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510(k) Data Aggregation

    K Number
    K091689
    Device Name
    SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2009-07-10

    (30 days)

    Product Code
    KWP,MNH,MNI
    Regulation Number
    888.3050
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Synthes Synapse System is indicated 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 and/or autograft 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 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.

    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.

    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) and screws (T1-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 skeletally mature patients using allograft and/or autograft 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 spinal 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.

    Device Description

    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 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-thoracic 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) and screws (T1-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 occipital clamps are manufactured from both commercially pure Titanium, grade 4 and Titanium Aluminum Niobium (Ti-6Al-7Nb).

    The plates are manufactured from commercially pure Titanium, grade 2. The two bodies in the plate that serve as rod connection points are manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) as are the rods, and occipital screws.

    AI/ML Overview

    The provided 510(k) summary for the Synthes Synapse 4.0mm System and the Synthes OC Fusion 4.0mm System does not describe a study that involves acceptance criteria and device performance in the way typically associated with AI/ML-enabled medical devices or diagnostic tools.

    Instead, this document details a submission for spinal implant systems, where the "acceptance criteria" for clearance are based on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical performance data. Clinical data was explicitly stated as not needed for these devices.

    Therefore, many of the requested points regarding sample size, data provenance, ground truth establishment, expert adjudication, MRMC studies, and standalone performance are not applicable to this type of medical device submission.

    Here's the information that can be extracted or deduced from the provided text according to your request:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (for Substantial Equivalence)Reported Device Performance
    Intended Use Equivalence: The device's intended use should be equivalent to previously cleared predicate devices.The Synthes Synapse 4.0mm System and Synthes OC Fusion 4.0mm System have indications for use that are equivalent to already cleared devices like Synthes CerviFix, Synthes Axon, and Synthes OC Fusion Systems. Their intended uses include providing stabilization as an adjunct to fusion for various cervical and occipitocervical conditions (e.g., DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, tumor).
    Material Equivalence: The device's materials of manufacture should be equivalent to previously cleared predicate devices.The implants are manufactured from Titanium Aluminum Niobium (TAN) (Ti-6Al-7Nb) ASTM F1295, commercially pure Titanium Grade 4, and commercially pure Titanium Grade 2. These materials are stated to be the same or equivalent to the predicate devices.
    Design Equivalence: The device's design should be equivalent to previously cleared predicate devices.The 4.0mm components of both systems are a result of design modifications but are stated to be substantially equivalent to the predicates in design.
    Function Equivalence: The device's function should be equivalent to previously cleared predicate devices.The 4.0mm components of both systems are stated to be substantially equivalent to the predicates in function.
    Anatomic Sites Equivalence: The device's anatomic sites of use should be equivalent to previously cleared predicate devices.The devices are intended for use in the cervical and/or upper thoracic spine (C1-T3), with specific limitations on screw placement, which aligns with predicate devices.
    Performance Equivalence: Non-clinical performance demonstrates equivalence.Non-Clinical Performance and Conclusions: Documentation was provided which demonstrated the [Device Name] System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance, and material of manufacture.
    No Clinical Data Needed: Clearance did not require clinical studies to demonstrate safety and effectiveness.Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.

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

    • Not applicable. No test set in the context of AI/ML or diagnostic performance evaluation was used. The substantial equivalence was based on non-clinical performance documentation, generally referring to mechanical testing, material characterization, and design principle comparisons, rather than a "test set" of 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)

    • Not applicable. There was no "ground truth" establishment in the context of diagnostic assessment or expert consensus for a test set. The evaluation was primarily of engineering and material properties, compared against predicate devices.

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

    • Not applicable. No adjudication method was mentioned or required for this type of submission.

    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

    • Not applicable. This device is a spinal implant system, not an AI-assisted diagnostic tool.

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

    • Not applicable. This is a physical medical device.

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

    • Not applicable directly. The "ground truth" in this context is implicitly the established safety and effectiveness of the predicate devices based on their prior clearance, and the new devices' ability to meet comparable engineering and material standards. No clinical outcomes data or pathology was used or required for this 510(k) clearance itself.

    8. The sample size for the training set

    • Not applicable. There was no "training set" as this is not an AI/ML device.

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

    • Not applicable. There was no "training set" or corresponding ground truth establishment described for this device.
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