(45 days)
The Orthofix Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and indicated for:
- Degenerative disc disease (as defined as back pain of discogenic origin with degenerative a) disc confirmed by patient history and radiographic studies);
- Spondylolisthesis; b)
- Trauma (i.e., fracture or dislocation); c)
- d) Spinal stenosis;
- Deformities (i.e., scoliosis, kyphosis, and/or lordosis); e)
- Tumor; f)
- Pseudoarthrosis; g)
- Revision of previous surgery h)
The Orthofix Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) and Nitinol (per ASTM 2063) components that allow a surgeon to build a temporary anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices. The instrumentation provided to facilitate implantation are Class I, manual orthopedic standard surgical instruments.
The Orthofix Anterior Cervical Plate System is a medical device that underwent non-clinical testing to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Standard / Test / FDA Guidance) | Reported Device Performance |
|---|---|---|
| Static Torsion Test | ASTM F1717-11 | Test results demonstrated that the new, proposed device is substantially equivalent to the predicate device, the Hallmark Anterior Cervical Plate System (K050892 and K100614), that have the same intended use, similar indications, technological characteristics, and principles of operation. (The document does not provide specific numerical results, but states that equivalence was met according to the standard.) |
| Static Axial Compression Bending Test | ASTM F1717-11 | Test results demonstrated that the new, proposed device is substantially equivalent to the predicate device, the Hallmark Anterior Cervical Plate System (K050892 and K100614), that have the same intended use, similar indications, technological characteristics, and principles of operation. (The document does not provide specific numerical results, but states that equivalence was met according to the standard.) |
| Dynamic Axial Compression Bending Test | ASTM F1717-11 | Test results demonstrated that the new, proposed device is substantially equivalent to the predicate device, the Hallmark Anterior Cervical Plate System (K050892 and K100614), that have the same intended use, similar indications, technological characteristics, and principles of operation. (The document does not provide specific numerical results, but states that equivalence was met according to the standard.) |
2. Sample Size and Data Provenance:
The document describes non-clinical mechanical testing. The sample size for this type of testing is generally governed by the specific ASTM standard. The document does not explicitly state the sample size used for the tests.
Data Provenance: The testing was conducted to fulfill regulatory requirements for a 510(k) submission in the United States, indicating the tests were performed on physical device samples. It is not patient or human subject data, so concepts like "country of origin of the data" or "retrospective/prospective" do not apply in the typical sense for clinical studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the described study is a non-clinical mechanical performance study, not a study involving human experts establishing ground truth for a diagnostic or AI device. The "ground truth" here is compliance with the ASTM standard.
4. Adjudication Method for the Test Set:
This information is not applicable for a mechanical performance study. The evaluation is based on whether the physical testing results meet the defined parameters of the ASTM standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI, not for mechanical device performance.
6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance):
No, a standalone performance study was not done. This device is a physical implant, not a software algorithm that would have standalone performance.
7. Type of Ground Truth Used:
The ground truth used was adherence to the ASTM F1717-11 standard for "Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model." This standard defines the methodologies and expected performance characteristics for such devices.
8. Sample Size for the Training Set:
This information is not applicable. There is no "training set" as this is a mechanical device performance study, not an AI/machine learning model.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set involved in this mechanical performance study.
§ 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.