(122 days)
The InterFuse® T - 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 T 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 T 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® T - Intervertebral Body Fusion device is made of implant grade PEEK-OPTIMA® (Polyetheretherketone), 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-rav. 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 ramp lock to help ensure that it is properly aligned and engaged with the adjacent segment. The exposed rail of the segments is removed after the middle segment (B) is installed. 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) each for parallel and 10 lordotic configurations to fit the angular geometry of the disc at each disc level. InterFuse T device will be available in two anterior - posterior (AP) lengths of 20 mm and 24 mm. The middle segment (B) comes in two widths (9 mm or 10 mm).
The provided text describes a 510(k) premarket notification for a medical device called the InterFuse® T - Intervertebral Body Fusion Device, which is a spinal implant. This submission is for a modification to an already cleared device, and the primary focus of the document is to demonstrate substantial equivalence to the predicate device through non-clinical testing.
Therefore, the requested information about acceptance criteria and device performance as it pertains to AI/algorithm performance metrics (like sensitivity, specificity, MRMC studies, standalone performance, and ground truth establishment with experts) is not applicable to this submission. This document details a physical medical device, not an AI or software device.
However, I can extract the information relevant to the non-clinical performance claims and the study conducted to demonstrate the modified device's equivalence to its predicate.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for performance in the typical sense of a clinical trial or AI evaluation. Instead, it states that the modified device was tested to ensure it met performance standards for intervertebral body fusion devices, and the results supported substantial equivalence to the predicate. The "acceptance criteria" implicitly are that the modified device's performance is comparable to or better than the predicate device in the specified tests, conforming to relevant ASTM standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance comparable to predicate device per ASTM standards. | Modified device passed all tested parameters. |
| Meet standards for: | |
| - Static and Dynamic Compression (per ASTM F2077) | Demonstrated sufficient static and dynamic compression. |
| - Static and Dynamic Compression Shear (per ASTM F2077) | Demonstrated sufficient static and dynamic compression shear. |
| - Subsidence (per ASTM F2267) | Demonstrated acceptable subsidence characteristics. |
| - Expulsion testing | Demonstrated acceptable expulsion resistance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of a number of devices or iterations for each test. The document refers to "bench testing" and "performance data" but does not quantify the number of units tested.
- Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting, not with human or animal subjects. Thus, there is no country of origin of data or retrospective/prospective nature to describe in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This is not applicable to the non-clinical bench testing described. "Ground truth" in this context would refer to the validated measurement methods and standards (e.g., ASTM F2077, F2267) used in the mechanical testing. There were no human experts establishing a subjective ground truth.
4. Adjudication Method for the Test Set
- Not applicable. This refers to the process of resolving discrepancies in expert opinions, which did not occur in this bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC study was not done. This type of study is relevant for evaluating human interpretation of medical images or data, often with AI assistance, which is not the subject of this 510(k) submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- For this mechanical device, the "ground truth" for the non-clinical tests is based on established engineering standards and validated test methodologies as outlined by organizations like ASTM (e.g., ASTM F2077, ASTM F2267). The performance is measured against these objective, quantitative standards.
8. The Sample Size for the Training Set
- Not applicable. This refers to training data for algorithms, which is not relevant for this physical device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the same reason as above.
§ 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.