(108 days)
The ProAM ALIF System is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels of the lumbrosacral (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 deqenerative 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 use in the lumbar spine in addition to the integrated fixation.
Interbody devices used with three 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 use in the lumbar spine in addition to the integrated fixation. Interbody devices used with fewer than three screws (OLIF devices and 2-Hole ALIF devices) must be used with supplemental spinal fixation systems cleared by the FDA for use in 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 graff 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 screws 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 screws that are available in various diameters and lengths. Screws engage the vertebral bodies by passing through the intervertebral body fusion device and into bone. They are turned to fixate to the bone.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device performance.
The document is a 510(k) summary for the ProAM ALIF System, which is a premarket notification for a medical device. This type of document primarily focuses on establishing "substantial equivalence" to existing legally marketed predicate devices, rather than providing a detailed report on a specific study designed to meet pre-defined acceptance criteria for performance.
While the document mentions "mechanical testing" was performed (static and dynamic compression, compression-shear, subsidence, and expulsion testing), it does not include:
- A table of acceptance criteria and reported device performance. It only states that the testing demonstrated the device performs "as well or better than the predicates."
- Sample sizes used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts and their qualifications used to establish ground truth.
- Adjudication method.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- Whether a standalone performance study was done.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
These details are typical for studies assessing the performance of AI/ML or diagnostic devices against specific clinical endpoints or reference standards. The ProAM ALIF System is an intervertebral body fusion device, and the "performance data" refers to mechanical integrity and suitability for its intended biomechanical function, compared to predicate devices.
§ 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.