(84 days)
The SP-LINK™ System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for single level plate attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The SP-LINK™ System is intended for use with bone graft material, and not for stand-alone use.
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The provided text is a 510(k) clearance letter from the FDA for the SP-LINK™ System, a spinal interlaminal fixation orthosis. It primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory provisions.
Crucially, this document does NOT contain any information regarding acceptance criteria or the study that proves the device meets specific performance criteria for AI-related tasks. The device described is a physical medical implant, not an AI/software as a medical device (SaMD). Therefore, it would not have the types of acceptance criteria or performance studies (like MRMC, standalone AI performance, ground truth establishment for AI, etc.) that would apply to an AI-driven medical device.
The information you are asking for (e.g., acceptance criteria tables, sample sizes for AI test/training sets, expert adjudication methods, MRMC studies) is directly relevant to the validation of AI/ML-driven medical devices, especially those involved in image analysis or diagnostic support. Since the SP-LINK™ System is a hardware device, these concepts are not applicable as described in this FDA clearance letter.
Therefore, I cannot fulfill your request based on the provided text.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.