(240 days)
The Nu Vasive® VuePoint® II 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 thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical 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 VuePoint II 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.
In order to achieve additional levels of fixation, the VuePoint II OCT System may be connected to the Nu Vasive® SpheRx® Spinal System, Precept® Spinal System, Armada® Spinal System and Reline™ System via the rod to rod connectors or transition rods.
The NuVasive VuePoint II OCT System consists of screws, hooks, rods, offset connectors, set screws, cross connectors, occipital plates and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of configurations to suit the individual pathology and anatomical conditions of the patient. The scope of this submission includes indications for the use of bone screws in the cervical (C1-C7) and thoracic (T1 to T3) spine.
The information provided does not describe a study that uses AI or machine learning, nor does it include many of the requested details such as specific acceptance criteria or performance metrics for such a device. The device described is the NuVasive® VuePoint® II OCT System, which is a spinal fixation system intended for immobilization and stabilization of spinal segments. The document is a 510(k) summary for FDA clearance, focusing on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing.
Here's an attempt to answer the questions based on the provided text, acknowledging where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document focuses on substantial equivalence based on material composition, design, labeling, and function, rather than specific numerical acceptance criteria for performance against a defined metric (which would typically be found for an AI/ML device's accuracy, sensitivity, specificity, etc.). The performance described is primarily non-clinical mechanical testing.
| Acceptance Criterion (Type) | Reported Device Performance (Reference to Predicate) |
|---|---|
| Mechanical Strength | Demonstrated substantial equivalence to predicate devices through static and dynamic compression, static and dynamic torsion, static axial rotation, lateral translation, and flexion bending interconnection strength testing. |
| Stability | "Rigidly locked into a variety of configurations" |
| Material Composition | Equivalent to predicate and reference devices. |
| Intended Use | Substantially equivalent to predicate devices for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable in the context of this 510(k) summary for a physical medical device. The "test set" here refers to the actual physical devices (implants and instruments) that were subjected to non-clinical mechanical testing. The document does not specify the number of devices tested for each mechanical test. Data provenance in this context would refer to the testing facility and methodology, which aligns with ASTM standards rather than patient data. The document does reference a "review of published literature" to support the use of bone screws in the cervical and upper thoracic spine, but this is not a "test set" for the device's performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. For a physical device like a spinal fixation system, ground truth is established through engineering and material science standards (e.g., ASTM standards) and direct measurement of mechanical properties, not through expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "test set" refers to mechanical testing of the physical device, not a diagnostic or interpretative task requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The NuVasive® VuePoint® II OCT System is a physical spinal fixation device, not a diagnostic or AI-assisted system that would involve human readers interpreting images.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Not applicable. This device is not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established through physical measurements and adherence to recognized mechanical testing standards (e.g., ASTM F2706, ASTM F1717, ASTM F1798). The results of these tests demonstrate that the device met specified engineering benchmarks for strength, stability, and integrity, which are considered "ground truth" for its mechanical properties.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML product and does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.