(28 days)
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When used with the Centurion POCT System or Ascent POCT System for Posterior Occipital-Cervical-Thoracic (Occ - T3) The Connector System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 – T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Connector System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
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When used with the Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation
System or Spinal Fixation System (SFS) for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/llium) The Connector System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Illium), or as an anterolateral fixation system (T8-L5), in the treatment of the following acute and chronic instabilities or deformities:
- degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
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- spondylolisthesis,
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- trauma (i.e., fracture or dislocation),
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- spinal stenosis.
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- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
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- tumor,
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- pseudoarthrosis, and
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- failed previous fusion
When used for posterior pedicle screw fixation in pediatric patients, the Connector System implants are indicated as an adjunct to tusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach. The Connector System is intended to be used with autograft or allograft.
The Connector System is designed to reduce the complexity of revising and extending existing constructs from the Occiput to the Ilium. The Connector System includes a variety of non-sterile implants manufactured from titanium alloy comprised of bypass connectors, rod to rod connectors. Z rods, and an axial in-line connector with an attached rod. The Connector System implant options offered eliminate the need to remove existing hardware while providing stability to adjacent levels. The Connector System is compatible with posterior spinal fixation systems (e.g. Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System, Spinal Fixation System, Centurion POCT System, and Ascent POCT System) which offer titanium and/or cobalt chrome rods ranging in sizes of 3.0mm to 6.35mm.
This K172194 submission from Orthofix Inc. for their "Connector System" describes a modification to an already cleared device (K170647). As such, the submission focuses on demonstrating that the modifications do not negatively impact the device's safety and effectiveness compared to the predicate device.
Given that this is a 510(k) summary for modifications to an already cleared spinal fixation system, the information typically requested for AI/software-as-a-medical-device (SaMD) studies (like multi-reader multi-case studies, ground truth establishment for AI models, training sets, etc.) is not applicable to this submission. This is a traditional K-submission for hardware modification, not a SaMD.
The "device" in this context is a system of physical connectors and rods used in spinal surgery, not a software algorithm. Therefore, the "acceptance criteria" and "study" are engineering performance standards and mechanical tests.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document only lists the type of mechanical testing performed and a "justification" for one component. It does not provide specific quantitative acceptance criteria or detailed numerical results from the tests. This is common for 510(k) summaries where the full detailed test reports are submitted to the FDA but not typically included in the public summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| For Side/Top Loading Connector: Meet ASTM F1798 Static Axial Grip requirements. | Passed ASTM F1798 Static Axial Grip testing (Appendix F). The modifications (color anodization) did not adversely affect performance. |
| For Z-Rod: Maintain structural integrity and performance. | Performance justified (Appendix G). The modification (adding a second line for induced curvature identification) did not adversely affect performance. |
| General (for all modifications): Modifications (color anodization) do not negatively impact the design, materials, intended use, or performance characteristics when compared to the predicate device. | "There are no significant differences between the subject devices and the predicate devices which would adversely affect the use of the product." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the summary. Mechanical testing typically involves multiple samples for statistical validity, but the exact number is not provided.
- Data Provenance: Not applicable in the context of clinical data for a medical device. This refers to in-vitro mechanical robustness testing conducted in a lab environment to engineering standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. "Ground truth" in this context refers to engineering specifications and test standards (like ASTM F1798), not clinical expert reviews or labels for AI. The performance is assessed against established engineering criteria by qualified engineers in a testing lab.
4. Adjudication Method for the Test Set
- Not applicable. This is not a clinical study requiring adjudication of findings. Mechanical tests have pass/fail criteria based on load, displacement, and failure modes according to the specific ASTM standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance
- No, an MRMC study was not done. This device is a physical implant (spinal fixation system) and not an AI or software product. Therefore, comparative effectiveness studies involving human readers and AI assistance are not relevant.
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 is a hardware device, not an algorithm.
7. The Type of Ground Truth Used
- Engineering Standards: The "ground truth" for the mechanical performance testing is the compliance with established mechanical engineering standards, specifically ASTM F1798 for static axial grip testing, and general biomechanical performance expectations for spinal fixation devices.
8. The Sample Size for the Training Set
- Not applicable. This device does not use machine learning or AI models, therefore there is no training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply.
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.