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The Percusys® Plus Pedicle Screw 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 thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Percusys® Plus Pedicle Screw System is a multiple component, posterior spinal fixation system which consists of pedicle screws and rods. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All implant components are made from titanium alloy (ASTM F136).

The Percusys® Plus Pedicle Screw System is provided in sterile form. All implants are intended for single use only.

This document is a 510(k) Premarket Notification from the FDA regarding the joimax GmbH's Percusys® Plus Pedicle Screw System. It is primarily concerned with establishing substantial equivalence to legally marketed predicate devices, not with clinical performance based on AI or advanced algorithms requiring extensive performance studies as outlined in the prompt's request.

Therefore, the requested information regarding acceptance criteria, training/test set sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and ground truth types is not present in this document. This typically applies to devices that rely on novel algorithms or AI for diagnosis or treatment.

The performance data provided for the Percusys® Plus Pedicle Screw System is mechanical in nature, focusing on the physical properties and stability of the pedicle screw system itself. The document states:

"The following performance data were provided in support of the substantial equivalence.

• Dynamic Axial Compression Bending (ASTM F1717)
• Dynamic Flexion Bending (ASTM F1798)
• Buckling Test
• Torsion Testing
  The Percusys® Plus Pedicle Screw System met all specified criteria and did not raise new safety or performance questions."

This indicates that the acceptance criteria for this device are based on meeting specific mechanical testing standards (ASTM F1717, ASTM F1798) and other physical tests (Buckling, Torsion). The "performance" here refers to the device's structural integrity and mechanical behavior, not its diagnostic or clinical efficacy in the context of AI assistance.

Therefore, I cannot provide the requested table and detailed study information because the provided text describes a mechanical device clearance based on substantial equivalence, not an AI-driven medical device requiring the type of performance study details you've asked for.

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