(72 days)
The SC-AcuFix Thinline Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
The SC-AcuFix Thinline Anterior Cervical Plate System consists of various sizes of bone plates, screws and surgical instruments. The screws are used to secure the vertebral bodies of the cervical spine through an anterior approach. The plates have an integrated locking mechanism that captures the screw upon full insertion, preventing screw-backout. Plates and screws are manufactured from titanium alloy (ASTM F-136) and may be supplied sterile or non-sterile.
The medical device in question is the SC-AcuFix Thinline Anterior Cervical Plate System, a spinal fixation system.
Here's an analysis of the acceptance criteria and study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Design Requirements) | Reported Device Performance |
|---|---|
| Static data requirements | Met design requirements |
| Fatigue data requirements | Met design requirements |
Note: The specific numerical values or detailed specifications of the "design requirements" for static and fatigue data are not provided in the document. The document only states that these requirements were met.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size used for the mechanical testing (static and fatigue data). It only mentions that "Mechanical testing data, collected in accordance with ASTM 1717, was collected."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that it's mechanical testing of a medical device, it is inherently prospective, as the tests are performed to evaluate the device's properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device and study. The "ground truth" for mechanical testing is established through standardized testing protocols (like ASTM 1717) and engineering principles, not through expert clinical consensus on patient data.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of data by multiple readers, often for diagnostic devices. For mechanical testing, the results are derived from physical measurements and analysis, not expert interpretation requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. A Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed as this is a mechanical engineering study for a spinal implant, not a study evaluating human reader performance with medical images or clinical data.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This device is a physical medical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this study was established by standardized mechanical testing protocols (specifically ASTM F-1717, an ASTM International standard for spinal implants) and engineering performance specifications (labeled as "design requirements" in the text). The device's performance was compared against these predefined physical and mechanical thresholds.
8. The Sample Size for the Training Set
This information is not applicable. This is a mechanical testing study, not a machine learning study where a "training set" would be used to train an algorithm. The device itself is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
§ 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.