(266 days)
When used as a cervical intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System is intended for spinal fusion procedures in skeletally mature patients with degenerative 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. Nanovis Intervertebral Body Fusion System 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 is 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). Nanovis Intervertebral Body Fusion System 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 consists of implants (cages) and related instruments intended to be used for intervertebral body fusion procedures involving the cervical (C2 - T1) and lumbar (L2 - S1) spine. The cages are available in a variety of shapes and sizes to accommodate the individual anatomic and clinical circumstances of each patient, and are available in two materials: polyetheretherketone (PEEK) and titanium alloy (Ti-6AI-4V ELI).
The provided text is a 510(k) Summary for the Nanovis Intervertebral Body Fusion System. This document is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study report detailing clinical performance and acceptance criteria for a novel device against predetermined benchmarks.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance defined in terms of clinical accuracy metrics (e.g., sensitivity, specificity for a diagnostic device).
- Details about a "test set" for performance evaluation against ground truth (e.g., sample size, data provenance).
- Information on "experts" establishing ground truth or adjudication methods.
- A "multi-reader multi-case (MRMC) comparative effectiveness study" or its effect size.
- A "standalone (algorithm only without human-in-the-loop performance)" study.
- The "type of ground truth used" in the context of device performance metrics.
- Training set sample size or how ground truth was established for a training set.
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Intended Use: The Nanovis system has the same intended use as the predicate devices for spinal fusion.
- Technological Characteristics: The device is made of the same materials (PEEK and titanium alloy), has similar overall shapes, and encompasses the same range of physical dimensions as the predicate devices.
- Performance Testing: While performance testing was done, it was focused on mechanical testing against engineering standards to confirm that the device's physical properties are comparable to the predicates, not on clinical performance metrics. The standards mentioned are:
- ASTM F2077 (static and dynamic axial compression, and static and dynamic torsion)
- ASTM F2267 (subsidence)
- Draft standard ASTM F04.25.02.02 (expulsion)
The document explicitly states: "Any differences in technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy." This is the core argument for 510(k) clearance, not the achievement of specific clinical performance acceptance criteria.
§ 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.