(26 days)
The ProAM ALIF System is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels of the lumbosacral (L2-S1) spine in skeletally mature patients with degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (radiographs, CT, MRI). DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The ProAM ALIF System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis and spinal stenosis at one or two adjacent levels, the system must be used with supplemental spinal fixation systems cleared by the FDA for fusion of the lumbar spine in addition to the integrated fixation.
Interbody devices used with three fully threaded bone screws and which have a lordotic angle of 20° or less can be used as standalone interbody fusion devices at one or two contiguous levels without the need for supplemental fixation. Interbody devices with a lordotic angle greater than 20° must be used with supplemental spinal fixation systems cleared by the FDA for fusion of the lumbar spine in addition to the integrated fixation. Interbody devices used with fewer than three fixation components (OLIF devices and 2-Hole ALIF devices) or used with anchors or impacted screws must be used with supplemental spinal fixation systems cleared by the FDA for fusion of the lumbar spine in addition to the integrated fixation.
The ProAM ALIF System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
The ProAM ALIF System is an intervertebral body fusion system that consists of an intervertebral body fusion device manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F3001) and fixation devices manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F136).
The intervertebral body fusion device has a cross-sectional shape that is somewhat oval, and the device is otherwise box-shaped in stature with cavities for containment of bone graft material. The device is available in sizes that vary in footprint size, height, and lordotic angle. It is available in configurations meant for direct anterior insertion (ALIF) or oblique-anterior (OLIF) insertion. Devices for implantation via a direct anterior approach are available with 2 or 3 holes through which screws are placed to affix to bone. Devices for implantation via an oblique-anterior approach have 2 holes through which screws are placed to affix to bone. All devices have an open, porous architecture throughout and a pyramidal textured porous surface at the endplate contacting surfaces that helps prevent device migration.
The fixation devices consist of Bone Screws, Impacted Screws, and Curved Anchors. Bone Screws are available in various diameters and lengths and engage the vertebral bodies by passing through the intervertebral body fusion device and into bone. They are turned to fixate to the bone. Impacted Screws are available in various lengths. They are first impacted through the intervertebral body fusion device into bone and then turned to further fixate to the bone. Curved Anchors are available in various lengths and are impacted into the bone through the intervertebral body fusion device.
The purpose of this premarket notification is to add the Impacted Screws and Curved Anchors as fixation devices for the ProAM ALIF System
The provided FDA 510(k) clearance letter for the ProAM ALIF System does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, as typically seen for AI/ML-based medical devices.
This document is a standard 510(k) clearance for an intervertebral body fusion device, which is a physical implant. The information provided focuses on material composition, mechanical testing (static and dynamic cantilever, expulsion), and substantial equivalence to predicate devices based on design, indications for use, and performance of the physical implant.
Therefore, I cannot answer the questions posed regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, training sets, or adjudication methods, as these are all relevant to the evaluation of AI/ML or software-driven medical devices, not a physical orthopedic implant like the ProAM ALIF System.
The questions are highly appropriate for an AI/ML medical device, but the provided text is a clearance letter for a mechanical 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.