(101 days)
When used as a cervical intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (definded as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System and Zavation Cervical Plate System.
The Zavation IBF implants offers a variety of heights, widths and lengths. There are six main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone).
The Zavation IBF implants are available in a range of sizes, as well as parallel and lordotic angled · implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.
The provided text describes a medical device, the Zavation IBF System, and its acceptance criteria as demonstrated through performance data. However, it does not describe a study involving an AI/algorithmic device or its performance against ground truth established by experts.
The "Performance Data" section specifically states: "Mechanical test results demonstrated that the Zavation IBF System is substantially equivalent to the predicate devices. Testing was performed in accordance with ASTM F2077 and ASTM F2267. Static and Dynamic axial compression, subsidence and expulsion tests were completed."
This indicates that the study performed was a mechanical test of the physical implant device, not a study evaluating an AI algorithm's diagnostic or predictive performance. Therefore, most of the requested information regarding AI device performance (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI) cannot be extracted from this document because it is not relevant to the described studies.
Here's the information that can be extracted:
Acceptance Criteria and Device Performance (Mechanical Testing)
| Acceptance Criteria (What was tested) | Reported Device Performance (How it met the criteria) |
|---|---|
| Static Axial Compression | Met criteria demonstrating substantial equivalence to predicate devices. |
| Dynamic Axial Compression | Met criteria demonstrating substantial equivalence to predicate devices. |
| Subsidence | Met criteria demonstrating substantial equivalence to predicate devices. |
| Expulsion | Met criteria demonstrating substantial equivalence to predicate devices. |
| Compliance with ASTM F2077 | Testing performed in accordance with this standard. |
| Compliance with ASTM F2267 | Testing performed in accordance with this standard. |
Explanation of Missing Information for AI/Algorithmic Devices:
- Sample size used for the test set and the data provenance: Not applicable. The study was mechanical testing of a physical implant.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineered specifications and standardized test methods.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is not about an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For mechanical testing, the "ground truth" is defined by the physical properties and performance standards (like ASTM F2077 and F2267) which the device must meet or exceed, or demonstrate equivalence to predicate devices.
- The sample size for the training set: Not applicable. (No AI training set.)
- How the ground truth for the training set was established: Not applicable. (No AI training set.)
§ 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.