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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 treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior noncervical 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. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device. The subject product line extension of the PERLA® TL Posterior Osteosynthesis System manufactured by Spineart (K193396; K203222; K203506) consists of addition of cannulated fenestrated sagittal screws in various sizes and designs to accommodate different patient anatomies or surgeon's techniques.

The provided text describes a 510(k) premarket notification for a medical device called the "PERLA® TL Posterior Osteosynthesis System." This document primarily discusses the substantial equivalence of the new components (cannulated fenestrated sagittal screws) to previously cleared predicate devices based on mechanical performance and design.

However, the provided text DOES NOT contain information regarding the acceptance criteria for an AI/ML powered medical device, nor does it describe a study involving human readers or AI performance metrics such as sensitivity, specificity, or AUC.

The document details the FDA's acknowledgement of the 510(k) submission, the indications for use of the device, and a summary of the technical characteristics and non-clinical performance testing (mechanical testing like static and dynamic compression bending) to demonstrate substantial equivalence to predicate devices. It states:

• "Static compression bending, static torsion and dynamic compression bending testing were conducted in conformance to ASTM F1717-18. Results demonstrated substantial equivalence between Cannulated Fenestrated Sagittal Screw added component to the PerlaⓇTL system and the identified predicate devices."
• "As was established in this submission, the PERLA® TL added components are substantially equivalent and have the same technological characteristics to predicate devices in areas including indications for use, function, material composition, design, range of sizes and mechanical performance."

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves an AI-powered device meets the acceptance criteria based on the provided text. The device described (PERLA® TL Posterior Osteosynthesis System) is a physical medical implant (pedicle screw system), not an AI/ML-powered software device.

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