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The PathLoc-L MIS Spinal System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The PathLoc-L MIS Spinal System can be used in an open approach and a percutaneous approach.

The PathLoc-L MIS Spinal System is intended for the following indications:

· Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

• · Spondylolisthesis
• · Trauma (i.e., fracture or dislocation)
• · Spinal stenosis
• · Curvatures (i.e., scoliosis, kyphosis, lordosis)
• · Tumor
• Pseudarthrosis
• · Failed previous fusion

PathLoc-L MIS System consists of cannulated poly screws, straight rods, curved rods and set screw components that can be used via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are made from titanium alloy (ASTM F136). The implants will be provided non-sterile.

The provided text is an FDA 510(k) Premarket Notification from L&K BIOMED Company, Limited for their Pathloc-L MIS Spinal System. It is an approval letter and a summary of the device and its intended use, as well as a comparison to a predicate device and a statement on performance testing.

However, this document does not contain information about an AI/ML-based device that would require acceptance criteria for algorithmic performance, expert adjudication, or MRMC studies. The device described is a physical medical implant (pedicle screw spinal system) for surgical use. The "performance testing" mentioned in the document refers to mechanical testing (pullout testing per ASTM F543-13) of the physical screws, not the performance of an AI algorithm.

Therefore, the requested information regarding acceptance criteria, study details for AI performance, sample sizes for AI test/training sets, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from this document as it pertains to a mechanical medical device, not a software or AI-driven diagnostic/therapeutic device.

If the request was based on a misunderstanding of the document's content, please provide a different document that describes an AI/ML medical device for analysis.

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