(73 days)
The VertiFlex™ PEEK VBR is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaqed, or unstable vertebral body due to tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The VertiFlex™ PEEK VBR is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period. The interior of the VertiFlex™ PEEK VBR may be packed with bone graft.
The VertiFlex™ Octane™ PEEK Vertebral Body Replacement, or PEEK VBR, is an implant composed of pure Poly(Etheretherketone), or PEEK, intended to serve as a partial or total replacement of a vertebral body that is collapsed, damaged, or unstable as a result of tumor or trauma (i.e., fracture). The implant is available in a range of sizes, and is intended to achieve anterior decompression of the spinal cord and neural structures, and to restore vertebral height. In so doing, the device is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column. The device is hollow to permit packing with bone graft to facilitate fusion, but is of sufficient strength to provide column support even in the absence of fusion for prolonged periods. The device may be implanted by either conventional surgical methods, or via minimally-invasive techniques, using manual instrumentation provided by VertiFlex™, Inc., specifically for use with the subject device. The device is offered non-sterile.
The provided text describes a 510(k) premarket notification for a medical device, the VertiFlex™ Octane™ PEEK Vertebral Body Replacement. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy and safety through extensive clinical trials for de novo approval. As such, the study described is not a typical clinical trial assessing device performance against specific, pre-defined acceptance criteria for a new therapy, but rather non-clinical tests to show equivalence in performance to existing devices.
Here's an analysis of the provided text based on your request:
Acceptance Criteria and Study to Prove Device Meets Them
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance | The device is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column. This is fundamental to its function as a vertebral body replacement. | "Tests conducted in accordance with such recognized standards as ASTM F2077-03, Test Methods for Intervertebral Body Fusion Devices, have demonstrated the substantial equivalence of the subject device to commercially-available predicate devices in terms of performance." This implies the device meets or exceeds the mechanical properties expected of such implants. |
| Material Equivalence | The device is composed of pure Poly(Etheretherketone), or PEEK. The acceptance criterion is that this material choice (and its physical properties) is substantially equivalent to predicate devices. | "Testing and comparisons of design characteristics and features have established that the subject VertiFlex™ PEEK VBR is substantially equivalent in design, materials of composition, indications, performance, and other features, to other vertebral body replacement devices commercially available in the U.S." This indicates the material (PEEK) and its performance are equivalent to predicate devices. |
| Mechanical Performance (e.g., strength, fatigue, subsidence) | The device must be of "sufficient strength to provide column support even in the absence of fusion for prolonged periods." This implies specific mechanical performance requirements (e.g., compressive strength, fatigue life) that are typically assessed by standards like ASTM F2077. | "Non-clinical tests, including those conducted in accordance with such recognized standards as ASTM F2077-03, Test Methods for Intervertebral Body Fusion Devices, have demonstrated the substantial equivalence of the subject device to commercially-available predicate devices in terms of performance." ASTM F2077 specifically covers mechanical testing for intervertebral body fusion devices, addressing aspects like static compression, dynamic compression, and expulsion resistance. |
| Dimensions and Sizing | The device should be available in a range of sizes to achieve anterior decompression and restore vertebral height, comparable to predicate devices. | "The implant is available in a range of sizes..." This design characteristic, along with comparison to predicate devices, implies the sizing is appropriate and equivalent. Comparison studies would verify this. |
| Biocompatibility | As an implant, the PEEK material must be biocompatible and substantially equivalent to predicate devices using similar materials. | While not explicitly stated as an "acceptance criterion" in the provided text, biocompatibility is an inherent requirement for any implant. The statement "substantially equivalent in... materials of composition" implies that PEEK's biocompatibility has been established and is equivalent to the PEEK used in predicate devices. |
Study Description:
The study conducted was a non-clinical comparative testing program designed to demonstrate "substantial equivalence" of the VertiFlex™ Octane™ PEEK Vertebral Body Replacement device to several legally marketed predicate devices.
- Type of Study: Non-clinical (benchtop)
- Purpose: To establish substantial equivalence in design, materials, indications, and performance to predicate devices (Interpore Cross PEEK CAS, Quantum Orthopedics Crystal™ and Lucent™, Signus Medizintechnik Curved Tetris™, Stryker Spine AVSTM PL Spacer, Synthes Vertebral Spacer).
- Methodology: The study included tests conducted in accordance with recognized standards, specifically ASTM F2077-03, Test Methods for Intervertebral Body Fusion Devices. This standard outlines various mechanical tests such as static and dynamic compression, expulsion resistance, and subsidence, appropriate for assessing the structural integrity and performance of vertebral body replacement devices.
- Outcome: The study concluded that the VertiFlex™ Octane™ PEEK Vertebral Body Replacement device is substantially equivalent to the identified predicate devices in terms of performance.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The provided text does not specify the sample size used for the non-clinical tests. ASTM F2077-03 would provide guidance on the number of samples required for each specific test (e.g., number of constructs for static compression, fatigue testing).
- Data Provenance: The data provenance is laboratory-generated data from non-clinical (benchtop) testing. It is not patient or human subject data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This question is not applicable to this type of submission. The "ground truth" in this context is established by recognized international standards (like ASTM F2077-03) for mechanical testing. Expert consensus would be involved in interpreting the results relative to these standards and the predicate devices, but the text does not detail an "expert panel" for establishing clinical ground truth for a diagnostic device.
- For mechanical testing, the "experts" would be the engineers and technicians performing the tests and interpreting the data against material and mechanical engineering principles, as well as the requirements of the ASTM standard.
4. Adjudication Method for the Test Set
- This question is not applicable to a non-clinical, benchtop study for substantial equivalence based on mechanical properties. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or studies involving human expert assessment of images/data to establish a clinical ground truth.
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 question is not applicable. The device is a physical implant (Vertebral Body Replacement), not an AI-based diagnostic tool or software. Therefore, an MRMC study related to human readers and AI assistance is entirely outside the scope of this submission.
- No clinical testing was conducted or required for this 510(k) submission ("No clinical testing was conducted to support this submission").
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable. The device is a physical implant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this non-clinical study is based on established engineering principles and recognized industry standards (specifically ASTM F2077-03) for the mechanical performance of vertebral body fusion devices. The performance of the predicate devices also serves as a benchmark for comparison.
8. The sample size for the training set
- This question is not applicable. This is a non-clinical study for a physical device, not an AI or machine learning model that would require a training set.
9. How the ground truth for the training set was established
- This question is not applicable as there is no training set for a physical implant.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.