(58 days)
The ZSFab Cervical Interbody System is intended for anterior interbody fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The ZSFab Cervical Interbody System is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by clinical image (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The ZSFab Cervical Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical spine a lordotic angulation >10° are required to be used with an anterior cervical plate as the form of supplemental fixation.
The ZSFab Lumbar Interbody System is intended for lumbar interbody fusion. The devices are indicated for use at one or two contiguous levels in the lumbar spine from L2-S1, in skeletally mature patients who have had at least six months of non-operative treatment. The ZSFab Lumbar Interbody System is indicated to treat lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by imaging studies (radiographs, CT, MRL). Additionally, the ZSFab Lumbar Interbody System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The ZSFab lumbar Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone marrow aspirate to facilitate fusion and to be used with supplemental fixation cleared for use in the lumbosacral spine.
The ZSFab Cervical Interbody System includes additively manufactured interbody fusion devices for cervical implantation. The implants are designed with lattice structures to provide surgical stabilization of the spine. The lattices have near-elliptical pores with minor axis length of 500-920μm and major axis length of 810-1390μm. The ZSFab Lumbar Interbody System includes additively manufactured interbody fusion devices for lumbar implants are designed as a solid frame that includes lattice structures to provide surgical stabilization of the spine. The lattices have near-elliptical pores with axis lengths of 610-1000m. The endplates are featured with teeth design and stochastic lattice structures with average pore size of 620-710m. Each cervical and lumbar interbody has a bone graft window that can be packed with bone graft material. The implants are available in a variety of height, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances.
This document is a 510(k) premarket notification from the FDA, approving the ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving performance against novel acceptance criteria through a clinical validation study of an AI/software device.
Therefore, the requested information regarding acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies is not present in this document. This submission does not describe a study that validates a device's performance against defined clinical metrics or uses an AI algorithm.
The "Performance Testing" section refers to mechanical testing (e.g., static and dynamic axial compression, torsion, subsidence, expulsion) to show the physical properties of the manufactured devices are equivalent to the predicate devices. This is a common requirement for implantable medical devices to demonstrate that manufacturing changes (like a new location) do not alter the established mechanical performance of the product.
In summary, this document does not contain the information required to answer your questions about acceptance criteria, study design, and performance data for an AI/software-based medical device.
§ 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.