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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 junction (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 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 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, pedicle hooks, 4.2 mm screws, and the 5.0 mm/6.0 mm parallel connector.

The Synthes System can be linked to the DePuy EXPEDIUM 5.5 Titanium Spine System using the 3.5 mm/5.5 mm and 4.0 mm/5.5 mm titanium tapered rods.

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 tapered rods are intended to create a single construct by linking system components that receive different rod diameters. These rods are manufactured from titaniumaluminum-niobium (Ti-6Al-7Nb (TAN)). These rods taper from a diameter of 3.5 mm or 4.0 mm to a diameter of 5.5 mm and are both 500 mm in length.

The Synthes Synapse System is a hook, rod and pedicle screw spinal system intended to provide posterior stabilization of the upper spine (C1-T3) as an adjunct to fusion in skeletally mature patients. This system consists of multiple components manufactured from either titanium aluminum niobium (Ti-6Al-7Nb (TAN)) or commercially pure grade 4 Titanium and include rods (straight, tapered and curved), plate/rods, hooks, clamps, screws, nuts, variable axis screws, locking screws, transconnector clamps, transverse bars, parallel connectors and variable axis/top loading transconnectors. These system components are implanted using Class I general surgical instruments. A complete occipital-cervical-thoracic construct can be created by using components from the previously cleared Synthes CerviFix System, Synthes Axon System, and Synthes OC Fusion System. When combined with the Synthes Universal Spinal System (including Matrix) using parallel connectors or tapered rods, constructs can extend from the occiput to the lower spine.

This document is a 510(k) premarket notification for the DePuy Synthes Spine's Synapse System. It primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, rather than conducting a de novo study with acceptance criteria and a specific performance study as one might see for novel AI/ML devices or completely new technologies.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, and expert adjudication as they would apply to an AI/ML algorithm or a new diagnostic device are not present in this document.

Here's an analysis of what can be extracted and what information is missing based on the provided text:

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

• Acceptance Criteria: Not explicitly defined in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). The document focuses on demonstrating substantial equivalence to predicate devices. This means the "acceptance criteria" are generally that the device performs as well as the predicate device and has similar technological characteristics and intended use.
• Reported Device Performance: No specific quantitative performance metrics (e.g., success rates, failure rates, accuracy) are reported for the Synapse System in this document. The "performance" assessment is based on the lack of change from the predicate device and engineering rationale.

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

• Test Set Sample Size: Not applicable/not provided. This document does not describe a clinical study with a "test set" in the context of evaluating a diagnostic or AI/ML algorithm.
• Data Provenance: Not applicable/not provided.

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)

• Not applicable/not provided. Ground truth establishment by experts for a test set is not described as this is not a study evaluating human reader or algorithm performance on a test set.

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

• Not applicable/not provided. No test set adjudication method is described.

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. This document pertains to a spinal fixation system, not an AI-assisted diagnostic tool.
• Effect Size of AI: Not applicable, as no AI component or human reader study is described.

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

• Standalone Performance: No, a standalone performance study as described (algorithm only without human-in-the-loop performance) was not done. This document is not about an algorithm or AI device.

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

• The concept of "ground truth" as it would apply to a diagnostic or AI algorithm study is not applicable here. The document relies on previous testing and validation of the predicate devices and engineering rationale.

8. The sample size for the training set

• Not applicable/not provided. There is no mention of a "training set" as this is not an AI/ML device.

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

• Not applicable/not provided.

Summary of Device and Regulatory Basis:

This 510(k) submission for the Synapse System (incorporating tapered rods) is a request for clearance based on substantial equivalence to predicate devices (Synthes Synapse System, DePuy EXPEDIUM Spine System, and Synthes Matrix Spine System). The core argument for equivalence is:

• Technological Characteristics: The design, material (titanium alloy), and established performance of the tapered rods and other Synapse System components remain unchanged from their previously cleared predicate versions.
• Intended Use: The intended use of the devices also remains unchanged from their predicate versions (as an adjunct to fusion for various spinal conditions in skeletally mature patients, primarily C1-T3).
• Performance Data: Instead of new performance testing, an engineering rationale is provided because the designs and technological characteristics are unchanged and have been "extensively tested in their predicate submissions." The specific modification being addressed is the ability of the Synapse System to link with the DePuy EXPEDIUM 5.5 Titanium Spine System using titanium tapered rods.

In essence, this document is a regulatory filing asserting that because the device is fundamentally the same as previously cleared devices, new comprehensive performance studies (as would be required for a novel device or AI/ML product) are not necessary.

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