(92 days)
The V2F™ Anterior Fixation System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), turnor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis or a failed previous spine surgery.
The V2F™ Anterior Fixation System is a temporary supplemental fixation device consisting of: thoracolumbar plates, cap screws, bone screws and instrumentation necessary for implantation of the system.
The V2FTM Anterior Fixation System is used as an implant for the correction and stabilization of the spine. This system provides temporary stabilization and augments the development of a solid spinal fusion. Additionally, this system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The plates are low profile and anatomically designed to provide optimal fit from either anterior or anteriorlateral approach. All implant components are manufactured from titanium alloy as specified in ASTM F136.
Here's an analysis of the provided text regarding the V2F™ Anterior Fixation System, focusing on acceptance criteria and supporting studies:
This submission is for a medical device (spinal fixation system), and the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally related to mechanical performance and substantial equivalence to predicate devices, rather than diagnostic performance or algorithm efficacy which would involve the concepts of sensitivity, specificity, human readers, ground truth consensus, etc.
Therefore, many of the questions related to AI/algorithm performance (e.g., sample size for test set, experts, MRMC studies, standalone performance, training set) are not applicable to this type of device submission.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Static Compression Bending (ASTM F1717) | "The test results demonstrate that the V2FM Anterior Fixation System functioned as intended and performed in a manner substantially equivalent to that of the predicate(s)." | The specific numerical acceptance criteria (e.g., minimum load, displacement) are not provided in this summary. The performance is stated in terms of meeting the intent and being substantially equivalent to the predicates. |
| Static Torsion (ASTM F1717) | "The test results demonstrate that the V2FM Anterior Fixation System functioned as intended and performed in a manner substantially equivalent to that of the predicate(s)." | Similar to static compression bending, detailed numerical results are not included, but the general conclusion of substantial equivalence is given. |
| Dynamic Compression Bending (ASTM F1717) | "The test results demonstrate that the V2FM Anterior Fixation System functioned as intended and performed in a manner substantially equivalent to that of the predicate(s)." | Similar to the static tests, the device's performance in dynamic compression bending is reported as meeting the intended function and achieving substantial equivalence. |
Study Proving Acceptance Criteria:
The study referenced is based on mechanical testing according to ASTM F1717 standards. The specific tests performed were:
- Static compression bending
- Static torsion
- Dynamic compression bending
The conclusion drawn from these tests is that the V2F™ Anterior Fixation System functioned as intended and performed in a manner substantially equivalent to that of the predicate(s). The predicate devices used for comparison are:
- InCompass Spinal Fixation System (K021564)
- Synthes Thoracolumbar Spine Locking Plate (TSLP) System (K020244)
Additional Information (Where Applicable)
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable (N/A): This is a mechanical device. The "test set" would refer to the number of physical samples of the device components subjected to the ASTM F1717 tests. This information (specific number of samples tested) is not detailed in the summary but would be part of the full test report. Data provenance (country, retrospective/prospective) is not relevant for mechanical testing of this nature.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- N/A: Ground truth in the context of diagnostic or AI performance is not relevant for the mechanical testing of a spinal fixation system. The "ground truth" for mechanical testing is defined by the ASTM standards themselves and the physical laws governing material properties and structural integrity.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A: Adjudication methods are used to resolve discrepancies in human interpretations or classifications, typically in the context of diagnostic performance studies. This is not applicable to standardized mechanical engineering tests.
-
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:
- N/A: MRMC studies are used for evaluating diagnostic imaging systems or AI algorithms with human readers. This device is a surgical implant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A: This submission is for a physical medical device, not an algorithm or AI system.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A: As mentioned, ground truth in this context refers to the adherence to established mechanical testing standards (ASTM F1717) and the physical properties of the materials and design compared to predicates.
-
The sample size for the training set:
- N/A: There is no "training set" as this is not an AI/machine learning device.
-
How the ground truth for the training set was established:
- N/A: No training set exists.
Summary of Device Performance Determination:
The V2F™ Anterior Fixation System's acceptance criteria are centered on its mechanical properties and performance. The device is deemed to meet these criteria by demonstrating substantial equivalence to predicate devices through conformity to the ASTM F1717 standard for static compression bending, static torsion, and dynamic compression bending. The "study" is the mechanical testing conducted according to this recognized standard.
§ 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.