(83 days)
When used as an anterior, thoracic/lumbar screw fixation system, the Centaur™ Spinal System is intended to treat deformities of curvature (i.e. scoliosis, kyphosis and/or lordosis), fracture, tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e.discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The Centaur "Spinal System is a spinal fixation device for the noncervical spine. All components are manufactured from ISO 5832/3 (ASTM F-136-96) titanium alloy (Ti6Al-4V ELI). The system consists of primary and secondary screws, rods, lateral connectors, plates, and accessories.
Bone Screws: There are two different types of screws in the Centaur" Spinal System. They are primary and secondary screws. The head of the primary screw receives the connectors and the tightening screws for both the plate and rod systems. The head of the secondary screw is shaped to allow for a 5° angulation in all directions. Both the primary and secondary screws are threaded at the distal end. The distal aspect of the screws feature cancellous bone threads. Screws are available in two diameters: 5.5mm and 7mm, and in lengths of 25mm (in 5mm increments).
Rods: There are two types of spinal rods used in the Centaur" Spinal System. The first type is 4mm in diameter and the second type is 6mm in diameter. Both types range in length from 60mm to 160mm in 10mm increments. Rods are slipped into the rod connector and ball ring and are tightened down by rod locking screws. The rod connectors have a specific anatomic shape. They can be adapted to both the antero-posterior and craniocaudal shape of the lateral vertebra. A ball ring allows for a +1-15 angulation of the 6mmod. The posterior aspect of the rod system uses the larger rods, and this is the aspect that has the higher profile when implanted. The anterior aspect of the rod system uses the smaller rods which have the lower profile of the implant.
Plates: There are three types of plates used in the Centaur" Spinal System. All three are L-shaped. The first type, straight plates, range from 30mm in length in 10mm increments The second type, lordotic plates, range from 60mm to 90mm in length in 10mm increments. The third type, kyphotic plates, range in length from 50mm in 10mm increments. The plate system is not monoblock, thereby allowing more flexibility and greater opportunity for compression which aids fusion. Plates are assembled to the screws through the use of a plate connector and are locked down by set screws.
Here's an analysis of the provided text regarding the Centaur™ Spinal System's acceptance criteria and studies, organized according to your requested information.
It's important to note that the provided 510(k) summary (K994347) is for a spinal fixation system, not a device that involves AI, diagnostic imaging, or human reader performance. Therefore, many of your requested items, which are typical for AI/diagnostic device submissions, are not applicable to this medical hardware submission. The information provided heavily emphasizes mechanical and material equivalence.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from predicate device equivalence) | Reported Device Performance (Centaur™ Spinal System) |
|---|---|
| Substantial equivalence to predicate device (MOSS Miami Spinal System) in intended use and basic design concepts. | Demonstrated comparable mechanical and endurance properties to the MOSS Miami Spinal System. |
| Components manufactured from ISO 5832/3 (ASTM F-136-96) titanium alloy (Ti6Al-4V ELI). | Components are manufactured from ISO 5832/3 (ASTM F-136-96) titanium alloy (Ti6Al-4V ELI). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to this type of device submission. The "test set" in this context refers to mechanical testing of the physical device components, not a dataset of patient images or clinical outcomes. The submission focuses on device equivalence through material specifications and mechanical performance data, not clinical data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. "Ground truth" in this context would refer to expert consensus on clinical findings or pathology, which is not relevant for a mechanical spinal implant. The "ground truth" for mechanical testing is typically engineering specifications and established test methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are used for disagreements in human reader assessments, which are not part of this device's evaluation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This is a spinal hardware system, not an AI or diagnostic imaging device that involves human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is based on mechanical engineering standards and established material properties. The device's performance is compared against the known performance characteristics of the predicate device and the specified material (Ti6Al-4V ELI).
8. The sample size for the training set
This information is not applicable. The concept of a "training set" applies to machine learning models, not to the development and testing of a physical spinal implant.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" in the context of this device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the Centaur™ Spinal System meets the acceptance criteria is described as a comparison to a predicate device and mechanical testing.
The acceptance criterion is primarily demonstrating substantial equivalence to the predicate device, the MOSS Miami Spinal System (K983583), in terms of intended use, basic design concepts, and material.
The study presented to establish this equivalence involved:
- Statement of Technological Comparison: The submission explicitly states that the Centaur™ Spinal System shares the same intended use and basic design concepts as the MOSS Miami Spinal System.
- Material Equivalence: Both systems use ISO 5832/3 (ASTM F-136-96) titanium alloy (Ti6Al-4V ELI), which has a "long and successful history of use in orthopedic implant surgery."
- Mechanical Testing: The crucial evidence provided is that "Fatigue and static testing demonstrates the comparable mechanical and endurance properties of these components" when compared to the predicate device. While specific numbers for fatigue and static loads are not detailed in the summary, the statement indicates that such tests were performed and showed comparable results.
In essence, the "study" for the Centaur™ Spinal System was a bench-top engineering evaluation demonstrating material compatibility and equivalent mechanical performance to a previously cleared device. It's a technical dossier proving physical and functional equivalence, rather than a clinical study evaluating diagnostic accuracy or treatment outcomes.
§ 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.