(73 days)
These Systems are intended for the following:
Hooks, Plate/Rods, Plates, Rods and Screws
When intended to provide stabilization as an adjunct to fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, plates, rod, hook and screw (3.2 mm cortex) components of the Synthes CerviFix, Axon, OC Fusion and Synapse Systems are indicated for skeletally mature patients using allograft for the following:
· Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
· Spondylolisthesis
- · Spinal Stenosis
- · Fracture/dislocation
- Atlantoaxial fracture with instability
- Occipitocervical dislocation
- · Revision of previous cervical spine surgery
- Tumor
When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only.
Hooks and Rods
The rod and hook components are also intended to provide stabilization following reduction of fracture/ dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws, and Transverse Bars
The rods, clamps, screws, nuts, variable axis screws, and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3).
The use of these screws (3.5 mm, 4.0 mm cancellous, and 3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Synthes CerviFix, Axon, and Synapse Systems can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm and 4.0 mm/6.0 mm parallel connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse process hooks, 4.2 mm screws, and the 5.0 mm/6.0 mm parallel connector.
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine.
OC Fusion System
The Synthes OC Fusion System is intended to provide stabilization as an adjunct to fusion of the occipital-cervical junction. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System, and Synthes Synapse System.
The OC Fusion System is indicated for skeletally mature patients using allograft and/or autograft for the following indications:
· Degenerative disc disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- · Spondylolisthesis
- · Spinal Stenosis
- · Fracture/dislocation
- Atlanto/axial fracture with instability
- · Occipital-cervical dislocation
- · Revision of previous cervical spine surgery
- · Tumors (primary and metastatic)
The use of screws is limited to placement in the occiput. Screws are not intended to be placed into the cervical spine.
The Synapse System is a hook, pedicle screw, and rod spinal system which is designed to provide spinal fixation to allow for stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The Synapse System is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Axon System and CerviFix System also included in the indications for use statement are additional hook, pedicle screw, and rod spinal systems. These systems consist of anchors including bone screws, pedicle screws and hooks; interconnection mechanisms including locking screws, set screws, parallel rod connectors, clamps, transverse bars, rod collars and nuts; longitudinal members including rods and rod/plates; and transverse connectors including transconnectors.
The OC Fusion System consists of occipital plates, occipital screws, and rods intended to provide stabilization as an adjunct to fusion of the occipital-cervical junction. The OC Fusion System can be used with components from the Synthes CerviFix System including Axon and Synapse components to create a complete occipital-cervical-thoracic spinal construct.
Fixation of the rods included in the Synapse and OC Fusion Systems is achieved by using hooks from one of the aforementioned cleared systems. System components in the Synapse and OC Fusion Systems are implanted with Class I general use surgical instruments.
The provided text describes a 510(k) premarket notification for medical devices, specifically the Synapse System and OC Fusion System, which are spinal interlaminal fixation orthoses. The document focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a study that defines and tests against acceptance criteria for a new device's performance characteristics.
Therefore, many of the requested details, such as a table of acceptance criteria with reported device performance, sample sizes for test and training sets, expert qualifications, and ground truth establishment, are not explicitly provided in this type of regulatory submission. This document confirms the material, intended use, and general performance testing (mechanical testing for a specific component) to demonstrate equivalence.
Here's an attempt to answer the questions based on the available information, noting where information is not present:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria for a newly developed performance characteristic nor detailed reported device performance against such criteria. The submission states that the device was evaluated using mechanical testing and found to be "substantially equivalent to or better than the predicate devices." This implies that the 'acceptance criteria' were likely an equivalence or superiority comparison to the predicate device's established performance, rather than specific numerical thresholds for novel performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to or betterment of predicate devices in mechanical testing (static compression bending, dynamic compression bending, dynamic torsion testing). | "Test results and analyses showed that the proposed components to the Synapse and OC Fusion Systems were substantially equivalent to or better than the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes mechanical testing for the OC Fusion System components. It does not specify a sample size (e.g., number of test articles) for this mechanical testing. There is no information provided regarding data provenance (country of origin, retrospective/prospective) as the testing described is in vitro mechanical testing, not human-patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The study described is mechanical testing of physical device components, not an assessment requiring expert interpretation of medical images or patient data to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of ambiguous cases, particularly in imaging, and are not relevant to mechanical performance testing.
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
There is no MRMC study or AI component mentioned in this document. This submission is for physical spinal fixation devices, not a diagnostic or AI-powered medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. There is no algorithm or software device described in this submission.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the mechanical testing performed, the "ground truth" would be the direct physical measurements of device strength, fatigue, and other mechanical properties under controlled conditions, compared against the equivalent properties of the predicate devices according to ASTM F2706-08.
8. The sample size for the training set
This is not applicable. There is no training set mentioned as this is not a machine learning or AI-based device.
9. How the ground truth for the training set was established
This is not applicable. There is no training set.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.