(78 days)
The Alphatec Spine Anterior Lumbar Plating System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved.
The Alphatec Spine Anterior Lumbar Plating System is intended for anterior lumbar spine (L1-S1) fixation for the following indications:
- Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies)
- Pseudoarthrosis
- Spondylolysis
- Spondylolisthesis
- Trauma (i.e., fracture or dislocation)
- Spinal stenosis
- Unsuccessful previous fusion surgery
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
The Alphatec Spine Anterior Lumbar Plating System is intended to be used with autograft and/or allograft as an adjunct to fusion.
The Alphatec Spine Anterior Lumbar Plating System is a spinal fixation system that consists of a variety of non-sterile, single-use plates and screws. All implants are manufactured from titanium alloy conforming to ASTM F136. The system also contains Class I manual instruments. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar/lumbosacral spine (levels L1-S1) providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
The provided text describes a medical device, the "Alphatec Spine Anterior Lumbar Plating System," which is a spinal fixation system. However, the document is a 510(k) summary for regulatory clearance, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study on acceptance criteria for a new device's performance against specific clinical outcomes.
This document details non-clinical performance data (mechanical testing) for the device's safety and effectiveness, but it does not contain information about studies involving human readers, AI, or clinical outcomes that would allow for a complete answer to your request in the context of device performance against specific acceptance criteria related to accuracy, sensitivity, specificity, etc.
Therefore, I cannot provide a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor information on sample sizes for test sets (human or AI), expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth for training and test sets in the way you've outlined. This information is typically found in clinical validation studies for diagnostic devices or AI-powered systems.
Here's what can be extracted from the provided text, primarily regarding non-clinical performance:
1. A table of acceptance criteria and the reported device performance
The document primarily discusses non-clinical performance data related to mechanical testing to ensure safety and effectiveness.
| Acceptance Criteria Category (Non-Clinical) | Reported Device Performance |
|---|---|
| Mechanical Static Performance | Satisfies requirements for anterolateral lumbar fixation |
| Mechanical Torsion Performance | Satisfies requirements for anterolateral lumbar fixation |
| Dynamic Testing Performance | Satisfies requirements for anterolateral lumbar fixation |
| Adherence to Consensus Standards | Performed per recognized consensus standards |
| Adherence to Guidance Document | Performed per "Spinal System 510(k)s - Guidance for Industry and FDA Staff" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present for clinical or diagnostic performance. The document describes mechanical tests, not studies with human subjects or AI algorithms reviewing data.
3. 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)
This information is not present. The document discusses mechanical testing, not ground truth established by experts for diagnostic purposes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present. No such adjudication method would be relevant for the mechanical testing described.
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 information is not present. The device is a physical spinal implant, not an AI diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present. The device is a physical spinal implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical mechanical testing, the "ground truth" or reference for performance is established by the recognized consensus standards and guidance documents for spinal systems.
8. The sample size for the training set
This information is not present. There is no mention of a "training set" as this is a physical medical device, not an AI algorithm.
9. How the ground truth for the training set was established
This information is not present. Not applicable to the device described.
§ 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.