(263 days)
FortiCore® is intended for spinal fusion procedures in skeletally mature patients with disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally, FortiCore® can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. FortiCore® devices are to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation indicated for lumbar spinal fusion procedures.
FortiCore® consists of implants and instruments for implantation. The upper and lower aspects of the implant incorporate a three-dimensional titanium scaffold electrochemically treated to possess a controlled nanotopography composed of nanotube arrays with an average pore size between 60-80 nanometers, which assists in securing the implant in the intervertebral space and provides radiographic confirmation of the implant location. Calcium and phosphate are incorporated into the nanotube surface. Nanovis has not submitted data to show that phenomena, including chemical properties or biological effects are attributable to these features. The devices are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.
The provided text is a 510(k) summary for the FortiCore® intervertebral body fusion device. It does not contain information about acceptance criteria for a device's performance in terms of diagnostic accuracy or a study proving that the device meets such criteria for an AI/ML device.
Instead, the "Performance Data" section of the 510(k) summary (page 3) discusses mechanical testing related to the physical device itself:
- Acceptance Criteria and Reported Device Performance: This document describes mechanical performance testing, not clinical or diagnostic performance.
- Acceptance Criteria (Implicit): That the device's mechanical performance (dynamic compression, static and dynamic compression shear) is "substantially equivalent to the predicate devices" according to ASTM F2077.
- Reported Device Performance: Mechanical testing was performed on "worst case FortiCore® devices" according to ASTM F2077. The results "demonstrate that the FortiCore device performance is substantially equivalent to the predicate devices."
The following points refer to information typically found in studies for AI/ML devices, which are not present in this document as it's for a physical intervertebral fusion device, not a diagnostic AI/ML algorithm.
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical FortiCore® devices subjected to mechanical testing, not a dataset of patient images or clinical data.
- 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 established by engineering standards and measurement, not expert opinion.
- Adjudication method: 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 is for a physical implant, not an AI assistance tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For this device, the "ground truth" for performance is compliance with mechanical testing standards (ASTM F2077) and comparison to predicate devices, demonstrating substantial equivalence in physical performance.
- The sample size for the training set: Not applicable.
- 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.