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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.

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.

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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 and the Synthes Axon System.

Synthes OC Fusion System is indicated for the following:

• 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 in the cervical 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 and the Synthes Axon 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 provided text describes the 510(k) summary for the Synthes OC Fusion System, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data (bench testing), rather than clinical studies or the use of AI. Therefore, many of the requested categories related to AI performance, clinical trials, and ground truth establishment are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

A non-clinical performance study (bench testing) was conducted to demonstrate substantial equivalence. The document states: "Bench testing results demonstrate that the Synthes OC Fusion System is substantially equivalent to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the given 510(k) summary. The document focuses on bench testing, not a clinical test set with patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable/not provided. The device approval is based on non-clinical bench testing, not on clinical data requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods are relevant for clinical studies involving human assessments, which were not part of this submission for substantial equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is a physical implant, not an AI-powered diagnostic or assistive tool, and the submission did not include clinical studies.

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

No, a standalone algorithm performance study was not done. This device is a physical implant, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance was established through engineering specifications and performance standards applicable to spinal fixation systems, as evaluated via bench testing against the predicate device. It was not based on expert consensus, pathology, or outcomes data in a clinical trial.

8. The Sample Size for the Training Set

This information is not applicable/not provided. There is no mention of a "training set" as this is not an AI/machine learning device. The design and manufacturing processes follow established engineering principles and quality system regulations.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided. As there is no AI training set, there is no ground truth established for it. The "ground truth" in the context of this device's development would relate to validated engineering principles and material properties used in its design and manufacturing.

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