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LnK Spinal Fixation System is non-cervical spinal fixation devices intended for use as 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 dis 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 is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the LnK Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

This system is comprised of screws, set screws, rods, crosslink, Hook and connectors. The components of this system are manufactured by Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The screws are available from 4.0 to 8.5mm diameters with lengths ranging from 20-150mm. The purpose of this submission is to add Hooks to this system.

The provided document describes a 510(k) premarket notification for the "Lnk Spinal Fixation System" and focuses on demonstrating its substantial equivalence to predicate devices, rather than a study on a new AI/software device that requires acceptance criteria and performance data in the typical sense of a diagnostic or assistive AI.

The "acceptance criteria" and "device performance" in this context refer to the mechanical and material properties of the spinal fixation system, compared against established standards and predicate devices.

Here's the information extracted and interpreted based on the content:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance

The document does not specify the exact sample sizes (number of fixation devices tested) for each bench test. The provenance is "Bench testing," meaning laboratory-controlled mechanical tests, not human or patient data. Details on the specific lab or country of origin for these tests are not provided, other than the manufacturer being based in the Republic of Korea. These are non-clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a mechanical device, and "ground truth" is established by adherence to ASTM standards and comparison to predicate devices, not by expert consensus on clinical data.

4. Adjudication method for the test set

Not applicable, as this involves mechanical bench testing against established standards, not human expert adjudication of clinical outcomes or interpretations.

5. 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 a spinal fixation system, not an AI/software device, and therefore no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a spinal fixation system, not an AI/software device.

7. The type of ground truth used

The "ground truth" for the performance claims is defined by established ASTM standards for spinal implant testing (e.g., ASTM F1717-10, ASTM F1798) and the performance characteristics of legally marketed predicate devices. The goal is to demonstrate "substantial equivalence" in mechanical performance.

8. The sample size for the training set

Not applicable. This is not an AI/software device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/software device that requires a training set or its associated ground truth establishment.

Summary of the Study:

The study described is a non-clinical bench testing study designed to demonstrate the mechanical and material substantial equivalence of the "Lnk Spinal Fixation System" to predicate devices. The study involved subjecting the device components (screws, rods, hooks, connectors) to various mechanical tests, including static compression bending, static tension, static torsion, dynamic compression bending, and gripping-push down, in accordance with recognized ASTM standards (F1717-10 and F1798). The performance was then compared to that of the predicate devices. The conclusion was that the Lnk Spinal Fixation System performs equivalently to the predicates, sharing similar design, materials, and performance characteristics, thus supporting its substantial equivalence for the stated indications for use. No clinical data or AI performance studies were involved or required for this 510(k) submission.

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VENUS Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (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, and/or lordosis); .
• tumor;
• stenosis, and
• failed previous fusion (pseudoarthrosis)

The VENUS Spinal Fixation System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the VENUS Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).

This system is comprised of screws, set screws, rods, crosslink and connectors. The components of this system are manufactured of Titanium alloy (Titanium-6Aluminum-4 Vanadium ELI, per ASTM F136) and CoCrMo alloy (Cobalt-28Chromium-6Molybdenum, per ASTM F1537). The screws are available from 4.0 to 8.5mm diameters with lengths ranging from 20-150mm.

This document describes the design and testing of the VENUS Spinal Fixation System, a non-cervical spinal fixation device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the acceptance criterion for all performance tests is "equivalent to the predicates." The specific numerical or qualitative thresholds for this equivalence are not provided in this summary but would be detailed in the full test reports.

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not explicitly stated for each test. The document refers to "bench testing results," implying that multiple samples of the VENUS Spinal Fixation System components were subjected to each test.
• Data Provenance: The tests are "bench testing" conducted by L&K BIOMED, Co., Ltd. The country of origin for the testing would be South Korea, where L&K BIOMED is located. The data is prospective, generated specifically for this 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth of Test Set

This section is not applicable as the provided documentation describes a medical device (spinal fixation system) and its mechanical performance testing, not an AI/diagnostic device that would require expert-established ground truth for a test set. The "ground truth" here is the physical measurement of mechanical properties.

4. Adjudication Method for Test Set

This section is not applicable for the same reasons as point 3. Mechanical test results do not typically involve adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This section is not applicable as the provided documentation describes a medical device (spinal fixation system) and its mechanical performance testing, not an AI or diagnostic device that would involve human readers or MRMC studies.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This section is not applicable as the provided documentation describes a medical device (spinal fixation system) and its mechanical performance testing, not an AI or algorithm-based device.

7. Type of Ground Truth Used

The ground truth used for performance evaluation is based on standardized mechanical testing results (e.g., measurements of strength, stiffness, and fatigue performance) as per established ASTM standards (F1717-10 and F1798). The "ground truth" performance is then compared to that of legally marketed predicate devices.

8. Sample Size for the Training Set

This section is not applicable as the provided documentation describes a medical device (spinal fixation system) and its mechanical performance testing, not a machine learning or AI device that would have a training set.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reasons as point 8.

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