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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.

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