(90 days)
When used as a cervical intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System and FortiCore® are intended for spinal fusion procedures in skeletally mature patients with disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. The Nanovis Intervertebral Body Fusion System and FortiCore® implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures.
When used as a lumbar intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System and FortiCore® are intended for spinal fusion procedures in skeletally mature patients with 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 at the involved spinal level(s). The Nanovis Intervertebral Body Fusion System and FortiCore® implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.
The Nanovis Intervertebral Body Fusion System and FortiCore® consist of implants and related instruments for implantation. The upper and lower aspects of the implants from both systems are open and have a central column to be packed with autogenous bone graft. The FortiCore® implants have an integrated titanium scaffold which assists in securing the implant in the intervertebral space. The devices from both systems are available in a variety of shapes and sizes to accommodate the individual patient anatomy.
This document is a 510(k) summary for the Nanovis Intervertebral Body Fusion System and FortiCore®. It describes the device, its intended use, and the data submitted to demonstrate substantial equivalence to predicate devices. However, it does not contain a typical study design with acceptance criteria and performance metrics for an AI/ML device.
Instead, the performance data section describes engineering analyses for a physical medical device. Therefore, I cannot provide the information requested in your prompt as it pertains to an AI/ML device study.
Here's a breakdown of what the document does provide regarding performance and criteria for this non-AI/ML device:
1. A table of acceptance criteria and the reported device performance
The document describes performance data for the physical device, not an AI/ML algorithm.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Structural performance of modified sizes | Demonstrated substantial equivalence to predicate devices through finite element and dimensional analyses. |
| Bacterial Endotoxins Test (BET) | Results met the acceptance criterion according to ANSI/AAMI ST72. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The performance data section refers to "finite element and dimensional analyses" and a "Bacterial Endotoxins Test (BET)," which are engineering and laboratory tests, not clinical studies with human patient data or test sets in the context of AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This is not an AI/ML study involving expert interpretation of data to establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML study involving adjudication of human or algorithmic outputs.
5. 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 not an AI/ML device, and therefore no MRMC study comparing human readers with and without AI assistance was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical intervertebral body fusion system, not a software algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.)
For the engineering analyses, the "ground truth" would be established by validated engineering principles and test standards. For the Bacterial Endotoxins Test, the "ground truth" is meeting the specified endotoxin limits as defined by ANSI/AAMI ST72.
8. The sample size for the training set
Not applicable. This is not an AI/ML device; there is no training set in this context.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device; there is no training set ground truth to establish.
In summary: The provided document is for a physical medical device (intervertebral body fusion system) and the performance data presented relates to engineering analyses and laboratory testing, not the evaluation of an AI/ML algorithm. Therefore, many of the questions are not applicable to the content of this specific document.
§ 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.