(45 days)
The Accin™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disk disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (including fracture); tumor; deformity (defined as kyphosis, lordosis or scoliosis); pseudoarthrosis; and/or failed previous fusions. The Accin™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7.
The Accin™ Cervical Plate System consists of titanium cervical plates and both self-tapping and self-drilling screw components. The surgeon uses the components to make a construct that is placed anteriorly for spinal fixation. The construct is used for temporary fixation which allows for fusion of the cervical spine
The provided FDA 510(k) submission for the Accin™ Cervical Plate System does not describe a study involving an AI/Machine Learning device or software. Instead, it concerns a traditional medical device classification. Therefore, the questions related to AI device performance, sample sizes for test and training sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to this submission.
The acceptance criteria and the study performed relate to the mechanical and material equivalence of the Accin™ Cervical Plate System to its predicate devices.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Equivalence to Predicate Device | "The Accin™ Cervical Plate System consists of plates and screws manufactured from the same titanium alloy as the Vertebron, Inc. SPC and SSP Cervical Plate Systems." |
| Functional Performance Equivalence to Predicate Device | "The proposed device was equivalent to the predicate device for all testing performed." (This implies that the device met the performance standards demonstrated by the predicate.) |
| Compliance with FDA Guidance Document "Spinal System 510(k)s" | "Testing has shown that the proposed device meets the requirements of the current FDA Guidance document entitled 'Spinal System 510(k)s' dated May 3, 2004." (This signifies that the device's design, materials, and testing protocols align with FDA recommendations for spinal implant systems, demonstrating safety and effectiveness.) |
| Static and Fatigue Performance (as per ASTM F1717) | "Tests were performed on the cervical plate system. The testing was performed in accordance with ASTM F1717, Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model." (The reported performance is that it was "equivalent to the predicate device" under these tests, indicating it met the same static and fatigue strength requirements.) |
Summary of the Study:
The study conducted was a bench testing comparison study, not a clinical trial or an AI/ML performance study. The primary goal was to demonstrate substantial equivalence to legally marketed predicate devices (Vertebron SCP and SSP Cervical Plate Systems) based on material composition and mechanical performance.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of devices or components tested. It only states, "Tests were performed on the cervical plate system." For bench testing, sample sizes are typically determined by statistical methods for materials science or engineering, but this detail is not provided.
- Data Provenance: The data comes from laboratory bench testing performed by or for Accelerated Innovation, LLC. There is no information on the country of origin of the data beyond the submitter being in Clifton, NJ, USA. The study is a prospective test in the sense that the testing was performed on the new device (Accin™) specifically to support its 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was bench testing against a standard (ASTM F1717) and comparison to a predicate device's established performance, not a study requiring expert clinical ground truth assessment.
4. Adjudication method for the test set:
- Not applicable. This was mechanical testing, not a subjective assessment requiring adjudication. The results would be quantitative measurements of physical 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:
- Not applicable. This study does not involve human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This study does not involve an algorithm or AI.
7. The type of ground truth used:
- The "ground truth" in this context is the established mechanical performance characteristics and material composition of the predicate devices, as well as the requirements outlined in the ASTM F1717 standard and the FDA guidance document "Spinal System 510(k)s." The device's performance was compared directly to these objective benchmarks.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML study, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set.
§ 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.