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The 4CIS® Chiron 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:

1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
2. Spondylolisthesis
3. Trauma (i.e., fracture or dislocation)
4. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
5. Tumor
6. Stenosis
7. Failed previous fusion (pseudoarthrosis).

The 4CIS® Chiron 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 or minimally invasive 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) that conforms to ASTM F 136 and Cobalt Alloy (Co-28Cr-6Mo) per ASTM F1537. Also, instruments are available for the application and removal of the Spinal Fixation System.

This document is a 510(k) premarket notification for the "4CIS® Chiron Spinal Fixation System." It details the device's characteristics, indications for use, and a comparison to predicate devices, along with performance data. However, it does not include detailed acceptance criteria or extensive study results that would typically be found in a clinical trial report.

Here's an analysis of the provided text in relation to your questions:

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

The document provides summary statements about performance data but does not explicitly list acceptance criteria or specific numerical results in a table format. It states:

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 was performed," but does not explicitly state the sample size (e.g., number of spinal fixation systems tested) for this testing. It also doesn't specify the country of origin for the data or whether it was retrospective or prospective. Given it's mechanical testing of a physical device, it's typically performed in a lab setting rather than involving human subjects or real-world data in the same way clinical studies do.

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 question is not applicable to the type of data presented. The "ground truth" for mechanical testing is based on the physical properties and performance of the device under defined conditions, typically measured by engineering standards and equipment, not by expert medical interpretation.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert consensus is needed to establish ground truth for diagnoses or interpretations. Mechanical testing uses objective measurements against predefined standards.

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 such study was mentioned or performed. This document is for a spinal fixation system, which is a physical implant, not an AI software or a device that assists human readers/diagnosticians.

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

This question is not applicable, as this is a physical medical device, not a software algorithm.

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

The ground truth for the performance of the 4CIS® Chiron Spinal Fixation System, as described, is based on mechanical testing results against established ASTM standards (ASTM F1717 and ASTM F1798) and comparison to the performance of predicate devices. This is an engineering-based ground truth.

8. The sample size for the training set

This question is not applicable. The device is a physical implant. The concept of a "training set" is relevant for machine learning models, not for mechanical testing of a spinal fixation system.

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

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

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The 4CIS® Chiron 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:

1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies):
2. Spondylolisthesis;
3. Trauma (i.e., fracture or dislocation);
4. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
5. Tumor;
6. Stenosis:
7. Failed previous fusion (pseudoarthrosis).

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 or minimally invasive 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) that conforms to ASTM F136 and Cobalt Alloy (Co-28Cr-6Mo) per ASTM F1537. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System.

The provided document is a 510(k) Premarket Notification for a spinal fixation system (4CIS® Chiron Spinal Fixation System). It focuses on demonstrating substantial equivalence to previously marketed devices through mechanical testing and comparison of design features and indications for use.

Crucially, this document does NOT contain information about an AI/ML-driven medical device or any study involving human readers, ground truth establishment by experts, or performance metrics like sensitivity, specificity, or AUC.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves a device meets them for an AI/ML product based on this document. The document describes a traditional medical device (implantable hardware) and its clearance pathway, which relies on engineering and mechanical testing, not software performance studies.

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4CIS® Marlin PEEK ACIF Cage is indicated for use in cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at the levels from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have six weeks of non-operative therapy in advance. The 4CIS® Marlin PEEK ACIF Cage is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open, anterior approach. It is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine, such as Anterior Cervical Plate system.

4CIS® Marlin PEEK ACIF Cage is single component devices used to restore height of disc space by anterior approach and to facilitate cervical interbody fusion with maintaining physiological lordotic angulation of cervical spine. To allow maximum preservation and ensure ample contact surfaces with bony endplate, a variety of shapes and sizes are available and each device has three tantalum markers for ease of visualization on radiographs. The vertical square teeth on the top and the bottom surface prevent subsidence of the cage into the vertebral body while they increase the anchoring and prevent slipping or expulsion. To make solid fusion of intervertebral body, hollow space in the implant allows bone graft material to be filled. The implant has safety proven structure and material (Poly-ether-ether-ketone, ASTM F2026) to promote biological synostosis and assures mechanical safety against load.

This FDA 510(k) summary describes a medical device, the 4CIS® Marlin PEEK ACIF Cage, which is an intervertebral body fusion device. The provided text is a regulatory filing for this device and does not contain information about software or AI performance metrics. Therefore, it is not possible to answer your questions regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these pertain to the evaluation of AI/software device performance, which is not discussed in this document.

The document focuses on demonstrating substantial equivalence of the physical implant device to predicate devices through mechanical testing and comparison of characteristics.

Here's a breakdown of the information that is present and why your specific questions about AI/software performance cannot be answered from this text:

Information Present in the Document:

• Device Name: 4CIS® Marlin PEEK ACIF Cage
• Intended Use: Cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at specific cervical levels (C2-C3 disc to C7-T1 disc). It is to be used with bone graft and supplemental spinal fixation systems.
• Material: Poly-ether-ether-ketone (PEEK), conforming to ASTM F2026.
• Design Features: Single component, designed to restore disc height, facilitate fusion, maintain lordotic angulation, various shapes/sizes, three tantalum markers for visualization, vertical square teeth to prevent subsidence and aid anchoring, hollow space for bone graft.
• Predicate Devices: 4CIS® Marlin ACIF Cage System (K162402) as primary; PATRIOT SPACERS: COLONIAL ACDF (K072991), TRYPTIK Ca (K091873), MATISSE Anterior Cervical Interbody Fusion Cage System (K162682) as additional.
• Performance Data (Non-Clinical): Mechanical testing was conducted in accordance with ASTM F2077-17 and F2267-04. This included static axial compression, static compression-shear, static torsion, dynamic axial compression, dynamic compression-shear, dynamic torsion, and static subsidence.
• Conclusion: The device is substantially equivalent to legally marketed predicate devices based on overall technology characteristics and mechanical performance data.

Why Your Questions Cannot Be Answered from This Document:

Your questions pertain to the evaluation of AI or software-based medical devices. The 4CIS® Marlin PEEK ACIF Cage is a physical medical implant, not a software or AI device. Therefore, the concept of "acceptance criteria" in the context of AI performance, "test set," "training set," "ground truth," "experts for ground truth," "adjudication," or "MRMC studies" as they relate to AI algorithms simply do not apply to this regulatory filing. The "performance data" mentioned refers solely to the biomechanical properties of the physical implant.

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The Spinal Fusion Cage System is an intervertebral body fusion devices intended for use to skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Spinal Fusion Cage System is indicated to be used with autologous bone graft to facilitate fusion and are intended to be used with supplemental fixation. The device is to be used in patients who have had six months of nonoperative treatment.

The Spinal Fusion Cage System is single component devices used to restore height of disc space via posterior, lateral, anterior, oblique approach and to facilitate lumbar intervertebral body fusion with maintaining physiological lordotic angulation of lumbar spine. To allow maximum preservation and ensure ample contact surfaces with bony endplate, a variety of shapes and sizes are available and each device has tantalum (ASTM F560) markers for ease of visualization on radiographs. Vertical square teeth on the top and the bottom surface prevent subsidence of the cage into the vertebral body while they increase the anchoring and prevent slipping or expulsion. To make solid fusion of intervertebral body, hollow space in the implant allows autologous bone graft material to be filled. The implant has safety proven structure and material (Polyetheretherketone, ASTM F2026) to promote biological synostosis and assures mechanical safety against load.

This looks like a 510(k) summary for a medical device (Spinal Fusion Cage System), not an AI/ML device. Therefore, the questions related to acceptance criteria for an algorithm's performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance, are not applicable to this document.

The document discusses performance data in the context of mechanical testing for the spinal fusion cages, comparing them to predicate devices. It states:

• Mechanical testing (static axial compression, static compression-shear, static subsidence and dynamic axial compression) was conducted in accordance with ASTM F2077-14 and F2267-04.
• "The subject device demonstrated equivalent mechanical performance to the cited predicate device under the same test conditions."

However, specific numerical acceptance criteria (e.g., "subsidence must be less than X mm") and the exact results showing the device meets these criteria are not explicitly detailed in the provided text. The document concludes that "The overall technology characteristics and mechanical performance data lead to the conclusion that the subject device is substantially equivalent to legally marketed predicate devices."

To answer the user's request, I would need a 510(k) summary or similar regulatory document for an AI/ML medical device that includes details about its algorithmic performance evaluation. This document only pertains to a physical implantable device.

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The 4CIS® Chiron 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 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, and/or lordosis); tumor; stenosis; and failed previous fusion (pseudoarthrosis).

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 or minimally invasive 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) that conforms to ASTM F 136 and CoCr Alloy per ASTM F1537. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System.

The provided text is a 510(k) Summary for a medical device called the "4CIS® Chiron Spinal Fixation System." It details the device's purpose, components, indications for use, and a comparison to predicate devices, including performance data. However, this document does not describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven medical device.

The "Performance Data" section explicitly states:

"Mechanical testing (static and dynamic compression bending, static tension bending, static torsion) was conducted in accordance with ASTM F1717. Above non-clinical performance data in the form of a comprehensive literature review was provided in support of substantial equivalence of the subject device to the predicate devices."

This indicates that the performance data for this spinal fixation system is based on mechanical testing to ensure its structural integrity and equivalence to existing devices, not on the performance of an AI model in interpreting or diagnosing medical images or other data.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device's performance, as the provided document pertains to a physical medical implant and its mechanical properties.

To answer your request, I would need a document related to the regulatory submission of an AI/ML-driven medical device, which would typically involve clinical performance studies assessing the algorithm's accuracy, sensitivity, specificity, and potentially its impact on human reader performance.

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The 4CIS® Pinehurst Anterior Cervical Plate system is intended for anterior interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) Spondylolisthesis, 3) trauma (including fractures), 4) Spinal Stenosis, 5) tumors, 6) deformity (defined as kyphosis, lordosis, or scoliosis), 7) pseudarthrosis, and/or 8) failed previous fusions.

The 4CIS® Pinehurst Anterior Cervical Plate system is intended for anterior cervical intervertebral body screw fixation from C2 to T1. Rigid fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. Implant components consist of a variety of shapes and sizes of plates, bone screws and associated instruments. Locking caps are pre- assembled to the plates. They cover the heads of the bone screws to reduce the potential for screw back-out. With this locking mechanism, implant components can be rigidly locked into many different configurations to suit the individual pathology and anatomical conditions of the mature patient. They are made of titanium alloy (Ti-6AI-4V ELI) per ASTM F136. Implants must not be used with the components from any other system or manufacturer in a construct.

This FDA document is a 510(k) clearance letter for a medical device called the "4CIS® Pinehurst Anterior Cervical Plate System". It addresses the regulatory approval of the device and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices. The "Performance Data" section (page 4) mentions mechanical testing according to ASTM F1717 but does not provide details on specific acceptance criteria or results. It explicitly states that "Above non-clinical performance data in the form of a comprehensive literature review was provided".

Therefore, I cannot extract the requested information about acceptance criteria and a study proving the device meets them from this document. The provided text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance (as it's not an AI/ML study).
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about standalone (algorithm-only) performance.
7. The type of ground truth used (other than mechanical testing standards).
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document is for a physical orthopedic implant, not a software device, and thus the requested AI/ML specific information is not relevant or present.

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4CIS® Marlin ACIF Cage System is indicated for use in cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at the levels from C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have six weeks of non-operative therapy. The 4CIS® Marlin ACIF Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft, and is to be implanted via an open, anterior approach. It is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine, such as Anterior Cervical Plate system.

4CIS® Marlin ACIF cages are hollow, generally rectangular box shape made either from poly-ether-ether-ketone [PEEK-OPTIMA® LT1 (Invibio, Inc., West Conshohocken, PA USA) / VESTAKEEP® i4R (Evonik Industries, Essen Germany)] or Titanium alloy according to ASTM F2026(PEEK), F136(64ELI), F560(Tantalum). The cages are available in a variety of sizes and geometric options to fit the anatomical needs of a wide variety of patients. The device is filled with a bone graft material and inserted into the intervertebral body space of the cervical spine through an anterior cervical approach. As the design requirements, this cage design maintains the spacing between two vertebral bones following discectomy until fusion occurs. Each PEEK cage has three(3) x-ray markers made of tantalum for ease of visualization on the radiographs. Angled shape for lordotic curve and anatomic shape is available to allow maximum preservation of bony endplate with this system and teeth on the surfaces ensure enough contact with bony endplate, which prevents subsidence of the cage into the vertebral body when the teeth increase the anchoring and prevent slipping or expulsion.

This is a medical device 510(k) summary for the "4CIS® Marlin ACIF Cage System," an intervertebral body fusion device. The document describes the device, its intended use, and its comparison to predicate devices for substantial equivalence.

Here's an analysis of the provided text for acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for clinical performance usually seen in AI/software studies (e.g., sensitivity, specificity, AUC). Instead, it focuses on mechanical performance for this implantable device. The "Performance Specification" section states:

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

This document describes a mechanical device, not an AI/software product requiring a "test set" of patient data. Therefore, the concepts of "sample size for the test set" and "data provenance" (country, retrospective/prospective) are not applicable in the context of this medical device submission. The performance data comes from laboratory mechanical testing.

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

As this is a mechanical device submission, there is no mention of experts establishing ground truth for a test set in the way it would be for an AI diagnostic algorithm. Ground truth here refers to the physical properties and performance of the device under mechanical stress, evaluated against established ASTM standards.

4. Adjudication Method for the Test Set

Again, this is not applicable as there is no "test set" in the context of clinical interpretation by experts. Mechanical testing results are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and AI assistance. This submission pertains to an implantable surgical device.

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

Not Applicable. This is a physical intervertebral cage, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by Mechanical Testing Standards (ASTM F2077 and ASTM F2267). This involves objective measurements of physical properties like static and dynamic compression, torsion, subsidence, and expulsion, compared against the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This isn't an AI model requiring a training set. The device's design and manufacturing processes are developed through engineering and material science, not machine learning training.

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

Not applicable. See point 8.

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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® SOLAR Spine System and 4CIS® APOLLON Spine System are 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 bon 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® SOLAR Spine System and 4CIS® APOLLON 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 4C15® SOLAR Spine System and 4CIS® APOLLON Spine System are a toploading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) linking mechanism.

The 4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. 4CIS® SOLAR Spine System and 4CIS® APOLLON 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® SOLAR Spine System and 4CIS® APOLLON Spine System.

The provided text describes a medical device, the "4CIS® SOLAR Spine System and 4CIS® APOLLON Spine System," which is a pedicle screw spinal fixation system. However, the document does not contain any information regarding acceptance criteria, device performance metrics, or a study that specifically addresses these points as typically expected for software or AI-based devices.

The core of the document is a 510(k) summary for a spinal implant system, focusing on its substantial equivalence to predicate devices based on mechanical testing. It does not involve AI or software performance metrics that would require the detailed study information you've requested.

Therefore, I cannot populate the requested sections because the information is not present in the provided text. The document discusses:

• Device Identification: Trade name, common name, classification.
• Substantially Equivalent Predicate Devices: Identification of similar devices already on the market.
• Device Description: What the device is made of and its components.
• Indications for Use: What the device is intended to treat and where it can be used in the spine.
• Performance Data and Test Method: This section explicitly states: "Mechanical testing has been carried out as listed in APPENDIX 10 which includes the static compression test and static torsion test as well as the dynamic compressive fatigue testing in accordance with ASTM F1717 demonstrates equivalence to the above predicate devices." This refers to physical, mechanical tests of the implant's strength and durability, not performance criteria for a diagnostic/AI tool.

The question's structure (acceptance criteria, sample size, ground truth, expert opinions, MRMC studies, standalone performance, training set) is typically relevant for evaluating AI/machine learning algorithms or diagnostic devices. Since this document describes a physical surgical implant, these types of details are not applicable as presented.

In conclusion, the input text does not contain the information requested regarding the acceptance criteria and the study that proves the device meets those criteria, as understood in the context of device performance metrics for AI/software/diagnostic tools.

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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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