(58 days)
The Virage® OCT Spinal Fixation 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-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 Vital Spinal Fixation System offered by Highridge Medical, using rod connectors and transition rods. Refer to the Vital Spinal Fixation System package insert for a list of the system specific indications of use. The Vital/Vitality Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
The Virage® OCT Spinal Fixation System is a posterior fixation system intended to provide immobilization and stabilization of the Occipital-Cervical-Thoracic spine (Occiput-T3). The system consists of a variety of rods, anchors, connectors, screws, and polyaxial screws to achieve an implant construct as necessary for the individual case. The system also includes the instruments necessary for inserting and securing the implants. The implant system is intended to be removed after solid fusion has occurred.
The Virage® System implants are fabricated from medical grade titanium alloy and medical grade cobalt chromium alloy. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together.
The provided FDA 510(k) clearance letter for the Virage® OCT Spinal Fixation System focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for an Artificial Intelligence (AI)/Machine Learning (ML) device.
Therefore, many of the requested criteria, such as those pertaining to AI model performance (sample size for test/training sets, expert ground truth adjudication, MRMC studies, standalone performance), are not applicable to this submission. This document describes a traditional 510(k) for a spinal fixation system, not an AI/ML diagnostic or therapeutic device.
However, I can extract the information that is relevant and state where the requested information is not applicable based on the provided document.
Analysis of Acceptance Criteria and Device Performance (Based on Provided Document)
The Virage® OCT Spinal Fixation System is a physical medical device (spinal fixation system), not an AI/ML software device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to mechanical testing and usability assessments to demonstrate substantial equivalence to a predicate device, not evaluation of an AI model's diagnostic or predictive performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Goals) | Reported Device Performance (Conclusion) |
|---|---|---|
| Mechanical Performance | Meet ASTM F1717 standards (Static Torsion, Dynamic/Static Compression Bending for Spinal Implant Constructs in Vertebrectomy Mode) | "Mechanical testing and usability were evaluated, which all met the acceptance criteria for the worst-case subject connectors." |
| Meet ASTM F1798 standards (Axial/Torsional Grip Testing for Static and Fatigue Properties of Interconnection Mechanisms) | "Mechanical testing and usability were evaluated, which all met the acceptance criteria for the worst-case subject connectors." | |
| Usability | Device is usable as intended. | "Mechanical testing and usability were evaluated, which all met the acceptance criteria..." |
| Packaging | Packaging integrity and safety maintained. | "...packaging, cleaning and sterilization were evaluated to determine no risks were introduced to the system." |
| Cleaning and Sterilization | Device can be effectively cleaned and sterilized. | "...packaging, cleaning and sterilization were evaluated to determine no risks were introduced to the system." |
| Risk Assessment | Risks are reduced as low as reasonably practicable, and no equally severe/probable alternative risks exist. | "A risk assessment was conducted that found risks have been reduced as far as possible and neither alternative design nor therapeutic options exist to avoid the introduced risks without introducing equally severe and/or probable risks." |
| Substantial Equivalence | Demonstrate substantial equivalence to the predicate Virage® System (K153631) regarding intended use, indications for use, design, materials, manufacturing methods, fundamental technology, and operational principles. | "The Virage® System's indications for use, intended use, design, materials, and performance assessments are substantially equivalent to the currently marketed Virage® System. As such, Highridge Medical, LLC concludes that the subject Virage® System is substantially equivalent to the predicate Virage® System." |
| MRI Compatibility | Meet ASTM F2052 (magnetically induced displacement force), ASTM F2182 (RF induced heating), ASTM F2213 (magnetically induced torque), and ASTM F2119 (MR image artifacts). | "Based on testing of the Virage® System in a magnetic resonance environment, the labeling was updated to include the addition of 'MR Conditional information'." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of an AI/ML test set. The document refers to "worst-case subject connectors" for mechanical testing, implying specific samples of the device components were tested, but not a "test set" of patient data or images.
- Data Provenance: Not applicable. The "data" are mechanical test results, not patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a physical device, not an AI/ML diagnostic tool that requires expert-established ground truth from images or patient data. Ground truth for mechanical testing would be defined by engineering specifications and standard test methods.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are for human expert consensus on medical images or patient outcomes, which is not relevant for mechanical testing of a spinal implant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is used to evaluate the impact of an AI/ML system on human reader performance for tasks like diagnosis or detection. This is a mechanical device, so an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
- Not Applicable. This is a physical spinal implant, not a standalone algorithm.
7. The type of Ground Truth Used
- Mechanical Test Standards and Engineering Specifications: The "ground truth" for this device's performance evaluation is adherence to standardized mechanical testing protocols (ASTM F1717, ASTM F1798) and internal engineering specifications for safety and performance, demonstrating equivalence to the predicate device.
- MRI Compatibility Standards: Compliance with relevant ASTM standards for MRI compatibility (F2052, F2182, F2213, F2119) serves as the ground truth for this aspect.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.
§ 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.