Search Results

The Advanced Research Medical Trident SI Screw System is intended for fusion of the sacroiliac joint for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Advanced Research Medical Trident SI Screw System consists of screws manufactured from Ti-6Al-4V ELI per ASTM F136. The screws are available in a variety of lengths and diameters to accommodate varying patient anatomy.

This document is an FDA 510(k) clearance letter for a medical device called the "Advanced Research Medical Trident SI Screw System." It explicitly states that clinical testing was not required for this device. Therefore, the document does not contain information about acceptance criteria for device performance, a study to prove it meets them, sample sizes, ground truth establishment, or expert involvement in such a study.

The FDA's determination of "substantial equivalence" for this device was based on:

• Comparison of mechanical testing results: Static and dynamic cantilever bending per ASTM F2193, and axial pullout, driving torque, and torsional strength per F543.
• Indications and intended uses: Identical to the predicate device.
• Device function: Identical to the predicate device.
• Material: Same as the predicate device (Ti-6Al-4V ELI per ASTM F136), which is recognized by the FDA and cleared for implantation.
• Cleaning and sterilization protocols: Validated cleaning procedure and steam sterilization protocol.

Since no clinical study was conducted as part of this 510(k) submission, the requested information cannot be extracted from the provided text.

Ask a specific question about this device

This system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Lumbar Interbody Fusion System consists of instruments and Titanium Alloy (Ti-6Al-4V per ASTM F136) implants which will be offered in twenty-four (24) size configurations to accommodate individual patient anatomy. The implants are designed to facilitate a specific surgical technique, the Oblique Lateral Lumbar approach (OLLIF). The implants are single use and the system is provided non-sterile.

This document is a 510(k) premarket notification for a medical device called the "Lumbar Interbody Fusion System (OLLIF)". It primarily focuses on demonstrating substantial equivalence to a predicate device based on intended use, indications for use, materials, technological characteristics, and labeling, supported by pre-clinical performance data.

Therefore, it does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device, which would typically involve human-in-the-loop or standalone performance metrics, ground truth establishment, expert adjudication, and sample sizes for training and testing.

The document details:

• Device Name: Lumbar Interbody Fusion System (OLLIF)
• Regulatory Class: Class II
• Product Code: MAX (Intervertebral Body Fusion Device, Lumbar)
• Indications for Use: Intervertebral body fusion of the lumbar spine (L2 to S1) in skeletally mature patients with degenerative disc disease (DDD) and up to Grade I spondylolisthesis, after six months of non-operative treatment, for one or two contiguous levels. It requires supplemental fixation and autograft.
• Predicate Devices: Python Interbody Fusion Device (K090064) and Buttress (Fang) Plate System (K090415)
• Performance Data: Static and dynamic axial compression testing following ASTM F2077-14, and subsidence testing following ASTM F2267-04. These are bench tests of the physical device's mechanical properties, not clinical performance or AI/ML algorithm performance.

In summary, this document is for a traditional medical device (spinal implant), not an AI/ML device. Therefore, the requested information about acceptance criteria for AI algorithm performance, study design (e.g., MRMC, standalone), ground truth derivation, and sample sizes for AI model training/testing is not present in this document.

Ask a specific question about this device