(105 days)
The Aurora® Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. The AURORA® Anterior Lumbar Plate System is indicated for in the treatment of lumbar and lumbosacral (L1-S1) spinal instability as a result of the following:
- degenerative disc disease (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
- pseudoarthrosis ●
- failed previous fusion ●
This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The Aurora® Anterior Lumbar Plate System consists of an assortment of plates and screws. Implant components are available in a variety of sizes to suit the individual patient anatomies. The Aurora® Anterior Lumbar Plate System implants are manufactured from medical grade titanium alloy Ti-6A1-4V per ASTM F136/ISO 5832-3. The Aurora® Anterior Lumbar Plate System also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification.
The provided text describes the regulatory clearance of a medical device, the "Aurora® Anterior Lumbar Plate System," and does not contain information about an AI/ML device study. Therefore, I cannot extract the requested details regarding acceptance criteria and performance studies for an AI/ML device.
The document discusses:
- Device: Aurora® Anterior Lumbar Plate System (a spinal intervertebral body fixation orthosis).
- Regulatory Pathway: 510(k) premarket notification.
- Acceptance Criteria (for this specific device): Substantial equivalence to predicate devices based on indications for use, materials, structural support, sizes, and mechanical performance testing (static and dynamic compression bending, static torsion, torsional properties, driving torque, pullout strength).
- Performance Data: Non-clinical (mechanical) testing per ASTM standards (F1717 and F543) showing sufficient strength for intended use and substantial equivalence to legally marketed predicate devices.
Missing Information (relevant to AI/ML device studies):
The document does not include any of the following details specific to AI/ML device performance and validation studies:
- A table of acceptance criteria with reported device performance for an AI/ML algorithm.
- Sample size used for a test set or data provenance for an AI/ML model.
- Number of experts or their qualifications for establishing ground truth for an AI/ML model.
- Adjudication method for an AI/ML test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
- Standalone (algorithm-only) performance data.
- Type of ground truth (beyond mechanical test results for a physical device).
- Sample size for a training set.
- How ground truth for a training set was established.
In summary, the provided text is for a physical medical implant, not an AI/ML-driven diagnostic or therapeutic device, and thus does not contain the information requested in your prompt.
§ 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.