(28 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.
The implantable portion of VT's IFD device is made of PEEK (Poly ether ether ketone), a polymer with a history of use in interbody fusion devices, 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. Each segment incorporates a stop to help ensure that it is properly aligned with the adjacent segment. The exposed rail, with a stainless steel tail, of each seqment 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 (8, 10, 12 and 14 mm) and two anterior-posterior dimensions (20 mm and 25 mm) to fit a range of potential disc spaces. The device will also be produced in flat and 5 angled (lordotic) shapes to fit the anqular geometry of the disc at each disc level.
The provided document is a 510(k) premarket notification for a medical device, specifically an Intervertebral Body Fusion Device. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing data from a clinical study on device performance against specific acceptance criteria.
As such, it does not contain the following information that would typically be found in a clinical study report:
- A table of acceptance criteria and reported device performance: The document only states that "All devices exceeded the minimum strength requirement which was used in the original validation testing referenced in K080673." It does not specify the minimum strength requirement or provide detailed performance data.
- Sample sizes used for the test set and data provenance: No information on a test set (in the context of clinical or image-based AI studies) is provided. The "test" here refers to bench testing of the device itself.
- Number of experts used to establish ground truth and their qualifications: Not applicable, as this is a device clearance based on bench testing, not an AI or diagnostic tool requiring ground truth from experts.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study information: Not applicable for this type of device clearance.
- Standalone (algorithm-only) performance: Not applicable, as this is a physical implantable device, not an algorithm.
- Type of ground truth used: For the bench testing, the "ground truth" would be the established engineering standards (ASTM F2077-03) and the performance of the predicate device.
- 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.
Acceptance Criteria and Study Details from the Provided Document:
The study described is a bench test to demonstrate that a modification to the InterFuse® Intervertebral Body Fusion Device (specifically the delivery system's tail and the sterilization method) does not negatively impact the device's performance compared to the predicate device.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Bench Test) | Reported Device Performance |
|---|---|
| Mechanical Strength: Must meet or exceed the minimum strength requirement from the original validation testing (referenced in K080673) for static compression after gamma sterilization, as per ASTM F2077-03. | "All devices exceeded the minimum strength requirement which was used in the original validation testing referenced in K080673." |
| Sterility: Achieve a Sterility Assurance Level (SAL) of 10⁻⁶ with gamma irradiation. | "The sterilization by gamma irradiation was validated to give a Sterility Assurance Level of 10⁻⁶." |
| Biocompatibility: Non-toxic. | "The InterFuse device was found to be "Non toxic" by testing for cytotoxicity." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for the mechanical, sterility, or cytotoxicity tests. The document only states "All devices" regarding the mechanical test.
- Data Provenance: The tests are "nonclinical tests submitted" and were performed by the manufacturer, Vertebral Technologies, Inc., to support their 510(k) submission. The exact location of testing (e.g., in-house lab, third-party lab) is not specified, but it would be considered internal company data for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this bench testing for a physical device. The "ground truth" or standard for performance is the ASTM standard and the predicate device's established performance.
4. Adjudication method for the test set:
- Not applicable. The tests are objective measurements against specified engineering and biological standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, this type of study was not done. This is a physical implantable device, not a diagnostic or interpretative system that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical implantable device, not an algorithm.
7. The type of ground truth used:
- Mechanical Strength: Established engineering standards (ASTM F2077-03) and the previously validated performance of the predicate device (K080673).
- Sterility: Industry-accepted standards for achieving a Sterility Assurance Level (SAL) of 10⁻⁶.
- Biocompatibility: Standardized cytotoxicity testing methods to determine non-toxicity.
8. The sample size for the training set:
- Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.