Search Results

The FloSpine PANAMA™ Anterior Cervical Plate System is intended for anterior cervical screw fixation of the cervical spine at levels C2-T1. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative discase (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis), or scoliosis), pseudoarthrosis, and/or failed previous fusions.

The PANAMA™ Anterior Cervical Plate System is an anterior cervical spine fixation system that provides cervical spine fixation for intervertebral disk replacement procedures. The PANAMA™ ACP System is designed to stabilize and facilitate fusion in intervertebral disk replacement surgeries.

The PANAMA™ Anterior Cervical Plate (ACP) System consists of cervical plates that are 2.25 mm thick, 16 mm wide, and length options between 18 and 110 mm (end-to-end length) to accommodate 1 to 5 levels of fusion between C2 and T1. The PANAMA ACP System includes fixed and variable angle screws with 4.0mm and 4.5mm diameters and length options between 12mm and 20mm with self-tapping and self-drilling options. The screws and plates are made from Ti-6AI-4V ELI conforming to ASTM F-136.

The plates and screws of the PANAMA™ ACP System include a primary and secondary mechanism to mitigate screw backout. The primary mechanism consists of a cover plate that is rotated in-situ that partially covers the screw. The secondary mechanism consists of a number of radial teeth on the screw head and mating grooves on the underside of the cover plate. In the event that the screws start to back out, the teeth and grooves will engage, thereby preventing further counter-clockwise rotation of the screw. The screws in the system have a threaded hole at the bottom of the drive to provide easy insertion and positioning during surgery. The PANAMA™ ACP System of implants and instruments is provided clean and non-sterile in one sterilization case.

The provided text describes a medical device's 510(k) submission, focusing on its design, indications for use, and a comparison to predicate devices, including performance data. However, it does not contain information related to an AI/ML-driven device or diagnostic software.

Therefore, I cannot extract the specific details required to complete your request, such as:

• A table of acceptance criteria and the reported device performance for an AI/ML device. The document discusses performance testing (biomechanical testing) for a physical implant (spinal plate) per ASTM F1717, which measures properties like static axial compression bend, dynamic axial compression, and static torsion. These are engineering performance metrics for a physical device, not diagnostic performance metrics for an AI model.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• MRMC comparative effectiveness study details.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI model.
• Sample size for the training set.
• How ground truth for the training set was established.

The document is for a PANAMA™ Anterior Cervical Plate (ACP) System, which is a physical implant used for spinal fixation. The "performance data" section G explicitly refers to "Performance testing of the PANAMA™ ACP System was performed per ASTM F1717 'Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model'". This is mechanical testing of a medical device, not an algorithm.

To fulfill your request, you would need documentation pertaining to the regulatory submission of an AI/ML-driven medical device or diagnostic software.

Ask a specific question about this device