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"CERVICAL" NITRO Interbody Fusion Cage System Family (i.e., the MATISSE NITRO Anterior Cervical Interbody Fusion Cage System and the MONET NITRO Anterior Cervical Interbody Fusion Cage System) are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels.

DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. Cervical NITRO Interbody Fusion Cage System Family are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Cervical NITRO Interbody Fusion Cage System Family are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

When the MONET Anterior Cervical Interbody Fusion Cage System is used with the Supplementary Fixation Plate assembly, the plate-spacer assembly is a stand-alone device intended for use at one disc level or two contiguous levels of the cervical spine (from the C2-C3 disc space to C7-T1 disc space).

"LUMBAR" NITRO Interbody Fusion Cage System Family (i.e.; the MONDRIAN NITRO Lumbar Interbody Fusion Cage System consisting of ALIF/OLIF, DLIF, PLIF, and TLIF) are indicated for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).

Lumbar NTRO Interbody Fusion Cage System Family are intended to be used with supplemental spinal fixation systems. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.

Lumbar NTRO Interbody Fusion Cage System Family with hyperlordotic cage offerings (>20°) require the use of anterior fixation.

The NITRO Interbody Fusion Cage System Family (Cervical and Lumbar ) cages offer a complete line of interbody cages for the cervical levels C2-C7 and the lumbar levels L2-S1 to be used with supplemental fixation and bone graft material. The cages are made of silicon nitride material and are available in a variety of widths, lengths, and lordotic angles, (parallel angles to accommodate varying degrees of lordosis and varying patient anatomy). The NITRO Interbody Fusion Cage System Family consists of hollow intervertebral spacers with an axial void designed to hold bone graft material. The bone graft is packed into and around the cage to further facilitate fusion.

Each system includes a complete set of instruments to implant the devices properly. The NITRO Interbody Fusion Cage System Family consists of following systems:

• MATISSE NITRO Anterior Cervical Interbody Fusion Cage (ACIF) System.
• MONET NITRO Anterior Cervical Interbody Fusion Cage (ACIF) System with Supplemental fixation.
• MONDRIAN NITRO Lumbar Interbody Fusion Cage System:
  • о MONDRIAN NITRO ALIF/OLIF Cage System
  • MONDRIAN NITRO DLIF Cage System о
  • O MONDRIAN NITRO PLIF Cage System
  • о MONDRIAN NITRO TLIF Cage System

The NITRO Interbody Fusion Cage System Family includes implants and instruments. The subject system uses the same instruments and fundamental technology as do their functional counterparts in CTL Medical's already cleared MATISSE, MONET, and MONDRIAN surgical instruments. As with the predicates, the subject device is implanted using a combination of device-specific and universal instruments manufactured from stainless steel materials that conform to ASTM F899.

This document pertains to the 510(k) premarket notification for the NITRO Interbody Fusion Cage System Family. It describes a mechanical device, not an AI/software device. Therefore, the information requested in the prompt, which is typical for demonstrating the performance of an AI/software medical device, is not applicable to this submission.

The acceptance criteria and study described in the document relate to the physical and mechanical performance of the interbody fusion cage system, such as:

• Mechanical Testing: Axial Static Compression, Shear Static Compression, Static Torsion, Axial Dynamic Compression, Subsidence, and Expulsion.
• Specific Component Testing: Plate Pull-Off, Screw Push Out.
• Biocompatibility Testing: Pyrogenicity testing.

The document concludes that "The technological differences between the subject device and the predicate do not raise new questions of safety and effectiveness. Any minor differences in technological characteristics have been tested and documented." This indicates that the device met the performance criteria established for interbody fusion devices by demonstrating substantial equivalence to predicate devices through these physical and biocompatibility tests.

To directly answer the prompt's request for an AI/software device, based on the provided text, the following would be the response:

1. A table of acceptance criteria and the reported device performance: Not applicable (N/A). The document details mechanical and biocompatibility testing for an implantable cage, not software performance metrics.
2. Sample sizes used for the test set and the data provenance: N/A. The testing involved mechanical samples of the device, not a data set of patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth, in the context of AI, refers to expert-labeled data. This document describes physical device testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. Adjudication methods are used for expert consensus on data labels, which is not relevant here.
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: N/A. This is a mechanical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. Not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. The "ground truth" for a mechanical device is its adherence to engineering standards and safety profiles through physical testing.
8. The sample size for the training set: N/A. No training set as this is not a learning algorithm.
9. How the ground truth for the training set was established: N/A. No training set.

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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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