(104 days)
The Velofix™ SA Cervical Cage is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Velofix™ SA Cervical Cage implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The Velofix™ SA Cervical Cage must be used with the internal screw fixation provided by screws of the Velofix™ SA Cervical Cage. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
The Velofix™ SA Cervical Cage consists of cages, screws, locking plate and set screw.
The cages are available in various heights, width and have only 7° lordotic angle with an open architecture to accept packing of autograft or autogenous bone graft, while the medical grade titanium alloy screws have various diameters and length for fixing the cages. The locking plate, made of radiolucent PEEK and titanium alloy, is to prevent screw loosening. The medical grade titanium alloy set screw is intended for fixation of the locking plate.
The Velofix™ SA Cervical Cage has two types:
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- The spacer which is made of radiolucent PEEK spacer (polymer polyether-ether-ketone, ASTM F2026) with the tantalum markers (ASTM F560).
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- The spacer which is a combination of radiolucent PEEK spacer with the x-ray markers and medical grade titanium alloy plate (Ti6AI4V ELI, ASTM F136).
The Velofix™ SA Cervical Cage is implanted as a single device via an anterior approach by using the instruments manufactured from stainless steel materials that conform to ASTM F899.
- The spacer which is a combination of radiolucent PEEK spacer with the x-ray markers and medical grade titanium alloy plate (Ti6AI4V ELI, ASTM F136).
The provided text describes a medical device, the Velofix™ SA Cervical Cage, and its substantial equivalence to predicate devices, based on performance testing. However, the document does not contain information related to software or AI performance, acceptance criteria for an AI/software device, or studies involving human readers or AI assistance.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text.
The document primarily focuses on the mechanical performance of the physical medical device (Velofix™ SA Cervical Cage) through bench testing, demonstrating its substantial equivalence to predicate devices based on standards like ASTM F2077, ASTM F2267, and ASTM F543.
§ 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.