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Synthes OC Fusion System is intended to provide stabilization to promote 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, Synthes Axon System, and Synthes Synapse System.

Synthes OC Fusion System is indicated for the following: DDD 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, atlanto/axial fracture with instability, occipital-cervical dislocation, revision of previous cervical spine surgery, and tumors (primary and metastatic)

The use of screws is limited to placement in the occiput. Screws are not intended to be placed in the cervical spine.

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 pervious 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, or lumbar spine.

The Synthes OC Fusion System consists of occipital plates, occipital screws, occipital clamps, and rods intended to provide stabilization to promote fusion of the occipital-cervical junction. This system allows an occipital-cervical construct of either the occipital plate and rods or occipital clamps and rods. Rods are connected to the occipital plate or occipital clamps using a locking screw. A complete occipital-cervical-thoracic construct can be created by using hooks (C1-T3) that have been previously cleared within the Synthes CerviFix System, Synthes Axon System, and Synthes Synapse System.

The occipital bone screws are available in 4.5mm and 5.0mm diameters in lengths from 4mm to 18mm. Variable angle screw insertion is possible.

The occipital clamps are available in either a one-hole or two-hole configuration. The occipital plate is available in two sizes in either a medial or lateral configuration for a total of four available plates.

The plates are manufactured from commercially pure Titanium, grade 4. The rod connection points (rod clamps) in the plate are manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) as are the occipital clamps, rods, and occipital screws.

The Synthes Synapse System consists of cancellous and cortex polyaxial screws, hooks, rods, transverse bars, parallel connectors, transconnectors, and locking screws. These implants are designed for fixation of the cervical, and/or upper thoracic spine (C1 - T3). A complete occipital-cervical-thoracic construct can be created by using components that have been previously cleared within the Synthes CerviFix System, Synthes Axon System, and Synthes OC Fusion System.

The implants are manufactured from Titanium Aluminum Niobium TAN (Ti-6Al-7Nb) ASTM F1295, the same as the predicate device.

The provided 510(k) summaries (K072434) for the Synthes OC Fusion System and Synthes Synapse System do not contain detailed acceptance criteria or a study proving the device meets specific performance metrics in the way that would typically be described for a diagnostic AI device.

Instead, these submissions are for spinal implant systems which demonstrate substantial equivalence to predicate devices through bench testing (non-clinical performance data) and explicitly state that clinical data and conclusions were not needed for these devices due to their nature (they are modifications of existing, already cleared devices).

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies, as these types of studies were not required or performed for these specific 510(k) clearances.

Here's what can be extracted from the provided text based on the request's categories, tailored to the context of these spinal implant devices:

Acceptance Criteria and Device Performance (Not Applicable in the traditional sense for Software/AI, but for Physical Device Equivalence)

The "acceptance criteria" and "reported device performance" in this context refer to the demonstration of substantial equivalence to predicate devices through non-clinical bench testing. The criteria are likely related to mechanical properties, material integrity, and functional performance matching or exceeding the predicate.

1. A table of acceptance criteria and the reported device performance:

As explained above, the "acceptance criteria" here is that the device is substantially equivalent to its predicate. The "reported device performance" is the statement that bench testing confirmed this substantial equivalence. Specific quantitative metrics such as sensitivity, specificity, accuracy, or specific mechanical thresholds are not detailed in these summaries.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Sample Size: Not applicable. These are physical devices evaluated through bench testing, not data-driven software. The "test set" would refer to the physical samples of the device undergoing mechanical testing. The specific number of samples tested for each mechanical assessment (e.g., fatigue, static strength) is not provided in the 510(k) summary.
• Data Provenance: Not applicable in the context of country of origin or retrospective/prospective data as these relate to clinical or AI data studies. These are non-clinical biomechanical bench tests typically performed in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable. For physical device bench testing, "ground truth" is established by engineering specifications, material science standards, and comparison to predicate device performance. It doesn't rely on expert human consensus in the way an AI diagnostic device would.
• Qualifications of Experts: Not applicable. The validation is based on objective measurements against engineering standards and predicate device data, not expert clinical judgment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Adjudication Method: Not applicable. This concept is relevant for reconciling discrepancies in human expert opinions for ground truth establishment in studies involving subjective interpretation (like medical image analysis). For physical device bench testing, results are objective measurements.

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:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. These devices are spinal implants, not AI-powered diagnostic tools intended to assist human readers.
• Effect Size: Not applicable.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:

• Standalone Performance: No, a standalone algorithm performance study was not done. These are physical medical devices, not algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: For the "study" (bench testing), the "ground truth" is the established mechanical performance and material properties of the predicate device(s) and relevant engineering standards. The goal is to demonstrate that the modified device performs equivalently or better.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. These are physical devices; there is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:

• Training Set Ground Truth Establishment: Not applicable. Since there's no training set, there's no ground truth established for it.

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