(68 days)
The Virage OCT Spinal Fixation 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-C7) and the thoracic spine from T1-T3; traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g., pseudoarthorsis); 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 Virage OCT Spinal Fixation 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 advance 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 Virage OCT Spinal Fixation System may be connected to the Instinct Java and Sequoia Spinal Systems offered by Zimmer Spine, using rod connectors and transition rods. Refer to the Instinct Java and Sequoia Spinal System package insert for a list of the system specific indications of use.
The titanium SONGER® Spinal Cable System to be used with the Virage OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.
The Zimmer Spine Virage® OCT Spinal Fixation System intended for the Occipital-Cervical-Thoracic spine (Occiput-T3). The system consists of a variety of rods, anchors, screws and connectors to build a spinal construct as necessary for the individual patient. The system also includes the instruments necessary for inserting and securing the implants are intended to be removed after solid fusion has occurred.
The Virage System implants are fabricated from medical grade titanium alloy or medical grade cobalt chromium allov. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together. Never use titanium alloy, and/or cobalt chromium with stainless steel in the same construct. All implants are single use only and should not be reused under any circumstances.
This document is a 510(k) summary for the "Virage OCT Spinal Fixation System," a medical device. It does not describe a study involving algorithms, AI, or human readers. Instead, it focuses on demonstrating substantial equivalence to a predicate device through mechanical testing, sterilization, and biocompatibility assessments. Therefore, I cannot provide information for most of your requested points, as they are related to studies on AI/algorithm performance.
However, I can extract the information related to performance testing and acceptance criteria as described in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device must demonstrate) | Reported Device Performance (How the device performed) |
|---|---|
| Axial and Torsional Gripping per ASTM F1798 | Device performed as intended. |
| Static Torsion, Static and Dynamic Compression Bending per ASTM F1717 | Device performed as intended. |
| Sterilization | Assessed and determined to be substantially equivalent to predicate. |
| Biocompatibility | Assessed and determined to be substantially equivalent to predicate. |
Summary of the study conducted to prove the device meets acceptance criteria:
The study was a series of non-clinical, mechanical performance tests, along with assessments for sterilization and biocompatibility.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of units or samples used for each test (e.g., how many open rod connectors were tested for axial gripping). It states "Performance mechanical testing concluded the Virage open rod connector performed as intended."
- Data Provenance: Not applicable as this is not a study involving human data or retrospective/prospective clinical data. The tests are laboratory-based mechanical testing and material assessments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The "ground truth" in this context is defined by the standards (ASTM F1798, ASTM F1717) themselves and the predefined pass/fail criteria within those standards for mechanical performance, and established methods for assessing sterilization and biocompatibility. There are no "experts" establishing ground truth in the sense of medical diagnosis or interpretation for this type of device submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable as there is no human interpretation or subjective assessment being adjudicated. The tests are objective mechanical and material properties.
5. 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:
This is not applicable. The document describes a spinal fixation system, not an AI or imaging device with readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical spinal implant system, not an algorithm.
7. The type of ground truth used:
The "ground truth" for the performance testing was based on:
- Engineering standards and recognized test methodologies (ASTM F1798 for axial and torsional gripping, ASTM F1717 for static torsion, static and dynamic compression bending).
- Established scientific principles and regulatory requirements for sterilization and biocompatibility.
8. The sample size for the training set:
This is not applicable. There is no concept of a "training set" for this type of mechanical and material performance testing of a physical medical device.
9. How the ground truth for the training set was established:
This is not applicable. The concept of "ground truth for a training set" is relevant to machine learning or AI models, which are not involved in this device's submission.
§ 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.