(40 days)
The DualX™ PLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The DualX™ PLIF is indicated for unilateral implantation.
The DualX™ LLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to L5, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The DualX™ TLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The DualX™ Lumbar Intervertebral Body Fusion Device implants are an expanding family of interbody fusion devices that expand sequentially in lateral and then vertical directions. The implants are designed to be used in minimally invasive spine surgery and, in the collapsed configuration, are between 12.3 mm wide (TLIF and PLIF) and 13.3mm wide (LLIF).
After entering the joint space, the implants expand laterally to maximize the contact area around the cortical rim of the vertebral bodies. The implants then expand vertically to maintain distraction of the vertebral bodies and maximize clearance for exiting nerve roots. The implants are binary, and each implant can only be locked out in the fully expanded state. Specific sizes are included in the system with various expanded heights to optimize the fit for the patient.
The DualX™ Lumbar Intervertebral Body Fusion Device is made from titanium that conforms to ASTM F136.
This looks like a 510(k) premarket notification for a medical device called the DualX™ Lumbar Intervertebral Body Fusion Device. The provided document does not contain information typically found in a study proving a device meets acceptance criteria, especially not for an AI/algorithm-based device.
The document describes a modification to the sterilization trays of the device, allowing for non-sterile implants to be sterilized by the end user. It explicitly states: "mechanical testing was not required to demonstrate substantial equivalent mechanical strength since there are no modifications to the implants and instruments. The substantial equivalence of mechanical strength for the DualX™ Lumbar Intervertebral Body Fusion Device was established in the clearance of K181397."
This means the submission is not about proving the initial performance of the device itself (the implant), but rather about a change in how it is processed (sterilization trays), and relies on the previously established substantial equivalence of the device's mechanical strength under K181397.
Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI-based device, as this is a physical medical implant called an "intervertebral body fusion device" and the submission is for a minor modification to its packaging/sterilization.
If you have a document related to K181397 or a different type of medical device (like an AI/algorithm-based one) that includes performance study data, I would be happy to analyze that.
§ 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.