(111 days)
When used as a cervical intervertebral body fusion device, the Zavation Ti 3Z Cervical Interbody System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The cervical IBF 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 Ti 3Z Cervical Interbody implants offer a variety of heights, widths and lengths in the CIF configuration. The implants are additively manufactured from medical grade Titanium Ti64ELI powder by way of laser sintering.
The Zavation Ti 3Z Cervical Interbody implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. The internal body of the implants 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 each implant are printed simultaneously.
The provided text is a 510(k) summary for a medical device called the "Ti 3Z Cervical Interbody System." This document describes the device, its intended use, materials, and testing conducted to demonstrate its substantial equivalence to previously cleared predicate devices.
However, this document does not contain any information about a study that proves the device meets acceptance criteria related to AI/algorithm performance, human-in-the-loop studies (MRMC), or a comprehensive evaluation against specific diagnostic performance metrics (like sensitivity, specificity, etc.).
The "Performance Data" section of the document solely focuses on:
- Mechanical Testing: Demonstrating structural integrity and durability in accordance with ASTM F2077 (Static/Dynamic Axial Compression, Torsion, Subsidence, Expulsion). This is standard for implantable devices to ensure they can withstand physiological loads.
- Process Validation Testing: Ensuring the manufacturing process results in clean, sterile implants (ASTM F 2847-10, Gravimetric Analysis, Cytotoxicity, TOC, LAL). This is crucial for patient safety regarding biocompatibility and infection control.
The device described is a physical implant (intervertebral body fusion device) and not a software-as-a-medical-device (SaMD) or an AI-powered diagnostic tool. Therefore, the questions related to AI/algorithm performance, data provenance, ground truth establishment by experts, adjudication methods, MRMC studies, standalone algorithm performance, and training/test set details are not applicable to this specific 510(k) submission.
In summary, based on the provided document, there is no information available to answer the specific questions about acceptance criteria and study designs related to an AI/algorithm-driven device. The document is for a physical medical implant, and its "acceptance criteria" are based on mechanical and material biocompatibility standards, not diagnostic or AI performance.
§ 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.