(68 days)
The Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.
The Vertera Spine Coalesce Thoracolumbar Interbody Fusion System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Vertera Spine Coalesce Thoracolumbar Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
The Vertera Spine Coalesce Thoracolumbar Interbody Fusion System comprises of sterile, single use implant grade polyetheretherketone (PEEK) devices, available in varied footprints and heights, designed for supplemental stabilization of the thoracolumbar spinal column in thoracolumbar intervertebral body fusion procedures.
Each device within the Coalesce System is comprised of a continuous body of PEEK formed into the final product shape with a porous architecture on select faces of the implant. The porous architecture is derived directly from the implant body and is not a sintered or otherwise additive coating. In addition to PEEK, the device assembly may contain two or more tantalum markers, depending on footprint, to enable visibility under x-ray in vivo.
The purpose of this 510(k) submission is to expand indications for use to match indications for use of the predicate device. NuVasive CoRoent Thoracolumbar System (K170962).
The provided document is a 510(k) premarket notification for a medical device (Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System). It focuses on establishing substantial equivalence to previously cleared predicate devices, primarily for extending the indications for use.
Based on the provided text, there is no information regarding acceptance criteria for a study proving the device meets those criteria, nor is there any mention of a study involving AI, human readers, or ground truth establishment in the context of diagnostic performance.
The document states:
- "Mechanical performance testing data was provided as part of the previous submissions to establish substantial equivalence for their use. Since no design changes are a part of the present submission, additional non clinical testing is not warranted. Therefore, no new mechanical testing was performed for this 510(k) submission." (Section G. Performance Data)
- "This device does not contain software or electrical equipment." (Section F. Technological Characteristics)
This indicates that the submission relies on previously conducted mechanical performance testing for the original device and its predicates to demonstrate substantial equivalence, rather than new clinical or diagnostic performance studies for this specific 510(k) (which is for an expanded indication).
Therefore, I cannot provide the requested information about acceptance criteria, device performance tables, sample sizes, expert involvement, adjudication, MRMC studies, standalone algorithm performance, or ground truth for the training/test sets, as this type of data is not present in the provided 510(k) summary. The device in question is an intervertebral body fusion system, which are implants, not diagnostic devices that would typically undergo the kind of performance studies you are asking about (related to AI, human readers, or image interpretation).
§ 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.