(80 days)
Synthes Synapse System is indicated for the following:
Hooks, Plate/Rods, Plates, Rods and Screws
When intended to promote 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 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 to promote fusion 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, locking 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 and 4.5 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 parallel connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle 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.
The Synthes Synapse Transconnector is a top-loading transconnector placed on top of two mono-segmental variable axis screws to cover the exposed spinal cord following laminectomy. The Synthes Synapse Transconnector is designed to be a rigid link between longitudinal rods, and is compatible only with Synthes Synapse System.
The Synthes Synapse Transconnector is a line extension to Synthes Synapse System, and a modification to the Synthes Cervifix transconnector.
The implants are manufactured from Titanium Aluminum Niobium TAN (Ti-6Al-7Nb) ASTM F1295, the same as the predicate device.
The provided document is a 510(k) summary for a medical device called the "Synthes Synapse Transconnector," which is a component of a posterior cervical system. It describes the device, its intended use, and its comparison to predicate devices for regulatory clearance.
However, this document does not contain information about acceptance criteria, detailed study designs, or performance metrics in the way you've requested for AI/algorithm performance. The 510(k) summary primarily focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices based on design, function, material, and intended use.
Here's a breakdown of why this document doesn't fit your request and what information it does provide:
Key Takeaways from the Document Regarding "Performance":
- Non-Clinical Performance and Conclusions: "Bench testing results demonstrate that the Synthes Synapse System is substantially equivalent to the predicate device." This indicates that physical/mechanical testing was performed to show the new device performs similarly to existing ones.
- Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device." This is crucial. For this specific device and 510(k) submission (K090549), clinical studies in humans were not required by the FDA to establish substantial equivalence.
Therefore, the following information you requested cannot be found or is not applicable based on the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study and effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
In summary, this document describes a traditional medical device (a surgical implant component) and its regulatory clearance process, not an AI or algorithm-based device. Therefore, the detailed performance study information relevant to AI/algorithm acceptance criteria is not present.
§ 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.