(97 days)
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)
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Durability (Static) | Verified by static testing per ASTM F2077-11 for axial load deflection and shear deflection. |
| Durability (Dynamic) | Verified by dynamic testing per ASTM F2077-11 for axial load cyclic fatigue and shear load cyclic fatigue. |
| Subsidence | Tested per ASTM F2267-04. |
| Biocompatibility | Tested for cytotoxicity per ISO 10993-5:2009 and found to be non-cytotoxic. |
| Sterility | Sterilized by gamma irradiation to a sterility assurance level of 10-6. |
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:
- 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.
- 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.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- 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.
- The sample size for the training set: Not applicable. There is no training set mentioned for this type of device submission.
- 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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.