(26 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 1 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 Intervertebral Body Fusion device is made of 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. Each segment incorporates a stop to or sior in the unjudent cogment 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 suction's and lew as three segments to be used, annough most politics. Each segment has a vertical slott segments for uptimatir coverage or the vertise and that will provide a path for solid Infough the belice for the Salgeon to mi With Bategis produced in four heights (8, 10, 12 and 14 bone grown during the foston process. " The (2011-11 and 25 mm) and two antenor-posicilion allifensity (is and 5 angled (lordotic) shapes to fit the angular geometry of the disc at each disc level.
This document refers to a Special 510(k) Pre-market Notification for the InterFuse® Intervertebral Body Fusion Device, which is essentially a modification of an already cleared device. Therefore, the "study" described is primarily focused on demonstrating that the modified device remains substantially equivalent to its predicate, rather than an entirely new clinical efficacy study.
Here's an analysis of the provided information, structured around your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Shelf-life Testing Protocol) | Reported Device Performance (from Accelerated Aging) |
|---|---|
| Seal integrity of packages (unspecified criteria) | Tested for seal integrity by dye penetration and bubble test (passed - implied by conclusion of equivalence) |
| Performance of aged devices (unspecified criteria) | Conformity with ASTM F2077-03 - Test methods for Intervertebral Body Fusion Devices (passed - implied by conclusion of equivalence) |
| Cytotoxicity (ISO 10993) | Tested for cytotoxicity (passed - implied by conclusion of equivalence) |
| 2-year shelf-life at 55℃ | Demonstrated a 2-year shelf-life based on accelerated aging at 55℃ |
Note: The document explicitly states that the acceptance criteria for seal integrity, performance, and cytotoxicity were "specified in the shelf-life testing protocol" but does not provide the specific criteria themselves. It only states that the tests were performed and implies successful adherence to these criteria to claim substantial equivalence. The primary change and therefore the primary acceptance criteria for this specific 510(k) was the extension of the shelf-life from 6 months (of the predicate) to 2 years.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The tests were performed on "packages" and "aged devices" at the end of the accelerated aging process. The number of samples tested for seal integrity, performance, and cytotoxicity is not provided.
- Data Provenance: Not applicable in the traditional sense of patient data. The data is from bench testing and laboratory testing (accelerated aging, seal integrity, mechanical performance, cytotoxicity) conducted on the manufactured devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable for this type of submission. Ground truth, in the context of this 510(k) for a physical implant, is established by laboratory measurements against recognized standards (like ASTM F2077-03, ISO 10993) and internal protocols. There is no expert consensus on a "ground truth" for shelf-life, seal integrity, or material cytotoxicity in the way there would be for image interpretation.
4. Adjudication Method for the Test Set
- Not applicable. This was a series of laboratory tests with objective pass/fail criteria based on established standards and internal protocols, not an expert panel adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC comparative effectiveness study is typically relevant for interpretative diagnostic devices (e.g., AI for medical imaging) where human readers are involved. This device is an implantable medical device, and the submission is about confirming its shelf-life and continued substantial equivalence, not its effectiveness in a reader study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" here is based on objective measurements against established engineering and biocompatibility standards.
- Mechanical Integrity: Conformity to ASTM F2077-03 (Standard Test Methods for Intervertebral Body Fusion Devices).
- Biocompatibility: Conformity to ISO 10993 (Biological Evaluation of Medical Devices) for cytotoxicity.
- Packaging Integrity: Testing standards such as dye penetration and bubble test (implied, specific ASTM or ISO standard not mentioned but recognized tests for seal integrity).
- Shelf-life: Based on accelerated aging results correlated with real-time stability (ASTM F1980-07 for accelerated aging).
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of this device. A training set is used for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, there is no ground truth for it to be established.
§ 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.