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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. 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) consists of addition of cannulated screws (various models), fenestrated screws (various models), percutaneous rods and associated surgical instruments.

This is a 510(k) premarket notification for a medical device (PERLA® TL posterior osteosynthesis system), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and data provenance related to AI/ML performance is not present in the provided document.

The document discusses the substantial equivalence of the PERLA® TL device to legally marketed predicate devices, focusing on:

• Indications for Use: The system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for various spinal conditions in skeletally mature patients and for adolescent idiopathic scoliosis in pediatric patients.
• Device Description: It consists of screws, rods, set screws, hooks, rod connectors, and cross-connectors made from medical-grade titanium alloy and cobalt chromium. The current submission is a product line extension adding cannulated and fenestrated screws, percutaneous rods, and associated instruments.
• Technological Characteristics: The added components share the same indications for use, function, material composition, design, range of sizes, and mechanical performance as predicate devices.
• Non-clinical Performance Testing: Static compression bending, static torsion, and dynamic compression bending tests were conducted according to ASTM F1717 to demonstrate comparable mechanical properties to predicate devices.

Therefore, the information regarding acceptance criteria, study design, and data specifics that would be relevant for an AI/ML-based device (e.g., sample size, expert consensus, ground truth, effect size) is not applicable to this submission.

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The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.

With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis) or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation' attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The subject CD HORIZON® Solera™ Spinal System offers dual rod multi-axial screws (DRMAS) that have an opened head. The subject screws offer the ability to place two rods in parallel. The subject DRMAS are provided sterile.

The provided text is a 510(k) summary for the Medtronic CD HORIZON® Spinal System. It describes the device's indications for use, comparison to predicate devices, and performance data from mechanical testing and biocompatibility assessments.

However, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.

The document describes a spinal implant system, not a software or AI/ML device. The "performance data" section refers to mechanical testing (Static Compression, Static Torsion, Compression Fatigue, Axial Grip, Axial Torsional Grip, Flexion Extension Fatigue) and biocompatibility of the physical implant components, not performance metrics like sensitivity, specificity, or accuracy that would be relevant for an AI/ML device.

Therefore, the requested information specifically related to acceptance criteria and studies proving an AI/ML device meets them, along with details about sample sizes, data provenance, ground truth establishment, expert qualifications, and MRMC studies, cannot be extracted from this document.

The document primarily focuses on demonstrating substantial equivalence of a physical medical device (spinal system) to predicate devices through material properties and mechanical performance.

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