Search Results

Cezanne Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bonegraft. Cezanne Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Cezanne Lumbar Interbody Fusion Cage System is intended to help provide support in the intervertebral body space during fusion of vertebral bodies in the lumbar spine. This system is intended to be used with supplemental fixation. The Cezanne Lumbar Interbody Fusion Cage System consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The Implants are made of PEEK-OPTIMA CTI (ASTM F2026) body with the tantalum(ASTM F560) marker pins.

This document describes the regulatory submission for the "Cezanne Lumbar Interbody Fusion Cage System" and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study where a device's performance is measured against acceptance criteria in a clinical setting.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, how ground truth for training set was established) are not applicable or provided in this type of submission.

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

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

This document does not present acceptance criteria and reported device performance in the context of a clinical study or a study designed to measure the device's diagnostic/performance characteristics against specific numerical targets. Instead, it relies on non-clinical (bench) testing to ensure mechanical integrity and comparability to predicate devices. The acceptance criteria for these tests would typically be defined by the ASTM standards cited.

Explanation: The document states that the system "has been tested" according to these ASTM standards. In a 510(k) submission, the implicit understanding is that these tests demonstrated performance comparable to predicate devices or within acceptable limits defined by the standards, thus supporting the claim of substantial equivalence. The specific numerical results are not provided in this summary but would be available in detailed test reports.

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

This information is not applicable as this submission focuses on substantial equivalence based on mechanical testing and comparison to existing predicate devices, not on a clinical test set for performance evaluation in patients. The "test set" here refers to the physical devices subjected to bench testing.

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. Ground truth, in the context of clinical expert consensus, is not relevant for this type of mechanical testing and substantial equivalence claim. The "ground truth" for these tests would be the established scientific principles of mechanical engineering and material science, as embodied in the ASTM standards.

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

This information is not applicable. Adjudication methods are used in clinical studies, particularly for subjective assessments or when there's disagreement among experts. For mechanical bench testing, results are typically objective and quantifiable by standardized methods, not 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

This information is not applicable. This is a submission for a physical intervertebral fusion cage, not an AI or imaging device that would involve human readers or AI assistance.

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

This information is not applicable. This is a physical medical device; there is no "algorithm only" performance to evaluate.

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

For the non-clinical testing, the "ground truth" is established by engineering principles and standardized testing methodologies (ASTM International standards). These standards define how the material properties and device performance under specified loads should be measured and what constitutes acceptable performance for intervertebral fusion devices.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of this 510(k) submission, as it relates to mechanical testing and substantial equivalence, not machine learning or AI.

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

This information is not applicable. As there is no training set, there is no ground truth for a training set to establish.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that "proves" the device meets acceptance criteria is a series of non-clinical bench tests conducted according to recognized ASTM International standards. These tests assess the mechanical properties and performance of the Cezanne Lumbar Interbody Fusion Cage System.

• Test Standards Utilized:

  • ASTM F2077: Standard Test Methods for Static and Dynamic Axial Compression, Compression-Shear, and Torsion Testing of Intervertebral Body Fusion Devices
  • ASTM F2267: Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

• Objective of Testing: To demonstrate that the mechanical performance (e.g., strength, stability, resistance to subsidence, expulsion, etc.) of the Cezanne device is comparable to that of legally marketed predicate devices and is suitable for its intended use within the lumbar spine.

• Conclusion: The submission concludes that the "Cezanne Lumbar Interbody Fusion Cage System has been tested [according to the listed standards]" and shares technological characteristics similar to predicate devices, implying that its performance is equivalent and therefore "safe and effective for its intended use." The FDA's substantial equivalence determination (K121567) indicates agreement with this conclusion based on the submitted data.

Ask a specific question about this device