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The Posterior Cervical/Thoracic Hook/Rod System is intended to provide stabilization to promote tusion tollowing reduction of fracture/dislocation or trauma in the cervical/voper Ihoracic (C1-T3) spine.

Device Description

The Synthes Posterior Cervical/Thoracic Hook/Rod System consists of rods, clamps and set screws. These components are manufactured from the titanium alloy TiAlNb (ASTM F1295). The Posterior Cervical/Thoracic Hook/Rod System is intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine. Manual surgical instruments that will be marketed with this system include Rod Bending Plier for 3.5 rods, 2.5mm Hex screwdriver,and holding forcep. The rods are 3.5mm in diameter and are offered in lengths of 80 and 240mm. Hooks are available in both a left and right configuration to allow bilateral placement of the hook/rod construct.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SYNTHES Spine Posterior Cervical/Thoracic Hook/Rod System. This is a medical device, and the "study" referred to is the mechanical testing performed to demonstrate its safety and effectiveness, primarily through substantial equivalence to a predicate device.

Here's an analysis of the requested information based on the provided text. Please note that the information regarding AI-specific criteria (like MRMC studies, training set details, or ground truth establishment for AI models) is not applicable to this type of device submission as it predates widespread AI in medical devices and is focused on mechanical performance and substantial equivalence in a traditional sense.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured)	Reported Device Performance and Compliance
Static and Fatigue Performance Characteristics of the System	"Mechanical testing was performed in accordance with ASTM standard F1717. This testing documented both static and fatigue performance characteristics."
Meeting Requirements for Posterior Cervical and Upper Thoracic (C1-T3) Fixation	"This testing clearly demonstrated that the performance characteristics satisfy the requirements of posterior cervical and upper thoracic (C1-T3) fixation."
Clinical Indications Equivalence	"The SYNI HFS Spine Posterior Cervical/Thoracic Hook/Rod System is indicated for the same clinical indications as that of the AME Halifax Interlaminar Clamp System."
Material Composition Equivalence	"Material composition is identical to numerous other Synthes Spinal products that have been cleared via the 510(k) process."
Surgical Technique and Instrumentation Equivalence	"The surgical technique and instrumentation to implant this system is the same as that of the Synthes USS Hook/Rod systems."
Safety and Effectiveness for Levels of Use up to T3	"The levels of use to T3 do not have a significant effect on safety or effectiveness. This due to the fact that loading in these areas is not significantly different when compared to the cervical area. In addition, other systems such as the LIBERTY system by Sofamor Danek are cleared in the T1-T3 region."

Additional Information

Sample size used for the test set and the data provenance:
- The document refers to "mechanical testing" according to ASTM standard F1717. Mechanical testing typically involves a physical number of device units (the "sample size") subjected to various forces and cycles. However, the exact number of units tested is not specified in this summary.
- Data provenance: Not explicitly stated, but mechanical testing is typically performed in a laboratory setting, likely in the USA where Synthes is based. It is a retrospective evaluation of the device's physical properties.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable to this type of device. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1717) and the physical properties of the materials and design, not by human expert assessment in the same way as, for example, image interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies or expert review processes, not standalone mechanical engineering tests of a device's physical performance.
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:
- Not applicable. This device is a mechanical implant, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical testing, the "ground truth" is defined by the engineering specifications and performance requirements outlined in ASTM F1717 and by the performance of the predicate devices (AME Halifax Interlaminar Clamp System and Synthes USS Hook/Rod systems) which the current device aims to be substantially equivalent to.
- For the clinical indications and material composition, the ground truth is established by the regulatory clearance of predicate devices and existing medical knowledge regarding spinal fixation.
The sample size for the training set:
- Not applicable. This is a mechanical device, not a machine learning model. There is no concept of a "training set" in this context.
How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.

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