(179 days)
The SYMPHONY OCT System is intended to provide immobilization 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 upper thoracic spine (T1-T3):
- · Traumatic spinal fractures and/or traumatic dislocations;
- Instability or deformity;
- · Failed previous fusions (e.g. pseudarthrosis);
- · Tumors involving the cervical/thoracic spine;
· Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and
· Degenerative disease of the facets with instability.
The SYMPHONY OCT 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 turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The SYMPHONY OCT System is compatible with occipital fusion components (plates, rods and clamps) from the SYNAPSE Occipital-Cervical-Thoracic (OCT) System and the MOUNTAINEER OCT Spinal System. Additionally, the SYMPHONY OCT System is compatible with SYNAPSE OCT System hooks and rods.
The SONGER Wire/Cable System may be used with the SYMPHONY OCT System to allow for wire/cable attachment to the posterior cervical spine.
The SYMPHONY OCT System may be connected to the EXPEDIUM Spine System using connectors and tapered rods. The SYMPHONY OCT System can also be linked to the USS Spinal System and MATRIX Spine System using connectors and tapered rods.
The SYMPHONY OCT System is a posterior spinal fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3). The 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 system consists of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws) with optional transverse connectors (e.g., cross connectors) to link the longitudinal components for additional stability.
The provided text is a 510(k) summary for the SYMPHONY OCT System, which is a posterior spinal fixation system. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, specifically the SYMPHONY OCT System (K181949, K190895).
Therefore, this document does not contain information about acceptance criteria or a study proving the device meets those criteria in the way you might expect for a novel AI/software medical device. Instead, it asserts equivalence based on the device's technological characteristics, performance, and intended use remaining unchanged, with the notable addition of a sterile tube packaging configuration for some components.
Here's a breakdown based on your request, highlighting what is not available in this type of submission:
Acceptance Criteria and Device Performance Study (Not Applicable in the traditional sense for this submission)
This 510(k) submission does not present acceptance criteria for a novel device performance study because it relies on demonstrating substantial equivalence to predicate devices for which such performance has already been established. The core assertion is that the fundamental scientific technology and performance are unchanged.
The submission states: "The fundamental scientific technology of the subject devices remains unchanged from the predicate devices... The intended use, technological characteristics, and performance of the SYMPHONY OCT System are equivalent with those of the predicate devices."
The "performance data" mentioned refers to the fact that the performance remains unchanged compared to the predicate devices. This means that previous studies supporting the predicate devices effectively serve as the "proof" for the substantial equivalence of this updated device.
Detailed breakdown of your requested information:
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A table of acceptance criteria and the reported device performance
- Not Applicable (N/A): This document does not establish new acceptance criteria or present a new performance table against such criteria. The submission declares that the performance of the subject device is unchanged from the predicate devices. For a mechanical implant like this, "performance" would typically refer to mechanical testing (e.g., fatigue, static strength, push-out, pull-out forces) demonstrating its ability to withstand physiological loads, biocompatibility, and sterilization effectiveness. These types of tests were likely performed for the predicate devices.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A: No new clinical or stand-alone performance test set is described or implies. The submission is not for an AI/Software device that would typically have a "test set" in this context. The "performance data" mentioned (Section I) refers to the fact that it "remains unchanged" from the predicate devices, indicating that no new independent test set specific to this incremental change was conducted to re-evaluate fundamental performance. Data provenance would have been part of the predicate device submissions.
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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)
- N/A: This information is not relevant to a 510(k) for a spinal fixation system that is asserting substantial equivalence based on unchanged engineering performance. Ground truth establishment with experts is typical for diagnostic AI devices, not for mechanical implants.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A: No clinical or expert-based adjudication method for a test set is described.
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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
- N/A: This is a mechanical spinal implant, not an AI-assisted diagnostic device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant or reported.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A: This is a mechanical spinal implant, not an algorithm. Therefore, no standalone algorithm performance was assessed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A: No ground truth in this context is established or used for this type of submission. For mechanical implants, "proof" comes from meeting engineering standards and preclinical mechanical testing, as well as clinical experience with similar predicate devices.
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The sample size for the training set
- N/A: This is a mechanical spinal implant, not a machine learning model, so there is no "training set."
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How the ground truth for the training set was established
- N/A: Not applicable for the reasons stated above.
Summary based on the provided text:
The submission for the SYMPHONY OCT System (K192014) is a 510(k) Pre-market Notification. Its primary purpose is to demonstrate substantial equivalence to predicate devices (SYMPHONY OCT System, K181949, K190895) rather than presenting new performance data against specific acceptance criteria for a novel device. The key change highlighted is the addition of a sterile tube packaging configuration for polyaxial screw components. The applicant asserts that the device's "intended use, technological characteristics, and performance are equivalent with those of the predicate devices." Therefore, the "study" proving the device meets acceptance criteria is implicitly the body of evidence that supported the clearance of the predicate devices, as the current device's performance is claimed to be unchanged.
§ 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.