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The LAGUNA® Size 8 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); tumor pseudarthrosis; and/or failed previous fusion.

The LAGUNA® Size 8 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® Size 8 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 35 mm to 100 mm and 8mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The LAGUNA® Size 8 Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.

The provided text describes a medical device, the Allez Spine LAGUNA® Size 8 Pedicle Screw System, and its 510(k) premarket notification (K091995) to the FDA. The document focuses on the regulatory clearance process and includes information about the device's indications for use and equivalence to a previously marketed device.

However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.

The section "Performance data" states: "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading." This is a general statement and does not provide numerical acceptance criteria or detailed study results.

Therefore, I cannot populate the requested table or answer the specific questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present in the provided document.

To summarize the requested categories:

1. Table of acceptance criteria and reported device performance: Not provided in the text. The text only vaguely states "test results were equivalent to other similar implants and are sufficient for in vivo loading."
2. Sample size used for the test set and data provenance: Not provided in the text.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable, as no clinical study with expert ground truth is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable, as this device is a physical spinal fixation system, not an AI or imaging diagnostic device. The concept of "human readers improve with AI vs without AI assistance" does not apply here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device.
7. The type of ground truth used: Not explicitly stated for performance testing beyond "biomechanical tests."
8. The sample size for the training set: Not applicable, as this is not an AI/ML device with a training set.
9. How the ground truth for the training set was established: Not applicable.

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