface with the vertebral endplates to resist rotation and migration. The implant is available in a range of sizes, as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. The Titanium allows for radiographic visualization.
This document is a 510(k) premarket notification for the Phenix™ Vertebral Body Replacement (VBR) device. It is a submission to the FDA for market clearance, not a study demonstrating device performance against acceptance criteria in the manner of a clinical trial or AI algorithm validation. Therefore, many of the requested categories are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative measurement sense, nor does it report specific device performance metrics against such criteria in the provided text. The "Performance Data" section merely states: "Testing was completed to characterize the device." This implies mechanical or material property tests, but no results or acceptance criteria for those tests are detailed in this document.
Therefore, a table cannot be constructed from the provided information.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided because the document is a 510(k) premarket notification, not a clinical study report validating performance against specific acceptance criteria for software or an AI device. The "test set" in this context would likely refer to the physical Phenix™ VBR devices subjected to mechanical testing. The provenance of such physical tests (e.g., in a lab, specific conditions) is not detailed here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This is not an AI or diagnostic device requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI or diagnostic device requiring expert interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a physical spinal implant, not a diagnostic imaging device or an AI assistant for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical spinal implant, not an algorithm.
7. Type of Ground Truth Used
Not applicable in the typical sense for medical device performance (e.g., pathology for diagnostic accuracy). The "ground truth" for a physical implant would be its adherence to design specifications, material properties, and mechanical performance under various loads, which would be assessed through engineering tests, not a "ground truth" established by experts.
8. Sample Size for the Training Set
Not applicable. This is a physical spinal implant, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical spinal implant, not a machine learning model.
Summary of Device Information from the 510(k) Application:
- Device Name: Phenix™ Vertebral Body Replacement (VBR)
- Company: Spinal Devices, LLC
- Classification: Class II
- Product Code: MQP, 888.3060 (Spinal intervertebral body fixation orthosis)
- Device Description: Rectangular implant with an open center, made of titanium (Ti-6Al-4V). Features ridges on superior and inferior ends for vertebral endplate interface. Available in various sizes, flat and lordotic angles. Radiographically visible.
- Intended Use: For use in the thoracic spine (T1-L5) to replace collapsed, damaged, or unstable vertebral bodies resected due to tumor or trauma (fracture). Designed to restore mechanical integrity of the spinal column. Intended for use with supplemental spinal fixation systems labeled for thoracic spine use. Can be packed with bone graft (autograft bone mentioned in the "Indications for Use Statement").
- Predicate Device: Substantial equivalence was determined based on the same indications for use, intended use, design, and performance to a predicate device (not named in the provided text).
- Performance Data: "Testing was completed to characterize the device." (No specific results or acceptance criteria are detailed in this extract).
- FDA Clearance Date: October 15, 2007 (K072029)
§ 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.