(161 days)
When used as a cervical intervertebral body fusion device, the Zavation Ti 3Z Cervical Interbody System implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. The Ti3Z cervical implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined 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.
For all the above indications the Zavation Ti 3Z Cervical Interbody implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Cervical Plate System.
The Zavation Ti3Z Cervical Interbody System implants are offered in two configurations: Ti3Z cervical implants are additively manufactured entirely from medical grade Titanium Ti64ELI powder by way of laser sintering (ASTM F3001); Ti3Z-PEEK cervical implants have an exterior that is manufactured from medical grade PEEK (polyetherketone) with tantalum beads or pins embedded in the implants to allow for radiographic visualization. Ti3Z-PEEK implants also contain an interior titanium insert manufactured by way of laser sintering (ASTM F3001) and a wrought titanium pin (ASTM F136). The ends of the Ti3Z-PEEK implants have machined teeth which are designed to engage with the vertebral body end plates.
The Zavation Ti 3Z Cervical and Ti3Z-PEEK Cervical Interbody implants are available in a range of heights, widths and lengths as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. The internal body of both constructs have a porous structure while the external edges of the implants have a solid, roughened surface designed to engage with the vertebral body end plates. Both porous and solid aspects of the Ti3Z cervical implant are printed simultaneously. This modification seeks clearance for the addition of Ti3Z-PEEK cervical spacers. All implants will be provided sterile.
The provided text is a 510(k) premarket notification for a medical device, the Zavation Ti3Z Cervical Interbody System, specifically for the addition of a Ti3Z-PEEK cervical implant. It outlines the device description, intended use, materials, predicate devices, and performance data.
However, the questions you've asked are typically related to the performance evaluation of AI/ML-driven medical devices, often involving studies to assess diagnostic accuracy or clinical utility. The document describes a physical implantable device (intervertebral body fusion device) and its mechanical and manufacturing process validation.
Therefore, the provided document does not contain the information requested in your questions related to AI device performance evaluation. There is no mention of:
- AI/ML algorithms
- Acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC)
- Test sets, ground truth establishment by experts, or adjudication methods for AI
- Multi-reader multi-case (MRMC) studies for AI assistance
- Standalone algorithm performance
- Training sets for AI
The "Performance Data" section in the document refers to mechanical testing (e.g., ASTM F2077 for static/dynamic axial compression, torsion, shear; ASTM F2267 for subsidence/expulsion) and process validation (e.g., ASTM F 2847-10 for residues, cytotoxicity, TOC, LAL for contaminants). These are standard tests for spinal implants to demonstrate their structural integrity and biocompatibility, not for evaluating the diagnostic or assistive accuracy of an AI system.
In summary, the document details the regulatory submission for a physical medical implant and its mechanical and manufacturing properties, not an AI-powered device. Thus, it cannot provide answers to your specific questions about AI device acceptance criteria and performance studies.
§ 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.