(28 days)
The InterFuse® DA 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 at the involved level(s). The InterFuse DA 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 DA 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.
The implantable portion of VTI's InterFuse DA interbody fusion device (IFD) is made of implantable grade PEEK (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 and to aid in position retention when assembled in the disc space. 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 (see photos below). Each segment incorporates a stop to help ensure that it is properly aligned with the adjacent segment. The exposed rail, with a stainless steel (Grade 304) tail, of each segment is removed after the adjacent segment is installed. The modular system allows for as few as three segments to be used, although most patients will require between four and six segments for optimum coverage of the vertebral endplate. 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 and two anterior-posterior dimensions to fit a range of potential disc spaces. The device will also be produced in flat and angled (lordotic) shapes to fit the angular geometry of the disc at each disc level.
The provided text describes a 510(k) premarket notification for a medical device, specifically an Intervertebral Body Fusion Device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical trial data that would be typical for proving novel device efficacy or diagnostic accuracy.
Therefore, the document does not contain information regarding the acceptance criteria, study details, or performance metrics typically requested for AI/ML-based devices in the format specified in your prompt.
Specifically, the following information is not available in the provided text:
- Table of acceptance criteria and reported device performance: The document only mentions a minimum strength requirement in Newtons (8,500 N) for static compression testing but doesn't present a comprehensive table of acceptance criteria and reported performance across various metrics.
- Sample size used for the test set and data provenance: The study mentioned is a non-clinical, static compression test. It does not involve a test set of patient data, nor is there any mention of human readers or AI performance.
- Number of experts used to establish ground truth and qualifications: This is not applicable as the study described is a bench test, not an evaluation requiring expert interpretation of medical data.
- Adjudication method for the test set: Not applicable for a non-clinical bench test.
- Multi reader multi case (MRMC) comparative effectiveness study: No MRMC study was conducted or mentioned. The device is a physical implant, not an AI-assisted diagnostic tool.
- Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is not an AI algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the bench test was the physical measurement of load to failure as per ASTM F2077-03.
- Sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
However, based on the provided text, I can infer the primary acceptance criterion and the study used to meet it:
Acceptance Criterion and Study Information (Based on provided text)
| Category | Description |
|---|---|
| Device Name | InterFuse® DA Intervertebral Body Fusion Device |
| Device Type | Mechanical Intervertebral Body Fusion Device (implant) |
| Primary Acceptance Criterion | The device must exceed a minimum static compression strength of 8,500 Newtons (N). This criterion was established based on the original validation testing referenced in the predicate device (K091988). |
| Reported Device Performance | "All devices exceeded the minimum strength requirement of 8,500N." (Specific numerical values for the tested devices are not provided, only that they met/exceeded the threshold). |
| Study Name | Static Compression Testing (Report TR 582, referenced in Appendix 1) |
| Study Type | Non-clinical bench testing |
| Test Standard | ASTM F2077-03 - Test Methods for Intervertebral Body Fusion Devices |
| Sample Size (Test Set) | Not explicitly stated how many devices were tested, but the text says "All devices" implying a set was tested. |
| Data Provenance | Not applicable (bench test performed in a lab setting). |
| Number of Experts / Qualifications | Not applicable (bench test). |
| Adjudication Method | Not applicable (bench test). |
| MRMC Comparative Effectiveness Study | No. |
| Standalone Performance Study (AI) | No. |
| Type of Ground Truth | Engineering specifications/performance metrics (static compression load to failure). |
| Sample Size (Training Set) | Not applicable (not an AI/ML device). |
| Ground Truth for Training Set Establishment | Not applicable (not an AI/ML device). |
§ 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.