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The LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. This device is an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis).

The AccelFix Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis).

The LNK SPINAL FIXATION SYSTEM, OPENLOC-L SPINAL FIXATION SYSTEM are available in various sizes. This system is comprised of screws, rods, crosslinks, connectors and hooks. The screws are available from 4.0 mm to 10.5 mm diameters with lengths ranging from 20 mm to 150 mm. The rods are available from 5.0 mm, 6.0 mm and 6.35 mm diameter with lengths ranging from 40 mm to 600 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.

The AccelFix Spinal Fixation System consists of screws, rods, crosslinks, set screws, cross-link connectors, and hooks. The screws are available from 5.0 mm, 6.0 mm, 7.0, 7.5, 8.0, 8.5, 9.0 and 9.5mm diameters with working lengths ranging from 20 mm. The rods are available from 5.5 mm, 6.0mm and 6.35mm diameter with lengths ranging from 40 mm to 600 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.

The document provided does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria. This document is a 510(k) summary for a medical device (Spinal Fixation System), which focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting performance criteria and results from a clinical study or specific performance testing against those criteria.

Therefore, I cannot provide the requested table and study details. The document explicitly states that:

• No additional mechanical testing was required for the new components because they are not considered "worst-case" scenarios.
• The manufacturer "substitute[s] mechanical test data of additional components... with the predicate device".
• The primary argument for clearance is substantial equivalence based on identical indications for use, design with components, materials, dimensions, and sterilization methods with predicate devices.

In summary, the provided text does not contain information on:

1. Specific acceptance criteria for device performance.
2. A study proving the device meets acceptance criteria.
3. Sample sizes for test sets or data provenance of a performance study.
4. Number or qualifications of experts for ground truth establishment.
5. Adjudication methods.
6. MRMC comparative effectiveness study results.
7. Standalone algorithm performance.
8. Type of ground truth used (as it's not a diagnostic AI device).
9. Training set sample size or how ground truth for a training set was established.

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