(104 days)
The SUMMIT SI OCT Spinal Fixation System and MOUNTAINEER OCT Spinal System are intended to provide immobilization and stabilization of spinal segments as an adjunct to 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. 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 SUMMIT and MOUNTAINEER 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.
The SONGER Wire/Cable System to be used with the SUMMIT and MOUNTAINEER Systems allows for wire/cable attachment to the posterior cervical spine.
The SUMMIT and MOUNTAINEER Systems can also be linked to the ISOLA, MONARCH, MOSS MIAMI, VIPER and EXPEDIUM Spine Systems using the dual wedding band and axial connectors, and via dual diameter rods.
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 tumors 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 SUMMIT Plate System is intended for use in treating fractures of small bones such as the metacarpals, uha, radius, humerus, and metatarsals, and in treating fractures of the lateral malleoulus, olecranon, and intra-articular distal tibia.
The SUMMIT Rod System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus.
The MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, and SYMPHONY OCT System are posterior spinal fixation systems 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 systems are composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The systems consist 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 SUMMIT Fixation System is intended for fracture fixation. The device may be removed after healing of the fracture has occurred. The system includes various lengths of 3 mm rods, 3.5 mm, 4.0 mm and 4.5 mm bone screws, plates, washers, connector plates, pin nuts, and outer nuts.
This document is a 510(k) Pre-market Notification from the FDA for a medical device. It does not describe a study involving an AI/Machine Learning device or its acceptance criteria. Instead, it concerns the substantial equivalence of an orthopedic spinal fixation system (MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, and SUMMIT Fixation System) to previously cleared predicate devices, primarily for the purpose of adding Magnetic Resonance (MR) compatibility labeling.
Therefore, most of the requested information regarding acceptance criteria and performance studies for an AI/ML device is not present in this document. The document focuses on physical device characteristics and their MR compatibility through non-clinical testing.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table for acceptance criteria in the context of an AI/ML device's performance. Instead, it refers to non-clinical testing conducted in alignment with ASTM standards for magnetic resonance compatibility. The "performance" reported is simply that "Results demonstrated compatibility conditions of the subject devices in the MR environment."
| Acceptance Criteria (based on ASTM Standards for MR compatibility) | Reported Device Performance |
|---|---|
| Measurement of Magnetically Induced Torque (ASTM F2213) | Compatibility demonstrated |
| Measurement of Magnetically Induced Displacement Force (ASTM F2052) | Compatibility demonstrated |
| Evaluation of MR Image Artifacts (ASTM F2119) | Compatibility demonstrated |
| Measurement of Radio Frequency Induced Heating (ASTM F2182) | Compatibility demonstrated |
2. Sample size used for the test set and the data provenance
This document describes non-clinical testing of physical devices, not an AI/ML test set. Therefore, "sample size" and "data provenance" as applied to AI/ML models are not applicable. The testing was conducted on the devices themselves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is not an AI/ML device requiring clinical expert ground truth for its performance evaluation. The ground truth for MR compatibility is established by objective physical measurements based on ASTM standards.
4. Adjudication method for the test set
Not applicable. There is no adjudication method described as it's not a human-in-the-loop or expert consensus study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No. This document does not mention any MRMC study, as it is not for a diagnostic AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device. The "standalone" performance here refers to the physical device's MR compatibility.
7. The type of ground truth used
The ground truth used for the MR compatibility testing was based on physical measurements and established ASTM standards for evaluating how medical devices interact with an MR environment (e.g., torque, displacement, heating, image artifacts). It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI/ML device.
§ 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.