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When used with the Centurion POCT System or Ascent POCT System for Posterior Occipital-Cervical-Cloc -T3) The Connector System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical spine (C1 to C7) and the thoracic spine (T1 - T3): traumatic spinal fraumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Connector System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

When used with the Firebird System/Phoenix MIS Spinal Fixation System or Spinal Fixation System (SFS) for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/Ilium) The Connector System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Ilium), or as an anterolateral fixation system (T8-L5), in the treatment of the following acute and chronic instabilities or deformities: 1. degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) 2. spondylolisthesis, 3. trauma (i.e., fracture or dislocation), 4. spinal stenosis, 5. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), 6. tumor, 7. pseudoarthrosis, and 8. failed previous fusion When used for posterior pedicle screw fixation in pediatric patients, the Connector System implants are indicated as an adjunct to fusion to treat adolescent idiopathic pedicle screw fixation is limited to a posterior aproach. The Connector System is intended to be used with autograft or allograft.

The Connector System is designed to reduce the complexity of revising and extending existing constructs from the Occiput to the Ilium. The Connector System includes a variety of non-sterile implants manufactured from titanium alloy comprised of bypass connectors, rod to rod connectors, Z rods, and an axial in-line connector with an attached rod. The Connector System implant options offered eliminate the need to remove existing hardware while providing stability to adjacent levels. The Connector System is compatible with posterior spinal fixation systems (e.g. Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System, Spinal Fixation System, Centurion POCT System, and Ascent POCT System) which offer titanium and/or cobalt chrome rods ranging in sizes of 3.0mm to 6.35mm.

The provided text describes a 510(k) premarket notification for a medical device called the "Connector System." This submission is for additions and modifications to an already cleared device (K172194). The document does not describe any acceptance criteria or studies related to AI/ML device performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical mechanical testing for the physical components of the spinal fixation system.

Here's why the requested information about AI/ML acceptance criteria and studies cannot be extracted from this document:

• Device Type: The "Connector System" is a medical implant (spinal fixation system components like connectors and rods). It is a passive mechanical device and not an AI/ML-driven diagnostic or treatment planning tool.
• Performance Data Section: The "PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence" section explicitly states that mechanical testing was conducted. It lists specific physical components and the type of mechanical test (ASTM F1798 Axial Grip Testing) or justification (worst-case analysis, specification clarification). This confirms the evaluation of physical properties, not software performance.
• Lack of AI/ML Terminology: There is no mention of algorithms, machine learning, artificial intelligence, diagnostic accuracy, sensitivity, specificity, AUC, human readers, ground truth, training sets, test sets, or any other terms associated with AI/ML device evaluation.

Therefore, I cannot provide the requested information. The document details the regulatory submission for a traditional medical device, not an AI/ML device.

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