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The 4CIS VANE Spine System is a posterior non-cervical pedicle screw system intended for use as an adjunct to fusion in patients with degenerative spondylolisthesis (Grade 3 and 4) with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumour, and failed previous fusion (pseudarthrosis) of the lumbosacral spine vertebra and implants are removable after the attainment of a solid fusion. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

The 4CIS® VANE Spine System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) linking mechanism. The 4CIS® VANE Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. 4CIS® VANE Spine System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the 4CIS® VANE Spine System

The provided text describes a Special 510(k) submission for the 4CIS® VANE Spine System, focusing on the addition of new screw sizes. The core of the submission revolves around demonstrating that these size additions do not introduce any new safety risks and therefore the device remains substantially equivalent to its predicate.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance metric with a specific threshold (e.g., accuracy > 90%). Instead, the performance demonstrated is based on mechanical testing to ensure the new screw sizes maintain equivalence in strength.

2. Sample Size Used for the Test Set and Data Provenance

The "test set" in this context refers to the physical samples of the device components (screws) that underwent mechanical testing.

• Sample size: Not explicitly stated. The document refers to "testing (static and dynamic compression, static torsion testing per ASTM F1717)" but does not specify the number of samples tested for each condition or screw size.
• Data provenance: The tests were conducted on the device components themselves (presumably new poly axial and poly reduction screw sizes). The country of origin for the device manufacturer is South Korea (Republic of Korea). The testing itself is implied to be laboratory-based mechanical testing, not retrospective or prospective clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable to this submission. The "ground truth" for mechanical testing is established by the specified ASTM F1717 standards and the physical properties of the material and design, not by expert consensus.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for human review of clinical data, not for objective mechanical testing against a standard.

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

No. This submission did not involve an MRMC study. These studies are relevant for evaluating the impact of AI or assisted technologies on human reader performance, which is not the subject of this 510(k). Biomechanical testing for spinal implants does not involve human readers in this manner.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This device is a physical spinal implant system, not a software algorithm or AI. Therefore, standalone algorithm performance studies are not relevant.

7. Type of Ground Truth Used

The ground truth used for this submission is based on established engineering standards and biomechanical properties as defined by ASTM F1717 for static and dynamic compression and static torsion. The goal was to show that the new sizes conform to these standards and do not degrade the performance of the predicate device.

8. Sample Size for the Training Set

This is not applicable. The device is a physical implant, not an AI/ML algorithm that requires a "training set" of data.

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

This is not applicable, as there is no training set for this type of device submission.

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The 4CIS VANE Spine System is a posterior non-cervical pedicle screw system intended for use as an adjunct to fusion in patients with degenerative spondylolisthesis (Grade 3 and 4) with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumour, and failed previous fusion (pseudarthrosis) of the lumbosacral spine vertebra and implants are removable after the attainment of a solid fusion. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

The 4CIS® VANE Spine System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) linking mechanism. The 4CIS® VANE Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. 4CIS® VANE Spine System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the 4CIS® VANE Spine System.

The provided text describes a spinal fixation system, not an AI/ML powered device, thus the acceptance criteria and study details relevant to AI/ML performance metrics are not available in this document.

The document discusses the substantial equivalence of the 4CIS® VANE Spine System to predicate devices based on mechanical testing.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. The study involved mechanical testing of the device, not a test set of data for an AI/ML algorithm.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. Ground truth for AI/ML is not relevant here. The "ground truth" for mechanical testing is established by engineering standards and measurements.

4. Adjudication Method:

Not applicable. Mechanical testing does not involve adjudication.

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

Not applicable. This is not an AI/ML device.

6. Standalone Performance Study:

The "Performance Data" section indicates that "Mechanical testing... was conducted in accordance with ASTM F1717" to demonstrate equivalence to predicate devices. This represents a standalone evaluation of the device's mechanical properties against established standards and comparisons to existing devices.

7. Type of Ground Truth Used:

The ground truth for this device's performance is based on established engineering standards (ASTM F1717) and the mechanical properties of legally marketed predicate devices.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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The 4CIS® VANE Spine 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 4CIS® VANE Spine 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 (pseudarthrosis).

The 4CIS® VANE Spine System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) linking mechanism.

The 4CIS® VANE Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. 4CIS® VANE Spine System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the 4CIS® VANE Spine System

The provided text describes a 510(k) submission for the "4CIS® VANE Spine System," a pedicle screw spinal fixation system. It details the device's description, indications for use, and a statement on performance data.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based only on the provided text:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Mechanical testing" but does not specify a sample size or data provenance (country of origin, retrospective/prospective). It refers to "APPENDIX 10" for details, which is not provided in the input.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable or provided. The "ground truth" for this device's performance appears to be based on adherence to a standard (ASTM F1717) for mechanical properties, not expert clinical assessment of images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable or provided. The performance evaluation is based on mechanical testing against a standard, not on subjective assessment requiring adjudication.

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

No MRMC comparative effectiveness study was done. This device is a medical implant (pedicle screw system), not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable or provided. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" used for this device's performance is adherence to the mechanical testing standards outlined in ASTM F1717, which implies objective physical and material properties.

8. The sample size for the training set

This information is not applicable or provided. This is a hardware device, not a machine learning model requiring a training set.

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

This information is not applicable or provided. As above, this is a hardware device, not a machine learning model.

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The 4CIS® VANE Spine System is indicated for temporary or permanent correction or stabilization of the vertebral column from the thoracic to the sacrum and with the aim of helping consolidation or bone fusion, The 4CIS® VANE Spine System is designed for both posterior and anterior fixation procedure.

The 4CIS® VANE Spine 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 4CIS® VANE Spine 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, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The 4CIS® VANE Spine System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) linking mechanism.

The 4CIS® VANE Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. 4CIS® VANE Spine System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the 4CIS® VANE Spine System

Here's an analysis of the provided text regarding the acceptance criteria and study for the 4CIS® VANE Spine System:

Based on the provided document, the device's acceptance criteria and the study that proves it meets those criteria are primarily focused on mechanical testing for substantial equivalence to predicate devices.

Here's the breakdown of the information requested:

Acceptance Criteria and Device Performance

Note: The document does not specify quantifiable acceptance criteria (e.g., minimum torque, fatigue life cycles, etc.) or specific performance metrics from the study. It only states that the testing demonstrated "equivalence." A complete submission would typically include the specific values tested against and the results obtained.

Study Details

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Sample Size: Not explicitly stated. For mechanical testing, this would typically involve a specific number of devices tested for each parameter (e.g., 6 samples per test as per common ASTM standards).
   • Data Provenance: Not explicitly stated. Mechanical testing is performed in a laboratory setting, not typically on patient data.
   • Retrospective or Prospective: Not applicable, as this is laboratory mechanical testing, not a clinical study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable. This device undergoes mechanical testing against engineering standards (ASTM F1717), not clinical evaluation requiring expert interpretation of patient data.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. This is mechanical testing that measures physical properties against established standards, not a subjective assessment requiring adjudication.

4. 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:

   • No. This is a spinal fixation system, a physical implant. MRMC studies are relevant for AI-powered diagnostic devices, not for mechanical implants.

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

   • Not applicable. This is a physical medical device (implant), not an algorithm or AI system.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The "ground truth" for this study is the performance requirements established by the ASTM F1717 standard for spinal implant constructs, and the performance of the legally marketed predicate devices (Global Spinal Fixation System (K001668) and OPTIMATY, Spinal System (K031585)). The device must perform equivalently to these established standards and predicate devices in mechanical tests.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. As above, no training set is involved.

Summary of available information:

The provided 510(k) summary focuses on the mechanical performance of the 4CIS® VANE Spine System. The primary study mentioned indicates that mechanical testing was conducted in accordance with ASTM F1717, and these tests "demonstrate equivalence to the above predicate devices." This is a common approach for demonstrating substantial equivalence for physical implants where the function and materials are similar to already approved devices. The document does not provide specific numerical results, detailed methodologies, or quantitative acceptance criteria beyond the general statement of "equivalence" to the predicate devices and compliance with the ASTM standard.

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