(29 days)
The Construx™ Mini PEEK VBR System is indicated for use in the thoracolumbar spine (T1-L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Construx™M Mini PEEK VBR System is also indicated for treating fractures of the thoracic and lumbar spine.
The ConstruxTM Mini PEEK VBR 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 period of time. The VBR device is intended to be used with bone graft material
The Construx™ Mini PEEK VBR System is intended for use with supplemental internal fixation. The supplemental internal fixation system that may be used with the PEEK VBR System is the Blackstone Medical Spinal Fixation System.
Blackstone Medical, Inc. Contrux™ Mini PEEK Vertebral Body Replacement (VBR) System is comprised of a variety of implants fabricated and manufactured from Polyetheretherketone (PEEK Optima LT1) as described by ASTM F-2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. The teeth on the superior and inferior surfaces of the construct provide increased stability and help prevent anterior/posterior movement of the device.
This document is a 510(k) premarket notification for a medical device called the Construx™ Mini PEEK VBR System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance data in the way a PMA (Premarket Approval) submission would.
Therefore, the requested information about acceptance criteria and a study proving the device meets those criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this 510(k) submission.
Here's why and what information is provided:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. For a 510(k), the "acceptance criteria" for performance are primarily based on demonstrating that the new device is as safe and effective as a predicate device already on the market. There are no specific quantitative performance metrics (like sensitivity, specificity, accuracy, etc.) for the device itself that are 'accepted' by reaching a certain threshold. Instead, the "performance" demonstrated is that it is substantially equivalent to existing devices through comparison of design, materials, indications for use, and possibly bench testing to show similar mechanical properties (though specific bench test results are not detailed in this public summary).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This 510(k) does not mention clinical trials with test sets involving human subjects or data provenance in the context of device performance metrics. The demonstration of substantial equivalence typically relies on comparison to predicate devices, material specifications, and potentially non-clinical (e.g., mechanical) testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. No ground truth establishment by experts for a test set is mentioned, as this is not a study focused on diagnostic accuracy or clinical outcomes in the same way a diagnostic AI device would be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or expert adjudication is described in this 510(k) summary.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is a spinal implant (Vertebral Body Replacement System), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. As mentioned above, this is a physical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Applicable. No ground truth is established in the context of performance metrics for this type of device submission. The "ground truth" for a 510(k) is effectively the established safety and effectiveness of the predicate devices.
8. The sample size for the training set:
- Not Applicable. This is a physical medical implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. No training set is used for this physical medical device.
What is provided in this 510(k) summary is the basis for substantial equivalence:
- Device Name: Construx™ Mini PEEK VBR System
- Intended Use/Indications for Use: Replacement of diseased vertebral body (T1-L5) for tumors, anterior decompression, restoration of height, and treatment of fractures. Intended for use with bone graft material and supplemental internal fixation.
- Device Description: Made from Polyetheretherketone (PEEK Optima LT1) for radiolucency. Designed to restore biomechanical integrity.
- Predicate Devices:
- Basis of Substantial Equivalence: The Construx™ Mini PEEK VBR System is deemed substantially equivalent to the listed predicate devices which "have been cleared by FDA for use in patients with tumor, trauma or fractures." This implies that the new device shares similar technological characteristics, materials, design, and indications for use with these already cleared devices, making it equally safe and effective.
§ 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.