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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, 5.0 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 lengths ranging from 30 mm to 150 mm. The rods are available from 5.5 mm, 6.0mm and 6.35mm diameter with lengths ranging from 40 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.

This document describes the 510(k) premarket notification for the LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System, and AccelFix Spinal Fixation System. However, it does not contain the specific information required to complete your request regarding acceptance criteria and the study that proves the device meets the acceptance criteria.

The provided text primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, and manufacturing processes. It explicitly states in section 7, "PERFORMANCE DATA," that:

"The additional components to be added through this submission do not require additional mechanical testing. None of the additional components is the worst case of the LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System. Therefore, we substitute mechanical test data of additional components of LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System with the predicate device (LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System -K120270, K143363, K171813, K183168, K200790, / AccelFix Spinal Fixation System: K182544, K200794)."

This means that no new studies were conducted for these specific additional components to prove they meet specific acceptance criteria. Instead, the submission relies on the existing performance data and substantial equivalence of the predicate devices.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set or its provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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