Search Results

The InterFuse L - Intervertebral Body Fusion Device is indicated for intervertebral spinal 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 patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse L device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The InterFuse L device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.

VTI's InterFuse L - Intervertebral Body Fusion device is made of implant grade Polyetheretherketone (PEEK- OPTIMA®, Grade LT1), a polymer with a history of use in interbody fusion device designs, and which has a compressive modulus similar to bone. The device has two modules. Module A has a rail and Module B has a slot. The modules are installed by using VTI's proprietary slot riding the rail technology. Both modules have tantalum beads that aid in visualizing the implanted device under X-ravs. Each module incorporates a ramp lock to help ensure that it is properly aligned and engaged with the other module. Each module has two vertical slots through the device for the surgeon to fill with autogenous bone that will provide a path for solid bone growth during the fusion process. The device is produced in six heights (7 mm, 8 mm, 9 mm, 10 mm, 12 mm and 14 mm) each for parallel and 8 lordotic configurations to fit the angular geometry of the disc at each disc level. Four anterior - posterior (AP) lengths (16 mm, 18 mm, 21 mm and 24 mm) of the device are being offered. The device will be available in 7 Medial - Lateral (ML) dimensions (35 mm, 40 mm, 45 mm, 50 mm, 55 mm 60 mm and 65 mm). VTI will supply a set of Instruments (all non-sterile, re-usable manual instruments) for implantation of InterFuse L by a Direct-Lateral Lumbar Interbody Fusion technique.

The provided text describes the 510(k) summary for the "InterFuse L - Intervertebral Body Fusion Device." This document focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical bench testing. It does not contain information about a clinical study involving human subjects, AI performance, or ground truth establishment in a medical imaging context.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/medical imaging device cannot be extracted from this document.

However, I can provide what is available, specifically related to the non-clinical testing performed for this device.

Acceptance Criteria and Device Performance (Non-Clinical Bench Testing)

Study Information (Based on Non-Clinical Testing):

The provided document describes non-clinical bench testing rather than a clinical study for an AI device. As such, the following requested information is not applicable or not available within this submission:

2. Sample size used for the test set and the data provenance: Not applicable. The testing was bench testing on physical devices, not a dataset of patient images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering standards and measurements, not expert clinician consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) 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: No MRMC study was done, as this is a physical medical device (intervertebral body fusion device), not an AI/imaging diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of clinical AI/imaging ground truth. For the bench tests, the "ground truth" would be the measured physical properties and performance against established ASTM standards for intervertebral body fusion devices.
8. The sample size for the training set: Not applicable. There is no training set mentioned for this type of device submission.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study (Bench Testing):

The study described is a series of non-clinical bench tests designed to demonstrate the mechanical and material performance of the InterFuse L - Intervertebral Body Fusion Device. The tests were conducted according to recognized ASTM standards (ASTM F2077-11 for static and dynamic durability, and ASTM F2267-04 for subsidence) and ISO standards (ISO 10993-5:2009 for cytotoxicity). The purpose was to show substantial equivalence to predicate devices (K091988 and K102277) by demonstrating similar performance characteristics under these standardized test conditions. The device also underwent sterilization testing to ensure a sterility assurance level of 10-6.

Ask a specific question about this device

The InterFuse® T - Intervertebral Body Fusion Device is indicated for intervertebral spinal 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 patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse T device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The InterFuse T device is indicated for use with autogenous bone graft and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine.

VTI's InterFuse® T - Intervertebral Body Fusion device is made of implant grade PEEK-OPTIMA® (Poly ether ether ketone), a polymer with a history of use in interbody fusion device designs, and which has a compressive modulus similar to bone. Each segment of the device has embedded tantalum beads that aid in visualizing the implanted device under x-ray. Each segment has an integral rail and/or slot which slide through or over the rail or slot in the adjacent segment to complete the device. Each segment incorporates a ramp lock to help ensure that it is properly aligned and engaged with the adjacent segment. The exposed rail of the segments is removed after the middle segment is installed. Each segment has a vertical slot through the device for the surgeon to fill with autogenous bone that will provide a path for solid bone growth during the fusion process. The device is produced in four heights (8, 10, 12 and 14 mm) each for parallel and 10 lordotic configurations to fit the angular geometry of the disc at each disc level. The Anterior - Posterior (AP) length of the device is 24 mm. The middle seament (B) comes in two widths (9 mm or 10 mm).

1. Acceptance Criteria and Reported Device Performance:

The acceptance criteria for the InterFuse® T - Intervertebral Body Fusion Device are based on demonstrating substantial equivalence to the predicate device (InterFuse® Intervertebral Body Fusion Device, K091988) through non-clinical bench testing. The specific tests and their outcomes are summarized below:

Conclusion from Study: The study concludes that the modified device (InterFuse® T) is substantially equivalent to the unmodified InterFuse® device (K091988) based on these performance data.

2. Sample size used for the test set and the data provenance:

The provided document does not specify exact sample sizes for each test mentioned (e.g., number of devices tested for static compression). However, it implies that performance testing was conducted on the "modified device (InterFuse T)" after gamma irradiation sterilization.

The data provenance is from non-clinical bench testing conducted by the manufacturer, Vertebral Technologies, Inc. This is a prospective set of tests designed to demonstrate the mechanical and biological properties of the device. The country of origin of the data is not explicitly stated but would be presumed to be where the manufacturer is located or where they contracted the testing (Minnetonka, MN, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This submission describes non-clinical bench testing of a medical device, not a study involving human readers or clinical data requiring expert review for ground truth establishment. The "ground truth" for these tests is defined by the standards (ASTM and ISO) used.

4. Adjudication method for the test set:

Not applicable. As noted above, this is non-clinical bench testing governed by predefined engineering and biological standards, not a study requiring adjudication of expert opinions.

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 a 510(k) submission for an intervertebral body fusion device, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study comparing human readers with and without AI assistance was conducted.

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

Not applicable. This is a physical medical implant device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the non-clinical tests described is established by:

• Standardized testing protocols: Adherence to established industry standards such as ASTM F2077-03 (Standard Test Methods for Static and Dynamic Axial Compression and Shear Fatigue Properties of Intervertebral Body Fusion Devices), ASTM F2267-04 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Axial Compression), and ISO 10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity).
• Material specifications: The use of implant-grade PEEK-OPTIMA® and tantalum beads, materials with a history of use and defined properties.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The device itself is the "product" being evaluated.

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

Not applicable, as no training set was used.

Ask a specific question about this device