(266 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 either autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous 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 spacers, screws, locking plate and set screw. The spacers 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 spacers. 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 three types: 1) All PEEK Type, 2) Ti plate Type, 3) Ti plate-N type. The Velofix™ SA Cervical Cage is implanted as a single device via an anterior approach.
The provided text is a 510(k) premarket notification letter and summary for the Velofix™ SA Cervical Cage. It describes the device, its intended use, and its substantial equivalence to predicate devices, primarily based on mechanical performance testing.
However, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of software or AI performance. The entire document focuses on the mechanical and material properties of an intervertebral fusion device.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance (for software/AI).
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth for software.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is for a medical device (an implantable cage), not a software or AI product. The "performance testing" mentioned refers to mechanical strength evaluation of the physical implant, not algorithmic performance.
§ 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.