(267 days)
The Qualgenix Blue Mountain Cervical Plate is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Qualgenix Blue Mountain Cervical Plate is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies with degeneration of the disc), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, lordosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions.
This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.
The Qualgenix Blue Mountain Cervical Plate is a system that includes titanium alloy (ISO 5832-3) plates and screws that are intended to stabilize the spine during the interbody fusion process.
The provided text describes a 510(k) summary for the Qualgenix Blue Mountain Cervical Plate, a spinal fixation device. However, this document does not describe an AI medical device or a study involving AI performance. It details a traditional medical device submission, focusing on substantial equivalence to predicate devices through material and mechanical testing.
Therefore, most of the requested information regarding AI device performance, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies cannot be extracted from this document, as it pertains to a different type of medical device evaluation.
Below is a partial response based on the information that is available, specifically for mechanical testing.
Acceptance Criteria and Study for Qualgenix Blue Mountain Cervical Plate
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance (Goal) | Device Performance (Result) |
|---|---|---|
| Static Compression Bending | Substantially equivalent to predicate devices (per ASTM F1717-10) | Met (implied by "substantially equivalent") |
| Dynamic Compression Bending | Substantially equivalent to predicate devices (per ASTM F1717-10) | Met (implied by "substantially equivalent") |
| Static Torsion | Substantially equivalent to predicate devices (per ASTM F1717-10) | Met (implied by "substantially equivalent") |
Note: The document states that testing indicates the device is "substantially equivalent to predicate devices" and was performed "per ASTM F1717-10". This implies that the device's performance results met or exceeded the established benchmarks derived from the predicate devices under the specified ASTM standard.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. For mechanical testing, sample sizes would refer to the number of physical devices or components tested. The document does not specify these numbers or the provenance of any data beyond indicating "testing performed on this device."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable to this type of device and study. The study involves mechanical performance testing against an ASTM standard, not clinical data requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This is not applicable to this type of device and study. Mechanical tests follow predefined protocols and objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This is not applicable. This study concerns the mechanical equivalence of a spinal implant, not the diagnostic or interpretative performance of an AI system or human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable. This document describes a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
For the mechanical performance study, the "ground truth" or benchmark was established by testing per ASTM F1717-10 and demonstrating substantial equivalence to predicate devices. This means the performance of the predicate devices under this standard served as the reference.
8. The Sample Size for the Training Set
This is not applicable as this study does not involve an AI algorithm or a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as this study does not involve an AI algorithm or a "training set."
§ 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.