(55 days)
The Sintea Biotech Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C3 to C7).
The device is intended for single use only and is packaged non-sterile with sterilization required prior to use.
WARNING: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The Sintea Biotech Anterior Cervical Plate System is indicated for use in the cervical spine (levels C3 to C7) in the following conditions:
- Degenerative disc disease (defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis
- Trauma (fracture or dislocation)
- Spinal stenosis
- Deformities or curvature (scoliosis, kyphosis, lordosis)
- Tumor
- Pseudarthrosis
- Failed previous fusion
The Sintea Biotech Anterior Cervical Plate System is a family of anterior cervical spine locking plates, screws and associated instruments, providing an anterior buttress. opstruct for use following Corpectomy or discectomy. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. It is indicated for traumatic, degenerative, and tumor pathologies.
All system components are made of biocompatible Ti6A14V ELI titanium alloy, which minimizes the possibility of allergic reaction and enhances post-operative MRJ/CT analyses as described by ASTM F136. Do not use any of the Sintea Biotech Anterior Cervical Plate System components with components from any other system or manufacturer.
The provided text describes a medical device called the Sintea Biotech Anterior Cervical Plate System. It details its intended use, indications, and how its substantial equivalence to a predicate device was established. However, this document does not contain any information regarding clinical studies with acceptance criteria or device performance data as typically found for AI/ML-driven devices or diagnostic tools.
Instead, the document focuses on regulatory compliance, mechanical testing, and comparison to a predicate device to demonstrate safety and effectiveness for a conventional orthopedic implant.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and performance studies because this information is not present in the provided text.
Here's a breakdown of why this information is missing based on your request:
- Acceptance Criteria and Reported Device Performance (Table): The document provides "Performance Standards" but these are general regulatory and voluntary standards (ASTM, ISO, QSR/cGMP, in-house SOPs) for manufacturing and materials, not specific clinical performance metrics with acceptance thresholds and reported device results from a study. The "Summary of Biomechanical Testing" mentions overcoming static and fatigue tests according to ASTM F1717 without microscopic or macroscopic failures, but these are engineering/mechanical tests, not clinical performance acceptance criteria.
- Sample Size (Test Set) and Data Provenance: Not applicable, as no clinical test set is described. The "testing" refers to mechanical/biomechanical tests on constructs, not clinical data sets.
- Number of Experts & Qualifications: Not applicable, as no ground truth establishment for a clinical test set is described.
- Adjudication Method: Not applicable.
- Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned. No human readers or AI assistance are discussed.
- Standalone Performance: Not applicable, as this is a physical medical implant, not a software algorithm.
- Type of Ground Truth: Not applicable, as no ground truth for clinical performance is mentioned. The ground truth for mechanical testing would be the ASTM F1717 standard.
- Sample Size (Training Set): Not applicable, as no training set for an AI/ML model is mentioned.
- Ground Truth for Training Set: Not applicable.
In summary, the provided document is a 510(k) summary for a spinal implant, which relies on demonstrating substantial equivalence to a predicate device through mechanical testing and material compatibility, rather than clinical efficacy studies with specific performance metrics and acceptance criteria for a diagnostic or AI-based device.
§ 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.