(53 days)
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass of spinal segments in skeletally mature patients.
The NEXT GENERATION™ Anterior Cervical Plate system is intended for use in anterior cervical decompression and fusion (ACDF) surgery (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions:
- degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- spondylolisthesis
- trauma (i.e., fracture or dislocation)
- spinal stenosis
- pseudoarthrosis
- tumor
- and failed previous fusion.
The NEXT GENERATION™ Anterior Cervical Plating System is an anterior cervical plating system intended for use in anterior cervical decompression and fusion (ACDF) surgery (C2-C7). The subject components of this submission are cervical plates, screws, and various instrumentation.
The provided text describes a 510(k) submission for the Alphatec Spine NEXT GENERATION™ Anterior Cervical Plating System. This is a medical device, specifically a spinal implant, and not an AI/ML-driven device. Therefore, many of the requested criteria related to AI/ML device studies (such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this submission.
The "study" referenced in this document is a mechanical and dynamic testing of the device to demonstrate substantial equivalence to predicate devices, not a clinical study involving patients or AI performance.
Here's a breakdown of the relevant information from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by 510(k) Process) | Reported Device Performance (from text) |
|---|---|
| Mechanical Performance Equivalent to Predicate Devices | "Mechanical and dynamic testing of the cervical plate system was performed. The test results demonstrate that the mechanical performance of the NEXT GENERATION™ Anterior Cervical Plating System is substantially equivalent to the predicate devices." |
| Dynamic Performance Equivalent to Predicate Devices | "Mechanical and dynamic testing of the cervical plate system was performed. The test results demonstrate that the mechanical performance of the NEXT GENERATION™ Anterior Cervical Plating System is substantially equivalent to the predicate devices." |
| Compliance with Regulatory Requirements (e.g., QSR) | Device granted 510(k) clearance, implying compliance with general controls and manufacturing regulations. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This was mechanical and dynamic testing of the device itself, not a test set of data like in an AI/ML study.
- Data Provenance: Not applicable. The "data" comes from the physical testing of the device prototypes/samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as understood in AI/ML studies (e.g., expert consensus on medical images) is not relevant to mechanical device testing. The "ground truth" for mechanical testing would be engineering standards and measurement accuracy.
4. Adjudication method for the test set
- Not applicable. There was no "test set" in the AI/ML sense, nor a need for expert adjudication.
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
- No. This is a spinal implant device, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Ground Truth: For mechanical testing, the "ground truth" refers to established engineering standards, material properties, and biomechanical parameters. The device's performance is compared against these standards or the performance of predicate devices according to these standards.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
Summary of the Study:
The "study" described for the Alphatec Spine NEXT GENERATION™ Anterior Cervical Plating System was a mechanical and dynamic testing regimen. This testing compared the physical performance characteristics of the new device to those of two legally marketed predicate devices: the Synthes Spine CSLP (K000536) and the Scient'x Stella (K042317). The purpose of this testing was to demonstrate substantial equivalence in mechanical performance, which is a key requirement for 510(k) clearance for medical devices. The document explicitly states that "The test results demonstrate that the mechanical performance of the NEXT GENERATION™ Anterior Cervical Plating System is substantially equivalent to the predicate devices."
§ 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.