(195 days)
The ART Anterior Spinal System is intended for anterolateral screw fixation of the T6-L5 spine.
Indications for use include:
- 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 .
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .
- tumor .
- pscudoarthrosis .
- failed previous fusion .
The ART Anterior Spinal System consists of a Plate that attaches to the anterior or antero-lateral vertebral body of the thoraco-lumbar and lumbar spine. One place on each vertebral body. The single size plate is attached to the vertebral body with two diverging Ø6.5mm Screws. The superior portion of the plate is U-shaned to receive a Ø6mm Rod. The inner surface of the U-shaped opening of the plate is threaded to receive a Locking Nut. When tightened the Locking Nut firmly secures the Rod to the Plate. In this manner the Rods connect two or more Plates. Sce schematic in Exhibit III.
A rod connector component, called a Domino, attaches two rods for use in multi-level fusions. Rods can be connected in series or parallel.
The provided text describes a 510(k) premarket notification for a medical device called the "ART Anterior Spinal System." It is a spinal intervertebral body fixation orthosis. However, the document does not contain any acceptance criteria, reported device performance data, details of a study on acceptance criteria, AI components, or human reader effectiveness studies.
The information provided focuses on:
- Device Description: The physical components of the ART Anterior Spinal System.
- Intended Use/Indications for Use: The medical conditions for which the device is designed (e.g., degenerative disc disease, spondylolisthesis, trauma).
- Equivalency: Stating that the device is similar to previously cleared devices (Kaneda SR Anterior Spinal System and M-2 Anterior Plate).
- Nonclinical Tests: A brief mention that "Testing was performed according to ASTM F1717." This refers to a standard for spinal implant testing, but no specific results or acceptance criteria from these tests are detailed.
- Regulatory Information: Communication from the FDA confirming substantial equivalence to predicate devices, classification, and general regulatory requirements.
Therefore, requested information about acceptance criteria, device performance, study details (sample sizes, provenance, ground truth, experts, adjudication, MRMC, standalone), and AI components cannot be extracted from this document, as it is not present.
To summarize, for the given input:
1. A table of acceptance criteria and the reported device performance:
- Not Available. The document states "Testing was performed according to ASTM F1717" but does not provide specific acceptance criteria or the results of these tests.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Available. No information on specific test sets, sample sizes, or data provenance is provided. The testing mentioned (ASTM F1717) is for mechanical properties, not clinical data sets.
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 Available. This information is for clinical studies, which are not described in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Available. This information is for clinical studies, which are not described in this document.
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 document describes a physical medical device (spinal fixation system), not an AI-enabled diagnostic or therapeutic tool for which MRMC studies are typically performed. There is no mention of AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This document describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Available. This information is for clinical studies, which are not described in this document. The "ground truth" for a mechanical device would be its physical properties meeting engineering standards.
8. The sample size for the training set:
- Not Applicable. No training set is mentioned as this is a physical medical device clearance, not an AI model.
9. How the ground truth for the training set was established:
- Not Applicable. No training set is mentioned.
§ 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.