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Elite™ Expandable implants are intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Elite™ Expandable implants are designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

The Elite™ Expandable Interbody Fusion System is designed for use as a lumbar intervertebral body fusion device and consists of medical grade titanium alloy (Ti-6AL-4V, ELI) cages and implantation instrumentation. The cages are available in various geometries and sizes to accommodate patient anatomy. The cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft. Components of the Elite™ IBF Expandable Lumbar Fusion System should not be used with components of any other system or manufacturer.

This document does not contain information about acceptance criteria, device performance metrics, or a study specifically designed to establish acceptance criteria for the Elite™ Expandable Interbody Fusion Device.

The document is an FDA 510(k) clearance letter and a 510(k) summary for the Elite™ Expandable Interbody Fusion Device. It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on proving that the device meets specific performance acceptance criteria through a clinical study or detailed non-clinical performance report.

Here's what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The document lists mechanical tests performed (ASTM F2077, F2267) and bacterial endotoxin testing, but it does not specify quantitative acceptance criteria for these tests nor does it report specific numeric results against those criteria. It only states that these tests were "conducted in accordance with FDA's Class II Special Controls Guidance Document... and applicable American Society for Testing and Materials (ASTM) standards." This implies the tests were performed to demonstrate mechanical integrity and biocompatibility, but the specific performance values and acceptable ranges are not disclosed.

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

• Test Set Sample Size: Not applicable as no specific clinical or performance test set (in the context of real-world patient data or detailed device performance metrics) is described in terms of a sample size. The "test set" here refers to the physical devices subjected to mechanical testing.
• Data Provenance: The document refers to non-clinical mechanical testing and bacterial endotoxin testing. This is laboratory-based testing, not clinical data from patients.

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

Not applicable. The document describes mechanical and biocompatibility testing of the device, not a study evaluating human interpretation or diagnosis. Therefore, there's no "ground truth" established by experts in the context of diagnostic performance.

4. Adjudication Method:

Not applicable. There's no adjudication method mentioned as this document does not describe a study involving expert review or interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, Effect Size:

No. An MRMC comparative effectiveness study was not done. This type of study typically assesses the performance of human readers (e.g., radiologists) with and without AI assistance, which is not relevant to this mechanical device submission.

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

Not applicable. This is a physical intervertebral body fusion device, not an algorithm or AI software. Therefore, "standalone performance" in the context of an algorithm is not relevant.

7. Type of Ground Truth Used:

Not applicable in the context of diagnostic or interpretive performance. For the mechanical and biocompatibility testing, the "ground truth" would be established by the physical properties of the materials and the manufacturing process, verified by standardized laboratory tests.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable for the same reason as point 8.

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The ELITE™ L Expandable Lumbar Fusion System is indicated for use as intervertebral body fusion devices in sketetally mature patients with Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine from L2-L5. Patients should have received a minimum of six months of non-operative treatment prior to surgery. These patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). These implants are intended for use with autogenous bone graft and supplemental internal fixation systems such as a pedicle screw or anterior plating system.

The Elite™ L is a titanium alloy (Ti6Al4V-ELI) implant that is designed to provide mechanical support of the intradiscal space while biologic fusion occurs. The device is available in a variety of footprints, all of which are inserted in the unexpanded state and are expanded in situ. There are various heights to accommodate varied patients' anatomy. The implants are available in parallel and lordotic angles, with the implant end plates being bi-convex to optimize contact with the vertebral body end plates. All implants are made from medical grade titanium alloy. Implants have a locking mechanism to hold the implant in the expanded position once deployed.

This document is a 510(k) summary for the ELITE™ L Expandable Lumbar Fusion System, which is an intervertebral body fusion device. The purpose of this submission is to add devices to be implanted from the lateral surgical approach.

Unfortunately, the provided text does not contain explicit acceptance criteria or details of a study that proves the device meets specific performance criteria in the way you've outlined for statistical performance of an AI/ML device.

This document describes a medical device and its substantial equivalence to a predicate device, which is a common pathway for FDA clearance for certain medical devices. The "performance testing" mentioned refers to mechanical and functional testing of the physical implant, not performance in terms of diagnostic accuracy or clinical outcomes of an AI/ML system.

Therefore, I cannot populate your requested table and study details. The information provided is for a physical medical implant and focuses on:

• Mechanical Testing: According to ASTM F2077 (Static and dynamic axial compression, subsidence resistance, and expulsion resistance of an intervertebral body fusion device) and ASTM F2267 (Standard Test Method for Measuring Load-Displacement Properties of Spine Implants Under Compression or Shear).
• Finite Element Analysis (FEA): Used to compare the new device (Elite™ L) to the primary predicate device (Elite Expandable Interbody Fusion Device) and demonstrated "greater strength and durability to static and dynamic forces."

The criteria for this type of device are primarily related to its mechanical properties and biocompatibility, ensuring it can perform its intended function of supporting the intradiscal space and facilitating fusion without failure. The "acceptance criteria" here would implicitly be that the device performs at least as well as, or better than, the predicate device in these mechanical tests and that its materials, dimensions, and function are substantially equivalent to legally marketed predicate devices.

To directly answer your numbered points based on the provided text, I must state that most of the requested information regarding AI/ML device performance is not available.

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and the data provenance: Not applicable. This refers to mechanical testing of physical implants, not data analysis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Gor mechanical testing, ground truth is established by engineering standards and measurements.

4. Adjudication method for the test set: Not applicable.

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: Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used: For mechanical testing, the "ground truth" would be the direct measurements obtained from standardized physical tests and the results of Finite Element Analysis.

8. The 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.

In summary, the provided document describes the mechanical and functional characteristics of a physical medical device and asserts its substantial equivalence to a predicate device based on standardized mechanical testing and FEA. It does not involve any AI/ML components or studies of diagnostic accuracy in the way your questions are framed.

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