(126 days)
When used as a cervical intervertebral fusion device, the Matrixx™ System open devices are indicated for use at up to two contiguous levels in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.
When used as a lumbar intervertebral fusion device, the Matrixx® System open 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 six months of non-operative the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. Additionally, the Matrixx™ System lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The device is intended for use with autograft and or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.
When used as a vertebral body replacement device, the Matrixx™ System open and solid devices are indicated for use in the thoracolumbar spine (TI-L5) for partial replacement (i.e., partial vertebrectory) of a diseased vertebral body resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal tissues, and to restore the height of a collapsed vertebral body. The device is intended for use with autograft or allograft and with supplemental internal fixation.
The Matrixx™ System is a collection of additively manufactured spacers for cervical, lumbar/lumbosacral and thoracolumbar implantation. The basic shape of these implants is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7μm). The intervening geometric lattices have pores 300-700μm.
The inferior/superior aspects of the Matrixx™ open devices incorporate a large vertical cavity which can be packed with bone graft material. The inferior/superior aspects of the Matrixx™ solid devices are closed and do not permit the packing of bone graft within the implant. The solid devices are only to be used for partial vertebral body replacement. The open and solid devices are available in an assortment of height, length, width and lordotic angulation combinations to accommodate the individual anatomic and clinical circumstances of each patient.
This document, K171140, is a 510(k) premarket notification for a medical device called the "Matrixx™ System," which is an implantable spinal fusion device. It is a submission to the FDA requesting clearance to market the device based on substantial equivalence to predicate devices.
The information provided does not describe a study involving an AI medical device or its performance with respect to acceptance criteria. Instead, it details the mechanical and material testing conducted for a physical implantable medical device (the Matrixx™ System) and its comparison to legally marketed predicate devices.
Therefore, I cannot extract the requested information about acceptance criteria and study data for an AI medical device from this document. The document primarily focuses on:
- Device Description: Additively manufactured spacers made of Ti-6Al-4V ELI titanium alloy for cervical, lumbar/lumbosacral, and thoracolumbar implantation.
- Intended Use: Spinal intervertebral fusion and vertebral body replacement.
- Performance Data: Mechanical testing (static/dynamic compression, compression shear, torsion, subsidence, expulsion) according to ASTM standards (F2077, F2267, and a draft ASTM standard). The manufactured surface was evaluated according to ASTM F1978.
- Conclusion: The device's mechanical test results demonstrate substantial equivalence to predicate devices.
None of the concepts you've asked about (AI, test sets, training sets, ground truth, expert adjudication, MRMC studies, human reader improvement) are relevant to the contents of this 510(k) submission for an implantable spinal 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.