(95 days)
FortiCore® cervical devices are intended for anterior cervical spinal fusion procedures in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at multiple contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. FortiCore® cervical devices are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures. Nano FortiCore® cervical devices are intended for anterior cervical spinal fusion procedures in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at multiple contiguous levels from C2-T1. These patients should have had at least six weeks of non-operative treatment. Nano FortiCore® cervical devices are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures. Nano FortiCore® lumbar devices are intended for spinal fusion procedures in skeletally mature patients with degenerative 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, Nano FortiCore® lumbar devices can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. Nano FortiCore® lumbar 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® and Nano FortiCore® consist of implants and instruments for implantation. The upper and lower surfaces of the implant incorporate a three-dimensional titanium scaffold with interconnected pores averaging 523 µm, and pore interconnections averaging 229 um in diameter. This product demonstrates the requirements for nanotechnology. The surface has been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. The scaffold of the Nano FortiCore® devices is electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having an average pore size between 60-80 nanometers. Calcium and phosphate are incorporated into the nanotube surface. The scaffold with nanotubes assists in securing the implant in the intervertebral space and provides radiographic confirmation of the implant location. The FortiCore® and Nano FortiCore® devices are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.
The provided text describes a 510(k) premarket notification for two intervertebral body fusion devices, FortiCore® and Nano FortiCore®, and asserts their substantial equivalence to predicate devices. However, this document does not include information about acceptance criteria or a study proving that the device meets such criteria in terms of AI/algorithm performance.
The "Performance Data" section solely discusses mechanical testing of the devices according to ASTM F2077 and F2267, as well as in vitro evaluations related to nanotechnology and bacterial endotoxin testing. It concludes that "The mechanical test results demonstrate the FortiCore® and Nano FortiCore® device performance is substantially equivalent to the predicate devices."
Therefore, based only on the provided text, I cannot answer the questions regarding acceptance criteria and an AI/algorithm-related study. The document pertains to a physical medical device (intervertebral body fusion device) and its mechanical/material properties, not an AI or software as a medical device (SaMD).
To explicitly answer your request based on the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable. The document discusses mechanical testing results in comparison to predicate devices, but doesn't present specific acceptance criteria in a table or quantitative performance metrics for an AI/algorithm.
- Sample sizes used for the test set and the data provenance: Not applicable. The "test set" refers to physical devices undergoing mechanical tests, not a data set for AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This concept is for AI/algorithm validation, not mechanical testing of a medical implant.
- Adjudication method (e.g. 2+1, 3+1, none) 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 is for AI-assisted diagnostic or interpretative devices.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here would be the physical properties and performance of the implant under mechanical stress, compared to established standards (ASTM).
- 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.