Search Results

The 4CIS SARA Spine System , 4CIS VERTU Spine System, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM and 4CIS WILL PEDICLE SCREW SYSTEM are the pedicle screw systems indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-Sl 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.

The 4CIS SARA Spine System , 4CIS VERTU Spine System, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM and 4CIS WILL PEDICLE SCREW SYSTEM are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in 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 ).

aBle Xt SPINAL FIXATION SYSTEM and 4CIS WILL PEDICLE SCREW SYSTEM are intended to used for Minimal Invasive Surgery (MIS).

The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, and nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) and Cobalt Chromium ally that conforms to ASTM F136 and ASTM F1537 respectively. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System.

This document details the FDA 510(k) clearance for several spine fusion systems. It primarily describes a comparison of the new devices to a previously cleared predicate device (K202498). The information provided focuses on the physical and mechanical properties of the medical devices, not on an AI/software-based diagnostic or treatment system.

Therefore, many of the requested details related to AI/software performance criteria (such as data provenance, expert ground truth establishment, MRMC studies, standalone algorithm performance, and training/test set sample sizes for AI) are not applicable to this submission.

The document discusses "acceptance criteria" in the context of mechanical performance testing for spinal implants.

Here's an extraction of the relevant information regarding acceptance criteria and performance, as can be gleaned from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not explicitly stated as this relates to mechanical testing of physical components rather than a dataset for AI. The text refers to testing "on the worst case construct," implying a representative sample of device configurations.
• Data Provenance: Not applicable in the context of patient data for AI. The "data" pertains to mechanical test results of the physical devices.

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

• Not applicable. Ground truth for mechanical devices is established through engineering standards and physical testing, not expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set:

• Not applicable as it's not an AI system being evaluated against human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:

• Not applicable. This is not a human-in-the-loop AI system.

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

• Not applicable. This is a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used:

• For mechanical performance, the "ground truth" is measured physical properties and performance against established ASTM (American Society for Testing and Materials) standards.
• For biocompatibility, the "ground truth" is established through the long history of safe and effective use of the materials conforming to ASTM standards.
• For intended use/indications, the "ground truth" is the regulatory clearance of predicate devices with similar indications.

8. The Sample Size for the Training Set:

• Not applicable, as this is not an AI system that requires a training set.

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

• Not applicable, as this is not an AI system. Ground truth for the device's design and manufacturing is based on engineering principles, materials science, and regulatory standards.

Ask a specific question about this device

The 4CIS SARA Spine System and 4CIS VERTU Spine System is a pedicle screw system indicated for the weathern 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 SARA Spine System and 4CIS VERTU Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in 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 Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) and Cobalt Chromium alloy that conforms to ASTM F136 and ASTM F1537 respectively. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System.

The provided document is a 510(k) summary for the "4CIS SARA Spine System" and "4CIS VERTU Spine System." It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to a diagnostic or AI-based function.

Instead, the "Performance Data" section states:

"Mechanical testing (static and dynamic compression bending, static tension bending, static torsion) is conducted in accordance with ASTM F1717. Static Tension Test, Static Torsion test, Static Compression test & Dynamic Compression bending test (Fatigue Test) meets performance requirement against predicates."

This indicates that the performance evaluation for this spine system is based on mechanical testing, not on diagnostic accuracy, sensitivity, specificity, or any other metrics typically associated with AI/ML-based medical devices or diagnostic tools. Therefore, the requested information about acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document.

The document primarily focuses on establishing substantial equivalence to predicate devices based on:

• Indications for Use: The devices have the "same or similar indications for use statements."
• Material: Composed of the "same material as the predicate devices" (titanium alloy and cobalt chromium alloy conforming to ASTM F136 and ASTM F1537 respectively).
• Design and Function: "Share similar basic design features and functions as well as their dimensions."
• Mechanical Performance: Demonstrated to meet performance requirements against predicates through mechanical testing according to ASTM F1717.

Ask a specific question about this device