(380 days)
The DSC/ALF Spinal System is a vertebral body replacement system intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The DSC/ALF Spinal System is to be used with supplemental fixation. Specifically, the DSC/ALF spinal system is to be used with the anterior lateral plate that is included in the system, and may also be used with Sintea Biotech's PLS Spinal System. Additionally, the DSC/ALF spinal system is intended to be used with autograft.
This 510(k) consists on the submission to add additional lengths and cross-sections, an improved locking mechanism, cage body redesign, and end-plate charges to a previously cleared system. The DSC/ALF Spinal System provides two basic components: A VBR (DSC) and an anterior lateral fixation plate (ALF). The DSC has a hollow internal module that can slide in relation to an external module, which enables the former to be locked in the most suitable position by means of two screws. These screws are inserted into two tooth rails on the internal cage, on both the anterior and posterior part, and mechanically lock the two modules. Both modules have endplates that optimize the contact with the vertebral bodies between which the device is inserted, thus ensuring better primary stability. The cages present a symmetrical geometry in order to make device placement simpler for the surgeon. The ALF is composed of two plates that connect to the anterior side of a vertebra by two screws. The two plates are connected by a rod. All components of the DSC/ALF Spinal System are made of medical grade titanium alloy (Ti-6Al-4V) as described by ASTM Standard F136.
Here is an analysis of the acceptance criteria and study information for the Sintea Plustek DSC/ALF Spinal System:
The provided text describes a 510(k) submission for the Sintea Plustek DSC/ALF Spinal System, which is a vertebral body replacement system. The submission focuses on adding additional lengths and cross-sections, an improved locking mechanism, cage body redesign, and end-plate changes to a previously cleared system.
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines a series of performance tests conducted on the new device (referring to the modifications made to the previously cleared system) and compares their results to those of a predicate device. The specific numerical acceptance criteria for these tests are not explicitly stated in the provided text. Instead, the performance is reported comparatively.
| Acceptance Criteria (Implicit) | Reported Device Performance (New Device vs. Predicate) |
|---|---|
| Static compression performance | Achieved better results than the predicate device. |
| Static torsion performance | Achieved better results than the predicate device. |
| Subsidence performance | Achieved better results than the predicate device. |
| Expulsion performance | Achieved comparable results to the predicate device. |
| Fatigue compression performance | Achieved better results than the predicate device. |
| Fatigue torsion performance | Achieved comparable results to the predicate device. |
The testing standards followed were ASTM F2077 and ASTM F2267.
2. Sample Size Used for the Test Set and Data Provenance:
The document describes mechanical testing rather than a clinical study involving human or animal subjects. Therefore, the concept of a "test set" in the context of human data or a specific provenance (country of origin, retrospective/prospective) is not applicable here. The "test set" would refer to the physical devices and components subjected to the mechanical tests. The sample size for these individual mechanical tests is not specified in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the "ground truth" for mechanical performance tests is established by objective physical measurements based on engineering standards (ASTM F2077 and ASTM F2267), rather than expert opinion or clinical interpretation.
4. Adjudication Method for the Test Set:
This information is not applicable as the "test set" involves objective mechanical measurements, not subjective evaluations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not performed as this is a mechanical device evaluation, not a study involving human readers interpreting medical images with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):
This information is not applicable as the device is a physical spinal implant, not a software algorithm or AI-powered system.
7. Type of Ground Truth Used:
The ground truth for the performance claims ("better results" or "comparable results") is established through objective mechanical testing results, compared against the predicate device, following established ASTM standards (ASTM F2077 and ASTM F2267).
8. Sample Size for the Training Set:
This information is not applicable as this is a mechanical device evaluation, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as above; there is no "training set" in the context of a physical device's mechanical performance evaluation.
§ 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.