(68 days)
The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
The Boundary Anterior Lumbar Buttress Plate is a fixation system used as a buttress of the interbody, to stabilize the allograft or autograft at one level during the development of a spinal fusion. The device consists in a plate shaped to conform to the anatomy of the anterior lumbar and lumbosacral spine (L1-S1). A screw fixates the system to the anterior surface of the vertebral body, allowing the plate to extend onto the adjacent intervertebral space. The buttress end of the plate may be oriented either caudal or cephalad. The Boundary Anterior Lumbar Buttress Plate may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials.
This document is a 510(k) premarket notification for a medical device called the "Boundary Anterior Lumbar Buttress Plate". It is not a study report for an AI/ML powered device, therefore, much of the requested information regarding AI acceptance criteria, training data, and expert review is not applicable.
However, I can extract the information relevant to the non-clinical testing performed and the substantial equivalence argument.
Here's a breakdown of the requested information where applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Test Performed | Reported Device Performance |
|---|---|---|
| ASTM F1717-13 (Static Cantilever Bending) | Static Cantilever Bending | The results indicate substantial equivalence to predicate devices. (Specific quantitative results or acceptance limits are not provided in this document). |
| ASTM F1717-13 (Dynamic Cantilever Bending) | Dynamic Cantilever Bending | The results indicate substantial equivalence to predicate devices. (Specific quantitative results or acceptance limits are not provided in this document). |
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 provided in the document. For non-clinical mechanical testing, "sample size" typically refers to the number of devices tested. The document only states that "the following tests were performed," but does not detail the number of units tested. Data provenance (country of origin, retrospective/prospective) is not applicable for this type of mechanical testing.
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)
Not applicable. Ground truth and expert review are concepts relevant to diagnostic or AI-powered devices, not mechanical fixation devices undergoing non-clinical bench testing. The "ground truth" for mechanical testing is derived from the physical properties and performance of the device under controlled conditions, measured against established engineering standards like ASTM F1717-13.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for human interpretation or AI output, not for mechanical testing.
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 is not an AI-powered device and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical testing, the "ground truth" is established by the specified test methods and acceptance criteria defined within standards like ASTM F1717-13. The performance of the device is measured directly against these objective, quantitative standards.
8. The sample size for the training set
Not applicable. This is not an AI-powered device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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.