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510(k) Data Aggregation
(85 days)
The Vital 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). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.
These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vital Spinal Fixation System is intended to be used with autograft and/or allograft.
In addition, the Vital Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5‑S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vital System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vital System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Vital™ (Vitality) Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the surgical correction of several types of spinal conditions. The system consists of a variety of spinal rods, pedicle screws, hooks, and connectors intended only to provide temporary stabilization during the development of a solid fusion of the spine with bone graft. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient's anatomy. All implants are single use only and should not be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred.
The system also includes instrumentation for insertion, securing and removal of the implants. All implants are made from medical grade titanium alloy; select rods are also available in medical grade cobalt chromium alloy. Implants made from medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct.
The Vital™ MIS System is a percutaneous screw delivery system that is an extension of the Vital™ System. The Vital MIS System implants consist of a variety of spinals rods and pedicle screws that are modified under the MIS line extension to feature cannulated screws (extended and non-extended tab) and modified spinal rods (bullet nose, connection, curvature). The system includes a variety of instrumentation which are also compatible with Vital and Vital MIS implant offerings in the Vital™ System and allow for a minimalized, percutaneous, or mini-open surgical approach, extending MIS capabilities to the cannulated implants of the wider Vital™ System.
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(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.
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