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The PERLA® TL posterior osteosynthesis system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior non-cervical pedicle screw fixation in pediatric patients, the PERLA® TL posterior osteosynthesis system is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL posterior osteosynthesis system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PERLA® TL posterior osteosynthesis system consists of a range of screws, rods, set screws, hooks, rod connectors and cross-connectors. These connecting components can be rigidly locked to the rod in a variety of configurations to be adapted for the individual case. The Perla®TL system is manufactured from medical grade titanium alloy and medical grade cobalt chromium conforming respectively to standards ASTM F136 and ASTM F1537. The PERLA® TL posterior osteosynthesis implants are delivered either non sterile or sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable – provided non-sterile except for the drill supplied as sterile or not sterile). Bacterial endotoxin testing in conformance to AAMI ST72 is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

The provided text is an FDA 510(k) clearance letter for a medical device: "PERLA TL Posterior Osteosynthesis System." It describes the device, its intended use, and its equivalence to previously marketed predicate devices based on design features, technological characteristics, indications for use, and non-clinical performance testing.

However, the document does not contain any information about an AI/ML-driven device, AI/ML-specific acceptance criteria, or a study proving that an AI/ML device meets those criteria.

Therefore, I cannot extract any information to answer your specific questions related to AI/ML device performance, as the document pertains to a physical medical implant, not an AI/ML software as a medical device.

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