(92 days)
The InterFuse™ 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 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 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 IFD device is made of PEEK, a polymer with a history of use in interbody fusion device designs, and which has modulus similar to bonc. Each segment of the device has embedded metal beads (tantalum) 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 slides through the rail or slot in the adjacent segment to complete the device. Each segment incorporates a stop to help ensure that it is properly aligned with the adjacent segment. The exposed rail 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 end plate. 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 the "InterFuse™ Intervertebral Body Fusion Device" and its 510(k) submission to the FDA. The submission focuses on establishing substantial equivalence to previously approved predicate devices through bench testing and cadaver evaluations, not clinical studies or AI/software performance evaluations. Therefore, many of the requested categories related to clinical study design, ground truth establishment, expert adjudication, and AI performance metrics are not applicable to this document.
Here's the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document describes "acceptance criteria" through successful bench testing and cadaver evaluations, verifying physical attributes, durability, and performance requirements. Specific quantitative thresholds for these criteria are not provided in this 510(k) summary. The performance is reported qualitatively as meeting these criteria.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Physical Attributes & Durability | Demonstrated by load deflection, cyclic fatigue resistance, material consistency and stability, and processing control through bench testing. |
| Device Stability (Resistance to Expulsion) | Verified during cadaver testing, demonstrating resistance of the device to expulsion from the disc space. |
| Device Stability (Resistance to Disassembly) | Verified during cadaver testing, demonstrating resistance to disassembly in the joint space. |
| Device Stability (Resistance to Subsidence) | Verified during cadaver testing, demonstrating resistance to subsidence. |
| Biocompatibility | Demonstrated to meet internationally recognized standards (ISO 10993). |
| Sterility | Demonstrated to meet internationally recognized standards (EN550). |
| Surgical Technique & Instrument Performance | Verified through cadaver testing. |
2. Sample Size for Test Set and Data Provenance
- Test Set Description: The "test set" in this context refers to the samples used for bench testing and cadaver evaluations.
- Sample Size: Not specified in the document.
- Data Provenance:
- Bench Testing: Performed according to a Master Test Plan, referencing voluntary standards (e.g., ISO, EN). The specific location or country of origin for the testing is not mentioned.
- Cadaver Testing: Performed, but the number of cadavers or the specific source (e.g., country) is not specified.
- Retrospective/Prospective: Not applicable, as no clinical data was used.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable: The "ground truth" in this context is defined by objective engineering and biological standards (e.g., ISO, EN for biocompatibility and sterility) and physical measurements demonstrated through bench and cadaver testing. It does not involve expert interpretation of medical images or patient data that would require a panel of medical experts to establish a "ground truth" in the way it's understood for AI/diagnostic devices. The "surgical technique and instrument performance" was verified by cadaver evaluation, implicitly involving surgical expertise, but the number and qualifications of these experts are not provided.
4. Adjudication Method for the Test Set
- Not applicable: No adjudication method is described, as the evaluation relied on objective measurements and compliance with standards rather than subjective expert consensus on complex medical data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: A MRMC comparative effectiveness study was not performed. The device is a physical intervertebral fusion device, not an AI or diagnostic tool where such a study would be relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable: This device is a physical implant, not an algorithm or software. No standalone algorithm performance study was conducted.
7. Type of Ground Truth Used
- Bench Testing Standards & Physical Measurements: For bench testing, the "ground truth" was defined by internationally recognized standards (ISO 10993 for biocompatibility, EN550 for sterility) and the physical properties and durability measured during load deflection and cyclic fatigue tests.
- Cadaveric Evaluation: For cadaver testing, the "ground truth" for device stability, resistance to expulsion/disassembly/subsidence, and surgical technique performance was established through direct observation and measurement in a simulated surgical environment.
8. Sample Size for the Training Set
- Not applicable: This document pertains to the evaluation of a physical medical device, not an AI or machine learning model. Therefore, there is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- Not applicable: As there is no training set for an AI model, this question is not relevant to the provided text.
§ 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.