(112 days)
The Catalyft™ LS Expandable Interbody System device, including those with or without micro- and nano-roughened surface textures, is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the Catalyft™ LS Expandable Interbody System can be used with patients diagnosed with multilevel degenerative scoliosis and sagittal deformities as an adjunct to fusion. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions, additional supplemental fixation (e.g. posterior fixation) must be used. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. Implants are used to facilitate fusion in the lumbar spine using autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
These implants may be implanted via a variety of open or minimally invasive anterior or oblique approaches.
The Catalyft™ LS Expandable Interbody System device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Catalyft™ LS Expandable Interbody System device is intended to be used with 4 titanium alloy screws. If the physician chooses to use less than 4 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. Implants with lordosis angles greater than 20° are intended to be used with 4 screws and supplemental fixation.
The Catalyft™ LS Expandable Interbody System is an expandable titanium alloy interbody device consisting of expandable interbodies of various widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
The interbody devices incorporate Titan Surface Technologies™, where exterior surfaces include nanoLOCK™ surface treatments designed to improve bone fixation to adjacent bone. nanoLOCK™ surface technology provides a microscopic, roughened surface with nano-scale features. nanoLOCK surface technology is specifically engineered to have nano textured features at a nanometer (10-9) level, which has demonstrated the ability to elicit an endogenous cellular and biochemical response attributed to these nanotextured features in vitro. nanoLOCK surface technology demonstrates elements to be considered nanotechnology as outlined in the FDA nanotechnology guidance document.
The provided document is a 510(k) Premarket Notification for a medical device called the Catalyft™ LS Expandable Interbody System. It details the device's characteristics, indications for use, and a comparison to predicate devices, along with performance data.
However, this document does not describe acceptance criteria for an AI/ML powered device, nor does it detail a study proving such a device meets acceptance criteria.
The device described, an intervertebral body fusion device, is a physical implant, not an AI/ML software device. The "Performance Data" section specifically lists mechanical tests (e.g., Static and Dynamic Compression, Subsidence, Expulsion, Wear Debris, Bone screw push out, MRI Safety Evaluation) that are relevant to the physical and biomechanical characteristics of an implantable device, not to the performance of an AI/ML algorithm.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving an AI/ML device meets them based on the provided input, as the input concerns a traditional medical implant.
§ 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.