Search Results

The Zavation Posterior LEIF(Lateral Expandable Interbody Fusion) implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Zavation Posterior LEIF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended to be used in patients who have had six months of non-operative treatment.

The Zavation Posterior LEIF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System.

The Zavation Posterior LEIF(Lateral Expandable Interbody Fusion) devices are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The implants are provided in a shape that accommodates a posterior or transforaminal approach to the lumbar spine. After insertion the implant can be expanded to a larger footprint. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These implants are to be filled with autogenous bone graft material. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of mechanical tests performed on the Zavation Posterior LEIF. The document states: "Mechanical test results demonstrated that the Zavation Posterior LEIF is substantially equivalent to the predicate devices." These tests were conducted in accordance with the listed ASTM standards.

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

The document does not specify a "test set" in terms of patient data. The evaluation relies on mechanical testing of the device itself. Therefore, the sample size refers to the number of devices or components tested. This information is not explicitly stated in the provided document (e.g., "n=X devices tested").

Data provenance for this type of mechanical testing is typically within a laboratory setting, not related to country of origin of patient data or retrospective/prospective studies.

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

This information is not applicable as the "test set" in this context refers to mechanical performance, not clinical data requiring expert review for ground truth. The acceptance criteria are based on established ASTM standards for mechanical performance.

4. Adjudication Method for the Test Set

This is not applicable as the "test set" refers to mechanical performance, not clinical data 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 is not applicable. The Zavation Posterior LEIF is a physical intervertebral body fusion device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This is not applicable. The Zavation Posterior LEIF is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical testing is based on the established performance specifications and methodologies outlined in the ASTM standards. The goal is to demonstrate that the device performs mechanically in a manner substantially equivalent to predicate devices, as defined by these industry standards.

8. The Sample Size for the Training Set

This is not applicable. The Zavation Posterior LEIF is a physical device, and the evaluation relies on mechanical testing against pre-defined standards, not a machine learning model that requires a training set.

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

This is not applicable for the reasons stated in point 8.

Ask a specific question about this device