(93 days)
The Adaptix™ PEEK Interbody System with Nanotechnology devices and the Capstone Control™ PEEK Spinal System with Nanotechnology devices including those with macro-, micro- and nano-roughened surface textures are intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s).
Additionally, Adaptix™ PEEK Interbody System with Nanotechnology and the Capstone Control™ PEEK Spinal System with Nanotechnology devices can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Adaptix™ PEEK and the Capstone Control™ PEEK devices are to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate. These implants are intended for use with supplemental fixation indicated for lumbar spinal fusion procedures and may be implanted via an open or a minimally invasive posterior approach and/or transforaminal approach.
The Adaptix™ PEEK Interbody System with Nanotechnology and Capstone Control™ PEEK Spinal System with Nanotechnology consist of interbody implants designed for restoration of sagittal alignment in the lumbar spine. The upper and lower surfaces of the implant incorporate a three-dimensional titanium scaffold with interconnected pores averaging 523 μm, and pore interconnections averaging 229 μm in diameter. This product demonstrates the requirements for nanotechnology. The surface has been deliberately manipulated to produce nanoscale dimensions which exhibit specific properties. The scaffold of the Adaptix™ PEEK and Capstone Control™ PEEK devices is electrochemically treated to possess a controlled nanotopography composed of nanotube arrays having a pore size diameter between 30-90 nanometers. Calcium and phosphate are incorporated into the nanotube surface. The scaffold with nanotubes assists in securing the implant in the intervertebral space and provides radiographic confirmation of the implant location. The Adaptix™ PEEK and Capstone Control™ PEEK devices are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.
The provided text describes a medical device, the Adaptix™ PEEK Interbody System with Nanotechnology and Capstone Control™ PEEK Spinal System with Nanotechnology, and its 510(k) submission for substantial equivalence to predicate devices. It does not present acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered medical device.
The "Performance Data" section solely discusses mechanical and MR compatibility testing, which are standard for interbody fusion devices and not related to AI/ML performance.
Therefore, I cannot extract the requested information about acceptance criteria and a study proving their fulfillment for an AI/ML device from the given document. The document pertains to a physical medical implant, not an AI/ML software.
§ 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.