(49 days)
The NuVasive® VuePoint® OCT 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 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 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 OCT System may be connected to the NuVasive SpheRx® Spinal System, Precept® Spinal System, Armada® Spinal System and Reline™ System via the rod to rod connectors or transition rods.
The NuVasive VuePoint® OCT System is a occipito-cervico-thoracic posterior fixation system manufactured from Titanium alloy (Ti6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3 and Cobalt Chromium alloy conforming to ASTM F90 or ASTM F1537. The NuVasive VuePoint OCT System consists of screws, hooks, 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 is to expand the indications for use of bone screws in the cervical (C1-C7) and thoracic (T1 to T3) spine.
This document (K153336) is a 510(k) premarket notification for a medical device called the NuVasive® VuePoint® OCT System. It aims to demonstrate that the device is substantially equivalent to legally marketed predicate devices.
The information provided does not describe a study that proves the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity, as one would expect for an AI/algorithm-based device. Instead, it focuses on mechanical performance testing and clinical literature review to support the safety and effectiveness of a spinal fixation system and its expanded indications for use.
Therefore, many of the requested details about acceptance criteria for an AI device, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable (N/A) to this specific device submission.
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance
This submission is for a spinal fixation system, not an AI or algorithm. The acceptance criteria revolve around mechanical performance and substantial equivalence to previously cleared predicate devices, rather than performance metrics of an AI model (e.g., accuracy, sensitivity, specificity).
| Acceptance Criteria Category | Specific Criteria (Inferred from Text) | Reported Device Performance/Evidence Provided |
|---|---|---|
| Mechanical Performance | The device must meet the mechanical performance standards (e.g., strength, durability, resistance to fatigue) demonstrated by the predicate device (VuePoint OCT System K093319) for the existing indications and be sufficient to support the expanded indications, even for "worst case" scenarios. Since no new device designs or worst-case sizes are introduced, the previously established mechanical performance is considered sufficient. | "Mechanical performance testing data was provided for the original VuePoint OCT System in 510(k) K093319 to establish substantial equivalence. Since no new device designs and no new worst case sizes are being introduced to the VuePoint OCT System, the previously presented mechanical testing data in K093319 is sufficient to support the expanded indications for the VuePoint OCT System." (Section G, "Performance Data") |
| Material Composition | Materials used must be biocompatible and conform to recognized standards (e.g., ASTM F136, ISO 5832-3, ASTM F90, ASTM F1537) and be substantially equivalent to predicate device materials. | "The NuVasive VuePoint® OCT System is a occipito-cervico-thoracic posterior fixation system manufactured from Titanium alloy (Ti6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3 and Cobalt Chromium alloy conforming to ASTM F90 or ASTM F1537." (Section D, "Device Description") and "The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, performance, material composition, and function." (Section F, "Technological Characteristics") |
| Functional Equivalence | The device's design, intended use, and function must be substantially equivalent to the predicate devices. This includes the ability to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the stated indications. The expanded indications (use of bone screws in cervical C1-C7 and thoracic T1-T3, and connection to other NuVasive systems) must also be supported as safe and effective. | "The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, performance, material composition, and function." (Section F, "Technological Characteristics") The "Indications for Use" (Section E) explicitly lists the expanded uses. |
| Clinical Efficacy/Support for Expanded Use | There must be sufficient clinical rationale or evidence to support the safety and effectiveness of using bone screws in the cervical (C1-C7) and upper thoracic (T1-T3) spine for the specified conditions, as the original predicate cleared these uses. The submission needs to provide evidence that this expanded use is safe and effective when performed with this specific device. | "Additionally, a clinical literature review was performed to support the use of bone screws in treating conditions of the cervical (C1-C7) and upper thoracic (T1-T3)." (Section G, "Performance Data") This indicates that previous clinical data/knowledge supported the general procedure, and this device is equivalent for that procedure. |
Study Details (Relevant to this type of device submission)
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Sample sizes used for the test set and data provenance:
- Test Set Sample Size: Not applicable in the context of an AI/algorithm test set. For mechanical testing, the "samples" would be the device components tested. The document states that "no new worst case sizes are being introduced," implying that the sample sizes from the original K093319 submission for mechanical testing were deemed sufficient and are reused. Specific numerical sample sizes for mechanical tests are not provided in this summary.
- Data Provenance: The mechanical testing data refers to previous 510(k) K093319. The clinical literature review would draw from published studies, which are typically retrospective analyses of patient outcomes or procedures.
- Retrospective/Prospective: The existing data for mechanical performance (from K093319) would have been generated prospectively during the development and clearance of that device. The clinical literature review is inherently retrospective.
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Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable. This submission relies on mechanical testing standards and clinical literature. "Ground truth" in the AI sense is not established for this device as it's not a diagnostic or AI-driven system. Mechanical testing standards and established clinical practice serve as the "ground truth."
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No human-based adjudication of performance on a test set is described, as this is not an AI/diagnostic device.
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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:
- No. This is not an AI device, so MRMC studies are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical spinal fixation device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For mechanical performance: Ground truth is established by engineering standards and benchmarks for spinal implants, likely defined by ISO or ASTM.
- For clinical justification of expanded indications: Ground truth comes from the existing clinical literature and established medical practice regarding the use of bone screws in the cervical and thoracic spine for the specified conditions.
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The sample size for the training set:
- Not applicable. This is not an AI device that requires training data.
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How the ground truth for the training set was established:
- Not applicable. No training set for an AI model is involved.
§ 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.