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The SeaSpine® NewPort™ Spinal System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine for the following indications:

• degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
• severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion,
• spondylolisthesis,
• trauma (i.e., fracture or dislocation),
• spinal stenosis,
• deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis).
• spinal tumor,
• pseudoarthrosis, and/or
• failed previous fusion.

The SeaSpine® NewPort™ Spinal System consists of pedicle screws, locking caps and rods, and is intended to act as a temporary or permanent posterior, non-cervical pedicle fixation implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The system also includes instruments to assist with implantation, and a tray for organization and storage.

The provided document, a 510(k) premarket notification for the SeaSpine® NewPort™ Spinal System, does not contain information about a device that relies on AI/ML or image analysis with specific acceptance criteria and a study to prove it meets those criteria.

Instead, this document is for a traditional medical device: a spinal implant system (pedicle screws, rods, and locking caps). The "study" mentioned refers to non-clinical mechanical testing, not a clinical study involving human patients or a process for establishing ground truth from expert consensus.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them in the context of AI/ML performance, as this information is not present in the provided text.

Here's why the document doesn't fit your request:

• Device Type: It's a spinal implant, not an AI/ML imaging or diagnostic device.
• Testing: The testing performed is "Non-clinical Testing" for "mechanical safety" (Dynamic Axial Compression, Static Axial Compression, Static Axial Torsion). This is engineering validation of the implant's physical properties, not performance metrics for an AI algorithm.
• No Clinical Testing: The document explicitly states, "No clinical testing was required to demonstrate equivalence." This means there was no study involving human patients to assess, for example, diagnostic accuracy or AI assistance.
• No Reference to AI/ML: There is no mention of algorithms, image analysis, ground truth, expert readers, or any other concept related to AI/ML device performance.

If you are looking for an example of a 510(k) submission for an AI/ML device, you would need a different document.

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