(85 days)
The Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody is indicated for use at one or two contiguous levels in the cervical spine, from C3-C7, in skeletally mature patients who have had six weeks of non-operative treatment for the degenerative disk disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody is intended to be used with additional FDA-cleared supplementary fixation systems.
The Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody system must be used with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
The Camber Spine Technologies SPIRA-C Open Matrix Cervical Interbody is a Cage that has spiral supports to allow for a hollow chamber to permit packing with autogenous bone to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place.
The provided text describes a 510(k) premarket notification for a medical intervertebral body fusion device, the "SPIRA-C Open Matrix Cervical Interbody." The document focuses on demonstrating substantial equivalence to predicate devices based on indications, design, materials, function, manufacturing, and performance.
However, the provided text does not contain any information about an AI-powered device or a study involving AI performance. The "acceptance criteria" and "device performance" mentioned in the document relate to the mechanical and material performance of the spinal implant itself, not to the performance of an AI system.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving an AI device's performance, as the provided input does not pertain to an AI device.
The "Performance Testing Summary" in the document states:
"Testing performed indicate that the SPIRA-C Open Matrix Cervical Interbody is as mechanically sound as predicate devices. Testing included static compression-shear, static torsion, dynamic compression, dynamic compression-shear, dynamic torsion, and subsidence per ASTM F2077-14 and F2267-04. The results demonstrate that the acceptance criteria defined by predicate device performance were met."
This clearly describes mechanical and physical performance testing of a physical medical implant, not an AI or digital health product.
If you have a document describing an AI device and its validation studies, please provide that, and I will be happy to answer your questions accordingly.
§ 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.