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The LAGUNA® Pedicle Screw System is intended to be used as an adjunct to fusion in skeletally mature patients using autograft or allograft in posterior, non-cervical fixation for the following conditions: 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; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumors; pseudarthrosis; and/or failed previous fusion.

The LAGUNA® Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The LAGUNA® Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Polyaxial screws are supplied in winged and non-winged configurations, in a variety of different length, ranging from 30 mm to 100 mm and 5 mm, 6 mm, 7 mm and 8mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The LAGUNA® Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.

The provided text describes a spinal fixation system, not an AI/ML device. Therefore, many of the requested criteria, such as those related to AI algorithm performance (standalone performance, MRMC studies, training/test set details, ground truth establishment for AI), are not applicable.

However, I can extract information related to the device's performance testing based on the provided text.

The device is the "LAGUNA® Pedicle Screw System," a spinal fixation system.

Acceptance Criteria and Device Performance:

The provided text states that the device was evaluated through biomechanical tests. The acceptance criteria are implicitly that the device performs equivalently to other similar implants.

Study Details (Non-AI/ML specific):

• Sample size used for the test set and the data provenance: Not explicitly stated in terms of number of devices tested, but the tests were "Biomechanical tests per ASTM F1717-10". These are laboratory tests on device components, not human or clinical data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for biomechanical testing is defined by the ASTM F1717-10 standard, which specifies test methodologies and performance characteristics. It does not involve human expert consensus for "ground truth" in the way an AI assessment would.
• Adjudication method for the test set: Not applicable for biomechanical testing. The results are quantitative measurements against a standard.
• 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 is not an AI/ML device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
• The type of ground truth used: The ground truth is defined by the performance requirements and methodologies outlined in the ASTM F1717-10 standard for biomechanical testing.
• The sample size for the training set: Not applicable. This is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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