(107 days)
The BALTEUM™ and BALTEUM - ONE™ Lumbar Plate System are intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, 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 device is intended as a temporary fixation device until fusion is achieved.
The BALTEUM - ONE™ Lumbar Plate System consists of non-sterile, single use, rigid plates and bone screws of varying sizes and lengths to fit the anatomical needs of a wide variety of patients. The plate attaches by means of screws to the vertebral body of the thoracolumbar spine (T1-L5) either through an antero-lateral, or lateral approach and to the lumbar/lumbosacral spine (L1-S1) through an anterior approach. The system includes instrumentation which assists in the surgical implantation of the device.
This document is a 510(k) summary for the BALTEUM - ONE™ Lumbar Plate System. It describes the device, its intended use, and the studies performed to demonstrate its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, detailed study results, or information typically found in a clinical study report for evaluating performance in terms of diagnostic accuracy or similar metrics.
It focuses on non-clinical (mechanical) testing to demonstrate substantial equivalence for a medical implant device, not a diagnostic AI device. Therefore, many of the requested categories are not applicable to the information provided.
Here's an breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in terms of statistical thresholds for diagnostic accuracy, sensitivity, specificity, etc. for a AI device. Instead, it states that "Non-clinical testing was performed to demonstrate that the subject BALTEUM - ONE™ Lumbar Plate System is substantially equivalent to the predicate device."
The reported performance is that the device "demonstrates that the BALTEUM - ONE™ Lumbar Plate System is substantially equivalent to the legally marketed predicate devices" based on the following tests conducted in accordance with ASTM F1717:
- Static compression
- Dynamic compression
- Static Torsion
A detailed table of acceptance criteria and specific numerical results for these mechanical tests is not provided in this summary. It only states that the device was found substantially equivalent based on these tests.
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 applicable and not provided. The testing described is non-clinical (mechanical) on the device itself, not on patient 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 applicable and not provided, as the study is not related to diagnostic accuracy or interpretation by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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 applicable and not provided. This is a mechanical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical testing, the "ground truth" would be established by the physical properties and performance characteristics of the predicate devices under standardized testing conditions (ASTM F1717).
8. The sample size for the training set
This information is not applicable and not provided, as this is not an AI/machine learning study.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as this is not an AI/machine learning study.
In summary: This document is a regulatory submission for a physical medical device (spinal implant), not a diagnostic device or an AI product. Therefore, the details requested about acceptance criteria, study design for diagnostic accuracy, expert involvement, and ground truth for AI models are not present. The studies performed were non-clinical mechanical tests to demonstrate that the new device is "substantially equivalent" in its physical performance to already-approved 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.